                                                 Toxicology Data Management System                                     Page: 1
 Version: 04/26/04                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                            Input File: 19-APR-2004
 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 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                         |
|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  059601003  09/16/98   729       50(3)      36  (687)    514.1     SODIUM DICHLORATE                          |
|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                             |
|________________________________________________________________________________________________________________________________|
                                                 Toxicology Data Management System                                     Page: 2
 Version: 04/26/04                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                            Input File: 19-APR-2004
 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 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                         |
|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  059601003  09/16/98   734       50(5)      37  (699)    341.7     SODIUM DICHLORATE                          |
|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                                |
|________________________________________________________________________________________________________________________________|
                                                 Toxicology Data Management System                                     Page: 3
 Version: 04/26/04                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 19-APR-2004
 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%)    |
|                                       47/50 (94%)   46/49 (94%)   50/50 (100%)        44/50 (88%)   38/49 (78%)   41/50 (82%)    |
|                                       50/50 (100%)  48/50 (96%)   99/100(99%)         37/50 (74%)   41/50 (82%)   92/100(92%)    |
|                                       48/50 (96%)   49/50 (98%)   48/50 (96%)         45/50 (90%)   43/50 (86%)   46/50 (92%)    |
|                                       60/60 (100%)  49/50 (98%)                       47/60 (78%)   33/50 (66%)   45/50 (90%)    |
| Overall Incidence               Total 1118/1159 (96.46Mean 96.14%  SD 3.64%     Total 991/1209 (81.97%)Mean 81.9%   SD 7.68%     |
 __________________________________________________________________________________________________________________________________
|#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%)    |
|                                       26/50 (52%)   34/49 (69%)   35/50 (70%)         25/50 (50%)   26/49 (53%)   33/50 (66%)    |
|                                       33/50 (66%)   28/50 (56%)   66/100(66%)         30/50 (60%)   28/50 (56%)   40/100(40%)    |
|                                       21/50 (42%)   22/50 (44%)   27/50 (54%)         18/50 (36%)   19/50 (38%)   21/50 (42%)    |
|                                       37/60 (62%)   33/50 (66%)                       24/60 (40%)   22/50 (44%)   20/50 (40%)    |
| Overall Incidence               Total 712/1159 (61.43%Mean 60.7%   SD 8.87%     Total 522/1209 (43.18%)Mean 44.19%  SD 10.18%    |
 __________________________________________________________________________________________________________________________________
|#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%)    |
|                                       49/50 (98%)   48/49 (98%)   50/50 (100%)        49/50 (98%)   44/49 (90%)   49/50 (98%)    |
|                                       50/50 (100%)  50/50 (100%) 100/100(100%)        44/50 (88%)   47/50 (94%)   98/100(98%)    |
|                                       50/50 (100%)  50/50 (100%)  49/50 (98%)         47/50 (94%)   45/50 (90%)   49/50 (98%)    |
|                                       60/60 (100%)  50/50 (100%)                      54/60 (90%)   43/50 (86%)   47/50 (94%)    |
| Overall Incidence               Total 1149/1159 (99.14Mean 99.05%  SD 1%        Total 1120/1209 (92.64%Mean 92.47%  SD 4.61%     |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     1/49 (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%)     |
|                                        0/60 (0%)     2/50 (4%)                         0/60 (0%)     1/50 (2%)     0/50 (0%)     |
| Overall Incidence               Total 3/1159 (0.26%)  Mean 0.25%   SD 0.91%     Total 4/1209 (0.33%)   Mean 0.29%   SD 0.72%     |
 __________________________________________________________________________________________________________________________________
|#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%)     |
|                                        1/50 (2%)     0/49 (0%)     0/50 (0%)           1/50 (2%)     1/49 (2%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/100(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%)     |
|                                        1/60 (2%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 4/1159 (0.35%)  Mean 0.38%   SD 0.79%     Total 3/1209 (0.25%)   Mean 0.29%   SD 0.72%     |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 4
 Version: 04/26/04                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 19-APR-2004
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|#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%)     |
|                                        1/50 (2%)     0/49 (0%)     0/50 (0%)           1/50 (2%)     2/49 (4%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/100(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%)     |
|                                        1/60 (2%)     2/50 (4%)                         0/60 (0%)     1/50 (2%)     0/50 (0%)     |
| Overall Incidence               Total 7/1159 (0.6%)   Mean 0.63%   SD 1.12%     Total 7/1209 (0.58%)   Mean 0.58%   SD 1.13%     |
 __________________________________________________________________________________________________________________________________
|#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%)     |
|                                        0/50 (0%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/100(0%)           0/50 (0%)     1/50 (2%)     0/100(0%)     |
|                                        1/50 (2%)     0/50 (0%)     1/50 (2%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        1/60 (2%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 3/1159 (0.26%)  Mean 0.28%   SD 0.69%     Total 1/1209 (0.08%)   Mean 0.1%    SD 0.44%     |
 __________________________________________________________________________________________________________________________________
|#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%)    |
|                                       16/50 (32%)   26/49 (53%)   33/50 (66%)         14/50 (28%)   16/49 (33%)   24/50 (48%)    |
|                                       25/50 (50%)   22/50 (44%)   50/100(50%)         26/50 (52%)   21/50 (42%)   20/100(20%)    |
|                                       11/50 (22%)   15/50 (30%)   13/50 (26%)         10/50 (20%)    6/50 (12%)   11/50 (22%)    |
|                                       30/60 (50%)   24/50 (48%)                       21/60 (35%)   13/50 (26%)   12/50 (24%)    |
| Overall Incidence               Total 514/1159 (44.35%Mean 43.05%  SD 12.78%    Total 330/1209 (27.3%) Mean 28.03%  SD 11.15%    |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     2/50 (4%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 4/1159 (0.35%)  Mean 0.4%    SD 1.05%     Total 2/1209 (0.17%)   Mean 0.1%    SD 0.3%      |
 __________________________________________________________________________________________________________________________________
|#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%)     2/49 (4%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 3/1159 (0.26%)  Mean 0.3%    SD 0.99%     Total 0/1209 (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: 5
 Version: 04/26/04                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 19-APR-2004
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|#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%)     2/49 (4%)     2/50 (4%)           0/50 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/50 (2%)     4/100(4%)           0/50 (0%)     0/50 (0%)     0/100(0%)     |
|                                        4/50 (8%)     2/50 (4%)     0/50 (0%)           1/50 (2%)     0/50 (0%)     0/50 (0%)     |
|                                        2/60 (3%)     5/50 (10%)                        0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 49/1159 (4.23%) Mean 4.22%   SD 3.05%     Total 1/1209 (0.08%)   Mean 0.1%    SD 0.44%     |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     2/50 (4%)           0/50 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     1/50 (2%)     4/100(4%)           0/50 (0%)     0/50 (0%)     0/100(0%)     |
|                                        4/50 (8%)     2/50 (4%)     0/50 (0%)           1/50 (2%)     0/50 (0%)     0/50 (0%)     |
|                                        2/60 (3%)     5/50 (10%)                        0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 47/1159 (4.06%) Mean 4.02%   SD 3.19%     Total 1/1209 (0.08%)   Mean 0.1%    SD 0.44%     |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 2/1159 (0.17%)  Mean 0.2%    SD 0.89%     Total 0/1209 (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%)     |
|                                        3/50 (6%)     1/49 (2%)     1/50 (2%)           0/50 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        2/50 (4%)     1/50 (2%)     0/100(0%)           0/50 (0%)     0/50 (0%)     0/100(0%)     |
|                                        0/50 (0%)     0/50 (0%)     3/50 (6%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        1/60 (2%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 15/1159 (1.29%) Mean 1.49%   SD 1.93%     Total 1/1209 (0.08%)   Mean 0.05%   SD 0.22%     |
 __________________________________________________________________________________________________________________________________
|#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%)     |
|                                        3/50 (6%)     1/49 (2%)     1/50 (2%)           0/50 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        2/50 (4%)     1/50 (2%)     0/100(0%)           0/50 (0%)     0/50 (0%)     0/100(0%)     |
|                                        0/50 (0%)     2/50 (4%)     3/50 (6%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        1/60 (2%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 17/1159 (1.47%) Mean 1.69%   SD 1.98%     Total 1/1209 (0.08%)   Mean 0.05%   SD 0.22%     |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 6
 Version: 04/26/04                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 19-APR-2004
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|*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%)     2/49 (4%)     0/50 (0%)           1/49 (2%)     1/49 (2%)     2/49 (4%)     |
|                                        0/50 (0%)     0/50 (0%)     0/99 (0%)           0/50 (0%)     0/49 (0%)     6/100(6%)     |
|                                        1/50 (2%)     0/50 (0%)     0/49 (0%)           1/50 (2%)     5/50 (10%)    0/50 (0%)     |
|                                        0/60 (0%)     0/50 (0%)                         2/60 (3%)     0/50 (0%)     1/50 (2%)     |
| Overall Incidence               Total 6/1154 (0.52%)  Mean 0.5%    SD 1.11%     Total 28/1205 (2.32%)  Mean 2.22%   SD 2.39%     |
 __________________________________________________________________________________________________________________________________
|*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%)     0/49 (0%)     0/50 (0%)           1/49 (2%)     0/49 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/99 (0%)           1/50 (2%)     0/49 (0%)     1/100(1%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 0/1154 (0%)     Mean 0%      SD 0%        Total 3/1205 (0.25%)   Mean 0.24%   SD 0.63%     |
