                                                 Toxicology Data Management System                                     Page: 1
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                            Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   

                                                         Study Summary

 ________________________________________________________________________________________________________________________________
|                                                                                                                                |
|                                       Length     Number       Number      Maximum                                              |
|                               Study     of     of Animals    Surviving     Mean                                                |
|Laboratory          Study      Start   Study    Total and     and (Mean  Weekly Body                                            |
|Name                Number     Date   in Days    (#/Cage)     Life Span)   Weight             Chemical                          |
|________________________________________________________________________________________________________________________________|
|                                                                                                                                |
|                                                        MALE                                                                    |
|________________________________________________________________________________________________________________________________|
|                                                                                                                                |
|BATTELLE COLUMBUS  058813803  08/16/99   729       50(3)      22  (681)    501.7     BENZOPHENONE                               |
|BATTELLE COLUMBUS  055634803  06/06/96   726      100(3)      52  (681)    492.7     CITRAL                                     |
|BATTELLE COLUMBUS  058803105  03/31/97   729       50(3)      23  (662)    519.6     DIPROPYLENE GLYCOL                         |
|BATTELLE COLUMBUS  058812206  06/25/97   727       50(3)      26  (667)    483.6     ELMIRON (SODIUM PENTOSANPOLYSULFATE)       |
|BATTELLE COLUMBUS  058805005  10/30/95   729       50(3)      25  (665)    488.4     METHACRYLONITRILE                          |
|BATTELLE COLUMBUS  058812003  12/18/95   729       50(3)      24  (659)    496.8     P,P'-DICHLORODIPHENYL SULFONE              |
|BATTELLE COLUMBUS  058800705  08/14/95   729       50(3)      29  (665)    502.2     SODIUM NITRITE                             |
|BATTELLE COLUMBUS  055611103  09/08/97   731      100(3)      60  (689)    492.1     TRANS-CINNAMALDEHYDE                       |
|BATTELLE NORTHWEST 059302607  08/14/97   733       50( )      28  (684)    506.2     DECALIN                                    |
|BATTELLE NORTHWEST 058800405  09/13/99   729       50( )      31  (686)    519.5     DIVINYLBENZENE                             |
|BATTELLE NORTHWEST 058812403  01/18/96   733       50( )      27  (667)    501.0     INDIUM PHOSPHIDE                           |
|BATTELLE NORTHWEST 050511002  03/28/96   733       49( )      24  (681)    507.1     NAPHTHALENE                                |
|BATTELLE NORTHWEST 059000407  10/06/97   729       50( )      27  (675)    540.3     PROPYLENE GLYCOL MONO-T-BUTYL ETHER        |
|BATTELLE NORTHWEST 059600105  01/18/99   729       50( )      29  (701)    534.2     STODDARD SOLVENT (TYPE IIC)                |
|BATTELLE NORTHWEST 056142707  01/06/97   729       50( )      20  (668)    518.0     VANADIUM PENTOXIDE                         |
|BATTELLE TOXICOLOGY059700601T 05/25/00   726       50( )      32  (693)    529.3     METHYL ISOBUTYL KETONE                     |
|IITRI              058902905  09/26/94   736      100(5)      57  (692)    498.3     MAGNETIC FIELDS (EMF)                      |
|SOUTHERN RESEARCH  059302306  07/11/97   729       50(3)      37  (693)    510.6     2,4-HEXADIENAL                             |
|SOUTHERN RESEARCH  059201205  07/15/98   729       50(3)      35  (704)    446.9     2-METHYLIMIDAZOLE                          |
|SOUTHERN RESEARCH  059201305  01/20/00   730       50(3)      31  (702)    448.0     4-METHYLIMIDAZOLE                          |
|SOUTHERN RESEARCH  059601003  09/16/98   729       50(3)      36  (687)    514.1     SODIUM DICHLORATE                          |
|SOUTHERN RESEARCH  059302007  04/24/00   729       50(1)      20  (670)    484.2     DIISOPROPYLCARBODIIMIDE                    |
|SOUTHERN RESEARCH  050520308  02/08/96   729       60(3)      39  (698)    447.3     O-NITROTOLUENE                             |
|SOUTHERN RESEARCH  050520507  11/28/95   729       50(3)      31  (697)    443.8     P-NITROTOLUENE                             |
|SOUTHERN RESEARCH  059601803  12/15/98   729       50(3)      29  (682)    511.6     BROMODICHLOROMETHANE                       |
|SOUTHERN RESEARCH  059601705  03/08/00   729       50(3)      34  (683)    522.9     DIBROMOACETIC ACID                         |
|________________________________________________________________________________________________________________________________|
                                                 Toxicology Data Management System                                     Page: 2
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                            Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   

                                                         Study Summary

 ________________________________________________________________________________________________________________________________
|                                                                                                                                |
|                                       Length     Number       Number      Maximum                                              |
|                               Study     of     of Animals    Surviving     Mean                                                |
|Laboratory          Study      Start   Study    Total and     and (Mean  Weekly Body                                            |
|Name                Number     Date   in Days    (#/Cage)     Life Span)   Weight             Chemical                          |
|________________________________________________________________________________________________________________________________|
|                                                                                                                                |
|                                                       FEMALE                                                                   |
|________________________________________________________________________________________________________________________________|
|                                                                                                                                |
|BATTELLE COLUMBUS  058813803  08/16/99   729       50(5)      32  (688)    348.7     BENZOPHENONE                               |
|BATTELLE COLUMBUS  055634803  06/06/96   732      100(5)      75  (705)    335.2     CITRAL                                     |
|BATTELLE COLUMBUS  058803105  03/31/97   729       50(5)      30  (683)    350.8     DIPROPYLENE GLYCOL                         |
|BATTELLE COLUMBUS  058812206  06/25/97   728       50(5)      30  (672)    327.2     ELMIRON (SODIUM PENTOSANPOLYSULFATE)       |
|BATTELLE COLUMBUS  058805005  10/30/95   731       50(5)      38  (710)    315.4     METHACRYLONITRILE                          |
|BATTELLE COLUMBUS  058812003  12/18/95   730       50(5)      36  (694)    330.5     P,P'-DICHLORODIPHENYL SULFONE              |
|BATTELLE COLUMBUS  058800705  08/14/95   730       50(5)      33  (695)    350.1     SODIUM NITRITE                             |
|BATTELLE COLUMBUS  055611103  09/08/97   735      100(5)      70  (706)    344.4     TRANS-CINNAMALDEHYDE                       |
|BATTELLE NORTHWEST 059302607  08/14/97   734       50( )      32  (700)    345.9     DECALIN                                    |
|BATTELLE NORTHWEST 058800405  09/13/99   731       50( )      33  (679)    355.3     DIVINYLBENZENE                             |
|BATTELLE NORTHWEST 058812403  01/18/96   735       50( )      34  (682)    337.2     INDIUM PHOSPHIDE                           |
|BATTELLE NORTHWEST 050511002  03/28/96   734       49( )      28  (700)    325.2     NAPHTHALENE                                |
|BATTELLE NORTHWEST 059000407  10/06/97   730       50( )      33  (675)    366.9     PROPYLENE GLYCOL MONO-T-BUTYL ETHER        |
|BATTELLE NORTHWEST 059600105  01/18/99   730       50( )      36  (696)    362.8     STODDARD SOLVENT (TYPE IIC)                |
|BATTELLE NORTHWEST 056142707  01/06/97   731       50( )      33  (688)    351.1     VANADIUM PENTOXIDE                         |
|BATTELLE TOXICOLOGY059700601T 05/25/00   727       50( )      35  (694)    365.6     METHYL ISOBUTYL KETONE                     |
|IITRI              058902905  09/26/94   737      100(5)      59  (692)    338.0     MAGNETIC FIELDS (EMF)                      |
|SOUTHERN RESEARCH  059302306  07/11/97   732       50(5)      37  (699)    314.6     2,4-HEXADIENAL                             |
|SOUTHERN RESEARCH  059201205  07/15/98   734       50(5)      40  (707)    320.6     2-METHYLIMIDAZOLE                          |
|SOUTHERN RESEARCH  059201305  01/20/00   735       50(5)      40  (702)    311.3     4-METHYLIMIDAZOLE                          |
|SOUTHERN RESEARCH  059601003  09/16/98   734       50(5)      37  (699)    341.7     SODIUM DICHLORATE                          |
|SOUTHERN RESEARCH  059302007  04/24/00   731       50(1)      30  (672)    319.5     DIISOPROPYLCARBODIIMIDE                    |
|SOUTHERN RESEARCH  050520308  02/08/96   730       60(5)      47  (713)    299.3     O-NITROTOLUENE                             |
|SOUTHERN RESEARCH  050520507  11/28/95   729       50(5)      39  (702)    295.2     P-NITROTOLUENE                             |
|SOUTHERN RESEARCH  050516105  03/06/96   729       50(5)      33  (683)    322.1     RIDDELLIINE                                |
|SOUTHERN RESEARCH  059601705  03/08/00   734       50(5)      35  (693)    350.5     DIBROMOACETIC ACID                         |
|________________________________________________________________________________________________________________________________|
                                                 Toxicology Data Management System                                     Page: 3
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|#All Organs:                                                                                                                      |
|   Benign Tumors                       49/50 (98%)   97/100(97%)   47/50 (94%)         42/50 (84%)   78/100(78%)   44/50 (88%)    |
|                                       49/50 (98%)   47/50 (94%)   42/50 (84%)         37/50 (74%)   35/50 (70%)   37/50 (74%)    |
|                                       47/50 (94%)   99/100(99%)   47/50 (94%)         42/50 (84%)   78/100(78%)   46/50 (92%)    |
|                                       49/50 (98%)   47/50 (94%)   46/49 (94%)         43/50 (86%)   44/50 (88%)   38/49 (78%)    |
|                                       50/50 (100%)  50/50 (100%)  48/50 (96%)         41/50 (82%)   37/50 (74%)   41/50 (82%)    |
|                                       50/50 (100%)  99/100(99%)   48/50 (96%)         44/50 (88%)   92/100(92%)   45/50 (90%)    |
|                                       49/50 (98%)   50/50 (100%)  48/50 (96%)         43/50 (86%)   48/50 (96%)   46/50 (92%)    |
|                                       47/50 (94%)   60/60 (100%)  49/50 (98%)         44/50 (88%)   47/60 (78%)   33/50 (66%)    |
|                                       49/50 (98%)   47/50 (94%)                       45/50 (90%)   42/50 (84%)                  |
| Overall Incidence               Total 1410/1459 (96.64Mean 96.42%  SD 3.43%     Total 1212/1459 (83.07%Mean 83.15%  SD 7.58%     |
 __________________________________________________________________________________________________________________________________
|#All Organs:                                                                                                                      |
|   Malignant Tumors                    33/50 (66%)   76/100(76%)   35/50 (70%)         20/50 (40%)   30/100(30%)   25/50 (50%)    |
|                                       29/50 (58%)   29/50 (58%)   34/50 (68%)         12/50 (24%)   26/50 (52%)   16/50 (32%)    |
|                                       30/50 (60%)   57/100(57%)   27/50 (54%)         23/50 (46%)   39/100(39%)   25/50 (50%)    |
|                                       29/50 (58%)   26/50 (52%)   34/49 (69%)         17/50 (34%)   25/50 (50%)   26/49 (53%)    |
|                                       35/50 (70%)   33/50 (66%)   28/50 (56%)         33/50 (66%)   30/50 (60%)   28/50 (56%)    |
|                                       31/50 (62%)   66/100(66%)   21/50 (42%)         22/50 (44%)   40/100(40%)   18/50 (36%)    |
|                                       22/50 (44%)   22/50 (44%)   27/50 (54%)         19/50 (38%)   19/50 (38%)   21/50 (42%)    |
|                                       34/50 (68%)   37/60 (62%)   33/50 (66%)         22/50 (44%)   24/60 (40%)   22/50 (44%)    |
|                                       28/50 (56%)   29/50 (58%)                       20/50 (40%)   16/50 (32%)                  |
| Overall Incidence               Total 885/1459 (60.66%Mean 60%     SD 8.61%     Total 618/1459 (42.36%)Mean 43.08%  SD 9.66%     |
 __________________________________________________________________________________________________________________________________
|#All Organs:                                                                                                                      |
|   Malignant and Benign Tumors         50/50 (100%)  99/100(99%)   49/50 (98%)         46/50 (92%)   92/100(92%)   50/50 (100%)   |
|                                       49/50 (98%)   49/50 (98%)   49/50 (98%)         42/50 (84%)   45/50 (90%)   43/50 (86%)    |
|                                       49/50 (98%)  100/100(100%)  49/50 (98%)         45/50 (90%)   92/100(92%)   49/50 (98%)    |
|                                       50/50 (100%)  49/50 (98%)   48/49 (98%)         46/50 (92%)   49/50 (98%)   44/49 (90%)    |
|                                       50/50 (100%)  50/50 (100%)  50/50 (100%)        49/50 (98%)   44/50 (88%)   47/50 (94%)    |
|                                       50/50 (100%) 100/100(100%)  50/50 (100%)        46/50 (92%)   98/100(98%)   47/50 (94%)    |
|                                       50/50 (100%)  50/50 (100%)  49/50 (98%)         45/50 (90%)   48/50 (96%)   49/50 (98%)    |
|                                       50/50 (100%)  60/60 (100%)  50/50 (100%)        48/50 (96%)   54/60 (90%)   43/50 (86%)    |
|                                       50/50 (100%)  50/50 (100%)                      47/50 (94%)   45/50 (90%)                  |
| Overall Incidence               Total 1449/1459 (99.31Mean 99.27%  SD 0.96%     Total 1353/1459 (92.73%Mean 92.61%  SD 4.27%     |
 __________________________________________________________________________________________________________________________________
|#All Organs:                                                                                                                      |
|   Hemangioma                           0/50 (0%)     1/100(1%)     0/50 (0%)           0/50 (0%)     2/100(2%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     1/49 (2%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     2/50 (4%)           0/50 (0%)     0/60 (0%)     1/50 (2%)     |
|                                        0/50 (0%)     1/50 (2%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 5/1459 (0.34%)  Mean 0.35%   SD 0.94%     Total 4/1459 (0.27%)   Mean 0.23%   SD 0.66%     |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 4
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|#All Organs:                                                                                                                      |
|   Hemangiosarcoma                      0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     1/50 (2%)           0/50 (0%)     1/50 (2%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/50 (2%)     0/49 (0%)           0/50 (0%)     1/50 (2%)     1/49 (2%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/60 (2%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 5/1459 (0.34%)  Mean 0.37%   SD 0.78%     Total 3/1459 (0.21%)   Mean 0.23%   SD 0.66%     |
 __________________________________________________________________________________________________________________________________
|#All Organs:                                                                                                                      |
|   Hemangiosarcoma or Hemangioma        0/50 (0%)     1/100(1%)     0/50 (0%)           0/50 (0%)     2/100(2%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     1/50 (2%)           0/50 (0%)     1/50 (2%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/50 (2%)     0/49 (0%)           0/50 (0%)     1/50 (2%)     2/49 (4%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/60 (2%)     2/50 (4%)           0/50 (0%)     0/60 (0%)     1/50 (2%)     |
|                                        1/50 (2%)     1/50 (2%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 10/1459 (0.69%) Mean 0.72%   SD 1.1%      Total 7/1459 (0.48%)   Mean 0.46%   SD 1.04%     |
 __________________________________________________________________________________________________________________________________
|#All Organs:                                                                                                                      |
|   Histiocytic Sarcoma                  0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/50 (0%)     0/49 (0%)           2/50 (4%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     1/50 (2%)     |
|                                        0/50 (0%)     0/100(0%)     1/50 (2%)           2/50 (4%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     1/50 (2%)           0/50 (0%)     2/50 (4%)     0/50 (0%)     |
|                                        0/50 (0%)     1/60 (2%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     2/50 (4%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 6/1459 (0.41%)  Mean 0.45%   SD 1.01%     Total 7/1459 (0.48%)   Mean 0.54%   SD 1.33%     |
 __________________________________________________________________________________________________________________________________
|#All Organs:                                                                                                                      |
|   Leukemia: Lymphocytic, Monocytic,   27/50 (54%)   68/100(68%)   16/50 (32%)         19/50 (38%)   24/100(24%)   10/50 (20%)    |
|      Mononuclear, or Undifferentiated 15/50 (30%)   20/50 (40%)   27/50 (54%)          7/50 (14%)   21/50 (42%)    8/50 (16%)    |
|                                       17/50 (34%)   40/100(40%)   19/50 (38%)         15/50 (30%)   21/100(21%)   11/50 (22%)    |
|                                       22/50 (44%)   16/50 (32%)   26/49 (53%)         10/50 (20%)   14/50 (28%)   16/49 (33%)    |
|                                       33/50 (66%)   25/50 (50%)   22/50 (44%)         24/50 (48%)   26/50 (52%)   21/50 (42%)    |
|                                       25/50 (50%)   50/100(50%)   11/50 (22%)         14/50 (28%)   20/100(20%)   10/50 (20%)    |
|                                       15/50 (30%)   15/50 (30%)   13/50 (26%)          6/50 (12%)    9/50 (18%)   11/50 (22%)    |
|                                       13/50 (26%)   30/60 (50%)   24/50 (48%)          9/50 (18%)   21/60 (35%)   13/50 (26%)    |
|                                       16/50 (32%)   17/50 (34%)                       12/50 (24%)   11/50 (22%)                  |
| Overall Incidence               Total 622/1459 (42.63%Mean 41.43%  SD 12.25%    Total 383/1459 (26.25%)Mean 26.72%  SD 10.48%    |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 5
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|#All Organs:                                                                                                                      |
|   Malignant Lymphoma: Histiocytic,     0/50 (0%)     0/100(0%)     1/50 (2%)           0/50 (0%)     1/100(1%)     0/50 (0%)     |
|      Lymphocytic, Mixed, NOS, or       0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|      Undifferentiated Cell Type        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     1/100(1%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     1/50 (2%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        2/50 (4%)     0/60 (0%)     2/50 (4%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 6/1459 (0.41%)  Mean 0.46%   SD 1.17%     Total 2/1459 (0.14%)   Mean 0.08%   SD 0.27%     |
 __________________________________________________________________________________________________________________________________
|#All Organs:                                                                                                                      |
|   Mesothelioma: Benign                 0/50 (0%)     0/100(0%)     1/50 (2%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     2/49 (4%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 3/1459 (0.21%)  Mean 0.23%   SD 0.88%     Total 0/1459 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#All Organs:                                                                                                                      |
|   Mesothelioma: Benign, Malignant,     2/50 (4%)     4/100(4%)     6/50 (12%)          0/50 (0%)     0/100(0%)     0/50 (0%)     |
|      NOS                               2/50 (4%)     0/50 (0%)     2/50 (4%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        3/50 (6%)     5/100(5%)     1/50 (2%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        2/50 (4%)     2/50 (4%)     2/49 (4%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        2/50 (4%)     0/50 (0%)     1/50 (2%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        1/50 (2%)     4/100(4%)     4/50 (8%)           0/50 (0%)     0/100(0%)     1/50 (2%)     |
|                                        2/50 (4%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        1/50 (2%)     2/60 (3%)     5/50 (10%)          0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        3/50 (6%)     3/50 (6%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 59/1459 (4.04%) Mean 4.02%   SD 2.89%     Total 1/1459 (0.07%)   Mean 0.08%   SD 0.39%     |
 __________________________________________________________________________________________________________________________________
|#All Organs:                                                                                                                      |
|   Mesothelioma: Malignant              2/50 (4%)     4/100(4%)     6/50 (12%)          0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        2/50 (4%)     0/50 (0%)     2/50 (4%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        3/50 (6%)     5/100(5%)     1/50 (2%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        2/50 (4%)     2/50 (4%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        2/50 (4%)     0/50 (0%)     1/50 (2%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        1/50 (2%)     4/100(4%)     4/50 (8%)           0/50 (0%)     0/100(0%)     1/50 (2%)     |
|                                        2/50 (4%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        1/50 (2%)     2/60 (3%)     5/50 (10%)          0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        3/50 (6%)     3/50 (6%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 57/1459 (3.91%) Mean 3.86%   SD 3%        Total 1/1459 (0.07%)   Mean 0.08%   SD 0.39%     |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 6
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|#All Organs:                                                                                                                      |
|   Osteoma                              0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        2/50 (4%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 2/1459 (0.14%)  Mean 0.15%   SD 0.78%     Total 0/1459 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#All Organs:                                                                                                                      |
|   Osteosarcoma                         1/50 (2%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/50 (2%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/100(0%)     0/50 (0%)           0/50 (0%)     1/100(1%)     0/50 (0%)     |
|                                        1/50 (2%)     3/50 (6%)     1/49 (2%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        1/50 (2%)     2/50 (4%)     1/50 (2%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     3/50 (6%)           0/50 (0%)     1/50 (2%)     0/50 (0%)     |
|                                        0/50 (0%)     1/60 (2%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 16/1459 (1.1%)  Mean 1.22%   SD 1.79%     Total 2/1459 (0.14%)   Mean 0.12%   SD 0.43%     |
 __________________________________________________________________________________________________________________________________
|#All Organs:                                                                                                                      |
|   Osteosarcoma or Osteoma              1/50 (2%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/50 (2%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/100(0%)     0/50 (0%)           0/50 (0%)     1/100(1%)     0/50 (0%)     |
|                                        1/50 (2%)     3/50 (6%)     1/49 (2%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        1/50 (2%)     2/50 (4%)     1/50 (2%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        2/50 (4%)     0/50 (0%)     3/50 (6%)           0/50 (0%)     1/50 (2%)     0/50 (0%)     |
|                                        0/50 (0%)     1/60 (2%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 18/1459 (1.23%) Mean 1.37%   SD 1.85%     Total 2/1459 (0.14%)   Mean 0.12%   SD 0.43%     |
 __________________________________________________________________________________________________________________________________
|*Adrenal Cortex:                                                                                                                  |
|   Adenoma                              0/50 (0%)     2/100(2%)     0/47 (0%)           0/50 (0%)     2/100(2%)     1/49 (2%)     |
|                                        0/50 (0%)     1/50 (2%)     0/50 (0%)           1/50 (2%)     1/50 (2%)     2/50 (4%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           1/50 (2%)     1/100(1%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     2/49 (4%)           0/50 (0%)     1/49 (2%)     1/49 (2%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           2/49 (4%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/99 (0%)     1/50 (2%)           0/50 (0%)     6/100(6%)     1/50 (2%)     |
|                                        0/50 (0%)     1/50 (2%)     0/49 (0%)           5/50 (10%)    1/49 (2%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           3/50 (6%)     2/60 (3%)     0/50 (0%)     |
|                                        0/50 (0%)     0/49 (0%)                         1/50 (2%)     1/49 (2%)                   |
| Overall Incidence               Total 7/1453 (0.48%)  Mean 0.46%   SD 1.04%     Total 33/1453 (2.27%)  Mean 2.18%   SD 2.35%     |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 7
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|*Adrenal Cortex:                                                                                                                  |
|   Carcinoma                            0/50 (0%)     0/100(0%)     0/47 (0%)           0/50 (0%)     0/100(0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     1/49 (2%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/49 (0%)     1/50 (2%)     0/49 (0%)     |
|                                        0/50 (0%)     0/99 (0%)     0/50 (0%)           0/50 (0%)     1/100(1%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/49 (0%)                         0/50 (0%)     0/49 (0%)                   |
| Overall Incidence               Total 0/1453 (0%)     Mean 0%      SD 0%        Total 3/1453 (0.21%)   Mean 0.19%   SD 0.57%     |
 __________________________________________________________________________________________________________________________________
|*Adrenal Medulla:                                                                                                                 |
|   Ganglioneuroma                       0/50 (0%)     0/100(0%)     1/47 (2%)           0/50 (0%)     0/99 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/100(1%)     0/49 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/48 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/49 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/98 (0%)     0/50 (0%)           0/50 (0%)     0/96 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/49 (0%)     0/48 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/49 (0%)     0/60 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/49 (0%)                         0/50 (0%)     0/49 (0%)                   |
| Overall Incidence               Total 2/1451 (0.14%)  Mean 0.12%   SD 0.45%     Total 0/1444 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|*Adrenal Medulla:                                                                                                                 |
|   Pheochromocytoma Benign              8/50 (16%)   10/100(10%)    4/47 (9%)           0/50 (0%)     3/99 (3%)     0/49 (0%)     |
|                                        7/50 (14%)    3/50 (6%)     4/50 (8%)           2/50 (4%)     1/50 (2%)     2/50 (4%)     |
|                                        6/50 (12%)    5/100(5%)     7/49 (14%)          4/50 (8%)     1/100(1%)     1/50 (2%)     |
|                                       12/50 (24%)   10/50 (20%)    4/49 (8%)           2/50 (4%)     2/50 (4%)     3/48 (6%)     |
|                                       12/50 (24%)    5/50 (10%)    4/50 (8%)           2/49 (4%)     2/50 (4%)     2/49 (4%)     |
|                                        8/50 (16%)   24/98 (24%)    7/50 (14%)          3/50 (6%)     7/96 (7%)     1/50 (2%)     |
|                                        8/50 (16%)    8/50 (16%)    6/49 (12%)          0/49 (0%)     2/48 (4%)     2/50 (4%)     |
|                                        3/50 (6%)     2/60 (3%)     3/50 (6%)           0/49 (0%)     2/60 (3%)     2/49 (4%)     |
|                                        8/50 (16%)    7/49 (14%)                        1/50 (2%)     1/49 (2%)                   |
| Overall Incidence               Total 185/1451 (12.75%Mean 12.78%  SD 5.97%     Total 48/1444 (3.32%)  Mean 3.28%   SD 2.16%     |
 __________________________________________________________________________________________________________________________________
|*Adrenal Medulla:                                                                                                                 |
|   Pheochromocytoma Complex             0/50 (0%)     1/100(1%)     0/47 (0%)           0/50 (0%)     0/99 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/49 (0%)           0/50 (0%)     1/100(1%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/48 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/49 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/98 (0%)     0/50 (0%)           0/50 (0%)     0/96 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     2/50 (4%)     0/49 (0%)           0/49 (0%)     0/48 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/49 (0%)     0/60 (0%)     0/49 (0%)     |
|                                        2/50 (4%)     0/49 (0%)                         0/50 (0%)     0/49 (0%)                   |
| Overall Incidence               Total 5/1451 (0.34%)  Mean 0.35%   SD 1.09%     Total 1/1444 (0.07%)   Mean 0.04%   SD 0.2%      |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 8
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|*Adrenal Medulla:                                                                                                                 |
|   Pheochromocytoma Malignant           0/50 (0%)     0/100(0%)     5/47 (11%)          0/50 (0%)     0/99 (0%)     2/49 (4%)     |
|                                        1/50 (2%)     1/50 (2%)     2/50 (4%)           1/50 (2%)     0/50 (0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/100(0%)     2/49 (4%)           0/50 (0%)     2/100(2%)     0/50 (0%)     |
|                                        1/50 (2%)     0/50 (0%)     1/49 (2%)           0/50 (0%)     0/50 (0%)     0/48 (0%)     |
|                                        2/50 (4%)     1/50 (2%)     1/50 (2%)           0/49 (0%)     1/50 (2%)     0/49 (0%)     |
|                                        0/50 (0%)     2/98 (2%)     0/50 (0%)           0/50 (0%)     0/96 (0%)     1/50 (2%)     |
|                                        0/50 (0%)     0/50 (0%)     3/49 (6%)           0/49 (0%)     1/48 (2%)     0/50 (0%)     |
|                                        4/50 (8%)     2/60 (3%)     0/50 (0%)           0/49 (0%)     0/60 (0%)     0/49 (0%)     |
|                                        1/50 (2%)     0/49 (0%)                         1/50 (2%)     0/49 (0%)                   |
| Overall Incidence               Total 30/1451 (2.07%) Mean 2.24%   SD 2.68%     Total 9/1444 (0.62%)   Mean 0.62%   SD 1.11%     |
 __________________________________________________________________________________________________________________________________
|*Adrenal Medulla:                                                                                                                 |
|   Pheochromocytoma: Benign,            8/50 (16%)   11/100(11%)    9/47 (19%)          0/50 (0%)     3/99 (3%)     2/49 (4%)     |
|      Complex, Malignant, NOS           7/50 (14%)    4/50 (8%)     6/50 (12%)          3/50 (6%)     1/50 (2%)     2/50 (4%)     |
|                                        7/50 (14%)    5/100(5%)     8/49 (16%)          4/50 (8%)     4/100(4%)     1/50 (2%)     |
|                                       13/50 (26%)   10/50 (20%)    5/49 (10%)          2/50 (4%)     2/50 (4%)     3/48 (6%)     |
|                                       14/50 (28%)    6/50 (12%)    5/50 (10%)          2/49 (4%)     3/50 (6%)     2/49 (4%)     |
|                                        8/50 (16%)   26/98 (27%)    7/50 (14%)          3/50 (6%)     7/96 (7%)     2/50 (4%)     |
|                                        8/50 (16%)   10/50 (20%)    9/49 (18%)          0/49 (0%)     3/48 (6%)     2/50 (4%)     |
|                                        6/50 (12%)    4/60 (7%)     3/50 (6%)           0/49 (0%)     2/60 (3%)     2/49 (4%)     |
|                                       11/50 (22%)    7/49 (14%)                        2/50 (4%)     1/49 (2%)                   |
| Overall Incidence               Total 217/1451 (14.96%Mean 15.14%  SD 6.16%     Total 58/1444 (4.02%)  Mean 3.94%   SD 2.1%      |
 __________________________________________________________________________________________________________________________________
|#Blood Vessel:                                                                                                                    |
|   Osteosarcoma                         0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     1/50 (2%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 1/1459 (0.07%)  Mean 0.08%   SD 0.39%     Total 0/1459 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#Bone:                                                                                                                            |
|   Chordoma                             1/50 (2%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 2/1459 (0.14%)  Mean 0.15%   SD 0.54%     Total 0/1459 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 9
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|#Bone:                                                                                                                            |
|   Osteoma                              0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        2/50 (4%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 2/1459 (0.14%)  Mean 0.15%   SD 0.78%     Total 0/1459 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#Bone:                                                                                                                            |
|   Osteosarcoma                         0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/50 (2%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/100(0%)     0/50 (0%)           0/50 (0%)     1/100(1%)     0/50 (0%)     |
|                                        1/50 (2%)     3/50 (6%)     1/49 (2%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        1/50 (2%)     2/50 (4%)     1/50 (2%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     1/50 (2%)           0/50 (0%)     1/50 (2%)     0/50 (0%)     |
|                                        0/50 (0%)     1/60 (2%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 13/1459 (0.89%) Mean 0.99%   SD 1.52%     Total 2/1459 (0.14%)   Mean 0.12%   SD 0.43%     |
 __________________________________________________________________________________________________________________________________
|#Bone:                                                                                                                            |
|   Osteosarcoma or Osteoma              0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/50 (2%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/100(0%)     0/50 (0%)           0/50 (0%)     1/100(1%)     0/50 (0%)     |
|                                        1/50 (2%)     3/50 (6%)     1/49 (2%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        1/50 (2%)     2/50 (4%)     1/50 (2%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        2/50 (4%)     0/50 (0%)     1/50 (2%)           0/50 (0%)     1/50 (2%)     0/50 (0%)     |
|                                        0/50 (0%)     1/60 (2%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 15/1459 (1.03%) Mean 1.14%   SD 1.61%     Total 2/1459 (0.14%)   Mean 0.12%   SD 0.43%     |
 __________________________________________________________________________________________________________________________________
|*Brain:                                                                                                                           |
|   Astrocytoma Malignant                0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     1/50 (2%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     1/100(1%)     0/50 (0%)     |
|                                        0/49 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     1/50 (2%)     0/50 (0%)           0/49 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/100(1%)     0/50 (0%)           0/50 (0%)     1/100(1%)     2/50 (4%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        1/50 (2%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     1/50 (2%)     |
|                                        1/50 (2%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 4/1458 (0.27%)  Mean 0.27%   SD 0.67%     Total 6/1456 (0.41%)   Mean 0.38%   SD 0.94%     |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 10
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|*Brain:                                                                                                                           |
|   Glioma Malignant                     0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     1/50 (2%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/49 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/49 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     1/100(1%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/50 (2%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 2/1458 (0.14%)  Mean 0.15%   SD 0.54%     Total 1/1456 (0.07%)   Mean 0.04%   SD 0.2%      |
 __________________________________________________________________________________________________________________________________
|*Brain:                                                                                                                           |
|   Granular Cell Tumor Malignant        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/49 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/49 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     1/50 (2%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 1/1458 (0.07%)  Mean 0.08%   SD 0.39%     Total 0/1456 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|*Brain:                                                                                                                           |
|   Meningioma Malignant                 0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     1/100(1%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/49 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/49 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     1/50 (2%)                   |
| Overall Incidence               Total 0/1458 (0%)     Mean 0%      SD 0%        Total 2/1456 (0.14%)   Mean 0.12%   SD 0.43%     |
 __________________________________________________________________________________________________________________________________
|*Brain:                                                                                                                           |
|   Meningioma: Benign, Malignant, NOS   0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     1/100(1%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/49 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/49 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     1/50 (2%)                   |
| Overall Incidence               Total 0/1458 (0%)     Mean 0%      SD 0%        Total 2/1456 (0.14%)   Mean 0.12%   SD 0.43%     |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 11
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|*Brain:                                                                                                                           |
|   Oligodendroglioma Benign             0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     1/50 (2%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/49 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/49 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 1/1458 (0.07%)  Mean 0.08%   SD 0.39%     Total 1/1456 (0.07%)   Mean 0.08%   SD 0.39%     |
 __________________________________________________________________________________________________________________________________
|*Brain:                                                                                                                           |
|   Oligodendroglioma Malignant          0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/49 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     1/50 (2%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/49 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/100(1%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 1/1458 (0.07%)  Mean 0.04%   SD 0.2%      Total 1/1456 (0.07%)   Mean 0.08%   SD 0.39%     |
 __________________________________________________________________________________________________________________________________
|*Brain:                                                                                                                           |
|   Oligodendroglioma, Glioma, or        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|      Astrocytoma                       0/50 (0%)     0/50 (0%)     1/50 (2%)           0/50 (0%)     1/50 (2%)     1/50 (2%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     1/100(1%)     0/50 (0%)     |
|                                        0/49 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     1/50 (2%)     0/49 (0%)     |
|                                        0/50 (0%)     1/50 (2%)     0/50 (0%)           0/49 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     2/100(2%)     0/50 (0%)           0/50 (0%)     2/100(2%)     2/50 (4%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        1/50 (2%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     1/50 (2%)     |
|                                        2/50 (4%)     1/50 (2%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 8/1458 (0.55%)  Mean 0.54%   SD 1.07%     Total 9/1456 (0.62%)   Mean 0.58%   SD 1.06%     |
 __________________________________________________________________________________________________________________________________
|*Brain:                                                                                                                           |
|   Sarcoma                              0/50 (0%)     0/100(0%)     1/50 (2%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/49 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/49 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 1/1458 (0.07%)  Mean 0.08%   SD 0.39%     Total 0/1456 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 12
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|*Clitoral/Preputial Gland:                                                                                                        |
|   Adenoma                              0/50 (0%)     7/100(7%)     3/50 (6%)           3/50 (6%)    15/98 (15%)    6/48 (13%)    |
|                                        1/50 (2%)     2/50 (4%)     3/50 (6%)           3/50 (6%)     2/49 (4%)     1/47 (2%)     |
|                                        0/50 (0%)     7/100(7%)     0/50 (0%)           8/46 (17%)    4/99 (4%)     8/48 (17%)    |
|                                        0/48 (0%)     1/50 (2%)     3/48 (6%)           0/50 (0%)     5/49 (10%)    4/49 (8%)     |
|                                        1/50 (2%)     0/50 (0%)     0/50 (0%)           1/50 (2%)     0/49 (0%)     2/50 (4%)     |
|                                        0/50 (0%)    13/100(13%)    1/49 (2%)           0/50 (0%)    11/90 (12%)    5/50 (10%)    |
|                                        0/50 (0%)     2/50 (4%)     1/48 (2%)           5/50 (10%)    8/50 (16%)   11/49 (22%)    |
|                                        1/50 (2%)     2/60 (3%)     2/50 (4%)           2/50 (4%)    12/59 (20%)    7/50 (14%)    |
|                                        2/50 (4%)     3/50 (6%)                         7/49 (14%)    8/50 (16%)                  |
| Overall Incidence               Total 55/1453 (3.79%) Mean 3.18%   SD 3.17%     Total 138/1429 (9.66%) Mean 9.53%   SD 6.65%     |
 __________________________________________________________________________________________________________________________________
|*Clitoral/Preputial Gland:                                                                                                        |
|   Carcinoma                            1/50 (2%)     1/100(1%)     3/50 (6%)           1/50 (2%)     1/98 (1%)     5/48 (10%)    |
|                                        1/50 (2%)     1/50 (2%)     0/50 (0%)           0/50 (0%)     1/49 (2%)     0/47 (0%)     |
|                                        5/50 (10%)    4/100(4%)     0/50 (0%)           2/46 (4%)     9/99 (9%)     1/48 (2%)     |
|                                        0/48 (0%)     2/50 (4%)     3/48 (6%)           0/50 (0%)     0/49 (0%)     0/49 (0%)     |
|                                        1/50 (2%)     0/50 (0%)     0/50 (0%)           2/50 (4%)     1/49 (2%)     0/50 (0%)     |
|                                        1/50 (2%)     0/100(0%)     3/49 (6%)           1/50 (2%)     0/90 (0%)     2/50 (4%)     |
|                                        0/50 (0%)     0/50 (0%)     3/48 (6%)           3/50 (6%)     2/50 (4%)     3/49 (6%)     |
|                                        1/50 (2%)     2/60 (3%)     2/50 (4%)           2/50 (4%)     2/59 (3%)     2/50 (4%)     |
|                                        1/50 (2%)     0/50 (0%)                         3/49 (6%)     1/50 (2%)                   |
| Overall Incidence               Total 35/1453 (2.41%) Mean 2.5%    SD 2.66%     Total 44/1429 (3.08%)  Mean 3.03%   SD 2.83%     |
 __________________________________________________________________________________________________________________________________
|*Clitoral/Preputial Gland:                                                                                                        |
|   Carcinoma or Adenoma                 1/50 (2%)     8/100(8%)     6/50 (12%)          4/50 (8%)    16/98 (16%)   10/48 (21%)    |
|                                        2/50 (4%)     3/50 (6%)     3/50 (6%)           3/50 (6%)     3/49 (6%)     1/47 (2%)     |
|                                        5/50 (10%)   11/100(11%)    0/50 (0%)          10/46 (22%)   13/99 (13%)    9/48 (19%)    |
|                                        0/48 (0%)     3/50 (6%)     6/48 (13%)          0/50 (0%)     5/49 (10%)    4/49 (8%)     |
|                                        2/50 (4%)     0/50 (0%)     0/50 (0%)           3/50 (6%)     1/49 (2%)     2/50 (4%)     |
|                                        1/50 (2%)    13/100(13%)    4/49 (8%)           1/50 (2%)    11/90 (12%)    7/50 (14%)    |
|                                        0/50 (0%)     2/50 (4%)     4/48 (8%)           8/50 (16%)   10/50 (20%)   14/49 (29%)    |
|                                        2/50 (4%)     4/60 (7%)     4/50 (8%)           4/50 (8%)    14/59 (24%)    8/50 (16%)    |
|                                        3/50 (6%)     3/50 (6%)                        10/49 (20%)    9/50 (18%)                  |
| Overall Incidence               Total 90/1453 (6.19%) Mean 5.68%   SD 4.06%     Total 180/1429 (12.6%) Mean 12.4%   SD 7.78%     |
 __________________________________________________________________________________________________________________________________
|*Clitoral/Preputial Gland:                                                                                                        |
|   Hemangiosarcoma                      0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/98 (0%)     0/48 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     1/49 (2%)     0/47 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/46 (0%)     0/99 (0%)     0/48 (0%)     |
|                                        0/48 (0%)     0/50 (0%)     0/48 (0%)           0/50 (0%)     0/49 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/49 (0%)           0/50 (0%)     0/90 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/48 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/59 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/49 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 0/1453 (0%)     Mean 0%      SD 0%        Total 1/1429 (0.07%)   Mean 0.08%   SD 0.4%      |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 13
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|*Clitoral/Preputial Gland:                                                                                                        |
|   Sarcoma                              0/50 (0%)     0/100(0%)     1/50 (2%)           0/50 (0%)     0/98 (0%)     0/48 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/49 (0%)     0/47 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/46 (0%)     0/99 (0%)     0/48 (0%)     |
|                                        0/48 (0%)     0/50 (0%)     0/48 (0%)           0/50 (0%)     0/49 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/49 (0%)           0/50 (0%)     0/90 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/48 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/59 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/49 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 1/1453 (0.07%)  Mean 0.08%   SD 0.39%     Total 0/1429 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|*Clitoral/Preputial Gland:                                                                                                        |
|   Schwannoma Malignant                 0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/98 (0%)     0/48 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/49 (0%)     0/47 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/46 (0%)     0/99 (0%)     0/48 (0%)     |
|                                        0/48 (0%)     0/50 (0%)     0/48 (0%)           0/50 (0%)     0/49 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/49 (0%)           0/50 (0%)     0/90 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/48 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     1/50 (2%)           0/50 (0%)     0/59 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/49 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 1/1453 (0.07%)  Mean 0.08%   SD 0.39%     Total 0/1429 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|*Clitoral/Preputial Gland:                                                                                                        |
|   Squamous Cell Papilloma              0/50 (0%)     0/100(0%)     0/50 (0%)           1/50 (2%)     0/98 (0%)     0/48 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/49 (0%)     0/47 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/46 (0%)     0/99 (0%)     0/48 (0%)     |
|                                        0/48 (0%)     0/50 (0%)     0/48 (0%)           0/50 (0%)     0/49 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/49 (0%)           0/50 (0%)     0/90 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/48 (0%)           1/50 (2%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/59 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/50 (2%)                         0/49 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 1/1453 (0.07%)  Mean 0.08%   SD 0.39%     Total 2/1429 (0.14%)   Mean 0.15%   SD 0.54%     |
 __________________________________________________________________________________________________________________________________
|#Ear:                                                                                                                             |
|   Neural Crest Tumor                   0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 1/1459 (0.07%)  Mean 0.08%   SD 0.39%     Total 0/1459 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 14
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|#Eye:                                                                                                                             |
|   Amelanotic Melanoma, Benign          0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           1/50 (2%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 0/1459 (0%)     Mean 0%      SD 0%        Total 1/1459 (0.07%)   Mean 0.08%   SD 0.39%     |
 __________________________________________________________________________________________________________________________________
|#Eye:                                                                                                                             |
|   Melanoma Benign                      0/50 (0%)     0/100(0%)     0/50 (0%)           1/50 (2%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 0/1459 (0%)     Mean 0%      SD 0%        Total 1/1459 (0.07%)   Mean 0.08%   SD 0.39%     |
 __________________________________________________________________________________________________________________________________
|#Eye:                                                                                                                             |
|   Melanoma Malignant                   0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     1/50 (2%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 1/1459 (0.07%)  Mean 0.08%   SD 0.39%     Total 0/1459 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#Harderian Gland:                                                                                                                 |
|   Adenoma                              0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 1/1459 (0.07%)  Mean 0.08%   SD 0.39%     Total 0/1459 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 15
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|#Harderian Gland:                                                                                                                 |
|   Carcinoma                            0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     1/50 (2%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 1/1459 (0.07%)  Mean 0.08%   SD 0.39%     Total 0/1459 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#Harderian Gland:                                                                                                                 |
|   Carcinoma or Adenoma                 0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     1/50 (2%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 2/1459 (0.14%)  Mean 0.15%   SD 0.54%     Total 0/1459 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|*Heart:                                                                                                                           |