 __________________________________________________________________________________________________________________________________
|*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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/48 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/98 (0%)           0/50 (0%)     0/49 (0%)     0/96 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/49 (0%)     0/50 (0%)     |
| Overall Incidence               Total 2/1152 (0.17%)  Mean 0.16%   SD 0.51%     Total 0/1198 (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%)     |
|                                       10/50 (20%)    4/49 (8%)    12/50 (24%)          2/50 (4%)     3/48 (6%)     2/49 (4%)     |
|                                        5/50 (10%)    4/50 (8%)    24/98 (24%)          2/50 (4%)     2/49 (4%)     7/96 (7%)     |
|                                        7/50 (14%)    8/50 (16%)    6/49 (12%)          1/50 (2%)     0/49 (0%)     2/50 (4%)     |
|                                        2/60 (3%)     3/50 (6%)                         2/60 (3%)     2/49 (4%)     1/50 (2%)     |
| Overall Incidence               Total 139/1152 (12.07%Mean 12%     SD 5.95%     Total 40/1198 (3.34%)  Mean 3.29%   SD 2.19%     |
 __________________________________________________________________________________________________________________________________
|*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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/48 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/98 (0%)           0/50 (0%)     0/49 (0%)     0/96 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/49 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/1152 (0.09%)  Mean 0.05%   SD 0.22%     Total 1/1198 (0.08%)   Mean 0.05%   SD 0.22%     |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 7
 Version: 04/26/04                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 19-APR-2004
 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%)     |
|                                        0/50 (0%)     1/49 (2%)     2/50 (4%)           0/50 (0%)     0/48 (0%)     0/49 (0%)     |
|                                        1/50 (2%)     1/50 (2%)     2/98 (2%)           1/50 (2%)     0/49 (0%)     0/96 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     3/49 (6%)           1/50 (2%)     0/49 (0%)     0/50 (0%)     |
|                                        2/60 (3%)     0/50 (0%)                         0/60 (0%)     0/49 (0%)     1/50 (2%)     |
| Overall Incidence               Total 24/1152 (2.08%) Mean 2.31%   SD 2.63%     Total 8/1198 (0.67%)   Mean 0.67%   SD 1.17%     |
 __________________________________________________________________________________________________________________________________
|*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%)     |
|                                       10/50 (20%)    5/49 (10%)   14/50 (28%)          2/50 (4%)     3/48 (6%)     2/49 (4%)     |
|                                        6/50 (12%)    5/50 (10%)   26/98 (27%)          3/50 (6%)     2/49 (4%)     7/96 (7%)     |
|                                        7/50 (14%)    8/50 (16%)    9/49 (18%)          2/50 (4%)     0/49 (0%)     2/50 (4%)     |
|                                        4/60 (7%)     3/50 (6%)                         2/60 (3%)     2/49 (4%)     2/50 (4%)     |
| Overall Incidence               Total 162/1152 (14.06%Mean 14.16%  SD 6.2%      Total 49/1198 (4.09%)  Mean 4.01%   SD 2.02%     |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/1159 (0.09%)  Mean 0.1%    SD 0.45%     Total 0/1209 (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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 2/1159 (0.17%)  Mean 0.2%    SD 0.62%     Total 0/1209 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 2/1159 (0.17%)  Mean 0.2%    SD 0.89%     Total 0/1209 (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: 8
 Version: 04/26/04                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 19-APR-2004
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|#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%)     |
|                                        3/50 (6%)     1/49 (2%)     1/50 (2%)           0/50 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        2/50 (4%)     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%)     |
|                                        1/60 (2%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 12/1159 (1.04%) Mean 1.19%   SD 1.64%     Total 1/1209 (0.08%)   Mean 0.05%   SD 0.22%     |
 __________________________________________________________________________________________________________________________________
|#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%)     |
|                                        3/50 (6%)     1/49 (2%)     1/50 (2%)           0/50 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        2/50 (4%)     1/50 (2%)     0/100(0%)           0/50 (0%)     0/50 (0%)     0/100(0%)     |
|                                        0/50 (0%)     2/50 (4%)     1/50 (2%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        1/60 (2%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 14/1159 (1.21%) Mean 1.39%   SD 1.73%     Total 1/1209 (0.08%)   Mean 0.05%   SD 0.22%     |
 __________________________________________________________________________________________________________________________________
|*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%)     |
|                                        0/50 (0%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (0%)     0/49 (0%)     |
|                                        1/50 (2%)     0/50 (0%)     1/100(1%)           0/49 (0%)     0/50 (0%)     1/100(1%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           2/50 (4%)     0/50 (0%)     0/49 (0%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     1/50 (2%)     0/50 (0%)     |
| Overall Incidence               Total 2/1159 (0.17%)  Mean 0.15%   SD 0.49%     Total 6/1206 (0.5%)    Mean 0.48%   SD 1.03%     |
 __________________________________________________________________________________________________________________________________
|*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%)     |
|                                        0/50 (0%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (0%)     0/49 (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%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/1159 (0.09%)  Mean 0.1%    SD 0.45%     Total 1/1206 (0.08%)   Mean 0.05%   SD 0.22%     |
 __________________________________________________________________________________________________________________________________
|*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%)     |
|                                        0/50 (0%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (0%)     0/49 (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%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/60 (0%)     1/50 (2%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/1159 (0.09%)  Mean 0.1%    SD 0.45%     Total 0/1206 (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: 04/26/04                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 19-APR-2004
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|*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%)     |
|                                        0/50 (0%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (0%)     0/49 (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%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 0/1159 (0%)     Mean 0%      SD 0%        Total 1/1206 (0.08%)   Mean 0.05%   SD 0.22%     |
 __________________________________________________________________________________________________________________________________
|*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%)     |
|                                        0/50 (0%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (0%)     0/49 (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%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 0/1159 (0%)     Mean 0%      SD 0%        Total 1/1206 (0.08%)   Mean 0.05%   SD 0.22%     |
 __________________________________________________________________________________________________________________________________
|*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%)     |
|                                        0/50 (0%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (0%)     0/49 (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%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 0/1159 (0%)     Mean 0%      SD 0%        Total 1/1206 (0.08%)   Mean 0.1%    SD 0.44%     |
 __________________________________________________________________________________________________________________________________
|*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%)     |
|                                        0/50 (0%)     0/49 (0%)     0/50 (0%)           1/50 (2%)     0/49 (0%)     0/49 (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%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/1159 (0.09%)  Mean 0.05%   SD 0.22%     Total 1/1206 (0.08%)   Mean 0.1%    SD 0.44%     |
 __________________________________________________________________________________________________________________________________
|*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%)     |
|                                        0/50 (0%)     0/49 (0%)     0/50 (0%)           1/50 (2%)     0/49 (0%)     0/49 (0%)     |
|                                        1/50 (2%)     0/50 (0%)     2/100(2%)           0/49 (0%)     0/50 (0%)     2/100(2%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           2/50 (4%)     0/50 (0%)     0/49 (0%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     1/50 (2%)     0/50 (0%)     |
| Overall Incidence               Total 4/1159 (0.35%)  Mean 0.3%    SD 0.73%     Total 9/1206 (0.75%)   Mean 0.71%   SD 1.15%     |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 10
 Version: 04/26/04                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 19-APR-2004
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|*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%)     |
|                                        0/50 (0%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (0%)     0/49 (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%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/1159 (0.09%)  Mean 0.1%    SD 0.45%     Total 0/1206 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|*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%)    |
|                                        1/50 (2%)     3/48 (6%)     1/50 (2%)           5/49 (10%)    4/49 (8%)     1/50 (2%)     |
|                                        0/50 (0%)     0/50 (0%)    13/100(13%)          0/49 (0%)     2/50 (4%)    11/90 (12%)    |
|                                        1/49 (2%)     0/50 (0%)     1/48 (2%)           5/50 (10%)    5/50 (10%)   11/49 (22%)    |
|                                        2/60 (3%)     2/50 (4%)                        12/59 (20%)    7/50 (14%)    7/49 (14%)    |
| Overall Incidence               Total 47/1155 (4.07%) Mean 3.34%   SD 3.4%      Total 120/1179 (10.18%)Mean 10.08%  SD 6.33%     |
 __________________________________________________________________________________________________________________________________
|*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%)     |
|                                        2/50 (4%)     3/48 (6%)     1/50 (2%)           0/49 (0%)     0/49 (0%)     2/50 (4%)     |
|                                        0/50 (0%)     0/50 (0%)     0/100(0%)           1/49 (2%)     0/50 (0%)     0/90 (0%)     |
|                                        3/49 (6%)     0/50 (0%)     3/48 (6%)           2/50 (4%)     3/50 (6%)     3/49 (6%)     |
|                                        2/60 (3%)     2/50 (4%)                         2/59 (3%)     2/50 (4%)     3/49 (6%)     |
| Overall Incidence               Total 32/1155 (2.77%) Mean 2.95%   SD 2.85%     Total 38/1179 (3.22%)  Mean 3.18%   SD 3.05%     |