|   Schwannoma Benign                    0/50 (0%)     0/100(0%)     2/50 (4%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/50 (2%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     1/50 (2%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 4/1459 (0.27%)  Mean 0.31%   SD 0.93%     Total 1/1458 (0.07%)   Mean 0.08%   SD 0.39%     |
 __________________________________________________________________________________________________________________________________
|*Heart:                                                                                                                           |
|   Schwannoma Malignant                 1/50 (2%)     0/100(0%)     0/50 (0%)           1/50 (2%)     1/100(1%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        1/50 (2%)     2/100(2%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        1/50 (2%)     2/100(2%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/60 (0%)     0/50 (0%)           1/50 (2%)     0/60 (0%)     1/50 (2%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 8/1459 (0.55%)  Mean 0.46%   SD 0.86%     Total 4/1458 (0.27%)   Mean 0.27%   SD 0.67%     |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 16
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|#Intestine Large: Colon/Rectum                                                                                                    |
|   Adenoma                              0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 1/1459 (0.07%)  Mean 0.08%   SD 0.39%     Total 0/1459 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#Intestine Large: Colon/Rectum                                                                                                    |
|   Carcinoma                            0/50 (0%)     1/100(1%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 1/1459 (0.07%)  Mean 0.04%   SD 0.2%      Total 0/1459 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#Intestine Large: Colon/Rectum                                                                                                    |
|   Carcinoma or Adenoma                 0/50 (0%)     1/100(1%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 2/1459 (0.14%)  Mean 0.12%   SD 0.43%     Total 0/1459 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#Intestine Large: Colon/Rectum                                                                                                    |
|   Leiomyosarcoma                       0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     1/50 (2%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 0/1459 (0%)     Mean 0%      SD 0%        Total 1/1459 (0.07%)   Mean 0.08%   SD 0.39%     |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 17
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|#Intestine Large: Colon/Rectum                                                                                                    |
|   Polyp Adenomatous                    0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     1/100(1%)     0/50 (0%)     |
|                                        1/50 (2%)     1/50 (2%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        1/50 (2%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/60 (2%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         1/50 (2%)     0/50 (0%)                   |
| Overall Incidence               Total 4/1459 (0.27%)  Mean 0.29%   SD 0.71%     Total 2/1459 (0.14%)   Mean 0.12%   SD 0.43%     |
 __________________________________________________________________________________________________________________________________
|#Intestine Large: Colon/Rectum                                                                                                    |
|   Sarcoma                              0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     1/100(1%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 0/1459 (0%)     Mean 0%      SD 0%        Total 1/1459 (0.07%)   Mean 0.04%   SD 0.2%      |
 __________________________________________________________________________________________________________________________________
|#Intestine Small: Jejunum                                                                                                         |
|   Carcinoma                            0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     1/50 (2%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 1/1459 (0.07%)  Mean 0.08%   SD 0.39%     Total 0/1459 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#Intestine Small: Jejunum                                                                                                         |
|   Leiomyoma                            0/50 (0%)     1/100(1%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 1/1459 (0.07%)  Mean 0.04%   SD 0.2%      Total 0/1459 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 18
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|#Intestine Small: Jejunum                                                                                                         |
|   Sarcoma                              0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     1/100(1%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 0/1459 (0%)     Mean 0%      SD 0%        Total 1/1459 (0.07%)   Mean 0.04%   SD 0.2%      |
 __________________________________________________________________________________________________________________________________
|#Intestine Small: Site Unspecified                                                                                                |
|   Carcinoma                            0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     1/50 (2%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 1/1459 (0.07%)  Mean 0.08%   SD 0.39%     Total 0/1459 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#Intestine Small: Site Unspecified                                                                                                |
|   Carcinoma or Adenoma                 0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     1/50 (2%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 1/1459 (0.07%)  Mean 0.08%   SD 0.39%     Total 0/1459 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#Intestine Small: Site Unspecified                                                                                                |
|   Leiomyoma                            0/50 (0%)     1/100(1%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 1/1459 (0.07%)  Mean 0.04%   SD 0.2%      Total 0/1459 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 19
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|#Intestine Small: Site Unspecified                                                                                                |
|   Sarcoma                              0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     1/100(1%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 0/1459 (0%)     Mean 0%      SD 0%        Total 1/1459 (0.07%)   Mean 0.04%   SD 0.2%      |
 __________________________________________________________________________________________________________________________________
|*Islets, Pancreatic:                                                                                                              |
|   Adenoma                              1/50 (2%)     3/99 (3%)     2/44 (5%)           0/50 (0%)     0/100(0%)     0/47 (0%)     |
|                                        1/50 (2%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        4/50 (8%)     2/100(2%)     3/50 (6%)           0/50 (0%)     0/100(0%)     1/50 (2%)     |
|                                        5/50 (10%)    1/50 (2%)     2/49 (4%)           1/50 (2%)     1/50 (2%)     1/49 (2%)     |
|                                        4/50 (8%)     3/50 (6%)     1/50 (2%)           0/49 (0%)     1/49 (2%)     1/49 (2%)     |
|                                        3/50 (6%)     3/99 (3%)     4/50 (8%)           0/50 (0%)     1/100(1%)     1/50 (2%)     |
|                                        0/50 (0%)     3/50 (6%)     3/50 (6%)           0/50 (0%)     0/49 (0%)     2/50 (4%)     |
|                                        5/50 (10%)    2/60 (3%)     3/50 (6%)           0/50 (0%)     1/60 (2%)     0/50 (0%)     |
|                                        3/49 (6%)     5/48 (10%)                        2/50 (4%)     0/47 (0%)                   |
| Overall Incidence               Total 66/1448 (4.56%) Mean 4.79%   SD 3.12%     Total 13/1449 (0.9%)   Mean 0.95%   SD 1.27%     |
 __________________________________________________________________________________________________________________________________
|*Islets, Pancreatic:                                                                                                              |
|   Carcinoma                            0/50 (0%)     0/99 (0%)     0/44 (0%)           0/50 (0%)     0/100(0%)     0/47 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     1/50 (2%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/100(0%)     4/50 (8%)           0/50 (0%)     2/100(2%)     1/50 (2%)     |
|                                        1/50 (2%)     2/50 (4%)     4/49 (8%)           0/50 (0%)     0/50 (0%)     1/49 (2%)     |
|                                        0/50 (0%)     1/50 (2%)     1/50 (2%)           1/49 (2%)     0/49 (0%)     1/49 (2%)     |
|                                        4/50 (8%)     1/99 (1%)     0/50 (0%)           0/50 (0%)     1/100(1%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     2/50 (4%)           2/50 (4%)     0/49 (0%)     1/50 (2%)     |
|                                        2/50 (4%)     0/60 (0%)     2/50 (4%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/49 (0%)     0/48 (0%)                         0/50 (0%)     0/47 (0%)                   |
| Overall Incidence               Total 26/1448 (1.8%)  Mean 1.97%   SD 2.68%     Total 10/1449 (0.69%)  Mean 0.66%   SD 1.1%      |
 __________________________________________________________________________________________________________________________________
|*Islets, Pancreatic:                                                                                                              |
|   Carcinoma or Adenoma                 1/50 (2%)     3/99 (3%)     2/44 (5%)           0/50 (0%)     0/100(0%)     0/47 (0%)     |
|                                        1/50 (2%)     0/50 (0%)     1/50 (2%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        5/50 (10%)    2/100(2%)     7/50 (14%)          0/50 (0%)     2/100(2%)     2/50 (4%)     |
|                                        6/50 (12%)    3/50 (6%)     6/49 (12%)          1/50 (2%)     1/50 (2%)     2/49 (4%)     |
|                                        4/50 (8%)     4/50 (8%)     2/50 (4%)           1/49 (2%)     1/49 (2%)     2/49 (4%)     |
|                                        7/50 (14%)    4/99 (4%)     4/50 (8%)           0/50 (0%)     2/100(2%)     1/50 (2%)     |
|                                        0/50 (0%)     3/50 (6%)     5/50 (10%)          2/50 (4%)     0/49 (0%)     3/50 (6%)     |
|                                        7/50 (14%)    2/60 (3%)     5/50 (10%)          0/50 (0%)     1/60 (2%)     0/50 (0%)     |
|                                        3/49 (6%)     5/48 (10%)                        2/50 (4%)     0/47 (0%)                   |
| Overall Incidence               Total 92/1448 (6.35%) Mean 6.76%   SD 4.44%     Total 23/1449 (1.59%)  Mean 1.61%   SD 1.8%      |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 20
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|*Kidney: Pelvis and Transitional                                                                                                  |
| Epithelium                             0/50 (0%)     0/100(0%)     0/47 (0%)           0/50 (0%)     0/100(0%)     0/49 (0%)     |
|   Carcinoma                            0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     1/50 (2%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/50 (0%)     1/49 (2%)           0/50 (0%)     0/50 (0%)     0/48 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/49 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/49 (0%)     0/48 (0%)     0/47 (0%)           0/50 (0%)     0/48 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/49 (0%)     0/49 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 3/1448 (0.21%)  Mean 0.23%   SD 0.66%     Total 0/1453 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|*Kidney: Pelvis and Transitional                                                                                                  |
| Epithelium                             0/50 (0%)     0/100(0%)     0/47 (0%)           0/50 (0%)     0/100(0%)     0/49 (0%)     |
|   Carcinoma or Adenoma                 0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     1/50 (2%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/50 (0%)     1/49 (2%)           0/50 (0%)     0/50 (0%)     0/48 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/49 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/49 (0%)     0/48 (0%)     0/47 (0%)           0/50 (0%)     0/48 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/49 (0%)     0/49 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 3/1448 (0.21%)  Mean 0.23%   SD 0.66%     Total 0/1453 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|*Kidney: Pelvis and Transitional                                                                                                  |
| Epithelium                             0/50 (0%)     0/100(0%)     0/47 (0%)           0/50 (0%)     0/100(0%)     0/49 (0%)     |
|   Papilloma                            0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/48 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/49 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/49 (0%)     0/48 (0%)     0/47 (0%)           0/50 (0%)     1/48 (2%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/49 (0%)     0/49 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 0/1448 (0%)     Mean 0%      SD 0%        Total 1/1453 (0.07%)   Mean 0.08%   SD 0.41%     |
 __________________________________________________________________________________________________________________________________
|*Kidney: Renal Tubule                                                                                                             |
|   Adenoma                              1/50 (2%)     0/100(0%)     1/47 (2%)           0/50 (0%)     1/100(1%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     1/50 (2%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/48 (0%)     |
|                                        1/50 (2%)     0/50 (0%)     1/50 (2%)           0/49 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/49 (0%)     0/48 (0%)     0/47 (0%)           0/50 (0%)     0/48 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/49 (0%)     1/49 (2%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 6/1448 (0.41%)  Mean 0.47%   SD 0.87%     Total 1/1453 (0.07%)   Mean 0.04%   SD 0.2%      |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 21
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|*Kidney: Renal Tubule                                                                                                             |
|   Carcinoma                            0/50 (0%)     0/100(0%)     0/47 (0%)           0/50 (0%)     1/100(1%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     1/48 (2%)     |
|                                        0/50 (0%)     1/50 (2%)     0/50 (0%)           0/49 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     1/50 (2%)     |
|                                        0/49 (0%)     0/48 (0%)     0/47 (0%)           0/50 (0%)     0/48 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/49 (0%)     0/49 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 1/1448 (0.07%)  Mean 0.08%   SD 0.39%     Total 3/1453 (0.21%)   Mean 0.2%    SD 0.58%     |
 __________________________________________________________________________________________________________________________________
|*Kidney: Renal Tubule                                                                                                             |
|   Carcinoma or Adenoma                 1/50 (2%)     0/100(0%)     1/47 (2%)           0/50 (0%)     2/100(2%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     1/50 (2%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     1/48 (2%)     |
|                                        1/50 (2%)     1/50 (2%)     1/50 (2%)           0/49 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     1/50 (2%)     |
|                                        0/49 (0%)     0/48 (0%)     0/47 (0%)           0/50 (0%)     0/48 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/49 (0%)     1/49 (2%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 7/1448 (0.48%)  Mean 0.54%   SD 0.92%     Total 4/1453 (0.28%)   Mean 0.23%   SD 0.66%     |
 __________________________________________________________________________________________________________________________________
|*Kidney: Renal Tubule                                                                                                             |
|   Fibroma                              0/50 (0%)     0/100(0%)     0/47 (0%)           0/50 (0%)     0/100(0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/48 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/49 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/100(1%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/49 (0%)     0/48 (0%)     0/47 (0%)           0/50 (0%)     0/48 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/49 (0%)     0/49 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 1/1448 (0.07%)  Mean 0.04%   SD 0.2%      Total 0/1453 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|*Kidney: Renal Tubule                                                                                                             |
|   Lipoma                               0/50 (0%)     0/100(0%)     0/47 (0%)           0/50 (0%)     0/100(0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     1/50 (2%)     0/48 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/49 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/49 (0%)     0/48 (0%)     0/47 (0%)           0/50 (0%)     0/48 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/49 (0%)     0/49 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 0/1448 (0%)     Mean 0%      SD 0%        Total 1/1453 (0.07%)   Mean 0.08%   SD 0.39%     |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 22
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|*Kidney: Renal Tubule                                                                                                             |
|   Liposarcoma                          0/50 (0%)     0/100(0%)     0/47 (0%)           0/50 (0%)     0/100(0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/48 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/49 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/49 (0%)     0/48 (0%)     0/47 (0%)           0/50 (0%)     0/48 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/49 (0%)     0/49 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 1/1448 (0.07%)  Mean 0.08%   SD 0.39%     Total 0/1453 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|*Kidney: Renal Tubule                                                                                                             |
|   Sarcoma                              0/50 (0%)     0/100(0%)     0/47 (0%)           0/50 (0%)     0/100(0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/48 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/49 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/100(1%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/49 (0%)     1/48 (2%)     0/47 (0%)           0/50 (0%)     0/48 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/49 (0%)     0/49 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 2/1448 (0.14%)  Mean 0.12%   SD 0.45%     Total 0/1453 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|*Kidney: Renal Tubule                                                                                                             |
|   Stromal Nephroma                     0/50 (0%)     0/100(0%)     1/47 (2%)           0/50 (0%)     0/100(0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/48 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/49 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/49 (0%)     0/48 (0%)     0/47 (0%)           0/50 (0%)     0/48 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/49 (0%)     0/49 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 1/1448 (0.07%)  Mean 0.08%   SD 0.42%     Total 0/1453 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|*Liver:                                                                                                                           |
|   Cholangiocarcinoma                   0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/100(1%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/49 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/50 (0%)     0/50 (0%)           1/50 (2%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 2/1459 (0.14%)  Mean 0.12%   SD 0.43%     Total 1/1457 (0.07%)   Mean 0.08%   SD 0.39%     |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 23
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|*Liver:                                                                                                                           |
|   Hepatocellular Adenoma               2/50 (4%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/50 (2%)     0/50 (0%)           0/50 (0%)     1/50 (2%)     0/50 (0%)     |
|                                        0/50 (0%)     2/100(2%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     1/49 (2%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        3/50 (6%)     0/50 (0%)     0/50 (0%)           1/49 (2%)     0/49 (0%)     1/50 (2%)     |
|                                        1/50 (2%)     1/100(1%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           1/50 (2%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     2/60 (3%)     0/50 (0%)           6/50 (12%)    1/60 (2%)     0/50 (0%)     |
|                                        1/50 (2%)     1/50 (2%)                         1/50 (2%)     2/50 (4%)                   |
| Overall Incidence               Total 15/1459 (1.03%) Mean 1.01%   SD 1.57%     Total 14/1457 (0.96%)  Mean 1.07%   SD 2.48%     |
 __________________________________________________________________________________________________________________________________
|*Liver:                                                                                                                           |
|   Hepatocellular Carcinoma             0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     2/50 (4%)           1/50 (2%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     1/49 (2%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/49 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/60 (2%)     1/50 (2%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 5/1459 (0.34%)  Mean 0.37%   SD 0.97%     Total 1/1457 (0.07%)   Mean 0.08%   SD 0.39%     |
 __________________________________________________________________________________________________________________________________
|*Liver:                                                                                                                           |
|   Hepatocellular Carcinoma or          0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|      Hepatoblastoma                    0/50 (0%)     0/50 (0%)     2/50 (4%)           1/50 (2%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     1/49 (2%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/49 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/60 (2%)     1/50 (2%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 5/1459 (0.34%)  Mean 0.37%   SD 0.97%     Total 1/1457 (0.07%)   Mean 0.08%   SD 0.39%     |
 __________________________________________________________________________________________________________________________________
|*Liver:                                                                                                                           |
|   Hepatocellular Carcinoma or          2/50 (4%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|      Hepatocellular Adenoma            0/50 (0%)     1/50 (2%)     2/50 (4%)           1/50 (2%)     1/50 (2%)     0/50 (0%)     |
|                                        0/50 (0%)     2/100(2%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     2/49 (4%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        3/50 (6%)     0/50 (0%)     0/50 (0%)           1/49 (2%)     0/49 (0%)     1/50 (2%)     |
|                                        1/50 (2%)     1/100(1%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           1/50 (2%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     3/60 (5%)     1/50 (2%)           6/50 (12%)    1/60 (2%)     0/50 (0%)     |
|                                        1/50 (2%)     1/50 (2%)                         1/50 (2%)     2/50 (4%)                   |
| Overall Incidence               Total 20/1459 (1.37%) Mean 1.39%   SD 1.84%     Total 15/1457 (1.03%)  Mean 1.14%   SD 2.47%     |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 24
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|*Liver:                                                                                                                           |
|   Hepatocellular Carcinoma,            2/50 (4%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|      Hepatocellular Adenoma, or        0/50 (0%)     1/50 (2%)     2/50 (4%)           1/50 (2%)     1/50 (2%)     0/50 (0%)     |
|      Hepatoblastoma                    0/50 (0%)     2/100(2%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     2/49 (4%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        3/50 (6%)     0/50 (0%)     0/50 (0%)           1/49 (2%)     0/49 (0%)     1/50 (2%)     |
|                                        1/50 (2%)     1/100(1%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           1/50 (2%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     3/60 (5%)     1/50 (2%)           6/50 (12%)    1/60 (2%)     0/50 (0%)     |
|                                        1/50 (2%)     1/50 (2%)                         1/50 (2%)     2/50 (4%)                   |
| Overall Incidence               Total 20/1459 (1.37%) Mean 1.39%   SD 1.84%     Total 15/1457 (1.03%)  Mean 1.14%   SD 2.47%     |
 __________________________________________________________________________________________________________________________________
|*Lung:                                                                                                                            |
|   Adenoma                              0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/49 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     1/100(1%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 1/1459 (0.07%)  Mean 0.04%   SD 0.2%      Total 0/1457 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|*Lung:                                                                                                                            |
|   Alveolar/Bronchiolar Adenoma         4/50 (8%)     3/100(3%)     2/50 (4%)           4/50 (8%)     2/100(2%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     2/50 (4%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        2/50 (4%)     4/100(4%)     1/50 (2%)           3/50 (6%)     6/100(6%)     1/50 (2%)     |
|                                        0/50 (0%)     6/50 (12%)    2/49 (4%)           0/50 (0%)     0/50 (0%)     1/49 (2%)     |
|                                        0/50 (0%)     1/50 (2%)     4/50 (8%)           0/50 (0%)     0/49 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     3/100(3%)     1/50 (2%)           1/50 (2%)     3/100(3%)     3/50 (6%)     |
|                                        2/50 (4%)     0/50 (0%)     1/50 (2%)           0/50 (0%)     0/50 (0%)     1/50 (2%)     |
|                                        1/50 (2%)     1/60 (2%)     1/50 (2%)           0/50 (0%)     1/60 (2%)     0/50 (0%)     |
|                                        0/50 (0%)     2/50 (4%)                         2/50 (4%)     1/50 (2%)                   |
| Overall Incidence               Total 43/1459 (2.95%) Mean 2.91%   SD 2.89%     Total 29/1457 (1.99%)  Mean 1.8%    SD 2.37%     |
 __________________________________________________________________________________________________________________________________
|*Lung:                                                                                                                            |
|   Alveolar/Bronchiolar Carcinoma       0/50 (0%)     0/100(0%)     1/50 (2%)           0/50 (0%)     1/100(1%)     1/50 (2%)     |
|                                        2/50 (4%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/100(1%)     1/50 (2%)           0/50 (0%)     1/100(1%)     1/50 (2%)     |
|                                        1/50 (2%)     1/50 (2%)     0/49 (0%)           0/50 (0%)     1/50 (2%)     0/49 (0%)     |
|                                        1/50 (2%)     1/50 (2%)     0/50 (0%)           0/50 (0%)     0/49 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     1/100(1%)     0/50 (0%)     |
|                                        2/50 (4%)     0/50 (0%)     3/50 (6%)           0/50 (0%)     0/50 (0%)     1/50 (2%)     |
|                                        0/50 (0%)     1/60 (2%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/50 (0%)                         0/50 (0%)     1/50 (2%)                   |
| Overall Incidence               Total 16/1459 (1.1%)  Mean 1.18%   SD 1.6%      Total 8/1457 (0.55%)   Mean 0.5%    SD 0.81%     |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 25
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|*Lung:                                                                                                                            |
|   Alveolar/Bronchiolar Carcinoma or    4/50 (8%)     3/100(3%)     3/50 (6%)           4/50 (8%)     3/100(3%)     1/50 (2%)     |
|      Alveolar/Bronchiolar Adenoma      2/50 (4%)     0/50 (0%)     2/50 (4%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        2/50 (4%)     5/100(5%)     2/50 (4%)           3/50 (6%)     7/100(7%)     2/50 (4%)     |
|                                        1/50 (2%)     7/50 (14%)    2/49 (4%)           0/50 (0%)     1/50 (2%)     1/49 (2%)     |
|                                        1/50 (2%)     2/50 (4%)     4/50 (8%)           0/50 (0%)     0/49 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     3/100(3%)     1/50 (2%)           1/50 (2%)     4/100(4%)     3/50 (6%)     |
|                                        4/50 (8%)     0/50 (0%)     4/50 (8%)           0/50 (0%)     0/50 (0%)     2/50 (4%)     |
|                                        1/50 (2%)     2/60 (3%)     1/50 (2%)           0/50 (0%)     1/60 (2%)     0/50 (0%)     |
|                                        1/50 (2%)     2/50 (4%)                         2/50 (4%)     2/50 (4%)                   |
| Overall Incidence               Total 59/1459 (4.04%) Mean 4.09%   SD 3.12%     Total 37/1457 (2.54%)  Mean 2.3%    SD 2.5%      |
 __________________________________________________________________________________________________________________________________
|*Lung:                                                                                                                            |
|   Carcinoma                            0/50 (0%)     1/100(1%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/49 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 1/1459 (0.07%)  Mean 0.04%   SD 0.2%      Total 0/1457 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|*Lung:                                                                                                                            |
|   Sarcoma                              0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/49 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/50 (2%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 1/1459 (0.07%)  Mean 0.08%   SD 0.39%     Total 0/1457 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|*Lung:                                                                                                                            |
|   Squamous Cell Carcinoma              0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     1/100(1%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/49 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 0/1459 (0%)     Mean 0%      SD 0%        Total 1/1457 (0.07%)   Mean 0.04%   SD 0.2%      |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 26
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|#Lymph Node, Mesenteric:                                                                                                          |
|   Carcinoma                            0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/50 (2%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 1/1459 (0.07%)  Mean 0.08%   SD 0.39%     Total 0/1459 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#Lymph Node, Mesenteric:                                                                                                          |
|   Hemangioma                           0/50 (0%)     1/100(1%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 1/1459 (0.07%)  Mean 0.04%   SD 0.2%      Total 0/1459 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#Lymph Node, Mesenteric:                                                                                                          |
|   Hemangiosarcoma                      0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     1/50 (2%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 0/1459 (0%)     Mean 0%      SD 0%        Total 1/1459 (0.07%)   Mean 0.08%   SD 0.39%     |
 __________________________________________________________________________________________________________________________________
|#Lymph Node, Mesenteric:                                                                                                          |
|   Sarcoma                              0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 1/1459 (0.07%)  Mean 0.08%   SD 0.39%     Total 0/1459 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 27
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|#Mammary Gland:                                                                                                                   |
|   Adenoma                              0/50 (0%)     1/100(1%)     0/50 (0%)           2/50 (4%)     0/100(0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     1/50 (2%)     1/50 (2%)     |
|                                        0/50 (0%)     0/100(0%)     1/50 (2%)           2/50 (4%)     1/100(1%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     1/50 (2%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     1/100(1%)     2/50 (4%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     3/50 (6%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/50 (0%)                         1/50 (2%)     0/50 (0%)                   |
| Overall Incidence               Total 4/1459 (0.27%)  Mean 0.27%   SD 0.67%     Total 15/1459 (1.03%)  Mean 1.08%   SD 1.7%      |
 __________________________________________________________________________________________________________________________________
|#Mammary Gland:                                                                                                                   |
|   Carcinoma                            0/50 (0%)     2/100(2%)     0/50 (0%)           0/50 (0%)     0/100(0%)     4/50 (8%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           1/50 (2%)     3/50 (6%)     1/50 (2%)     |
|                                        0/50 (0%)     0/100(0%)     1/50 (2%)           1/50 (2%)     1/100(1%)     5/50 (10%)    |
|                                        1/50 (2%)     0/50 (0%)     1/49 (2%)           3/50 (6%)     0/50 (0%)     3/49 (6%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           5/50 (10%)    4/50 (8%)     2/50 (4%)     |
|                                        2/50 (4%)     0/100(0%)     2/50 (4%)           5/50 (10%)    2/100(2%)     2/50 (4%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           4/50 (8%)     2/50 (4%)     3/50 (6%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           4/50 (8%)     0/60 (0%)     1/50 (2%)     |
|                                        0/50 (0%)     1/50 (2%)                         2/50 (4%)     3/50 (6%)                   |
| Overall Incidence               Total 10/1459 (0.69%) Mean 0.69%   SD 1.26%     Total 61/1459 (4.18%)  Mean 4.58%   SD 3.33%     |
 __________________________________________________________________________________________________________________________________
|#Mammary Gland:                                                                                                                   |
|   Carcinoma or Adenoma                 0/50 (0%)     3/100(3%)     0/50 (0%)           2/50 (4%)     0/100(0%)     4/50 (8%)     |
|                                        1/50 (2%)     0/50 (0%)     0/50 (0%)           1/50 (2%)     3/50 (6%)     2/50 (4%)     |
|                                        0/50 (0%)     0/100(0%)     2/50 (4%)           2/50 (4%)     2/100(2%)     5/50 (10%)    |
|                                        1/50 (2%)     0/50 (0%)     1/49 (2%)           3/50 (6%)     0/50 (0%)     3/49 (6%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           5/50 (10%)    4/50 (8%)     3/50 (6%)     |
|                                        2/50 (4%)     0/100(0%)     2/50 (4%)           5/50 (10%)    3/100(3%)     3/50 (6%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           4/50 (8%)     2/50 (4%)     6/50 (12%)    |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           4/50 (8%)     0/60 (0%)     1/50 (2%)     |
|                                        1/50 (2%)     1/50 (2%)                         3/50 (6%)     3/50 (6%)                   |
| Overall Incidence               Total 14/1459 (0.96%) Mean 0.96%   SD 1.46%     Total 73/1459 (5%)     Mean 5.43%   SD 3.3%      |
 __________________________________________________________________________________________________________________________________
|#Mammary Gland:                                                                                                                   |
|   Fibroadenoma                         2/50 (4%)     8/100(8%)     1/50 (2%)          27/50 (54%)   53/100(53%)   36/50 (72%)    |
|                                        2/50 (4%)     2/50 (4%)     3/50 (6%)          15/50 (30%)   21/50 (42%)   15/50 (30%)    |
|                                        3/50 (6%)     3/100(3%)     2/50 (4%)          21/50 (42%)   55/100(55%)   25/50 (50%)    |
|                                        1/50 (2%)     2/50 (4%)     0/49 (0%)          20/50 (40%)   20/50 (40%)   17/49 (35%)    |
|                                        2/50 (4%)     3/50 (6%)     2/50 (4%)          25/50 (50%)   19/50 (38%)   16/50 (32%)    |
|                                        2/50 (4%)     6/100(6%)     3/50 (6%)          22/50 (44%)   56/100(56%)   22/50 (44%)    |
|                                        0/50 (0%)     3/50 (6%)     2/50 (4%)          26/50 (52%)   24/50 (48%)   33/50 (66%)    |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)          12/50 (24%)   23/60 (38%)   14/50 (28%)    |
|                                        1/50 (2%)     4/50 (8%)                        28/50 (56%)   32/50 (64%)                  |
| Overall Incidence               Total 57/1459 (3.91%) Mean 3.73%   SD 2.43%     Total 677/1459 (46.4%) Mean 45.5%   SD 12.23%    |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 28
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|#Mammary Gland:                                                                                                                   |
|   Fibroma                              0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 1/1459 (0.07%)  Mean 0.08%   SD 0.39%     Total 0/1459 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#Mammary Gland:                                                                                                                   |
|   Fibroma, Fibroadenoma or Adenoma     2/50 (4%)     9/100(9%)     1/50 (2%)          28/50 (56%)   53/100(53%)   36/50 (72%)    |
|                                        4/50 (8%)     2/50 (4%)     3/50 (6%)          15/50 (30%)   21/50 (42%)   16/50 (32%)    |
|                                        3/50 (6%)     3/100(3%)     3/50 (6%)          23/50 (46%)   55/100(55%)   25/50 (50%)    |
|                                        1/50 (2%)     2/50 (4%)     0/49 (0%)          20/50 (40%)   20/50 (40%)   17/49 (35%)    |
|                                        2/50 (4%)     3/50 (6%)     2/50 (4%)          25/50 (50%)   19/50 (38%)   17/50 (34%)    |
|                                        2/50 (4%)     6/100(6%)     3/50 (6%)          22/50 (44%)   56/100(56%)   23/50 (46%)    |
|                                        0/50 (0%)     3/50 (6%)     2/50 (4%)          26/50 (52%)   24/50 (48%)   35/50 (70%)    |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)          12/50 (24%)   23/60 (38%)   14/50 (28%)    |
|                                        2/50 (4%)     4/50 (8%)                        28/50 (56%)   32/50 (64%)                  |
| Overall Incidence               Total 62/1459 (4.25%) Mean 4.08%   SD 2.64%     Total 685/1459 (46.95%)Mean 46.12%  SD 12.37%    |
 __________________________________________________________________________________________________________________________________
|#Mammary Gland:                                                                                                                   |
|   Fibroma, Fibroadenoma, Carcinoma,    2/50 (4%)    11/100(11%)    1/50 (2%)          28/50 (56%)   53/100(53%)   37/50 (74%)    |
|      or Adenoma                        4/50 (8%)     2/50 (4%)     3/50 (6%)          16/50 (32%)   23/50 (46%)   16/50 (32%)    |
|                                        3/50 (6%)     3/100(3%)     4/50 (8%)          23/50 (46%)   56/100(56%)   29/50 (58%)    |
|                                        1/50 (2%)     2/50 (4%)     1/49 (2%)          22/50 (44%)   20/50 (40%)   18/49 (37%)    |
|                                        2/50 (4%)     3/50 (6%)     2/50 (4%)          27/50 (54%)   23/50 (46%)   19/50 (38%)    |
|                                        4/50 (8%)     6/100(6%)     5/50 (10%)         26/50 (52%)   58/100(58%)   24/50 (48%)    |
|                                        0/50 (0%)     3/50 (6%)     2/50 (4%)          28/50 (56%)   25/50 (50%)   37/50 (74%)    |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)          14/50 (28%)   23/60 (38%)   14/50 (28%)    |
|                                        2/50 (4%)     5/50 (10%)                       30/50 (60%)   32/50 (64%)                  |
| Overall Incidence               Total 71/1459 (4.87%) Mean 4.69%   SD 3.18%     Total 721/1459 (49.42%)Mean 48.77%  SD 12.54%    |
 __________________________________________________________________________________________________________________________________
|#Mammary Gland:                                                                                                                   |
|   Hemangioma                           0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     1/100(1%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 0/1459 (0%)     Mean 0%      SD 0%        Total 1/1459 (0.07%)   Mean 0.04%   SD 0.2%      |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 29
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|#Mammary Gland:                                                                                                                   |
|   Myoepithelioma                       0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     1/50 (2%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 0/1459 (0%)     Mean 0%      SD 0%        Total 1/1459 (0.07%)   Mean 0.08%   SD 0.39%     |
 __________________________________________________________________________________________________________________________________
|#Mesentery:                                                                                                                       |
|   Fibrosarcoma                         0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     1/50 (2%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 0/1459 (0%)     Mean 0%      SD 0%        Total 1/1459 (0.07%)   Mean 0.08%   SD 0.39%     |
 __________________________________________________________________________________________________________________________________
|#Mesentery:                                                                                                                       |
|   Hemangiosarcoma                      0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 1/1459 (0.07%)  Mean 0.08%   SD 0.39%     Total 0/1459 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#Mesentery:                                                                                                                       |
|   Lipoma                               0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/100(1%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 1/1459 (0.07%)  Mean 0.04%   SD 0.2%      Total 0/1459 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 30
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|#Mesentery:                                                                                                                       |
|   Liposarcoma                          0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           1/50 (2%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 0/1459 (0%)     Mean 0%      SD 0%        Total 1/1459 (0.07%)   Mean 0.08%   SD 0.39%     |
 __________________________________________________________________________________________________________________________________
|#Mesentery:                                                                                                                       |
|   Osteosarcoma                         0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     1/50 (2%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 1/1459 (0.07%)  Mean 0.08%   SD 0.39%     Total 0/1459 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#Mesentery:                                                                                                                       |
|   Rhabdomyosarcoma                     0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/50 (2%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 1/1459 (0.07%)  Mean 0.08%   SD 0.39%     Total 0/1459 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#Mesentery:                                                                                                                       |
|   Sarcoma                              0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/50 (2%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     1/49 (2%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 2/1459 (0.14%)  Mean 0.16%   SD 0.55%     Total 0/1459 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 31
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|*Nose:                                                                                                                            |
|   Adenoma                              0/50 (0%)     0/100(0%)     0/46 (0%)           0/50 (0%)     1/100(1%)     0/48 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/49 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     1/50 (2%)     0/49 (0%)           0/49 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/49 (0%)     0/49 (0%)           0/50 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/49 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 2/1450 (0.14%)  Mean 0.15%   SD 0.54%     Total 1/1454 (0.07%)   Mean 0.04%   SD 0.2%      |
 __________________________________________________________________________________________________________________________________
|*Nose:                                                                                                                            |
|   Chondroma                            0/50 (0%)     0/100(0%)     0/46 (0%)           0/50 (0%)     0/100(0%)     0/48 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/49 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/50 (2%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/49 (0%)     0/49 (0%)     1/50 (2%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/49 (0%)     0/49 (0%)           0/50 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/49 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 1/1450 (0.07%)  Mean 0.08%   SD 0.39%     Total 1/1454 (0.07%)   Mean 0.08%   SD 0.39%     |
 __________________________________________________________________________________________________________________________________
|*Nose:                                                                                                                            |
|   Sarcoma                              0/50 (0%)     0/100(0%)     0/46 (0%)           0/50 (0%)     0/100(0%)     0/48 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/49 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/49 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/49 (0%)     0/49 (0%)           0/50 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/49 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 1/1450 (0.07%)  Mean 0.08%   SD 0.39%     Total 0/1454 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|*Nose:                                                                                                                            |
|   Squamous Cell Carcinoma              0/50 (0%)     0/100(0%)     0/46 (0%)           0/50 (0%)     0/100(0%)     0/48 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/49 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/49 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/49 (0%)     0/49 (0%)           0/50 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/49 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 1/1450 (0.07%)  Mean 0.08%   SD 0.39%     Total 0/1454 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 32
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|#Oral Cavity (Oral Mucosa, Tongue,                                                                                                |
| Pharynx, Tooth, Gingiva):                                                                                                        |
|   Papilloma Squamous or Papilloma      1/50 (2%)     1/100(1%)     0/50 (0%)           0/50 (0%)     1/100(1%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/100(1%)     0/50 (0%)           0/50 (0%)     0/100(0%)     1/50 (2%)     |
|                                        1/50 (2%)     1/50 (2%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     1/50 (2%)           0/50 (0%)     0/100(0%)     1/50 (2%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           2/50 (4%)     0/60 (0%)     1/50 (2%)     |
|                                        1/50 (2%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 7/1459 (0.48%)  Mean 0.46%   SD 0.81%     Total 6/1459 (0.41%)   Mean 0.42%   SD 0.99%     |
 __________________________________________________________________________________________________________________________________
|#Oral Cavity (Oral Mucosa, Tongue,                                                                                                |
| Pharynx, Tooth, Gingiva):                                                                                                        |
|   Squamous Cell Carcinoma              0/50 (0%)     1/100(1%)     0/50 (0%)           0/50 (0%)     0/100(0%)     1/50 (2%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/100(1%)     0/50 (0%)           1/50 (2%)     0/100(0%)     2/50 (4%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           1/50 (2%)     0/60 (0%)     1/50 (2%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 3/1459 (0.21%)  Mean 0.15%   SD 0.46%     Total 6/1459 (0.41%)   Mean 0.46%   SD 1.03%     |
 __________________________________________________________________________________________________________________________________
|#Oral Cavity (Oral Mucosa, Tongue,                                                                                                |
| Pharynx, Tooth, Gingiva):                                                                                                        |
|   Squamous Cell Carcinoma,             1/50 (2%)     2/100(2%)     0/50 (0%)           0/50 (0%)     1/100(1%)     1/50 (2%)     |
|      Papilloma Squamous, or Papilloma  0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     2/100(2%)     0/50 (0%)           1/50 (2%)     0/100(0%)     3/50 (6%)     |
|                                        1/50 (2%)     1/50 (2%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/100(0%)     1/50 (2%)           0/50 (0%)     0/100(0%)     1/50 (2%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           3/50 (6%)     0/60 (0%)     2/50 (4%)     |
|                                        1/50 (2%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 10/1459 (0.69%) Mean 0.62%   SD 0.94%     Total 12/1459 (0.82%)  Mean 0.88%   SD 1.8%      |
 __________________________________________________________________________________________________________________________________
|#Oral Mucosa:                                                                                                                     |
|   Squamous Cell Carcinoma              0/50 (0%)     1/100(1%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/100(1%)     0/50 (0%)           1/50 (2%)     0/100(0%)     1/50 (2%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           1/50 (2%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 3/1459 (0.21%)  Mean 0.15%   SD 0.46%     Total 3/1459 (0.21%)   Mean 0.23%   SD 0.65%     |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 33
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|#Oral Mucosa:                                                                                                                     |
|   Squamous Cell Papilloma              0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/50 (2%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     1/50 (2%)           0/50 (0%)     0/100(0%)     1/50 (2%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     1/50 (2%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 2/1459 (0.14%)  Mean 0.15%   SD 0.54%     Total 2/1459 (0.14%)   Mean 0.15%   SD 0.54%     |
 __________________________________________________________________________________________________________________________________
|*Ovary:                                                                                                                           |
|   Cystadenoma                                                                          0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     1/100(1%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)                   |
| Overall Incidence                                                               Total 1/1459 (0.07%)   Mean 0.04%   SD 0.2%      |
 __________________________________________________________________________________________________________________________________
|*Ovary:                                                                                                                           |
|   Granulosa Cell Tumor Benign                                                          0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     1/50 (2%)     0/49 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     1/50 (2%)     |
|                                                                                        0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)                   |
| Overall Incidence                                                               Total 2/1459 (0.14%)   Mean 0.15%   SD 0.54%     |
 __________________________________________________________________________________________________________________________________
|*Ovary:                                                                                                                           |
|   Granulosa Cell Tumor Malignant                                                       0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     1/50 (2%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     2/49 (4%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)                   |
| Overall Incidence                                                               Total 3/1459 (0.21%)   Mean 0.23%   SD 0.88%     |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 34