 __________________________________________________________________________________________________________________________________
|*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%)    |
|                                        3/50 (6%)     6/48 (13%)    2/50 (4%)           5/49 (10%)    4/49 (8%)     3/50 (6%)     |
|                                        0/50 (0%)     0/50 (0%)    13/100(13%)          1/49 (2%)     2/50 (4%)    11/90 (12%)    |
|                                        4/49 (8%)     0/50 (0%)     4/48 (8%)           7/50 (14%)    8/50 (16%)   14/49 (29%)    |
|                                        4/60 (7%)     4/50 (8%)                        14/59 (24%)    8/50 (16%)   10/49 (20%)    |
| Overall Incidence               Total 79/1155 (6.84%) Mean 6.28%   SD 4.31%     Total 156/1179 (13.23%)Mean 13.07%  SD 7.53%     |
 __________________________________________________________________________________________________________________________________
|*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%)     |
|                                        0/50 (0%)     0/48 (0%)     0/50 (0%)           0/49 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/100(0%)           0/49 (0%)     0/50 (0%)     0/90 (0%)     |
|                                        0/49 (0%)     0/50 (0%)     0/48 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/59 (0%)     0/50 (0%)     0/49 (0%)     |
| Overall Incidence               Total 0/1155 (0%)     Mean 0%      SD 0%        Total 1/1179 (0.08%)   Mean 0.1%    SD 0.45%     |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 11
 Version: 04/26/04                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 19-APR-2004
 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%)     |
|                                        0/50 (0%)     0/48 (0%)     0/50 (0%)           0/49 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/100(0%)           0/49 (0%)     0/50 (0%)     0/90 (0%)     |
|                                        0/49 (0%)     0/50 (0%)     0/48 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/59 (0%)     0/50 (0%)     0/49 (0%)     |
| Overall Incidence               Total 1/1155 (0.09%)  Mean 0.1%    SD 0.45%     Total 0/1179 (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%)     |
|                                        0/50 (0%)     0/48 (0%)     0/50 (0%)           0/49 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/100(0%)           0/49 (0%)     0/50 (0%)     0/90 (0%)     |
|                                        0/49 (0%)     0/50 (0%)     0/48 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
|                                        0/60 (0%)     1/50 (2%)                         0/59 (0%)     0/50 (0%)     0/49 (0%)     |
| Overall Incidence               Total 1/1155 (0.09%)  Mean 0.1%    SD 0.45%     Total 0/1179 (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%)     |
|                                        0/50 (0%)     0/48 (0%)     0/50 (0%)           0/49 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/100(0%)           0/49 (0%)     0/50 (0%)     0/90 (0%)     |
|                                        0/49 (0%)     0/50 (0%)     0/48 (0%)           0/50 (0%)     1/50 (2%)     0/49 (0%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/59 (0%)     0/50 (0%)     0/49 (0%)     |
| Overall Incidence               Total 0/1155 (0%)     Mean 0%      SD 0%        Total 2/1179 (0.17%)   Mean 0.19%   SD 0.6%      |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 0/1159 (0%)     Mean 0%      SD 0%        Total 1/1209 (0.08%)   Mean 0.1%    SD 0.44%     |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     1/50 (2%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/1159 (0.09%)  Mean 0.1%    SD 0.45%     Total 0/1209 (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: 04/26/04                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 19-APR-2004
 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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/1159 (0.09%)  Mean 0.1%    SD 0.45%     Total 0/1209 (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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/1159 (0.09%)  Mean 0.1%    SD 0.45%     Total 0/1209 (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%)     |
|                                        1/50 (2%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/100(0%)           0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 3/1159 (0.26%)  Mean 0.3%    SD 0.98%     Total 0/1208 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|*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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     2/100(2%)           0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     1/50 (2%)     0/50 (0%)     |
| Overall Incidence               Total 6/1159 (0.52%)  Mean 0.4%    SD 0.82%     Total 3/1208 (0.25%)   Mean 0.24%   SD 0.62%     |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/1159 (0.09%)  Mean 0.05%   SD 0.22%     Total 0/1209 (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: 13
 Version: 04/26/04                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 19-APR-2004
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/1159 (0.09%)  Mean 0.05%   SD 0.22%     Total 0/1209 (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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 0/1159 (0%)     Mean 0%      SD 0%        Total 1/1209 (0.08%)   Mean 0.1%    SD 0.44%     |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     1/50 (2%)           0/50 (0%)     0/49 (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%)     |
|                                        1/60 (2%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     1/50 (2%)     |
| Overall Incidence               Total 4/1159 (0.35%)  Mean 0.38%   SD 0.79%     Total 2/1209 (0.17%)   Mean 0.14%   SD 0.48%     |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 0/1159 (0%)     Mean 0%      SD 0%        Total 1/1209 (0.08%)   Mean 0.05%   SD 0.22%     |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/1159 (0.09%)  Mean 0.1%    SD 0.45%     Total 0/1209 (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: 04/26/04                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 19-APR-2004
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/1159 (0.09%)  Mean 0.05%   SD 0.22%     Total 0/1209 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 0/1159 (0%)     Mean 0%      SD 0%        Total 1/1209 (0.08%)   Mean 0.05%   SD 0.22%     |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/1159 (0.09%)  Mean 0.1%    SD 0.45%     Total 0/1209 (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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/1159 (0.09%)  Mean 0.1%    SD 0.45%     Total 0/1209 (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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/1159 (0.09%)  Mean 0.05%   SD 0.22%     Total 0/1209 (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: 04/26/04                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 19-APR-2004
 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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 0/1159 (0%)     Mean 0%      SD 0%        Total 1/1209 (0.08%)   Mean 0.05%   SD 0.22%     |
 __________________________________________________________________________________________________________________________________
|*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%)     |
|                                        1/50 (2%)     2/49 (4%)     4/50 (8%)           1/50 (2%)     1/49 (2%)     0/49 (0%)     |
|                                        3/50 (6%)     1/50 (2%)     3/99 (3%)           1/49 (2%)     1/49 (2%)     1/100(1%)     |
|                                        4/50 (8%)     0/50 (0%)     3/50 (6%)           1/50 (2%)     0/50 (0%)     2/50 (4%)     |
|                                        2/60 (3%)     3/50 (6%)                         1/60 (2%)     0/50 (0%)     2/50 (4%)     |
| Overall Incidence               Total 42/1151 (3.65%) Mean 3.8%    SD 2.65%     Total 12/1203 (1%)     Mean 1.09%   SD 1.33%     |
 __________________________________________________________________________________________________________________________________
|*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%)     |
|                                        2/50 (4%)     4/49 (8%)     0/50 (0%)           0/50 (0%)     1/49 (2%)     1/49 (2%)     |
|                                        1/50 (2%)     1/50 (2%)     1/99 (1%)           0/49 (0%)     1/49 (2%)     1/100(1%)     |
|                                        0/50 (0%)     0/50 (0%)     2/50 (4%)           0/50 (0%)     2/50 (4%)     1/50 (2%)     |
|                                        0/60 (0%)     2/50 (4%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 19/1151 (1.65%) Mean 1.86%   SD 2.58%     Total 10/1203 (0.83%)  Mean 0.82%   SD 1.17%     |
 __________________________________________________________________________________________________________________________________
|*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%)     |
|                                        3/50 (6%)     6/49 (12%)    4/50 (8%)           1/50 (2%)     2/49 (4%)     1/49 (2%)     |
|                                        4/50 (8%)     2/50 (4%)     4/99 (4%)           1/49 (2%)     2/49 (4%)     2/100(2%)     |
|                                        4/50 (8%)     0/50 (0%)     5/50 (10%)          1/50 (2%)     2/50 (4%)     3/50 (6%)     |
|                                        2/60 (3%)     5/50 (10%)                        1/60 (2%)     0/50 (0%)     2/50 (4%)     |
| Overall Incidence               Total 61/1151 (5.3%)  Mean 5.66%   SD 4.12%     Total 22/1203 (1.83%)  Mean 1.9%    SD 1.85%     |
 __________________________________________________________________________________________________________________________________
|*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%)     |
|                                        0/50 (0%)     1/49 (2%)     0/50 (0%)           0/50 (0%)     0/48 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/100(0%)           0/49 (0%)     0/50 (0%)     0/100(0%)     |
|                                        0/50 (0%)     0/49 (0%)     0/47 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 2/1152 (0.17%)  Mean 0.2%    SD 0.62%     Total 0/1205 (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: 16
 Version: 04/26/04                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 19-APR-2004
 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 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%)     |
|                                        0/50 (0%)     1/49 (2%)     0/50 (0%)           0/50 (0%)     0/48 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/100(0%)           0/49 (0%)     0/50 (0%)     0/100(0%)     |
|                                        0/50 (0%)     0/49 (0%)     0/47 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 2/1152 (0.17%)  Mean 0.2%    SD 0.62%     Total 0/1205 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|*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%)     0/49 (0%)     1/50 (2%)           0/50 (0%)     0/48 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     1/50 (2%)     0/100(0%)           0/49 (0%)     0/50 (0%)     0/100(0%)     |
|                                        0/50 (0%)     0/49 (0%)     0/47 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 5/1152 (0.43%)  Mean 0.51%   SD 0.9%      Total 1/1205 (0.08%)   Mean 0.05%   SD 0.22%     |
 __________________________________________________________________________________________________________________________________
|*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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     1/48 (2%)     0/49 (0%)     |
|                                        1/50 (2%)     0/50 (0%)     0/100(0%)           0/49 (0%)     0/50 (0%)     0/100(0%)     |