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|*Ovary:                                                                                                                           |
|   Granulosa Cell Tumor: Benign,                                                        0/50 (0%)     0/100(0%)     0/50 (0%)     |
|      Malignant, NOS                                                                    0/50 (0%)     1/50 (2%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     1/50 (2%)     2/49 (4%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     1/50 (2%)     |
|                                                                                        0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)                   |
| Overall Incidence                                                               Total 5/1459 (0.34%)   Mean 0.39%   SD 0.99%     |
 __________________________________________________________________________________________________________________________________
|*Ovary:                                                                                                                           |
|   Granulosa-Theca Tumor Malignant                                                      0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     1/50 (2%)     1/49 (2%)     |
|                                                                                        1/50 (2%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)                   |
| Overall Incidence                                                               Total 3/1459 (0.21%)   Mean 0.23%   SD 0.66%     |
 __________________________________________________________________________________________________________________________________
|*Ovary:                                                                                                                           |
|   Luteoma                                                                              0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     1/100(1%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                                                                        1/50 (2%)     0/50 (0%)                   |
| Overall Incidence                                                               Total 2/1459 (0.14%)   Mean 0.12%   SD 0.43%     |
 __________________________________________________________________________________________________________________________________
|*Ovary:                                                                                                                           |
|   Sarcoma                                                                              0/50 (0%)     0/100(0%)     1/50 (2%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)                   |
| Overall Incidence                                                               Total 1/1459 (0.07%)   Mean 0.08%   SD 0.39%     |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 35
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|*Ovary:                                                                                                                           |
|   Thecoma Malignant                                                                    0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/100(0%)     1/50 (2%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)                   |
| Overall Incidence                                                               Total 1/1459 (0.07%)   Mean 0.08%   SD 0.39%     |
 __________________________________________________________________________________________________________________________________
|*Ovary:                                                                                                                           |
|   Tubulostromal Adenoma                                                                0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     3/100(3%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)                   |
| Overall Incidence                                                               Total 3/1459 (0.21%)   Mean 0.12%   SD 0.59%     |
 __________________________________________________________________________________________________________________________________
|*Pancreas:                                                                                                                        |
|   Adenoma                              0/50 (0%)     2/100(2%)     0/44 (0%)           0/50 (0%)     0/100(0%)     1/47 (2%)     |
|                                        0/50 (0%)     2/50 (4%)     0/50 (0%)           1/50 (2%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/100(1%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/50 (2%)     1/49 (2%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/49 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     3/98 (3%)    10/50 (20%)          0/50 (0%)     0/100(0%)     1/50 (2%)     |
|                                        1/49 (2%)     1/50 (2%)     0/49 (0%)           0/50 (0%)     0/49 (0%)     2/50 (4%)     |
|                                        3/50 (6%)     1/60 (2%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        3/49 (6%)     0/48 (0%)                         1/50 (2%)     0/47 (0%)                   |
| Overall Incidence               Total 29/1446 (2.01%) Mean 2%      SD 4.1%      Total 6/1450 (0.41%)   Mean 0.47%   SD 1.04%     |
 __________________________________________________________________________________________________________________________________
|*Pancreas:                                                                                                                        |
|   Carcinoma                            0/50 (0%)     0/100(0%)     1/44 (2%)           0/50 (0%)     0/100(0%)     0/47 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/49 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/98 (0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/49 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     1/50 (2%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/49 (0%)     0/48 (0%)                         0/50 (0%)     0/47 (0%)                   |
| Overall Incidence               Total 2/1446 (0.14%)  Mean 0.16%   SD 0.58%     Total 0/1450 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 36
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|*Pancreas:                                                                                                                        |
|   Carcinoma or Adenoma                 0/50 (0%)     2/100(2%)     1/44 (2%)           0/50 (0%)     0/100(0%)     1/47 (2%)     |
|                                        0/50 (0%)     2/50 (4%)     0/50 (0%)           1/50 (2%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/100(1%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/50 (2%)     1/49 (2%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/49 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     3/98 (3%)    10/50 (20%)          0/50 (0%)     0/100(0%)     1/50 (2%)     |
|                                        1/49 (2%)     1/50 (2%)     0/49 (0%)           0/50 (0%)     0/49 (0%)     2/50 (4%)     |
|                                        3/50 (6%)     1/60 (2%)     1/50 (2%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        3/49 (6%)     0/48 (0%)                         1/50 (2%)     0/47 (0%)                   |
| Overall Incidence               Total 31/1446 (2.14%) Mean 2.16%   SD 4.05%     Total 6/1450 (0.41%)   Mean 0.47%   SD 1.04%     |
 __________________________________________________________________________________________________________________________________
|*Pancreas:                                                                                                                        |
|   Fibroma                              0/50 (0%)     1/100(1%)     0/44 (0%)           0/50 (0%)     0/100(0%)     0/47 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/49 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/98 (0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/49 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/49 (0%)     0/48 (0%)                         0/50 (0%)     0/47 (0%)                   |
| Overall Incidence               Total 1/1446 (0.07%)  Mean 0.04%   SD 0.2%      Total 0/1450 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|*Pancreas:                                                                                                                        |
|   Mixed Tumor Benign                   1/50 (2%)     0/100(0%)     2/44 (5%)           0/50 (0%)     0/100(0%)     0/47 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/100(1%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/49 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/98 (0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/49 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/49 (0%)     0/48 (0%)                         0/50 (0%)     0/47 (0%)                   |
| Overall Incidence               Total 4/1446 (0.28%)  Mean 0.29%   SD 0.97%     Total 0/1450 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|*Parathyroid Gland:                                                                                                               |
|   Adenoma                              0/49 (0%)     0/93 (0%)     1/45 (2%)           0/47 (0%)     2/86 (2%)     0/49 (0%)     |
|                                        0/46 (0%)     0/46 (0%)     0/46 (0%)           1/46 (2%)     1/48 (2%)     0/45 (0%)     |
|                                        0/45 (0%)     0/92 (0%)     0/49 (0%)           0/46 (0%)     0/90 (0%)     0/49 (0%)     |
|                                        0/46 (0%)     1/44 (2%)     0/45 (0%)           0/49 (0%)     0/40 (0%)     0/42 (0%)     |
|                                        0/49 (0%)     0/50 (0%)     0/49 (0%)           0/49 (0%)     0/49 (0%)     0/45 (0%)     |
|                                        0/49 (0%)     0/85 (0%)     0/50 (0%)           0/46 (0%)     1/88 (1%)     0/49 (0%)     |
|                                        0/47 (0%)     1/48 (2%)     0/49 (0%)           0/49 (0%)     0/50 (0%)     0/47 (0%)     |
|                                        0/49 (0%)     0/58 (0%)     0/48 (0%)           0/45 (0%)     0/57 (0%)     0/46 (0%)     |
|                                        0/48 (0%)     0/50 (0%)                         0/48 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 3/1375 (0.22%)  Mean 0.25%   SD 0.71%     Total 5/1355 (0.37%)   Mean 0.3%    SD 0.73%     |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 37
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|#Peripheral Nerve:                                                                                                                |
|   Sarcoma                              0/50 (0%)     0/100(0%)     1/50 (2%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 1/1459 (0.07%)  Mean 0.08%   SD 0.39%     Total 0/1459 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|*Pituitary Gland: Pars Distalis or                                                                                                |
| Unspecified Site                      10/50 (20%)   17/100(17%)   15/47 (32%)         17/50 (34%)   29/100(29%)   20/48 (42%)    |
|   Adenoma                             19/50 (38%)   17/50 (34%)   11/50 (22%)         21/50 (42%)   12/50 (24%)   23/50 (46%)    |
|                                       13/50 (26%)   21/100(21%)   27/50 (54%)         24/50 (48%)   35/100(35%)   34/50 (68%)    |
|                                       36/50 (72%)   36/49 (73%)   31/49 (63%)         37/50 (74%)   30/50 (60%)   23/49 (47%)    |
|                                       35/50 (70%)   38/50 (76%)   35/50 (70%)         30/49 (61%)   27/49 (55%)   31/49 (63%)    |
|                                       35/50 (70%)   34/98 (35%)   12/50 (24%)         24/49 (49%)   61/99 (62%)   19/50 (38%)    |
|                                        9/50 (18%)   16/49 (33%)   16/48 (33%)         23/50 (46%)   29/48 (60%)   23/49 (47%)    |
|                                       29/50 (58%)   11/59 (19%)   15/48 (31%)         33/50 (66%)   19/59 (32%)   15/50 (30%)    |
|                                       22/49 (45%)   23/50 (46%)                       27/50 (54%)   26/50 (52%)                  |
| Overall Incidence               Total 583/1446 (40.32%Mean 42.31%  SD 20.43%    Total 692/1448 (47.79%)Mean 48.63%  SD 13.34%    |
 __________________________________________________________________________________________________________________________________
|*Pituitary Gland: Pars Distalis or                                                                                                |
| Unspecified Site                       0/50 (0%)     0/100(0%)     0/47 (0%)           0/50 (0%)     0/100(0%)     1/48 (2%)     |
|   Carcinoma                            1/50 (2%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     1/50 (2%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/49 (2%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     1/50 (2%)     0/50 (0%)           0/49 (0%)     0/49 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/98 (0%)     0/50 (0%)           0/49 (0%)     3/99 (3%)     0/50 (0%)     |
|                                        0/50 (0%)     0/49 (0%)     0/48 (0%)           2/50 (4%)     0/48 (0%)     1/49 (2%)     |
|                                        5/50 (10%)    0/59 (0%)     1/48 (2%)           3/50 (6%)     0/59 (0%)     0/50 (0%)     |
|                                        0/49 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 9/1446 (0.62%)  Mean 0.7%    SD 2.04%     Total 11/1448 (0.76%)  Mean 0.74%   SD 1.54%     |
 __________________________________________________________________________________________________________________________________
|*Pituitary Gland: Pars Distalis or                                                                                                |
| Unspecified Site                      10/50 (20%)   17/100(17%)   15/47 (32%)         17/50 (34%)   29/100(29%)   21/48 (44%)    |
|   Carcinoma or Adenoma                20/50 (40%)   17/50 (34%)   11/50 (22%)         21/50 (42%)   13/50 (26%)   23/50 (46%)    |
|                                       13/50 (26%)   21/100(21%)   27/50 (54%)         24/50 (48%)   35/100(35%)   34/50 (68%)    |
|                                       36/50 (72%)   37/49 (76%)   31/49 (63%)         37/50 (74%)   30/50 (60%)   23/49 (47%)    |
|                                       35/50 (70%)   39/50 (78%)   35/50 (70%)         30/49 (61%)   27/49 (55%)   31/49 (63%)    |
|                                       35/50 (70%)   34/98 (35%)   12/50 (24%)         24/49 (49%)   64/99 (65%)   19/50 (38%)    |
|                                        9/50 (18%)   16/49 (33%)   16/48 (33%)         25/50 (50%)   29/48 (60%)   24/49 (49%)    |
|                                       34/50 (68%)   11/59 (19%)   16/48 (33%)         36/50 (72%)   19/59 (32%)   15/50 (30%)    |
|                                       22/49 (45%)   23/50 (46%)                       27/50 (54%)   26/50 (52%)                  |
| Overall Incidence               Total 592/1446 (40.94%Mean 43.01%  SD 21.03%    Total 703/1448 (48.55%)Mean 49.37%  SD 13.62%    |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 38
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|*Pituitary Gland: Pars Intermedia                                                                                                 |
|   Adenoma                              0/50 (0%)     1/100(1%)     0/47 (0%)           0/50 (0%)     2/100(2%)     0/48 (0%)     |
|                                        1/50 (2%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/49 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/49 (0%)     0/49 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/98 (0%)     0/50 (0%)           0/49 (0%)     0/99 (0%)     1/50 (2%)     |
|                                        1/50 (2%)     0/49 (0%)     0/48 (0%)           0/50 (0%)     0/48 (0%)     1/49 (2%)     |
|                                        2/50 (4%)     0/59 (0%)     0/48 (0%)           0/50 (0%)     1/59 (2%)     0/50 (0%)     |
|                                        0/49 (0%)     0/50 (0%)                         0/50 (0%)     1/50 (2%)                   |
| Overall Incidence               Total 5/1446 (0.35%)  Mean 0.35%   SD 0.94%     Total 6/1448 (0.41%)   Mean 0.37%   SD 0.78%     |
 __________________________________________________________________________________________________________________________________
|*Pituitary Gland: Pars Intermedia                                                                                                 |
|   Carcinoma                            0/50 (0%)     0/100(0%)     0/47 (0%)           0/50 (0%)     0/100(0%)     0/48 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/49 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/49 (0%)     0/49 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/98 (0%)     0/50 (0%)           0/49 (0%)     0/99 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/49 (0%)     0/48 (0%)           0/50 (0%)     0/48 (0%)     0/49 (0%)     |
|                                        1/50 (2%)     0/59 (0%)     0/48 (0%)           0/50 (0%)     0/59 (0%)     0/50 (0%)     |
|                                        0/49 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 1/1446 (0.07%)  Mean 0.08%   SD 0.39%     Total 0/1448 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|*Pituitary Gland: Pars Intermedia                                                                                                 |
|   Carcinoma or Adenoma                 0/50 (0%)     1/100(1%)     0/47 (0%)           0/50 (0%)     2/100(2%)     0/48 (0%)     |
|                                        1/50 (2%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/49 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/49 (0%)     0/49 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/98 (0%)     0/50 (0%)           0/49 (0%)     0/99 (0%)     1/50 (2%)     |
|                                        1/50 (2%)     0/49 (0%)     0/48 (0%)           0/50 (0%)     0/48 (0%)     1/49 (2%)     |
|                                        3/50 (6%)     0/59 (0%)     0/48 (0%)           0/50 (0%)     1/59 (2%)     0/50 (0%)     |
|                                        0/49 (0%)     0/50 (0%)                         0/50 (0%)     1/50 (2%)                   |
| Overall Incidence               Total 6/1446 (0.41%)  Mean 0.42%   SD 1.27%     Total 6/1448 (0.41%)   Mean 0.37%   SD 0.78%     |
 __________________________________________________________________________________________________________________________________
|*Prostate:                                                                                                                        |
|   Adenoma                              0/50 (0%)     0/100(0%)     1/48 (2%)                                                     |
|                                        0/50 (0%)     1/50 (2%)     0/50 (0%)                                                     |
|                                        0/50 (0%)     4/100(4%)     0/50 (0%)                                                     |
|                                        0/50 (0%)     1/50 (2%)     0/49 (0%)                                                     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)                                                     |
|                                        0/50 (0%)     0/100(0%)     2/49 (4%)                                                     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)                                                     |
|                                        1/50 (2%)     2/60 (3%)     2/50 (4%)                                                     |
|                                        0/50 (0%)     0/50 (0%)                                                                   |
| Overall Incidence               Total 14/1456 (0.96%) Mean 0.9%    SD 1.48%                                                      |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 39
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|*Prostate:                                                                                                                        |
|   Carcinoma or Adenoma                 0/50 (0%)     0/100(0%)     1/48 (2%)                                                     |
|                                        0/50 (0%)     1/50 (2%)     0/50 (0%)                                                     |
|                                        0/50 (0%)     4/100(4%)     0/50 (0%)                                                     |
|                                        0/50 (0%)     1/50 (2%)     0/49 (0%)                                                     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)                                                     |
|                                        0/50 (0%)     0/100(0%)     2/49 (4%)                                                     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)                                                     |
|                                        1/50 (2%)     2/60 (3%)     2/50 (4%)                                                     |
|                                        0/50 (0%)     0/50 (0%)                                                                   |
| Overall Incidence               Total 14/1456 (0.96%) Mean 0.9%    SD 1.48%                                                      |
 __________________________________________________________________________________________________________________________________
|*Salivary Glands:                                                                                                                 |
|   Carcinoma                            0/49 (0%)     0/100(0%)     0/49 (0%)           0/50 (0%)     0/100(0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     1/50 (2%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/49 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/99 (0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/49 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 0/1453 (0%)     Mean 0%      SD 0%        Total 1/1456 (0.07%)   Mean 0.08%   SD 0.39%     |
 __________________________________________________________________________________________________________________________________
|*Salivary Glands:                                                                                                                 |
|   Carcinoma or Adenoma                 0/49 (0%)     0/100(0%)     0/49 (0%)           0/50 (0%)     0/100(0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     1/50 (2%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/49 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/99 (0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/49 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 0/1453 (0%)     Mean 0%      SD 0%        Total 1/1456 (0.07%)   Mean 0.08%   SD 0.39%     |
 __________________________________________________________________________________________________________________________________
|*Salivary Glands:                                                                                                                 |
|   Sarcoma                              0/49 (0%)     0/100(0%)     0/49 (0%)           0/50 (0%)     0/100(0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/49 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/99 (0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        1/49 (2%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 1/1453 (0.07%)  Mean 0.08%   SD 0.4%      Total 0/1456 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 40
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|*Salivary Glands:                                                                                                                 |
|   Schwannoma Malignant                 1/49 (2%)     0/100(0%)     0/49 (0%)           0/50 (0%)     0/100(0%)     0/49 (0%)     |
|                                        1/50 (2%)     2/50 (4%)     2/50 (4%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/49 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/99 (0%)     1/50 (2%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/49 (0%)     0/60 (0%)     1/50 (2%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 8/1453 (0.55%)  Mean 0.62%   SD 1.24%     Total 0/1456 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#Skeletal Muscle:                                                                                                                 |
|   Fibrosarcoma                         0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 1/1459 (0.07%)  Mean 0.08%   SD 0.39%     Total 0/1459 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#Skeletal Muscle:                                                                                                                 |
|   Hemangioma                           0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/50 (2%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 1/1459 (0.07%)  Mean 0.08%   SD 0.39%     Total 0/1459 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#Skeletal Muscle:                                                                                                                 |
|   Hemangiosarcoma                      0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 1/1459 (0.07%)  Mean 0.08%   SD 0.39%     Total 0/1459 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 41
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|#Skeletal Muscle:                                                                                                                 |
|   Lipoma                               0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     1/100(1%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     1/60 (2%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 1/1459 (0.07%)  Mean 0.08%   SD 0.39%     Total 2/1459 (0.14%)   Mean 0.1%    SD 0.37%     |
 __________________________________________________________________________________________________________________________________
|#Skeletal Muscle:                                                                                                                 |
|   Rhabdomyosarcoma                     0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/50 (2%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     1/50 (2%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 1/1459 (0.07%)  Mean 0.08%   SD 0.39%     Total 1/1459 (0.07%)   Mean 0.08%   SD 0.39%     |
 __________________________________________________________________________________________________________________________________
|#Skeletal Muscle:                                                                                                                 |
|   Rhabdomyosarcoma or Rhabdomyoma      0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/50 (2%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     1/50 (2%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 1/1459 (0.07%)  Mean 0.08%   SD 0.39%     Total 1/1459 (0.07%)   Mean 0.08%   SD 0.39%     |
 __________________________________________________________________________________________________________________________________
|#Skeletal Muscle:                                                                                                                 |
|   Sarcoma                              0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        1/50 (2%)     1/50 (2%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 3/1459 (0.21%)  Mean 0.23%   SD 0.65%     Total 0/1459 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 42
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|#Skin: Sebaceous Gland                                                                                                            |
|   Adenoma                              0/50 (0%)     0/100(0%)     1/50 (2%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/50 (2%)     1/49 (2%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        1/50 (2%)     3/50 (6%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 9/1459 (0.62%)  Mean 0.69%   SD 1.38%     Total 0/1459 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#Skin: Sebaceous Gland                                                                                                            |