|                                        0/50 (0%)     0/49 (0%)     0/47 (0%)           1/50 (2%)     0/50 (0%)     0/50 (0%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/1152 (0.09%)  Mean 0.1%    SD 0.45%     Total 3/1205 (0.25%)   Mean 0.24%   SD 0.64%     |
 __________________________________________________________________________________________________________________________________
|*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%)     0/49 (0%)     1/50 (2%)           0/50 (0%)     1/48 (2%)     0/49 (0%)     |
|                                        1/50 (2%)     1/50 (2%)     0/100(0%)           0/49 (0%)     0/50 (0%)     0/100(0%)     |
|                                        0/50 (0%)     0/49 (0%)     0/47 (0%)           1/50 (2%)     0/50 (0%)     0/50 (0%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 6/1152 (0.52%)  Mean 0.61%   SD 0.95%     Total 4/1205 (0.33%)   Mean 0.29%   SD 0.73%     |
 __________________________________________________________________________________________________________________________________
|*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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/48 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     1/100(1%)           0/49 (0%)     0/50 (0%)     0/100(0%)     |
|                                        0/50 (0%)     0/49 (0%)     0/47 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/1152 (0.09%)  Mean 0.05%   SD 0.22%     Total 0/1205 (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: 17
 Version: 04/26/04                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 19-APR-2004
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|*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%)     0/49 (0%)     0/50 (0%)           1/50 (2%)     0/48 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/100(0%)           0/49 (0%)     0/50 (0%)     0/100(0%)     |
|                                        0/50 (0%)     0/49 (0%)     0/47 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 0/1152 (0%)     Mean 0%      SD 0%        Total 1/1205 (0.08%)   Mean 0.1%    SD 0.44%     |
 __________________________________________________________________________________________________________________________________
|*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%)     |
|                                        0/50 (0%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/48 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/100(0%)           0/49 (0%)     0/50 (0%)     0/100(0%)     |
|                                        0/50 (0%)     0/49 (0%)     0/47 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 0/1152 (0%)     Mean 0%      SD 0%        Total 0/1205 (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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/48 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     1/100(1%)           0/49 (0%)     0/50 (0%)     0/100(0%)     |
|                                        0/50 (0%)     0/49 (0%)     0/47 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/1152 (0.09%)  Mean 0.05%   SD 0.22%     Total 0/1205 (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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/48 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/100(0%)           0/49 (0%)     0/50 (0%)     0/100(0%)     |
|                                        0/50 (0%)     0/49 (0%)     0/47 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/1152 (0.09%)  Mean 0.11%   SD 0.48%     Total 0/1205 (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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/100(0%)           0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 2/1159 (0.17%)  Mean 0.15%   SD 0.49%     Total 1/1207 (0.08%)   Mean 0.1%    SD 0.44%     |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 18
 Version: 04/26/04                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 19-APR-2004
 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%)     1/49 (2%)     3/50 (6%)           0/50 (0%)     0/49 (0%)     1/49 (2%)     |
|                                        0/50 (0%)     0/50 (0%)     1/100(1%)           0/49 (0%)     1/50 (2%)     0/100(0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     1/50 (2%)     0/50 (0%)     |
|                                        2/60 (3%)     0/50 (0%)                         1/60 (2%)     0/50 (0%)     1/50 (2%)     |
| Overall Incidence               Total 12/1159 (1.04%) Mean 1.02%   SD 1.71%     Total 6/1207 (0.5%)    Mean 0.56%   SD 0.91%     |
 __________________________________________________________________________________________________________________________________
|*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%)     1/49 (2%)     0/50 (0%)           0/50 (0%)     0/49 (0%)     0/49 (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%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        1/60 (2%)     1/50 (2%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 5/1159 (0.43%)  Mean 0.49%   SD 1.08%     Total 1/1207 (0.08%)   Mean 0.1%    SD 0.44%     |
 __________________________________________________________________________________________________________________________________
|*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%)     1/49 (2%)     0/50 (0%)           0/50 (0%)     0/49 (0%)     0/49 (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%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        1/60 (2%)     1/50 (2%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 5/1159 (0.43%)  Mean 0.49%   SD 1.08%     Total 1/1207 (0.08%)   Mean 0.1%    SD 0.44%     |
 __________________________________________________________________________________________________________________________________
|*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%)     2/49 (4%)     3/50 (6%)           0/50 (0%)     0/49 (0%)     1/49 (2%)     |
|                                        0/50 (0%)     0/50 (0%)     1/100(1%)           0/49 (0%)     1/50 (2%)     0/100(0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     1/50 (2%)     0/50 (0%)     |
|                                        3/60 (5%)     1/50 (2%)                         1/60 (2%)     0/50 (0%)     1/50 (2%)     |
| Overall Incidence               Total 17/1159 (1.47%) Mean 1.5%    SD 2.02%     Total 7/1207 (0.58%)   Mean 0.65%   SD 0.95%     |
 __________________________________________________________________________________________________________________________________
|*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%)     2/49 (4%)     3/50 (6%)           0/50 (0%)     0/49 (0%)     1/49 (2%)     |
|                                        0/50 (0%)     0/50 (0%)     1/100(1%)           0/49 (0%)     1/50 (2%)     0/100(0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     1/50 (2%)     0/50 (0%)     |
|                                        3/60 (5%)     1/50 (2%)                         1/60 (2%)     0/50 (0%)     1/50 (2%)     |
| Overall Incidence               Total 17/1159 (1.47%) Mean 1.5%    SD 2.02%     Total 7/1207 (0.58%)   Mean 0.65%   SD 0.95%     |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 19
 Version: 04/26/04                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 19-APR-2004
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|*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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     1/100(1%)           0/49 (0%)     0/49 (0%)     0/100(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%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/1159 (0.09%)  Mean 0.05%   SD 0.22%     Total 0/1207 (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%)     |
|                                        6/50 (12%)    2/49 (4%)     0/50 (0%)           0/50 (0%)     1/49 (2%)     0/50 (0%)     |
|                                        1/50 (2%)     4/50 (8%)     3/100(3%)           0/49 (0%)     0/49 (0%)     3/100(3%)     |
|                                        1/50 (2%)     2/50 (4%)     1/50 (2%)           3/50 (6%)     0/50 (0%)     1/50 (2%)     |
|                                        1/60 (2%)     1/50 (2%)                         1/60 (2%)     0/50 (0%)     2/50 (4%)     |
| Overall Incidence               Total 40/1159 (3.45%) Mean 3.49%   SD 2.96%     Total 27/1207 (2.24%)  Mean 2.03%   SD 2.54%     |
 __________________________________________________________________________________________________________________________________
|*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%)     0/49 (0%)     1/50 (2%)           1/50 (2%)     0/49 (0%)     0/50 (0%)     |
|                                        1/50 (2%)     0/50 (0%)     0/100(0%)           0/49 (0%)     0/49 (0%)     1/100(1%)     |
|                                        0/50 (0%)     2/50 (4%)     3/50 (6%)           0/50 (0%)     0/50 (0%)     1/50 (2%)     |
|                                        1/60 (2%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 14/1159 (1.21%) Mean 1.33%   SD 1.72%     Total 7/1207 (0.58%)   Mean 0.52%   SD 0.81%     |
 __________________________________________________________________________________________________________________________________
|*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%)     |
|                                        7/50 (14%)    2/49 (4%)     1/50 (2%)           1/50 (2%)     1/49 (2%)     0/50 (0%)     |
|                                        2/50 (4%)     4/50 (8%)     3/100(3%)           0/49 (0%)     0/49 (0%)     4/100(4%)     |
|                                        1/50 (2%)     4/50 (8%)     4/50 (8%)           3/50 (6%)     0/50 (0%)     2/50 (4%)     |
|                                        2/60 (3%)     1/50 (2%)                         1/60 (2%)     0/50 (0%)     2/50 (4%)     |
| Overall Incidence               Total 54/1159 (4.66%) Mean 4.82%   SD 3.13%     Total 34/1207 (2.82%)  Mean 2.56%   SD 2.6%      |
 __________________________________________________________________________________________________________________________________
|*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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/100(0%)           0/49 (0%)     0/49 (0%)     0/100(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%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/1159 (0.09%)  Mean 0.05%   SD 0.22%     Total 0/1207 (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: 20
 Version: 04/26/04                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 19-APR-2004
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|*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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/100(0%)           0/49 (0%)     0/49 (0%)     0/100(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%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 0/1159 (0%)     Mean 0%      SD 0%        Total 1/1207 (0.08%)   Mean 0.05%   SD 0.22%     |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/1159 (0.09%)  Mean 0.1%    SD 0.45%     Total 0/1209 (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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/1159 (0.09%)  Mean 0.05%   SD 0.22%     Total 0/1209 (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%)     0/49 (0%)     0/50 (0%)           1/50 (2%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 0/1159 (0%)     Mean 0%      SD 0%        Total 1/1209 (0.08%)   Mean 0.1%    SD 0.44%     |
 __________________________________________________________________________________________________________________________________
|#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%)     |
|                                        0/50 (0%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/100(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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 0/1159 (0%)     Mean 0%      SD 0%        Total 0/1209 (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: 21
 Version: 04/26/04                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 19-APR-2004