|   Carcinoma                            0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     1/50 (2%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/100(1%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 2/1459 (0.14%)  Mean 0.12%   SD 0.43%     Total 1/1459 (0.07%)   Mean 0.08%   SD 0.39%     |
 __________________________________________________________________________________________________________________________________
|#Skin: Sebaceous Gland                                                                                                            |
|   Carcinoma or Adenoma                 0/50 (0%)     0/100(0%)     1/50 (2%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/50 (2%)     1/49 (2%)           0/50 (0%)     1/50 (2%)     0/49 (0%)     |
|                                        1/50 (2%)     3/50 (6%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        1/50 (2%)     1/100(1%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 11/1459 (0.75%) Mean 0.81%   SD 1.39%     Total 1/1459 (0.07%)   Mean 0.08%   SD 0.39%     |
 __________________________________________________________________________________________________________________________________
|#Skin:                                                                                                                            |
|   Basal Cell Adenoma                   0/50 (0%)     1/100(1%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/50 (0%)     1/50 (2%)           1/50 (2%)     1/50 (2%)     0/50 (0%)     |
|                                        0/50 (0%)     1/100(1%)     1/50 (2%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     3/100(3%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/50 (2%)     0/50 (0%)           1/50 (2%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     2/60 (3%)     1/50 (2%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 13/1459 (0.89%) Mean 0.78%   SD 1.1%      Total 3/1459 (0.21%)   Mean 0.23%   SD 0.65%     |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 43
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|#Skin:                                                                                                                            |
|   Basal Cell Adenoma or                0/50 (0%)     1/100(1%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|      Basosquamous Tumor Benign         1/50 (2%)     0/50 (0%)     1/50 (2%)           1/50 (2%)     1/50 (2%)     0/50 (0%)     |
|                                        0/50 (0%)     1/100(1%)     1/50 (2%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     3/100(3%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/50 (2%)     0/50 (0%)           1/50 (2%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     2/60 (3%)     1/50 (2%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 13/1459 (0.89%) Mean 0.78%   SD 1.1%      Total 3/1459 (0.21%)   Mean 0.23%   SD 0.65%     |
 __________________________________________________________________________________________________________________________________
|#Skin:                                                                                                                            |
|   Basal Cell Adenoma, Basosquamous     0/50 (0%)     2/100(2%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|      Tumor Benign, or                  1/50 (2%)     0/50 (0%)     2/50 (4%)           1/50 (2%)     1/50 (2%)     0/50 (0%)     |
|      Trichoepithelioma                 0/50 (0%)     2/100(2%)     1/50 (2%)           1/50 (2%)     0/100(0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     3/100(3%)     1/50 (2%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        1/50 (2%)     1/50 (2%)     1/50 (2%)           1/50 (2%)     1/50 (2%)     2/50 (4%)     |
|                                        0/50 (0%)     2/60 (3%)     1/50 (2%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        1/50 (2%)     1/50 (2%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 21/1459 (1.44%) Mean 1.32%   SD 1.25%     Total 7/1459 (0.48%)   Mean 0.54%   SD 1.07%     |
 __________________________________________________________________________________________________________________________________
|#Skin:                                                                                                                            |
|   Basal Cell Carcinoma                 0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        1/50 (2%)     1/100(1%)     0/50 (0%)           1/50 (2%)     0/100(0%)     1/50 (2%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           1/50 (2%)     0/50 (0%)     1/50 (2%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        1/50 (2%)     1/50 (2%)                         1/50 (2%)     0/50 (0%)                   |
| Overall Incidence               Total 4/1459 (0.27%)  Mean 0.27%   SD 0.67%     Total 5/1459 (0.34%)   Mean 0.38%   SD 0.8%      |
 __________________________________________________________________________________________________________________________________
|#Skin:                                                                                                                            |
|   Basal Cell Carcinoma or              0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|      Basosquamous Tumor (malignant or  0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|      NOS)                              1/50 (2%)     1/100(1%)     0/50 (0%)           1/50 (2%)     0/100(0%)     1/50 (2%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           1/50 (2%)     0/50 (0%)     1/50 (2%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        1/50 (2%)     1/50 (2%)                         1/50 (2%)     0/50 (0%)                   |
| Overall Incidence               Total 4/1459 (0.27%)  Mean 0.27%   SD 0.67%     Total 5/1459 (0.34%)   Mean 0.38%   SD 0.8%      |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 44
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|#Skin:                                                                                                                            |
|   Basal Cell Carcinoma, Basal Cell     0/50 (0%)     2/100(2%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|      Adenoma, Basosquamous Tumor       1/50 (2%)     0/50 (0%)     2/50 (4%)           1/50 (2%)     1/50 (2%)     0/50 (0%)     |
|      (benign, malignant or NOS), or    1/50 (2%)     3/100(3%)     1/50 (2%)           2/50 (4%)     0/100(0%)     1/50 (2%)     |
|      Trichoepithelioma                 1/50 (2%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     3/100(3%)     1/50 (2%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        1/50 (2%)     1/50 (2%)     1/50 (2%)           2/50 (4%)     1/50 (2%)     3/50 (6%)     |
|                                        0/50 (0%)     2/60 (3%)     1/50 (2%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        2/50 (4%)     2/50 (4%)                         1/50 (2%)     0/50 (0%)                   |
| Overall Incidence               Total 25/1459 (1.71%) Mean 1.59%   SD 1.43%     Total 12/1459 (0.82%)  Mean 0.92%   SD 1.62%     |
 __________________________________________________________________________________________________________________________________
|#Skin:                                                                                                                            |
|   Basal or Sq. Cell Carcinoma,        11/50 (22%)   11/100(11%)    1/50 (2%)           3/50 (6%)     1/100(1%)     0/50 (0%)     |
|      Carcinoma, Basosq. Tumor (M or    4/50 (8%)     2/50 (4%)     6/50 (12%)          1/50 (2%)     2/50 (4%)     0/50 (0%)     |
|      B), Basal Cell Adenoma, Adenoma,  3/50 (6%)     8/100(8%)     3/50 (6%)           3/50 (6%)     0/100(0%)     1/50 (2%)     |
|      Papilloma, Sq Papilloma,          2/50 (4%)     2/50 (4%)     4/49 (8%)           0/50 (0%)     1/50 (2%)     1/49 (2%)     |
|      Keratoacanthoma,                  2/50 (4%)     1/50 (2%)     5/50 (10%)          0/50 (0%)     1/50 (2%)     0/50 (0%)     |
|      Trichoepithelioma                 0/50 (0%)    14/100(14%)    5/50 (10%)          0/50 (0%)     1/100(1%)     1/50 (2%)     |
|                                        2/50 (4%)     3/50 (6%)     5/50 (10%)          2/50 (4%)     2/50 (4%)     3/50 (6%)     |
|                                        4/50 (8%)     7/60 (12%)    4/50 (8%)           1/50 (2%)     0/60 (0%)     0/50 (0%)     |
|                                        4/50 (8%)     7/50 (14%)                        1/50 (2%)     1/50 (2%)                   |
| Overall Incidence               Total 120/1459 (8.22%)Mean 7.88%   SD 4.67%     Total 26/1459 (1.78%)  Mean 1.92%   SD 1.98%     |
 __________________________________________________________________________________________________________________________________
|#Skin:                                                                                                                            |
|   Hemangioma                           0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     1/49 (2%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     2/50 (4%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/50 (2%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 3/1459 (0.21%)  Mean 0.23%   SD 0.86%     Total 1/1459 (0.07%)   Mean 0.08%   SD 0.4%      |
 __________________________________________________________________________________________________________________________________
|#Skin:                                                                                                                            |
|   Hemangiopericytoma                   0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           1/50 (2%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 0/1459 (0%)     Mean 0%      SD 0%        Total 1/1459 (0.07%)   Mean 0.08%   SD 0.39%     |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 45
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|#Skin:                                                                                                                            |
|   Hemangiosarcoma                      0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     1/50 (2%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/50 (2%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/60 (2%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 3/1459 (0.21%)  Mean 0.22%   SD 0.62%     Total 0/1459 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#Skin:                                                                                                                            |
|   Keratoacanthoma                     10/50 (20%)    8/100(8%)     1/50 (2%)           3/50 (6%)     0/100(0%)     0/50 (0%)     |
|                                        2/50 (4%)     1/50 (2%)     3/50 (6%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        2/50 (4%)     5/100(5%)     1/50 (2%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     2/50 (4%)     4/49 (8%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        1/50 (2%)     0/50 (0%)     4/50 (8%)           0/50 (0%)     1/50 (2%)     0/50 (0%)     |
|                                        0/50 (0%)    10/100(10%)    3/50 (6%)           0/50 (0%)     1/100(1%)     1/50 (2%)     |
|                                        1/50 (2%)     1/50 (2%)     4/50 (8%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        3/50 (6%)     5/60 (8%)     2/50 (4%)           1/50 (2%)     0/60 (0%)     0/50 (0%)     |
|                                        3/50 (6%)     3/50 (6%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 79/1459 (5.41%) Mean 5.13%   SD 4.17%     Total 7/1459 (0.48%)   Mean 0.5%    SD 1.3%      |
 __________________________________________________________________________________________________________________________________
|#Skin:                                                                                                                            |
|   Lipoma                               0/50 (0%)     0/100(0%)     1/50 (2%)           0/50 (0%)     2/100(2%)     0/50 (0%)     |
|                                        1/50 (2%)     1/50 (2%)     1/50 (2%)           1/50 (2%)     0/50 (0%)     1/50 (2%)     |
|                                        1/50 (2%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        1/50 (2%)     1/50 (2%)     1/49 (2%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        1/50 (2%)     2/50 (4%)     2/50 (4%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/100(1%)     1/50 (2%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     1/50 (2%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     1/50 (2%)     |
|                                        0/50 (0%)     0/50 (0%)                         1/50 (2%)     0/50 (0%)                   |
| Overall Incidence               Total 15/1459 (1.03%) Mean 1.12%   SD 1.28%     Total 7/1459 (0.48%)   Mean 0.46%   SD 0.86%     |
 __________________________________________________________________________________________________________________________________
|#Skin:                                                                                                                            |
|   Liposarcoma                          0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           1/50 (2%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 0/1459 (0%)     Mean 0%      SD 0%        Total 1/1459 (0.07%)   Mean 0.08%   SD 0.39%     |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 46
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|#Skin:                                                                                                                            |
|   Melanoma Malignant                   0/50 (0%)     1/100(1%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 1/1459 (0.07%)  Mean 0.04%   SD 0.2%      Total 0/1459 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#Skin:                                                                                                                            |
|   Neural Crest Tumor                   0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     1/50 (2%)           0/50 (0%)     1/100(1%)     1/50 (2%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     1/50 (2%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     1/50 (2%)           0/50 (0%)     0/50 (0%)     1/50 (2%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/50 (2%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 4/1459 (0.27%)  Mean 0.31%   SD 0.74%     Total 3/1459 (0.21%)   Mean 0.19%   SD 0.57%     |
 __________________________________________________________________________________________________________________________________
|#Skin:                                                                                                                            |
|   Osteosarcoma                         1/50 (2%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 1/1459 (0.07%)  Mean 0.08%   SD 0.39%     Total 0/1459 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#Skin:                                                                                                                            |
|   Squamous Cell Carcinoma              0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/50 (2%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           1/50 (2%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     1/50 (2%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/50 (2%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/50 (2%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 3/1459 (0.21%)  Mean 0.23%   SD 0.65%     Total 2/1459 (0.14%)   Mean 0.15%   SD 0.54%     |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 47
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|#Skin:                                                                                                                            |
|   Squamous Cell Carcinoma, Basal       0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|      Cell Carcinoma, Basosquamous      0/50 (0%)     1/50 (2%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|      Tumor (malignant or NOS), or      1/50 (2%)     1/100(1%)     0/50 (0%)           2/50 (4%)     0/100(0%)     1/50 (2%)     |
|      Carcinoma                         0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     1/50 (2%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/50 (2%)     0/50 (0%)           1/50 (2%)     0/50 (0%)     1/50 (2%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        1/50 (2%)     1/50 (2%)                         1/50 (2%)     0/50 (0%)                   |
| Overall Incidence               Total 6/1459 (0.41%)  Mean 0.42%   SD 0.81%     Total 7/1459 (0.48%)   Mean 0.54%   SD 1.07%     |
 __________________________________________________________________________________________________________________________________
|#Skin:                                                                                                                            |
|   Squamous Cell Papilloma              1/50 (2%)     1/100(1%)     0/50 (0%)           0/50 (0%)     1/100(1%)     0/50 (0%)     |
|                                        1/50 (2%)     0/50 (0%)     1/50 (2%)           0/50 (0%)     1/50 (2%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     1/50 (2%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     1/49 (2%)     |
|                                        1/50 (2%)     1/50 (2%)     1/50 (2%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/100(1%)     1/50 (2%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     1/50 (2%)     0/50 (0%)     |
|                                        1/50 (2%)     0/60 (0%)     1/50 (2%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     2/50 (4%)                         0/50 (0%)     1/50 (2%)                   |
| Overall Incidence               Total 15/1459 (1.03%) Mean 1.08%   SD 1.13%     Total 5/1459 (0.34%)   Mean 0.35%   SD 0.75%     |
 __________________________________________________________________________________________________________________________________
|#Skin:                                                                                                                            |
|   Squamous Cell Papilloma or           1/50 (2%)     1/100(1%)     0/50 (0%)           0/50 (0%)     1/100(1%)     0/50 (0%)     |
|      Papilloma                         1/50 (2%)     0/50 (0%)     1/50 (2%)           0/50 (0%)     1/50 (2%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     1/50 (2%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     1/49 (2%)     |
|                                        1/50 (2%)     1/50 (2%)     1/50 (2%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/100(1%)     1/50 (2%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     1/50 (2%)     0/50 (0%)     |
|                                        1/50 (2%)     0/60 (0%)     1/50 (2%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     2/50 (4%)                         0/50 (0%)     1/50 (2%)                   |
| Overall Incidence               Total 15/1459 (1.03%) Mean 1.08%   SD 1.13%     Total 5/1459 (0.34%)   Mean 0.35%   SD 0.75%     |
 __________________________________________________________________________________________________________________________________
|#Skin:                                                                                                                            |
|   Squamous Cell Papilloma,            11/50 (22%)    9/100(9%)     1/50 (2%)           3/50 (6%)     1/100(1%)     0/50 (0%)     |
|      Papilloma, Squamous Cell          3/50 (6%)     2/50 (4%)     4/50 (8%)           0/50 (0%)     1/50 (2%)     0/50 (0%)     |
|      Carcinoma or Keratoacanthoma      2/50 (4%)     5/100(5%)     2/50 (4%)           1/50 (2%)     0/100(0%)     0/50 (0%)     |
|                                        1/50 (2%)     2/50 (4%)     4/49 (8%)           0/50 (0%)     1/50 (2%)     1/49 (2%)     |
|                                        2/50 (4%)     1/50 (2%)     5/50 (10%)          0/50 (0%)     1/50 (2%)     0/50 (0%)     |
|                                        0/50 (0%)    11/100(11%)    4/50 (8%)           0/50 (0%)     1/100(1%)     1/50 (2%)     |
|                                        1/50 (2%)     2/50 (4%)     4/50 (8%)           0/50 (0%)     1/50 (2%)     0/50 (0%)     |
|                                        4/50 (8%)     5/60 (8%)     3/50 (6%)           1/50 (2%)     0/60 (0%)     0/50 (0%)     |
|                                        3/50 (6%)     6/50 (12%)                        0/50 (0%)     1/50 (2%)                   |
| Overall Incidence               Total 97/1459 (6.65%) Mean 6.44%   SD 4.42%     Total 14/1459 (0.96%)  Mean 1%      SD 1.39%     |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 48
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|#Skin:                                                                                                                            |
|   Squamous Cell Papilloma,            11/50 (22%)    9/100(9%)     1/50 (2%)           3/50 (6%)     1/100(1%)     0/50 (0%)     |
|      Papilloma, or Keratoacanthoma     3/50 (6%)     1/50 (2%)     4/50 (8%)           0/50 (0%)     1/50 (2%)     0/50 (0%)     |
|                                        2/50 (4%)     5/100(5%)     2/50 (4%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        1/50 (2%)     2/50 (4%)     4/49 (8%)           0/50 (0%)     0/50 (0%)     1/49 (2%)     |
|                                        2/50 (4%)     1/50 (2%)     5/50 (10%)          0/50 (0%)     1/50 (2%)     0/50 (0%)     |
|                                        0/50 (0%)    11/100(11%)    4/50 (8%)           0/50 (0%)     1/100(1%)     1/50 (2%)     |
|                                        1/50 (2%)     1/50 (2%)     4/50 (8%)           0/50 (0%)     1/50 (2%)     0/50 (0%)     |
|                                        4/50 (8%)     5/60 (8%)     3/50 (6%)           1/50 (2%)     0/60 (0%)     0/50 (0%)     |
|                                        3/50 (6%)     5/50 (10%)                        0/50 (0%)     1/50 (2%)                   |
| Overall Incidence               Total 94/1459 (6.44%) Mean 6.21%   SD 4.45%     Total 12/1459 (0.82%)  Mean 0.85%   SD 1.38%     |
 __________________________________________________________________________________________________________________________________
|#Skin:                                                                                                                            |
|   Trichoepithelioma                    0/50 (0%)     1/100(1%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     1/50 (2%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/100(1%)     0/50 (0%)           1/50 (2%)     0/100(0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     1/50 (2%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/50 (0%)     1/50 (2%)           0/50 (0%)     1/50 (2%)     2/50 (4%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/50 (2%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 8/1459 (0.55%)  Mean 0.54%   SD 0.86%     Total 4/1459 (0.27%)   Mean 0.31%   SD 0.93%     |
 __________________________________________________________________________________________________________________________________
|#Skin:                                                                                                                            |
|   Fibroma                              5/50 (10%)    2/100(2%)     6/50 (12%)          3/50 (6%)     1/100(1%)     1/50 (2%)     |
|                                        1/50 (2%)     3/50 (6%)     2/50 (4%)           1/50 (2%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     7/100(7%)     2/50 (4%)           1/50 (2%)     1/100(1%)     0/50 (0%)     |
|                                        5/50 (10%)    1/50 (2%)     5/49 (10%)          0/50 (0%)     3/50 (6%)     0/49 (0%)     |
|                                        2/50 (4%)     2/50 (4%)     2/50 (4%)           1/50 (2%)     0/50 (0%)     1/50 (2%)     |
|                                        4/50 (8%)    12/100(12%)    4/50 (8%)           0/50 (0%)     4/100(4%)     2/50 (4%)     |
|                                        2/50 (4%)     8/50 (16%)    9/50 (18%)          1/50 (2%)     1/50 (2%)     4/50 (8%)     |
|                                        5/50 (10%)    5/60 (8%)     1/50 (2%)           0/50 (0%)     3/60 (5%)     0/50 (0%)     |
|                                        6/50 (12%)    5/50 (10%)                        1/50 (2%)     1/50 (2%)                   |
| Overall Incidence               Total 106/1459 (7.27%)Mean 7.29%   SD 4.6%      Total 30/1459 (2.06%)  Mean 2.04%   SD 2.22%     |
 __________________________________________________________________________________________________________________________________
|#Skin:                                                                                                                            |
|   Fibroma, Fibrosarcoma, Sarcoma,      6/50 (12%)    8/100(8%)     9/50 (18%)          4/50 (8%)     1/100(1%)     1/50 (2%)     |
|      Myxoma, Myxosarcoma, or Fibrous   3/50 (6%)     3/50 (6%)     4/50 (8%)           1/50 (2%)     0/50 (0%)     1/50 (2%)     |
|      Histiocytoma                      1/50 (2%)    12/100(12%)    4/50 (8%)           1/50 (2%)     1/100(1%)     2/50 (4%)     |
|                                        6/50 (12%)    2/50 (4%)     7/49 (14%)          0/50 (0%)     3/50 (6%)     1/49 (2%)     |
|                                        3/50 (6%)     3/50 (6%)     6/50 (12%)          3/50 (6%)     0/50 (0%)     1/50 (2%)     |
|                                        5/50 (10%)   13/100(13%)    7/50 (14%)          0/50 (0%)     6/100(6%)     2/50 (4%)     |
|                                        2/50 (4%)     8/50 (16%)   10/50 (20%)          1/50 (2%)     1/50 (2%)     4/50 (8%)     |
|                                        5/50 (10%)    5/60 (8%)     2/50 (4%)           0/50 (0%)     3/60 (5%)     2/50 (4%)     |
|                                        7/50 (14%)    6/50 (12%)                        3/50 (6%)     1/50 (2%)                   |
| Overall Incidence               Total 147/1459 (10.08%Mean 9.99%   SD 4.6%      Total 43/1459 (2.95%)  Mean 2.96%   SD 2.49%     |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 49
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|#Skin:                                                                                                                            |
|   Fibrosarcoma                         0/50 (0%)     2/100(2%)     0/50 (0%)           1/50 (2%)     0/100(0%)     0/50 (0%)     |
|                                        2/50 (4%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     1/50 (2%)     |
|                                        1/50 (2%)     6/100(6%)     2/50 (4%)           0/50 (0%)     0/100(0%)     1/50 (2%)     |
|                                        0/50 (0%)     1/50 (2%)     2/49 (4%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        1/50 (2%)     1/50 (2%)     1/50 (2%)           1/50 (2%)     0/50 (0%)     0/50 (0%)     |
|                                        1/50 (2%)     1/100(1%)     3/50 (6%)           0/50 (0%)     1/100(1%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     1/50 (2%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     1/50 (2%)     |
|                                        0/50 (0%)     0/50 (0%)                         1/50 (2%)     0/50 (0%)                   |
| Overall Incidence               Total 25/1459 (1.71%) Mean 1.58%   SD 1.88%     Total 7/1459 (0.48%)   Mean 0.5%    SD 0.86%     |
 __________________________________________________________________________________________________________________________________
|#Skin:                                                                                                                            |
|   Fibrosarcoma, Sarcoma,               1/50 (2%)     5/100(5%)     3/50 (6%)           1/50 (2%)     0/100(0%)     0/50 (0%)     |
|      Myxosarcoma, or Fibrous           2/50 (4%)     0/50 (0%)     2/50 (4%)           0/50 (0%)     0/50 (0%)     1/50 (2%)     |
|      Histiocytoma                      1/50 (2%)     6/100(6%)     2/50 (4%)           0/50 (0%)     0/100(0%)     2/50 (4%)     |
|                                        1/50 (2%)     1/50 (2%)     2/49 (4%)           0/50 (0%)     0/50 (0%)     1/49 (2%)     |
|                                        1/50 (2%)     1/50 (2%)     4/50 (8%)           2/50 (4%)     0/50 (0%)     0/50 (0%)     |