 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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/100(0%)           0/50 (0%)     1/50 (2%)     1/100(1%)     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)           2/50 (4%)     0/50 (0%)     3/50 (6%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     1/50 (2%)     |
| Overall Incidence               Total 3/1159 (0.26%)  Mean 0.25%   SD 0.64%     Total 15/1209 (1.24%)  Mean 1.33%   SD 1.8%      |
 __________________________________________________________________________________________________________________________________
|#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%)    |
|                                        0/50 (0%)     1/49 (2%)     0/50 (0%)           0/50 (0%)     3/49 (6%)     5/50 (10%)    |
|                                        0/50 (0%)     0/50 (0%)     0/100(0%)           4/50 (8%)     2/50 (4%)     2/100(2%)     |
|                                        2/50 (4%)     0/50 (0%)     0/50 (0%)           2/50 (4%)     4/50 (8%)     3/50 (6%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     1/50 (2%)     2/50 (4%)     |
| Overall Incidence               Total 6/1159 (0.52%)  Mean 0.5%    SD 1.1%      Total 44/1209 (3.64%)  Mean 4.05%   SD 3.36%     |
 __________________________________________________________________________________________________________________________________
|#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%)    |
|                                        0/50 (0%)     1/49 (2%)     0/50 (0%)           0/50 (0%)     3/49 (6%)     5/50 (10%)    |
|                                        0/50 (0%)     0/50 (0%)     0/100(0%)           4/50 (8%)     3/50 (6%)     3/100(3%)     |
|                                        2/50 (4%)     0/50 (0%)     0/50 (0%)           3/50 (6%)     4/50 (8%)     6/50 (12%)    |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     1/50 (2%)     3/50 (6%)     |
| Overall Incidence               Total 9/1159 (0.78%)  Mean 0.75%   SD 1.41%     Total 56/1209 (4.63%)  Mean 5.1%    SD 3.46%     |
 __________________________________________________________________________________________________________________________________
|#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%)    |
|                                        2/50 (4%)     0/49 (0%)     2/50 (4%)          20/50 (40%)   17/49 (35%)   25/50 (50%)    |
|                                        3/50 (6%)     2/50 (4%)     6/100(6%)          19/50 (38%)   16/50 (32%)   56/100(56%)    |
|                                        3/50 (6%)     0/50 (0%)     2/50 (4%)          22/50 (44%)   26/50 (52%)   33/50 (66%)    |
|                                        0/60 (0%)     0/50 (0%)                        23/60 (38%)   14/50 (28%)   28/50 (56%)    |
| Overall Incidence               Total 46/1159 (3.97%) Mean 3.75%   SD 2.34%     Total 567/1209 (46.9%) Mean 45.86%  SD 12.03%    |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/1159 (0.09%)  Mean 0.1%    SD 0.45%     Total 0/1209 (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: 22
 Version: 04/26/04                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 19-APR-2004
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|#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%)    |
|                                        2/50 (4%)     0/49 (0%)     2/50 (4%)          20/50 (40%)   17/49 (35%)   25/50 (50%)    |
|                                        3/50 (6%)     2/50 (4%)     6/100(6%)          19/50 (38%)   17/50 (34%)   56/100(56%)    |
|                                        3/50 (6%)     0/50 (0%)     2/50 (4%)          23/50 (46%)   26/50 (52%)   35/50 (70%)    |
|                                        0/60 (0%)     0/50 (0%)                        23/60 (38%)   14/50 (28%)   28/50 (56%)    |
| Overall Incidence               Total 50/1159 (4.31%) Mean 4.1%    SD 2.65%     Total 575/1209 (47.56%)Mean 46.62%  SD 12.17%    |
 __________________________________________________________________________________________________________________________________
|#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%)    |
|                                        2/50 (4%)     1/49 (2%)     2/50 (4%)          20/50 (40%)   18/49 (37%)   27/50 (54%)    |
|                                        3/50 (6%)     2/50 (4%)     6/100(6%)          23/50 (46%)   19/50 (38%)   58/100(58%)    |
|                                        5/50 (10%)    0/50 (0%)     2/50 (4%)          24/50 (48%)   28/50 (56%)   37/50 (74%)    |
|                                        0/60 (0%)     0/50 (0%)                        23/60 (38%)   14/50 (28%)   30/50 (60%)    |
| Overall Incidence               Total 56/1159 (4.83%) Mean 4.6%    SD 3.1%      Total 602/1209 (49.79%)Mean 49.05%  SD 12.72%    |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 0/1159 (0%)     Mean 0%      SD 0%        Total 1/1209 (0.08%)   Mean 0.05%   SD 0.22%     |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 0/1159 (0%)     Mean 0%      SD 0%        Total 1/1209 (0.08%)   Mean 0.1%    SD 0.44%     |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/1159 (0.09%)  Mean 0.1%    SD 0.45%     Total 0/1209 (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: 23
 Version: 04/26/04                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 19-APR-2004
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/1159 (0.09%)  Mean 0.05%   SD 0.22%     Total 0/1209 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 0/1159 (0%)     Mean 0%      SD 0%        Total 1/1209 (0.08%)   Mean 0.1%    SD 0.44%     |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/1159 (0.09%)  Mean 0.1%    SD 0.45%     Total 0/1209 (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%)     1/49 (2%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 2/1159 (0.17%)  Mean 0.2%    SD 0.62%     Total 0/1209 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|*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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (0%)     0/49 (0%)     |
|                                        1/50 (2%)     0/49 (0%)     0/100(0%)           0/49 (0%)     0/50 (0%)     0/100(0%)     |
|                                        0/50 (0%)     1/50 (2%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 2/1152 (0.17%)  Mean 0.2%    SD 0.62%     Total 1/1205 (0.08%)   Mean 0.05%   SD 0.22%     |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 24
 Version: 04/26/04                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 19-APR-2004
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|*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%)     |
|                                        1/50 (2%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/49 (0%)     0/100(0%)           0/49 (0%)     1/50 (2%)     0/100(0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/1152 (0.09%)  Mean 0.1%    SD 0.45%     Total 1/1205 (0.08%)   Mean 0.1%    SD 0.44%     |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)           1/50 (2%)     0/50 (0%)     0/50 (0%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     1/50 (2%)     0/50 (0%)     |
| Overall Incidence               Total 5/1159 (0.43%)  Mean 0.4%    SD 0.75%     Total 4/1209 (0.33%)   Mean 0.33%   SD 0.73%     |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     1/50 (2%)     0/50 (0%)     |
| Overall Incidence               Total 2/1159 (0.17%)  Mean 0.1%    SD 0.31%     Total 5/1209 (0.41%)   Mean 0.48%   SD 1.08%     |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)           1/50 (2%)     0/50 (0%)     0/50 (0%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     2/50 (4%)     0/50 (0%)     |
| Overall Incidence               Total 7/1159 (0.6%)   Mean 0.5%    SD 0.89%     Total 9/1209 (0.74%)   Mean 0.81%   SD 1.6%      |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 2/1159 (0.17%)  Mean 0.1%    SD 0.31%     Total 2/1209 (0.17%)   Mean 0.19%   SD 0.6%      |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 25
 Version: 04/26/04                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 19-APR-2004
 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%)     |
|                                        1/50 (2%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/100(0%)           0/50 (0%)     0/50 (0%)     0/100(0%)     |
|                                        1/50 (2%)     0/50 (0%)     0/50 (0%)           1/50 (2%)     0/50 (0%)     0/50 (0%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     1/50 (2%)     0/50 (0%)     |
| Overall Incidence               Total 2/1159 (0.17%)  Mean 0.2%    SD 0.62%     Total 2/1209 (0.17%)   Mean 0.19%   SD 0.6%      |
 __________________________________________________________________________________________________________________________________
|*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%)     0/49 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/100(0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence                                                               Total 1/1209 (0.08%)   Mean 0.05%   SD 0.22%     |
 __________________________________________________________________________________________________________________________________
|*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%)     |
|                                                                                        1/50 (2%)     0/49 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/100(0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     1/50 (2%)     |
|                                                                                        0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence                                                               Total 2/1209 (0.17%)   Mean 0.19%   SD 0.6%      |
 __________________________________________________________________________________________________________________________________
|*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%)     2/49 (4%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/100(0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence                                                               Total 3/1209 (0.25%)   Mean 0.29%   SD 0.97%     |
 __________________________________________________________________________________________________________________________________
|*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%)     |
|                                                                                        1/50 (2%)     2/49 (4%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/100(0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     1/50 (2%)     |
|                                                                                        0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence                                                               Total 5/1209 (0.41%)   Mean 0.48%   SD 1.09%     |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 26
 Version: 04/26/04                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 19-APR-2004
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|*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%)     |
|                                                                                        1/50 (2%)     1/49 (2%)     1/50 (2%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/100(0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence                                                               Total 3/1209 (0.25%)   Mean 0.29%   SD 0.72%     |
 __________________________________________________________________________________________________________________________________
|*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%)     0/49 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     1/100(1%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/60 (0%)     0/50 (0%)     1/50 (2%)     |
| Overall Incidence                                                               Total 2/1209 (0.17%)   Mean 0.14%   SD 0.48%     |
 __________________________________________________________________________________________________________________________________
|*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%)     0/49 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/100(0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence                                                               Total 1/1209 (0.08%)   Mean 0.1%    SD 0.44%     |
 __________________________________________________________________________________________________________________________________
|*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%)     0/49 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/100(0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence                                                               Total 1/1209 (0.08%)   Mean 0.1%    SD 0.44%     |
 __________________________________________________________________________________________________________________________________
|*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%)     0/49 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     3/100(3%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence                                                               Total 3/1209 (0.25%)   Mean 0.14%   SD 0.65%     |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 27
 Version: 04/26/04                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 19-APR-2004
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|*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%)     |
|                                        1/50 (2%)     1/49 (2%)     0/50 (0%)           0/50 (0%)     0/49 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     3/98 (3%)           0/49 (0%)     0/50 (0%)     0/100(0%)     |
|                                       10/50 (20%)    1/49 (2%)     0/49 (0%)           1/50 (2%)     0/50 (0%)     2/50 (4%)     |
|                                        1/60 (2%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     1/50 (2%)     |
| Overall Incidence               Total 22/1149 (1.91%) Mean 1.89%   SD 4.44%     Total 6/1204 (0.5%)    Mean 0.58%   SD 1.13%     |
 __________________________________________________________________________________________________________________________________
|*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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/98 (0%)           0/49 (0%)     0/50 (0%)     0/100(0%)     |
|                                        0/50 (0%)     0/49 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/60 (0%)     1/50 (2%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 2/1149 (0.17%)  Mean 0.21%   SD 0.66%     Total 0/1204 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|*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%)     |
|                                        1/50 (2%)     1/49 (2%)     0/50 (0%)           0/50 (0%)     0/49 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     3/98 (3%)           0/49 (0%)     0/50 (0%)     0/100(0%)     |
|                                       10/50 (20%)    1/49 (2%)     0/49 (0%)           1/50 (2%)     0/50 (0%)     2/50 (4%)     |
|                                        1/60 (2%)     1/50 (2%)                         0/60 (0%)     0/50 (0%)     1/50 (2%)     |
| Overall Incidence               Total 24/1149 (2.09%) Mean 2.1%    SD 4.39%     Total 6/1204 (0.5%)    Mean 0.58%   SD 1.13%     |
 __________________________________________________________________________________________________________________________________
|*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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/98 (0%)           0/49 (0%)     0/50 (0%)     0/100(0%)     |
|                                        0/50 (0%)     0/49 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/1149 (0.09%)  Mean 0.05%   SD 0.22%     Total 0/1204 (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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/98 (0%)           0/49 (0%)     0/50 (0%)     0/100(0%)     |
|                                        0/50 (0%)     0/49 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 4/1149 (0.35%)  Mean 0.38%   SD 1.1%      Total 0/1204 (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: 28
 Version: 04/26/04                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 19-APR-2004
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|*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%)     |
|                                        1/44 (2%)     0/45 (0%)     0/49 (0%)           0/40 (0%)     0/42 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/49 (0%)     0/85 (0%)           0/49 (0%)     0/45 (0%)     1/88 (1%)     |
|                                        0/50 (0%)     0/47 (0%)     0/49 (0%)           0/49 (0%)     0/49 (0%)     0/47 (0%)     |
|                                        0/58 (0%)     0/48 (0%)                         0/57 (0%)     0/46 (0%)     0/48 (0%)     |
| Overall Incidence               Total 2/1085 (0.18%)  Mean 0.22%   SD 0.69%     Total 5/1115 (0.45%)   Mean 0.37%   SD 0.8%      |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/1159 (0.09%)  Mean 0.1%    SD 0.45%     Total 0/1209 (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%)    |
|                                       36/49 (73%)   31/49 (63%)   35/50 (70%)         30/50 (60%)   23/49 (47%)   30/49 (61%)    |
|                                       38/50 (76%)   35/50 (70%)   34/98 (35%)         27/49 (55%)   31/49 (63%)   61/99 (62%)    |
|                                       12/50 (24%)    9/50 (18%)   16/48 (33%)         19/50 (38%)   23/50 (46%)   23/49 (47%)    |
|                                       11/59 (19%)   15/48 (31%)                       19/59 (32%)   15/50 (30%)   27/50 (54%)    |
| Overall Incidence               Total 422/1148 (36.76%Mean 38.83%  SD 20.76%    Total 543/1201 (45.21%)Mean 45.86%  SD 12.63%    |
 __________________________________________________________________________________________________________________________________
|*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%)     |
|                                        1/49 (2%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (0%)     0/49 (0%)     |
|                                        1/50 (2%)     0/50 (0%)     0/98 (0%)           0/49 (0%)     0/49 (0%)     3/99 (3%)     |
|                                        0/50 (0%)     0/50 (0%)     0/48 (0%)           0/50 (0%)     2/50 (4%)     1/49 (2%)     |
|                                        0/59 (0%)     1/48 (2%)                         0/59 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 4/1148 (0.35%)  Mean 0.41%   SD 0.83%     Total 8/1201 (0.67%)   Mean 0.63%   SD 1.21%     |
 __________________________________________________________________________________________________________________________________
|*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%)    |
|                                       37/49 (76%)   31/49 (63%)   35/50 (70%)         30/50 (60%)   23/49 (47%)   30/49 (61%)    |
|                                       39/50 (78%)   35/50 (70%)   34/98 (35%)         27/49 (55%)   31/49 (63%)   64/99 (65%)    |
|                                       12/50 (24%)    9/50 (18%)   16/48 (33%)         19/50 (38%)   25/50 (50%)   24/49 (49%)    |
|                                       11/59 (19%)   16/48 (33%)                       19/59 (32%)   15/50 (30%)   27/50 (54%)    |
| Overall Incidence               Total 426/1148 (37.11%Mean 39.23%  SD 21.1%     Total 551/1201 (45.88%)Mean 46.48%  SD 12.68%    |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 29
 Version: 04/26/04                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 19-APR-2004
 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%)     |
|                                        0/49 (0%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/98 (0%)           0/49 (0%)     0/49 (0%)     0/99 (0%)     |
|                                        0/50 (0%)     1/50 (2%)     0/48 (0%)           1/50 (2%)     0/50 (0%)     1/49 (2%)     |
|                                        0/59 (0%)     0/48 (0%)                         1/59 (2%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 3/1148 (0.26%)  Mean 0.25%   SD 0.64%     Total 5/1201 (0.42%)   Mean 0.37%   SD 0.78%     |
 __________________________________________________________________________________________________________________________________
|*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%)     |
|                                        0/49 (0%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/98 (0%)           0/49 (0%)     0/49 (0%)     0/99 (0%)     |
|                                        0/50 (0%)     1/50 (2%)     0/48 (0%)           1/50 (2%)     0/50 (0%)     1/49 (2%)     |
|                                        0/59 (0%)     0/48 (0%)                         1/59 (2%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 3/1148 (0.26%)  Mean 0.25%   SD 0.64%     Total 5/1201 (0.42%)   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%)                                                     |
|                                        1/50 (2%)     0/49 (0%)     0/50 (0%)                                                     |
|                                        0/50 (0%)     0/50 (0%)     0/100(0%)                                                     |
|                                        2/49 (4%)     0/50 (0%)     0/50 (0%)                                                     |
|                                        2/60 (3%)     2/50 (4%)                                                                   |
| Overall Incidence               Total 13/1156 (1.12%) Mean 1.07%   SD 1.61%                                                      |
 __________________________________________________________________________________________________________________________________
|*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%)                                                     |
|                                        1/50 (2%)     0/49 (0%)     0/50 (0%)                                                     |
|                                        0/50 (0%)     0/50 (0%)     0/100(0%)                                                     |
|                                        2/49 (4%)     0/50 (0%)     0/50 (0%)                                                     |
|                                        2/60 (3%)     2/50 (4%)                                                                   |
| Overall Incidence               Total 13/1156 (1.12%) Mean 1.07%   SD 1.61%                                                      |
 __________________________________________________________________________________________________________________________________
|*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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/49 (0%)     0/99 (0%)           0/49 (0%)     0/50 (0%)     0/100(0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 0/1154 (0%)     Mean 0%      SD 0%        Total 1/1206 (0.08%)   Mean 0.1%    SD 0.44%     |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 30
 Version: 04/26/04                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 19-APR-2004
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|*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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/49 (0%)     0/99 (0%)           0/49 (0%)     0/50 (0%)     0/100(0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 0/1154 (0%)     Mean 0%      SD 0%        Total 1/1206 (0.08%)   Mean 0.1%    SD 0.44%     |
 __________________________________________________________________________________________________________________________________
|*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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/49 (0%)     0/99 (0%)           0/49 (0%)     0/50 (0%)     0/100(0%)     |