|                                        1/50 (2%)     1/100(1%)     3/50 (6%)           0/50 (0%)     2/100(2%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     1/50 (2%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     1/50 (2%)           0/50 (0%)     0/60 (0%)     2/50 (4%)     |
|                                        1/50 (2%)     1/50 (2%)                         2/50 (4%)     0/50 (0%)                   |
| Overall Incidence               Total 41/1459 (2.81%) Mean 2.7%    SD 2.17%     Total 13/1459 (0.89%)  Mean 0.92%   SD 1.52%     |
 __________________________________________________________________________________________________________________________________
|#Skin:                                                                                                                            |
|   Fibrous Histiocytoma                 1/50 (2%)     2/100(2%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     1/50 (2%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     2/50 (4%)           1/50 (2%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     1/50 (2%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 8/1459 (0.55%)  Mean 0.54%   SD 1.07%     Total 1/1459 (0.07%)   Mean 0.08%   SD 0.39%     |
 __________________________________________________________________________________________________________________________________
|#Skin:                                                                                                                            |
|   Myxoma                               0/50 (0%)     1/100(1%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 1/1459 (0.07%)  Mean 0.04%   SD 0.2%      Total 0/1459 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 50
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|#Skin:                                                                                                                            |
|   Myxosarcoma                          0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         1/50 (2%)     0/50 (0%)                   |
| Overall Incidence               Total 0/1459 (0%)     Mean 0%      SD 0%        Total 1/1459 (0.07%)   Mean 0.08%   SD 0.39%     |
 __________________________________________________________________________________________________________________________________
|#Skin:                                                                                                                            |
|   Neurofibroma or Schwannoma benign    0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     1/50 (2%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 0/1459 (0%)     Mean 0%      SD 0%        Total 1/1459 (0.07%)   Mean 0.08%   SD 0.39%     |
 __________________________________________________________________________________________________________________________________
|#Skin:                                                                                                                            |
|   Neurofibrosarcoma or Schwannoma      0/50 (0%)     2/100(2%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|      (malignant or NOS)                0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     1/50 (2%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        2/50 (4%)     0/60 (0%)     0/50 (0%)           2/50 (4%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         1/50 (2%)     0/50 (0%)                   |
| Overall Incidence               Total 6/1459 (0.41%)  Mean 0.38%   SD 0.98%     Total 3/1459 (0.21%)   Mean 0.23%   SD 0.86%     |
 __________________________________________________________________________________________________________________________________
|#Skin:                                                                                                                            |
|   Neurofibrosarcoma, Neurofibroma,     0/50 (0%)     2/100(2%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|      or Schwannoma (benign, malignant  0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|      or NOS)                           0/50 (0%)     0/100(0%)     1/50 (2%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     1/50 (2%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        2/50 (4%)     0/60 (0%)     0/50 (0%)           2/50 (4%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         1/50 (2%)     0/50 (0%)                   |
| Overall Incidence               Total 6/1459 (0.41%)  Mean 0.38%   SD 0.98%     Total 4/1459 (0.27%)   Mean 0.31%   SD 0.93%     |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 51
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|#Skin:                                                                                                                            |
|   Sarcoma                              0/50 (0%)     1/100(1%)     3/50 (6%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     1/50 (2%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     1/50 (2%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     1/49 (2%)     |
|                                        0/50 (0%)     0/50 (0%)     1/50 (2%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     1/100(1%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     1/50 (2%)     |
|                                        1/50 (2%)     1/50 (2%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 8/1459 (0.55%)  Mean 0.58%   SD 1.33%     Total 4/1459 (0.27%)   Mean 0.27%   SD 0.67%     |
 __________________________________________________________________________________________________________________________________
|#Skin:                                                                                                                            |
|   Schwannoma Benign                    0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     1/50 (2%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 0/1459 (0%)     Mean 0%      SD 0%        Total 1/1459 (0.07%)   Mean 0.08%   SD 0.39%     |
 __________________________________________________________________________________________________________________________________
|#Skin:                                                                                                                            |
|   Schwannoma Malignant                 0/50 (0%)     2/100(2%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     1/50 (2%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        2/50 (4%)     0/60 (0%)     0/50 (0%)           2/50 (4%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         1/50 (2%)     0/50 (0%)                   |
| Overall Incidence               Total 6/1459 (0.41%)  Mean 0.38%   SD 0.98%     Total 3/1459 (0.21%)   Mean 0.23%   SD 0.86%     |
 __________________________________________________________________________________________________________________________________
|*Spleen:                                                                                                                          |
|   Hemangioma                           0/50 (0%)     0/100(0%)     0/43 (0%)           0/49 (0%)     0/100(0%)     0/48 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/49 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/49 (0%)     0/50 (0%)     0/48 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/48 (0%)     0/50 (0%)                         0/50 (0%)     0/47 (0%)                   |
| Overall Incidence               Total 1/1447 (0.07%)  Mean 0.08%   SD 0.39%     Total 0/1451 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 52
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|*Spleen:                                                                                                                          |
|   Hemangiosarcoma                      0/50 (0%)     0/100(0%)     0/43 (0%)           0/49 (0%)     0/100(0%)     0/48 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     1/49 (2%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/49 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/49 (0%)     0/50 (0%)     0/48 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        1/48 (2%)     0/50 (0%)                         0/50 (0%)     0/47 (0%)                   |
| Overall Incidence               Total 1/1447 (0.07%)  Mean 0.08%   SD 0.41%     Total 1/1451 (0.07%)   Mean 0.08%   SD 0.4%      |
 __________________________________________________________________________________________________________________________________
|#Stomach, Forestomach:                                                                                                            |
|   Leiomyosarcoma                       0/50 (0%)     1/100(1%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 1/1459 (0.07%)  Mean 0.04%   SD 0.2%      Total 0/1459 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#Stomach, Forestomach:                                                                                                            |
|   Lipoma                               0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     1/50 (2%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 1/1459 (0.07%)  Mean 0.08%   SD 0.39%     Total 0/1459 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#Stomach, Forestomach:                                                                                                            |
|   Schwannoma Malignant                 0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     1/50 (2%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 1/1459 (0.07%)  Mean 0.08%   SD 0.39%     Total 0/1459 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 53
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|#Stomach, Forestomach:                                                                                                            |
|   Squamous Cell Carcinoma or           0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     2/50 (4%)     |
|      Papilloma Squamous                0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        1/50 (2%)     1/100(1%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/100(1%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/50 (2%)                         0/50 (0%)     1/50 (2%)                   |
| Overall Incidence               Total 5/1459 (0.34%)  Mean 0.31%   SD 0.68%     Total 3/1459 (0.21%)   Mean 0.23%   SD 0.86%     |
 __________________________________________________________________________________________________________________________________
|#Stomach, Forestomach:                                                                                                            |
|   Squamous Cell Papilloma              0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     2/50 (4%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        1/50 (2%)     1/100(1%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/100(1%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/50 (2%)                         0/50 (0%)     1/50 (2%)                   |
| Overall Incidence               Total 5/1459 (0.34%)  Mean 0.31%   SD 0.68%     Total 3/1459 (0.21%)   Mean 0.23%   SD 0.86%     |
 __________________________________________________________________________________________________________________________________
|#Stomach, Glandular:                                                                                                              |
|   Carcinoma                            0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/50 (2%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 1/1459 (0.07%)  Mean 0.08%   SD 0.39%     Total 0/1459 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#Stomach, Glandular:                                                                                                              |
|   Carcinoma or Adenoma                 0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/50 (2%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 1/1459 (0.07%)  Mean 0.08%   SD 0.39%     Total 0/1459 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 54
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|#Stomach, Glandular:                                                                                                              |
|   Leiomyosarcoma                       0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 3/1459 (0.21%)  Mean 0.23%   SD 0.65%     Total 0/1459 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#Stomach, Glandular:                                                                                                              |
|   Lipoma                               0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        1/50 (2%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 1/1459 (0.07%)  Mean 0.08%   SD 0.39%     Total 0/1459 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|*Testes:                                                                                                                          |
|   Adenoma                             45/50 (90%)   96/100(96%)   45/50 (90%)                                                    |
|                                       44/50 (88%)   40/50 (80%)   41/50 (82%)                                                    |
|                                       47/50 (94%)   91/100(91%)   40/50 (80%)                                                    |
|                                       38/50 (76%)   40/50 (80%)   38/49 (78%)                                                    |
|                                       41/50 (82%)   41/50 (82%)   36/50 (72%)                                                    |
|                                       42/50 (84%)   93/100(93%)   41/50 (82%)                                                    |
|                                       48/50 (96%)   46/50 (92%)   45/50 (90%)                                                    |
|                                       36/50 (72%)   55/60 (92%)   49/50 (98%)                                                    |
|                                       45/50 (90%)   41/50 (82%)                                                                  |
| Overall Incidence               Total 1264/1459 (86.63Mean 85.82%  SD 7.41%                                                      |
 __________________________________________________________________________________________________________________________________
|*Testes:                                                                                                                          |
|   Carcinoma                            0/50 (0%)     0/100(0%)     0/50 (0%)                                                     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)                                                     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)                                                     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)                                                     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)                                                     |
|                                        0/50 (0%)     1/100(1%)     0/50 (0%)                                                     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)                                                     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)                                                     |
|                                        0/50 (0%)     0/50 (0%)                                                                   |
| Overall Incidence               Total 1/1459 (0.07%)  Mean 0.04%   SD 0.2%                                                       |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 55
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|*Thymus:                                                                                                                          |
|   Sarcoma                              0/48 (0%)     0/97 (0%)     0/39 (0%)           0/50 (0%)     0/96 (0%)     0/48 (0%)     |
|                                        0/45 (0%)     0/49 (0%)     0/46 (0%)           0/45 (0%)     0/48 (0%)     0/46 (0%)     |
|                                        0/50 (0%)     0/87 (0%)     0/50 (0%)           0/49 (0%)     0/92 (0%)     0/48 (0%)     |
|                                        0/48 (0%)     0/47 (0%)     0/47 (0%)           0/45 (0%)     0/45 (0%)     0/46 (0%)     |
|                                        0/47 (0%)     0/49 (0%)     0/49 (0%)           0/45 (0%)     0/47 (0%)     0/49 (0%)     |
|                                        0/49 (0%)     0/97 (0%)     0/50 (0%)           0/47 (0%)     0/95 (0%)     0/48 (0%)     |
|                                        0/48 (0%)     0/48 (0%)     0/48 (0%)           0/48 (0%)     0/47 (0%)     0/49 (0%)     |
|                                        0/49 (0%)     0/56 (0%)     0/49 (0%)           0/50 (0%)     0/57 (0%)     0/48 (0%)     |
|                                        0/48 (0%)     1/49 (2%)                         0/48 (0%)     0/49 (0%)                   |
| Overall Incidence               Total 1/1389 (0.07%)  Mean 0.08%   SD 0.4%      Total 0/1385 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|*Thymus:                                                                                                                          |
|   Thymoma Benign                       0/48 (0%)     0/97 (0%)     0/39 (0%)           0/50 (0%)     0/96 (0%)     1/48 (2%)     |
|                                        0/45 (0%)     0/49 (0%)     0/46 (0%)           0/45 (0%)     0/48 (0%)     0/46 (0%)     |
|                                        0/50 (0%)     1/87 (1%)     0/50 (0%)           0/49 (0%)     0/92 (0%)     0/48 (0%)     |
|                                        0/48 (0%)     0/47 (0%)     0/47 (0%)           0/45 (0%)     0/45 (0%)     0/46 (0%)     |
|                                        0/47 (0%)     0/49 (0%)     0/49 (0%)           0/45 (0%)     0/47 (0%)     0/49 (0%)     |
|                                        0/49 (0%)     2/97 (2%)     0/50 (0%)           0/47 (0%)     0/95 (0%)     0/48 (0%)     |
|                                        0/48 (0%)     0/48 (0%)     0/48 (0%)           0/48 (0%)     0/47 (0%)     0/49 (0%)     |
|                                        0/49 (0%)     0/56 (0%)     0/49 (0%)           0/50 (0%)     0/57 (0%)     0/48 (0%)     |
|                                        0/48 (0%)     1/49 (2%)                         0/48 (0%)     0/49 (0%)                   |
| Overall Incidence               Total 4/1389 (0.29%)  Mean 0.2%    SD 0.59%     Total 1/1385 (0.07%)   Mean 0.08%   SD 0.41%     |
 __________________________________________________________________________________________________________________________________
|*Thymus:                                                                                                                          |
|   Thymoma Malignant                    0/48 (0%)     0/97 (0%)     0/39 (0%)           0/50 (0%)     0/96 (0%)     0/48 (0%)     |
|                                        0/45 (0%)     0/49 (0%)     0/46 (0%)           0/45 (0%)     0/48 (0%)     0/46 (0%)     |
|                                        0/50 (0%)     0/87 (0%)     0/50 (0%)           0/49 (0%)     1/92 (1%)     0/48 (0%)     |
|                                        0/48 (0%)     0/47 (0%)     0/47 (0%)           0/45 (0%)     0/45 (0%)     0/46 (0%)     |
|                                        0/47 (0%)     1/49 (2%)     0/49 (0%)           0/45 (0%)     0/47 (0%)     0/49 (0%)     |
|                                        0/49 (0%)     0/97 (0%)     0/50 (0%)           0/47 (0%)     0/95 (0%)     0/48 (0%)     |
|                                        0/48 (0%)     0/48 (0%)     0/48 (0%)           0/48 (0%)     0/47 (0%)     0/49 (0%)     |
|                                        0/49 (0%)     0/56 (0%)     0/49 (0%)           0/50 (0%)     0/57 (0%)     0/48 (0%)     |
|                                        0/48 (0%)     0/49 (0%)                         1/48 (2%)     0/49 (0%)                   |
| Overall Incidence               Total 1/1389 (0.07%)  Mean 0.08%   SD 0.4%      Total 2/1385 (0.14%)   Mean 0.12%   SD 0.45%     |
 __________________________________________________________________________________________________________________________________
|*Thymus:                                                                                                                          |
|   Thymoma: Benign, Malignant, NOS      0/48 (0%)     0/97 (0%)     0/39 (0%)           0/50 (0%)     0/96 (0%)     1/48 (2%)     |
|                                        0/45 (0%)     0/49 (0%)     0/46 (0%)           0/45 (0%)     0/48 (0%)     0/46 (0%)     |
|                                        0/50 (0%)     1/87 (1%)     0/50 (0%)           0/49 (0%)     1/92 (1%)     0/48 (0%)     |
|                                        0/48 (0%)     0/47 (0%)     0/47 (0%)           0/45 (0%)     0/45 (0%)     0/46 (0%)     |
|                                        0/47 (0%)     1/49 (2%)     0/49 (0%)           0/45 (0%)     0/47 (0%)     0/49 (0%)     |
|                                        0/49 (0%)     2/97 (2%)     0/50 (0%)           0/47 (0%)     0/95 (0%)     0/48 (0%)     |
|                                        0/48 (0%)     0/48 (0%)     0/48 (0%)           0/48 (0%)     0/47 (0%)     0/49 (0%)     |
|                                        0/49 (0%)     0/56 (0%)     0/49 (0%)           0/50 (0%)     0/57 (0%)     0/48 (0%)     |
|                                        0/48 (0%)     1/49 (2%)                         1/48 (2%)     0/49 (0%)                   |
| Overall Incidence               Total 5/1389 (0.36%)  Mean 0.28%   SD 0.69%     Total 3/1385 (0.22%)   Mean 0.2%    SD 0.59%     |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 56
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|*Thyroid Gland: C-Cell                                                                                                            |
|   Adenoma                             10/50 (20%)   12/100(12%)    4/42 (10%)          4/50 (8%)    21/100(21%)    6/45 (13%)    |
|                                        8/50 (16%)    9/50 (18%)    8/50 (16%)         11/50 (22%)    3/50 (6%)     5/50 (10%)    |
|                                       12/50 (24%)   12/100(12%)    7/50 (14%)          7/50 (14%)   11/100(11%)    5/50 (10%)    |
|                                        2/50 (4%)     5/49 (10%)    9/46 (20%)          0/50 (0%)     6/47 (13%)    4/47 (9%)     |
|                                        3/50 (6%)     7/50 (14%)    1/50 (2%)           8/49 (16%)    3/49 (6%)     2/50 (4%)     |
|                                        1/50 (2%)    15/99 (15%)    4/50 (8%)           3/50 (6%)    15/100(15%)   12/50 (24%)    |
|                                        9/48 (19%)   11/47 (23%)    9/47 (19%)          9/49 (18%)   10/47 (21%)   12/47 (26%)    |
|                                        5/50 (10%)   10/59 (17%)   11/50 (22%)          3/50 (6%)     9/60 (15%)    6/50 (12%)    |
|                                        8/46 (17%)    6/50 (12%)                        2/49 (4%)     6/50 (12%)                  |
| Overall Incidence               Total 198/1433 (13.82%Mean 13.93%  SD 6.21%     Total 183/1439 (12.72%)Mean 12.4%   SD 6.71%     |
 __________________________________________________________________________________________________________________________________
|*Thyroid Gland: C-Cell                                                                                                            |
|   Carcinoma                            1/50 (2%)     4/100(4%)     2/42 (5%)           0/50 (0%)     0/100(0%)     1/45 (2%)     |
|                                        2/50 (4%)     1/50 (2%)     0/50 (0%)           0/50 (0%)     2/50 (4%)     2/50 (4%)     |
|                                        2/50 (4%)     3/100(3%)     0/50 (0%)           2/50 (4%)     3/100(3%)     3/50 (6%)     |
|                                        1/50 (2%)     1/49 (2%)     1/46 (2%)           1/50 (2%)     3/47 (6%)     3/47 (6%)     |
|                                        1/50 (2%)     2/50 (4%)     0/50 (0%)           2/49 (4%)     1/49 (2%)     1/50 (2%)     |
|                                        2/50 (4%)     1/99 (1%)     1/50 (2%)           1/50 (2%)     5/100(5%)     1/50 (2%)     |
|                                        1/48 (2%)     0/47 (0%)     2/47 (4%)           0/49 (0%)     1/47 (2%)     1/47 (2%)     |
|                                        5/50 (10%)    0/59 (0%)     0/50 (0%)           2/50 (4%)     1/60 (2%)     0/50 (0%)     |
|                                        1/46 (2%)     1/50 (2%)                         1/49 (2%)     0/50 (0%)                   |
| Overall Incidence               Total 35/1433 (2.44%) Mean 2.44%   SD 2.17%     Total 37/1439 (2.57%)  Mean 2.58%   SD 2%        |
 __________________________________________________________________________________________________________________________________
|*Thyroid Gland: C-Cell                                                                                                            |
|   Carcinoma or Adenoma                11/50 (22%)   16/100(16%)    6/42 (14%)          4/50 (8%)    21/100(21%)    7/45 (16%)    |
|                                       10/50 (20%)   10/50 (20%)    8/50 (16%)         11/50 (22%)    5/50 (10%)    7/50 (14%)    |
|                                       14/50 (28%)   15/100(15%)    7/50 (14%)          9/50 (18%)   14/100(14%)    8/50 (16%)    |
|                                        3/50 (6%)     6/49 (12%)   10/46 (22%)          1/50 (2%)     8/47 (17%)    7/47 (15%)    |
|                                        4/50 (8%)     9/50 (18%)    1/50 (2%)           9/49 (18%)    4/49 (8%)     3/50 (6%)     |
|                                        3/50 (6%)    16/99 (16%)    5/50 (10%)          4/50 (8%)    19/100(19%)   13/50 (26%)    |
|                                       10/48 (21%)   11/47 (23%)   11/47 (23%)          9/49 (18%)   11/47 (23%)   13/47 (28%)    |
|                                       10/50 (20%)   10/59 (17%)   11/50 (22%)          5/50 (10%)   10/60 (17%)    6/50 (12%)    |
|                                        9/46 (20%)    7/50 (14%)                        3/49 (6%)     6/50 (12%)                  |
| Overall Incidence               Total 233/1433 (16.26%Mean 16.37%  SD 6.22%     Total 217/1439 (15.08%)Mean 14.78%  SD 6.43%     |
 __________________________________________________________________________________________________________________________________
|*Thyroid Gland: Follicular Cell                                                                                                   |
|   Adenoma                              2/50 (4%)     3/100(3%)     1/42 (2%)           0/50 (0%)     0/100(0%)     0/45 (0%)     |
|                                        0/50 (0%)     1/50 (2%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     1/50 (2%)     |
|                                        1/50 (2%)     1/100(1%)     0/50 (0%)           1/50 (2%)     1/100(1%)     0/50 (0%)     |
|                                        1/50 (2%)     0/49 (0%)     0/46 (0%)           0/50 (0%)     0/47 (0%)     0/47 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/49 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/99 (1%)     0/50 (0%)           1/50 (2%)     0/100(0%)     0/50 (0%)     |
|                                        1/48 (2%)     0/47 (0%)     1/47 (2%)           0/49 (0%)     2/47 (4%)     0/47 (0%)     |
|                                        1/50 (2%)     0/59 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/46 (0%)     1/50 (2%)                         0/49 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 15/1433 (1.05%) Mean 0.98%   SD 1.21%     Total 6/1439 (0.42%)   Mean 0.43%   SD 1.02%     |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 57
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|*Thyroid Gland: Follicular Cell                                                                                                   |
|   Carcinoma                            0/50 (0%)     1/100(1%)     0/42 (0%)           0/50 (0%)     1/100(1%)     1/45 (2%)     |
|                                        2/50 (4%)     0/50 (0%)     0/50 (0%)           1/50 (2%)     1/50 (2%)     0/50 (0%)     |
|                                        1/50 (2%)     3/100(3%)     0/50 (0%)           1/50 (2%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/49 (0%)     0/46 (0%)           0/50 (0%)     1/47 (2%)     1/47 (2%)     |