|                                        1/50 (2%)     0/50 (0%)     0/49 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/60 (0%)     1/50 (2%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 8/1154 (0.69%)  Mean 0.8%    SD 1.36%     Total 0/1206 (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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/1159 (0.09%)  Mean 0.1%    SD 0.45%     Total 0/1209 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         1/60 (2%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 0/1159 (0%)     Mean 0%      SD 0%        Total 2/1209 (0.17%)   Mean 0.13%   SD 0.41%     |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/1159 (0.09%)  Mean 0.1%    SD 0.45%     Total 1/1209 (0.08%)   Mean 0.1%    SD 0.44%     |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 31
 Version: 04/26/04                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 19-APR-2004
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/1159 (0.09%)  Mean 0.1%    SD 0.45%     Total 1/1209 (0.08%)   Mean 0.1%    SD 0.44%     |
 __________________________________________________________________________________________________________________________________
|#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%)     |
|                                        1/50 (2%)     1/49 (2%)     1/50 (2%)           0/50 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        3/50 (6%)     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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 8/1159 (0.69%)  Mean 0.8%    SD 1.51%     Total 0/1209 (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%)     0/49 (0%)     0/50 (0%)           1/50 (2%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/1159 (0.09%)  Mean 0.05%   SD 0.22%     Total 1/1209 (0.08%)   Mean 0.1%    SD 0.44%     |
 __________________________________________________________________________________________________________________________________
|#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%)     |
|                                        1/50 (2%)     1/49 (2%)     1/50 (2%)           1/50 (2%)     0/49 (0%)     0/50 (0%)     |
|                                        3/50 (6%)     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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 9/1159 (0.78%)  Mean 0.85%   SD 1.5%      Total 1/1209 (0.08%)   Mean 0.1%    SD 0.44%     |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     0/50 (0%)           0/50 (0%)     1/50 (2%)     0/50 (0%)     |
|                                        2/60 (3%)     1/50 (2%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 11/1159 (0.95%) Mean 0.82%   SD 1.14%     Total 3/1209 (0.25%)   Mean 0.29%   SD 0.72%     |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 32
 Version: 04/26/04                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 19-APR-2004
 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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     0/50 (0%)           0/50 (0%)     1/50 (2%)     0/50 (0%)     |
|                                        2/60 (3%)     1/50 (2%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 11/1159 (0.95%) Mean 0.82%   SD 1.14%     Total 3/1209 (0.25%)   Mean 0.29%   SD 0.72%     |
 __________________________________________________________________________________________________________________________________
|#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%)     |
|                                        0/50 (0%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     3/100(3%)           0/50 (0%)     0/50 (0%)     0/100(0%)     |
|                                        1/50 (2%)     1/50 (2%)     1/50 (2%)           0/50 (0%)     1/50 (2%)     2/50 (4%)     |
|                                        2/60 (3%)     1/50 (2%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 17/1159 (1.47%) Mean 1.32%   SD 1.33%     Total 6/1209 (0.5%)    Mean 0.57%   SD 1.12%     |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     1/50 (2%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     1/50 (2%)     |
| Overall Incidence               Total 2/1159 (0.17%)  Mean 0.15%   SD 0.49%     Total 5/1209 (0.41%)   Mean 0.48%   SD 0.87%     |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     1/50 (2%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     1/50 (2%)     |
| Overall Incidence               Total 2/1159 (0.17%)  Mean 0.15%   SD 0.49%     Total 5/1209 (0.41%)   Mean 0.48%   SD 0.87%     |
 __________________________________________________________________________________________________________________________________
|#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                 0/50 (0%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     3/100(3%)           0/50 (0%)     0/50 (0%)     0/100(0%)     |
|                                        1/50 (2%)     1/50 (2%)     1/50 (2%)           0/50 (0%)     2/50 (4%)     3/50 (6%)     |
|                                        2/60 (3%)     1/50 (2%)                         0/60 (0%)     0/50 (0%)     1/50 (2%)     |
| Overall Incidence               Total 19/1159 (1.64%) Mean 1.47%   SD 1.34%     Total 11/1209 (0.91%)  Mean 1.05%   SD 1.75%     |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 33
 Version: 04/26/04                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 19-APR-2004
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|#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%)     4/49 (8%)     2/50 (4%)           1/50 (2%)     1/49 (2%)     0/50 (0%)     |
|      Keratoacanthoma,                  1/50 (2%)     5/50 (10%)   14/100(14%)          1/50 (2%)     0/50 (0%)     1/100(1%)     |
|      Trichoepithelioma                 5/50 (10%)    2/50 (4%)     5/50 (10%)          1/50 (2%)     2/50 (4%)     3/50 (6%)     |
|                                        7/60 (12%)    4/50 (8%)                         0/60 (0%)     0/50 (0%)     1/50 (2%)     |
| Overall Incidence               Total 100/1159 (8.63%)Mean 8.24%   SD 4.73%     Total 22/1209 (1.82%)  Mean 2%      SD 2.07%     |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     1/49 (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%)     |
|                                        0/60 (0%)     2/50 (4%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 2/1159 (0.17%)  Mean 0.2%    SD 0.89%     Total 1/1209 (0.08%)   Mean 0.1%    SD 0.45%     |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 0/1159 (0%)     Mean 0%      SD 0%        Total 1/1209 (0.08%)   Mean 0.1%    SD 0.44%     |
 __________________________________________________________________________________________________________________________________
|#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%)     |
|                                        1/50 (2%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/100(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%)     |
|                                        1/60 (2%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 3/1159 (0.26%)  Mean 0.28%   SD 0.69%     Total 0/1209 (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%)     |
|                                        2/50 (4%)     4/49 (8%)     1/50 (2%)           0/50 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     4/50 (8%)    10/100(10%)          1/50 (2%)     0/50 (0%)     1/100(1%)     |
|                                        3/50 (6%)     1/50 (2%)     4/50 (8%)           1/50 (2%)     0/50 (0%)     0/50 (0%)     |
|                                        5/60 (8%)     2/50 (4%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 69/1159 (5.95%) Mean 5.67%   SD 4.38%     Total 6/1209 (0.5%)    Mean 0.52%   SD 1.4%      |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 34
 Version: 04/26/04                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 19-APR-2004
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|#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%)     1/49 (2%)     1/50 (2%)           0/50 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        2/50 (4%)     2/50 (4%)     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%)     1/50 (2%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     1/50 (2%)     1/50 (2%)     |
| Overall Incidence               Total 14/1159 (1.21%) Mean 1.35%   SD 1.31%     Total 7/1209 (0.58%)   Mean 0.57%   SD 0.93%     |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 0/1159 (0%)     Mean 0%      SD 0%        Total 1/1209 (0.08%)   Mean 0.1%    SD 0.44%     |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/1159 (0.09%)  Mean 0.05%   SD 0.22%     Total 0/1209 (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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     1/50 (2%)           0/50 (0%)     0/50 (0%)     1/50 (2%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 3/1159 (0.26%)  Mean 0.3%    SD 0.73%     Total 3/1209 (0.25%)   Mean 0.24%   SD 0.62%     |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/1159 (0.09%)  Mean 0.1%    SD 0.45%     Total 0/1209 (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: 35
 Version: 04/26/04                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 19-APR-2004
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)           1/50 (2%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/1159 (0.09%)  Mean 0.1%    SD 0.45%     Total 2/1209 (0.17%)   Mean 0.19%   SD 0.6%      |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)           1/50 (2%)     0/49 (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%)     1/50 (2%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     1/50 (2%)     |
| Overall Incidence               Total 3/1159 (0.26%)  Mean 0.25%   SD 0.64%     Total 7/1209 (0.58%)   Mean 0.67%   SD 1.15%     |
 __________________________________________________________________________________________________________________________________
|#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%)     |
|                                        0/50 (0%)     0/49 (0%)     1/50 (2%)           0/50 (0%)     1/49 (2%)     0/50 (0%)     |
|                                        1/50 (2%)     1/50 (2%)     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%)     |
|                                        0/60 (0%)     1/50 (2%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 11/1159 (0.95%) Mean 1%      SD 0.97%     Total 3/1209 (0.25%)   Mean 0.24%   SD 0.63%     |
 __________________________________________________________________________________________________________________________________
|#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%)     |
|                                        0/50 (0%)     0/49 (0%)     1/50 (2%)           0/50 (0%)     1/49 (2%)     0/50 (0%)     |
|                                        1/50 (2%)     1/50 (2%)     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%)     |
|                                        0/60 (0%)     1/50 (2%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 11/1159 (0.95%) Mean 1%      SD 0.97%     Total 3/1209 (0.25%)   Mean 0.24%   SD 0.63%     |
 __________________________________________________________________________________________________________________________________
|#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%)     |
|                                        2/50 (4%)     4/49 (8%)     2/50 (4%)           1/50 (2%)     1/49 (2%)     0/50 (0%)     |
|                                        1/50 (2%)     5/50 (10%)   11/100(11%)          1/50 (2%)     0/50 (0%)     1/100(1%)     |
|                                        4/50 (8%)     1/50 (2%)     4/50 (8%)           1/50 (2%)     0/50 (0%)     0/50 (0%)     |
|                                        5/60 (8%)     3/50 (6%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 81/1159 (6.99%) Mean 6.77%   SD 4.5%      Total 11/1209 (0.91%)  Mean 0.95%   SD 1.47%     |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 36
 Version: 04/26/04                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 19-APR-2004
 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%)     |
|                                        2/50 (4%)     4/49 (8%)     2/50 (4%)           0/50 (0%)     1/49 (2%)     0/50 (0%)     |
|                                        1/50 (2%)     5/50 (10%)   11/100(11%)          1/50 (2%)     0/50 (0%)     1/100(1%)     |