|                                        1/50 (2%)     1/50 (2%)     0/50 (0%)           0/49 (0%)     0/49 (0%)     2/50 (4%)     |
|                                        1/50 (2%)     0/99 (0%)     1/50 (2%)           0/50 (0%)     0/100(0%)     1/50 (2%)     |
|                                        0/48 (0%)     0/47 (0%)     0/47 (0%)           1/49 (2%)     0/47 (0%)     1/47 (2%)     |
|                                        0/50 (0%)     1/59 (2%)     0/50 (0%)           1/50 (2%)     0/60 (0%)     1/50 (2%)     |
|                                        0/46 (0%)     0/50 (0%)                         0/49 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 12/1433 (0.84%) Mean 0.76%   SD 1.17%     Total 14/1439 (0.97%)  Mean 1.06%   SD 1.17%     |
 __________________________________________________________________________________________________________________________________
|*Thyroid Gland: Follicular Cell                                                                                                   |
|   Carcinoma or Adenoma                 2/50 (4%)     4/100(4%)     1/42 (2%)           0/50 (0%)     1/100(1%)     1/45 (2%)     |
|                                        2/50 (4%)     1/50 (2%)     0/50 (0%)           1/50 (2%)     1/50 (2%)     1/50 (2%)     |
|                                        2/50 (4%)     4/100(4%)     0/50 (0%)           2/50 (4%)     1/100(1%)     0/50 (0%)     |
|                                        1/50 (2%)     0/49 (0%)     0/46 (0%)           0/50 (0%)     1/47 (2%)     1/47 (2%)     |
|                                        1/50 (2%)     1/50 (2%)     0/50 (0%)           0/49 (0%)     0/49 (0%)     2/50 (4%)     |
|                                        1/50 (2%)     1/99 (1%)     1/50 (2%)           1/50 (2%)     0/100(0%)     1/50 (2%)     |
|                                        1/48 (2%)     0/47 (0%)     1/47 (2%)           1/49 (2%)     2/47 (4%)     1/47 (2%)     |
|                                        1/50 (2%)     1/59 (2%)     0/50 (0%)           1/50 (2%)     0/60 (0%)     1/50 (2%)     |
|                                        0/46 (0%)     1/50 (2%)                         0/49 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 27/1433 (1.88%) Mean 1.74%   SD 1.44%     Total 20/1439 (1.39%)  Mean 1.5%    SD 1.34%     |
 __________________________________________________________________________________________________________________________________
|#Tissue NOS:                                                                                                                      |
|   Fibrosarcoma                         0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           1/50 (2%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 0/1459 (0%)     Mean 0%      SD 0%        Total 1/1459 (0.07%)   Mean 0.08%   SD 0.39%     |
 __________________________________________________________________________________________________________________________________
|#Tissue NOS:                                                                                                                      |
|   Leiomyoma                            0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     1/50 (2%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 1/1459 (0.07%)  Mean 0.08%   SD 0.39%     Total 0/1459 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 58
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|#Tissue NOS:                                                                                                                      |
|   Paraganglioma                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     1/50 (2%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 1/1459 (0.07%)  Mean 0.08%   SD 0.39%     Total 0/1459 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#Tissue NOS:                                                                                                                      |
|   Sarcoma                              0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/100(1%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 2/1459 (0.14%)  Mean 0.12%   SD 0.43%     Total 0/1459 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#Tissue NOS:                                                                                                                      |
|   Schwannoma Malignant                 0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/100(1%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     1/50 (2%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 1/1459 (0.07%)  Mean 0.04%   SD 0.2%      Total 1/1459 (0.07%)   Mean 0.08%   SD 0.39%     |
 __________________________________________________________________________________________________________________________________
|#Tongue:                                                                                                                          |
|   Liposarcoma                          0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           1/50 (2%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 0/1459 (0%)     Mean 0%      SD 0%        Total 1/1459 (0.07%)   Mean 0.08%   SD 0.39%     |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 59
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|#Tongue:                                                                                                                          |
|   Squamous Cell Carcinoma              0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     1/50 (2%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     1/50 (2%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     1/50 (2%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 0/1459 (0%)     Mean 0%      SD 0%        Total 3/1459 (0.21%)   Mean 0.23%   SD 0.65%     |
 __________________________________________________________________________________________________________________________________
|#Tongue:                                                                                                                          |
|   Squamous Cell Carcinoma or           1/50 (2%)     1/100(1%)     0/50 (0%)           0/50 (0%)     1/100(1%)     1/50 (2%)     |
|      Papilloma Squamous                0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/100(1%)     0/50 (0%)           0/50 (0%)     0/100(0%)     2/50 (4%)     |
|                                        1/50 (2%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           2/50 (4%)     0/60 (0%)     1/50 (2%)     |
|                                        1/50 (2%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 5/1459 (0.34%)  Mean 0.31%   SD 0.68%     Total 7/1459 (0.48%)   Mean 0.5%    SD 1.17%     |
 __________________________________________________________________________________________________________________________________
|#Tongue:                                                                                                                          |
|   Squamous Cell Papilloma              1/50 (2%)     1/100(1%)     0/50 (0%)           0/50 (0%)     1/100(1%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/100(1%)     0/50 (0%)           0/50 (0%)     0/100(0%)     1/50 (2%)     |
|                                        1/50 (2%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           2/50 (4%)     0/60 (0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 5/1459 (0.34%)  Mean 0.31%   SD 0.68%     Total 4/1459 (0.27%)   Mean 0.27%   SD 0.87%     |
 __________________________________________________________________________________________________________________________________
|#Tooth:                                                                                                                           |
|   Odontogenic Tumor                    0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     1/50 (2%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 0/1459 (0%)     Mean 0%      SD 0%        Total 1/1459 (0.07%)   Mean 0.08%   SD 0.39%     |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 60
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|*Urinary Bladder:                                                                                                                 |
|   Carcinoma                            0/50 (0%)     0/100(0%)     0/46 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/49 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/48 (0%)           0/50 (0%)     0/49 (0%)     0/48 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/49 (0%)     0/49 (0%)     1/50 (2%)     |
|                                        0/50 (0%)     0/99 (0%)     0/50 (0%)           0/50 (0%)     0/99 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/49 (0%)     0/48 (0%)           0/50 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/49 (0%)     1/50 (2%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 1/1447 (0.07%)  Mean 0.08%   SD 0.39%     Total 1/1453 (0.07%)   Mean 0.08%   SD 0.39%     |
 __________________________________________________________________________________________________________________________________
|*Urinary Bladder:                                                                                                                 |
|   Carcinoma or Papilloma               0/50 (0%)     0/100(0%)     0/46 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     1/50 (2%)     |
|                                        1/49 (2%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     1/48 (2%)           0/50 (0%)     0/49 (0%)     1/48 (2%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/49 (0%)     1/49 (2%)     1/50 (2%)     |
|                                        1/50 (2%)     1/99 (1%)     0/50 (0%)           0/50 (0%)     0/99 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/49 (0%)     0/48 (0%)           1/50 (2%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/60 (2%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/49 (0%)     1/50 (2%)                         1/50 (2%)     0/50 (0%)                   |
| Overall Incidence               Total 6/1447 (0.41%)  Mean 0.42%   SD 0.8%      Total 6/1453 (0.41%)   Mean 0.47%   SD 0.87%     |
 __________________________________________________________________________________________________________________________________
|*Urinary Bladder:                                                                                                                 |
|   Leiomyosarcoma                       0/50 (0%)     0/100(0%)     0/46 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/49 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/48 (0%)           0/50 (0%)     0/49 (0%)     0/48 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/49 (0%)     1/49 (2%)     0/50 (0%)     |
|                                        0/50 (0%)     0/99 (0%)     0/50 (0%)           0/50 (0%)     0/99 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/49 (0%)     0/48 (0%)           0/50 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/49 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 0/1447 (0%)     Mean 0%      SD 0%        Total 1/1453 (0.07%)   Mean 0.08%   SD 0.4%      |
 __________________________________________________________________________________________________________________________________
|*Urinary Bladder:                                                                                                                 |
|   Papilloma                            0/50 (0%)     0/100(0%)     0/46 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     1/50 (2%)     |
|                                        1/49 (2%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     1/48 (2%)           0/50 (0%)     0/49 (0%)     1/48 (2%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/49 (0%)     1/49 (2%)     0/50 (0%)     |
|                                        1/50 (2%)     1/99 (1%)     0/50 (0%)           0/50 (0%)     0/99 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/49 (0%)     0/48 (0%)           1/50 (2%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/60 (2%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/49 (0%)     0/50 (0%)                         1/50 (2%)     0/50 (0%)                   |
| Overall Incidence               Total 5/1447 (0.35%)  Mean 0.34%   SD 0.73%     Total 5/1453 (0.34%)   Mean 0.39%   SD 0.81%     |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 61
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|*Urinary Bladder:                                                                                                                 |
|   Sarcoma                              0/50 (0%)     0/100(0%)     1/46 (2%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/49 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/48 (0%)           0/50 (0%)     0/49 (0%)     0/48 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/49 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/99 (0%)     0/50 (0%)           0/50 (0%)     0/99 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/49 (0%)     0/48 (0%)           0/50 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                        0/49 (0%)     0/50 (0%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 1/1447 (0.07%)  Mean 0.08%   SD 0.43%     Total 0/1453 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#Uterus:                                                                                                                          |
|   Adenoma                                                                              0/50 (0%)     1/100(1%)     1/50 (2%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                                                                        1/50 (2%)     0/50 (0%)     0/49 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)                   |
| Overall Incidence                                                               Total 3/1459 (0.21%)   Mean 0.19%   SD 0.57%     |
 __________________________________________________________________________________________________________________________________
|#Uterus:                                                                                                                          |
|   Carcinoma                                                                            0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        2/50 (4%)     0/100(0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/100(0%)     1/50 (2%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                                                                        1/50 (2%)     0/50 (0%)                   |
| Overall Incidence                                                               Total 4/1459 (0.27%)   Mean 0.31%   SD 0.93%     |
 __________________________________________________________________________________________________________________________________
|#Uterus:                                                                                                                          |
|   Hemangioma                                                                           0/50 (0%)     1/100(1%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/60 (0%)     1/50 (2%)     |
|                                                                                        0/50 (0%)     0/50 (0%)                   |
| Overall Incidence                                                               Total 2/1459 (0.14%)   Mean 0.12%   SD 0.43%     |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 62
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|#Uterus:                                                                                                                          |
|   Leiomyoma                                                                            0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        1/50 (2%)     0/60 (0%)     0/50 (0%)     |
|                                                                                        1/50 (2%)     0/50 (0%)                   |
| Overall Incidence                                                               Total 2/1459 (0.14%)   Mean 0.15%   SD 0.54%     |
 __________________________________________________________________________________________________________________________________
|#Uterus:                                                                                                                          |
|   Leiomyosarcoma                                                                       0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                                                                        1/50 (2%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                                                                        1/50 (2%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     2/100(2%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)                   |
| Overall Incidence                                                               Total 4/1459 (0.27%)   Mean 0.23%   SD 0.65%     |
 __________________________________________________________________________________________________________________________________
|#Uterus:                                                                                                                          |
|   Polyp Stromal                                                                        6/50 (12%)   19/100(19%)    8/50 (16%)    |
|                                                                                        7/50 (14%)    7/50 (14%)   10/50 (20%)    |
|                                                                                        7/50 (14%)   14/100(14%)    7/50 (14%)    |
|                                                                                        9/50 (18%)   10/50 (20%)   15/49 (31%)    |
|                                                                                        5/50 (10%)   10/50 (20%)    6/50 (12%)    |
|                                                                                       12/50 (24%)   13/100(13%)   14/50 (28%)    |
|                                                                                        8/50 (16%)   16/50 (32%)    9/50 (18%)    |
|                                                                                       10/50 (20%)   11/60 (18%)    6/50 (12%)    |
|                                                                                       11/50 (22%)    4/50 (8%)                   |
| Overall Incidence                                                               Total 254/1459 (17.41%)Mean 17.65%  SD 6.02%     |
 __________________________________________________________________________________________________________________________________
|#Uterus:                                                                                                                          |
|   Sarcoma                                                                              0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     1/50 (2%)     |
|                                                                                        0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)                   |
| Overall Incidence                                                               Total 1/1459 (0.07%)   Mean 0.08%   SD 0.39%     |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 63
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|#Uterus:                                                                                                                          |
|   Sarcoma Stromal                                                                      0/50 (0%)     0/100(0%)     1/50 (2%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     1/50 (2%)     |
|                                                                                        0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                                                                        0/50 (0%)     1/50 (2%)     0/50 (0%)     |
|                                                                                        1/50 (2%)     0/100(0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     1/50 (2%)     1/50 (2%)     |
|                                                                                        0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)                   |
| Overall Incidence                                                               Total 6/1459 (0.41%)   Mean 0.46%   SD 0.86%     |
 __________________________________________________________________________________________________________________________________
|#Uterus:                                                                                                                          |
|   Sarcoma Stromal or Polyp Stromal                                                     6/50 (12%)   19/100(19%)    9/50 (18%)    |
|                                                                                        7/50 (14%)    7/50 (14%)   11/50 (22%)    |
|                                                                                        7/50 (14%)   14/100(14%)    7/50 (14%)    |
|                                                                                        9/50 (18%)   10/50 (20%)   15/49 (31%)    |
|                                                                                        5/50 (10%)   11/50 (22%)    6/50 (12%)    |
|                                                                                       13/50 (26%)   13/100(13%)   14/50 (28%)    |
|                                                                                        8/50 (16%)   17/50 (34%)   10/50 (20%)    |
|                                                                                       10/50 (20%)   11/60 (18%)    6/50 (12%)    |
|                                                                                       11/50 (22%)    4/50 (8%)                   |
| Overall Incidence                                                               Total 260/1459 (17.82%)Mean 18.11%  SD 6.39%     |
 __________________________________________________________________________________________________________________________________
|#Uterus:                                                                                                                          |
|   Schwannoma Malignant                                                                 0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     3/100(3%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/60 (0%)     1/50 (2%)     |
|                                                                                        0/50 (0%)     0/50 (0%)                   |
| Overall Incidence                                                               Total 4/1459 (0.27%)   Mean 0.19%   SD 0.69%     |
 __________________________________________________________________________________________________________________________________
|#Vagina:                                                                                                                          |
|   Leiomyoma                                                                            0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     1/60 (2%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)                   |
| Overall Incidence                                                               Total 1/1459 (0.07%)   Mean 0.06%   SD 0.33%     |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 64
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|#Vagina:                                                                                                                          |
|   Leiomyosarcoma                                                                       0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     1/50 (2%)     0/49 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)                   |
| Overall Incidence                                                               Total 1/1459 (0.07%)   Mean 0.08%   SD 0.39%     |
 __________________________________________________________________________________________________________________________________
|#Vagina:                                                                                                                          |
|   Sarcoma                                                                              0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/100(0%)     1/50 (2%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                                                                        1/50 (2%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        1/50 (2%)     0/100(0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/60 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)                   |
| Overall Incidence                                                               Total 3/1459 (0.21%)   Mean 0.23%   SD 0.65%     |
 __________________________________________________________________________________________________________________________________
|#Zymbal's Gland:                                                                                                                  |
|   Adenoma                              0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           1/50 (2%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     0/50 (0%)           0/50 (0%)     1/100(1%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/100(0%)     1/50 (2%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     0/50 (0%)           0/50 (0%)     1/60 (2%)     0/50 (0%)     |
|                                        0/50 (0%)     1/50 (2%)                         0/50 (0%)     0/50 (0%)                   |
| Overall Incidence               Total 2/1459 (0.14%)  Mean 0.15%   SD 0.54%     Total 3/1459 (0.21%)   Mean 0.18%   SD 0.53%     |
 __________________________________________________________________________________________________________________________________
|#Zymbal's Gland:                                                                                                                  |
|   Carcinoma                            0/50 (0%)     1/100(1%)     3/50 (6%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     1/50 (2%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/100(0%)     0/50 (0%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           1/50 (2%)     1/50 (2%)     2/49 (4%)     |
|                                        1/50 (2%)     0/50 (0%)     0/50 (0%)           2/50 (4%)     1/50 (2%)     0/50 (0%)     |
|                                        1/50 (2%)     1/100(1%)     1/50 (2%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     3/50 (6%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     2/50 (4%)           0/50 (0%)     1/60 (2%)     0/50 (0%)     |
|                                        1/50 (2%)     0/50 (0%)                         0/50 (0%)     1/50 (2%)                   |
| Overall Incidence               Total 16/1459 (1.1%)  Mean 1.15%   SD 1.78%     Total 9/1459 (0.62%)   Mean 0.68%   SD 1.25%     |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 65
 Version: 01/28/05                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 28-JAN-2005
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|#Zymbal's Gland:                                                                                                                  |
|   Carcinoma or Adenoma                 0/50 (0%)     1/100(1%)     3/50 (6%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     1/50 (2%)           1/50 (2%)     0/50 (0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/100(0%)     0/50 (0%)           0/50 (0%)     1/100(1%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           1/50 (2%)     1/50 (2%)     2/49 (4%)     |
|                                        1/50 (2%)     0/50 (0%)     0/50 (0%)           2/50 (4%)     1/50 (2%)     0/50 (0%)     |
|                                        1/50 (2%)     1/100(1%)     2/50 (4%)           0/50 (0%)     0/100(0%)     0/50 (0%)     |
|                                        0/50 (0%)     3/50 (6%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/60 (0%)     2/50 (4%)           0/50 (0%)     2/60 (3%)     0/50 (0%)     |
|                                        1/50 (2%)     1/50 (2%)                         0/50 (0%)     1/50 (2%)                   |
| Overall Incidence               Total 18/1459 (1.23%) Mean 1.31%   SD 1.85%     Total 12/1459 (0.82%)  Mean 0.86%   SD 1.35%     |
 __________________________________________________________________________________________________________________________________