|                                        4/50 (8%)     1/50 (2%)     4/50 (8%)           1/50 (2%)     0/50 (0%)     0/50 (0%)     |
|                                        5/60 (8%)     3/50 (6%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 80/1159 (6.9%)  Mean 6.67%   SD 4.59%     Total 9/1209 (0.74%)   Mean 0.76%   SD 1.45%     |
 __________________________________________________________________________________________________________________________________
|#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%)     |
|                                        0/50 (0%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/100(0%)           0/50 (0%)     0/50 (0%)     0/100(0%)     |
|                                        1/50 (2%)     1/50 (2%)     1/50 (2%)           0/50 (0%)     0/50 (0%)     2/50 (4%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 6/1159 (0.52%)  Mean 0.5%    SD 0.83%     Total 3/1209 (0.25%)   Mean 0.29%   SD 0.96%     |
 __________________________________________________________________________________________________________________________________
|#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%)     |
|                                        1/50 (2%)     5/49 (10%)    2/50 (4%)           3/50 (6%)     0/49 (0%)     1/50 (2%)     |
|                                        2/50 (4%)     2/50 (4%)    12/100(12%)          0/50 (0%)     1/50 (2%)     4/100(4%)     |
|                                        4/50 (8%)     2/50 (4%)     9/50 (18%)          2/50 (4%)     1/50 (2%)     4/50 (8%)     |
|                                        5/60 (8%)     1/50 (2%)                         3/60 (5%)     0/50 (0%)     1/50 (2%)     |
| Overall Incidence               Total 73/1159 (6.3%)  Mean 6.18%   SD 4.49%     Total 28/1209 (2.32%)  Mean 2.33%   SD 2.33%     |
 __________________________________________________________________________________________________________________________________
|#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%)     |
|                                        2/50 (4%)     7/49 (14%)    3/50 (6%)           3/50 (6%)     1/49 (2%)     3/50 (6%)     |
|                                        3/50 (6%)     6/50 (12%)   13/100(13%)          0/50 (0%)     1/50 (2%)     6/100(6%)     |
|                                        7/50 (14%)    2/50 (4%)    10/50 (20%)          2/50 (4%)     1/50 (2%)     4/50 (8%)     |
|                                        5/60 (8%)     2/50 (4%)                         3/60 (5%)     2/50 (4%)     3/50 (6%)     |
| Overall Incidence               Total 110/1159 (9.49%)Mean 9.28%   SD 4.92%     Total 41/1209 (3.39%)  Mean 3.48%   SD 2.46%     |
 __________________________________________________________________________________________________________________________________
|#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%)     |
|                                        1/50 (2%)     2/49 (4%)     1/50 (2%)           0/50 (0%)     0/49 (0%)     1/50 (2%)     |
|                                        1/50 (2%)     1/50 (2%)     1/100(1%)           0/50 (0%)     0/50 (0%)     1/100(1%)     |
|                                        3/50 (6%)     0/50 (0%)     1/50 (2%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     1/50 (2%)     1/50 (2%)     |
| Overall Incidence               Total 24/1159 (2.07%) Mean 1.95%   SD 1.96%     Total 7/1209 (0.58%)   Mean 0.62%   SD 0.92%     |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 37
 Version: 04/26/04                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 19-APR-2004
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|#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%)     2/49 (4%)     1/50 (2%)           0/50 (0%)     1/49 (2%)     2/50 (4%)     |
|                                        1/50 (2%)     4/50 (8%)     1/100(1%)           0/50 (0%)     0/50 (0%)     2/100(2%)     |
|                                        3/50 (6%)     0/50 (0%)     1/50 (2%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/60 (0%)     1/50 (2%)                         0/60 (0%)     2/50 (4%)     2/50 (4%)     |
| Overall Incidence               Total 37/1159 (3.19%) Mean 3.1%    SD 2.27%     Total 13/1209 (1.08%)  Mean 1.14%   SD 1.62%     |
 __________________________________________________________________________________________________________________________________
|#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%)     |
|                                        0/50 (0%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (0%)     1/50 (2%)     |
|                                        0/50 (0%)     2/50 (4%)     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%)     |
|                                        0/60 (0%)     1/50 (2%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 7/1159 (0.6%)   Mean 0.6%    SD 1.14%     Total 1/1209 (0.08%)   Mean 0.1%    SD 0.44%     |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/1159 (0.09%)  Mean 0.05%   SD 0.22%     Total 0/1209 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     1/50 (2%)     |
| Overall Incidence               Total 0/1159 (0%)     Mean 0%      SD 0%        Total 1/1209 (0.08%)   Mean 0.1%    SD 0.44%     |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 0/1159 (0%)     Mean 0%      SD 0%        Total 1/1209 (0.08%)   Mean 0.1%    SD 0.44%     |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 38
 Version: 04/26/04                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 19-APR-2004
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     1/50 (2%)     |
| Overall Incidence               Total 4/1159 (0.35%)  Mean 0.3%    SD 0.73%     Total 1/1209 (0.08%)   Mean 0.1%    SD 0.44%     |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     1/50 (2%)     |
| Overall Incidence               Total 4/1159 (0.35%)  Mean 0.3%    SD 0.73%     Total 2/1209 (0.17%)   Mean 0.19%   SD 0.6%      |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     1/49 (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%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     1/50 (2%)     0/50 (0%)     |
| Overall Incidence               Total 6/1159 (0.52%)  Mean 0.55%   SD 1.43%     Total 4/1209 (0.33%)   Mean 0.34%   SD 0.73%     |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 0/1159 (0%)     Mean 0%      SD 0%        Total 1/1209 (0.08%)   Mean 0.1%    SD 0.44%     |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     1/50 (2%)     |
| Overall Incidence               Total 4/1159 (0.35%)  Mean 0.3%    SD 0.73%     Total 1/1209 (0.08%)   Mean 0.1%    SD 0.44%     |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 39
 Version: 04/26/04                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 19-APR-2004
 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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     1/49 (2%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/100(0%)           0/49 (0%)     0/50 (0%)     0/100(0%)     |
|                                        0/50 (0%)     0/49 (0%)     0/48 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 0/1149 (0%)     Mean 0%      SD 0%        Total 1/1204 (0.08%)   Mean 0.1%    SD 0.45%     |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/1159 (0.09%)  Mean 0.05%   SD 0.22%     Total 0/1209 (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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/1159 (0.09%)  Mean 0.1%    SD 0.45%     Total 0/1209 (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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/1159 (0.09%)  Mean 0.1%    SD 0.45%     Total 0/1209 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 3/1159 (0.26%)  Mean 0.2%    SD 0.52%     Total 2/1209 (0.17%)   Mean 0.19%   SD 0.87%     |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 40
 Version: 04/26/04                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 19-APR-2004
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 3/1159 (0.26%)  Mean 0.2%    SD 0.52%     Total 2/1209 (0.17%)   Mean 0.19%   SD 0.87%     |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/1159 (0.09%)  Mean 0.1%    SD 0.45%     Total 0/1209 (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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/1159 (0.09%)  Mean 0.1%    SD 0.45%     Total 0/1209 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#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%)     |
|                                        0/50 (0%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/100(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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 2/1159 (0.17%)  Mean 0.2%    SD 0.62%     Total 0/1209 (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%)     0/49 (0%)     1/50 (2%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/1159 (0.09%)  Mean 0.1%    SD 0.45%     Total 0/1209 (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: 04/26/04                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 19-APR-2004
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|*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%)                                                    |
|                                       40/50 (80%)   38/49 (78%)   41/50 (82%)                                                    |
|                                       41/50 (82%)   36/50 (72%)   93/100(93%)                                                    |
|                                       41/50 (82%)   48/50 (96%)   45/50 (90%)                                                    |
|                                       55/60 (92%)   49/50 (98%)                                                                  |
| Overall Incidence               Total 1016/1159 (87.66Mean 86.76%  SD 7.23%                                                      |
 __________________________________________________________________________________________________________________________________
|*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%)     0/49 (0%)     0/50 (0%)                                                     |
|                                        0/50 (0%)     0/50 (0%)     1/100(1%)                                                     |
|                                        0/50 (0%)     0/50 (0%)     0/50 (0%)                                                     |
|                                        0/60 (0%)     0/50 (0%)                                                                   |
| Overall Incidence               Total 1/1159 (0.09%)  Mean 0.05%   SD 0.22%                                                      |
 __________________________________________________________________________________________________________________________________
|*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%)     |
|                                        0/47 (0%)     0/47 (0%)     0/47 (0%)           0/45 (0%)     0/46 (0%)     0/45 (0%)     |
|                                        0/49 (0%)     0/49 (0%)     2/97 (2%)           0/47 (0%)     0/49 (0%)     0/95 (0%)     |
|                                        0/50 (0%)     0/48 (0%)     0/48 (0%)           0/48 (0%)     0/48 (0%)     0/49 (0%)     |
|                                        0/56 (0%)     0/49 (0%)                         0/57 (0%)     0/48 (0%)     0/48 (0%)     |
| Overall Incidence               Total 3/1098 (0.27%)  Mean 0.16%   SD 0.52%     Total 1/1147 (0.09%)   Mean 0.1%    SD 0.45%     |
 __________________________________________________________________________________________________________________________________
|*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%)     |
|                                        0/47 (0%)     0/47 (0%)     0/47 (0%)           0/45 (0%)     0/46 (0%)     0/45 (0%)     |
|                                        1/49 (2%)     0/49 (0%)     0/97 (0%)           0/47 (0%)     0/49 (0%)     0/95 (0%)     |
|                                        0/50 (0%)     0/48 (0%)     0/48 (0%)           0/48 (0%)     0/48 (0%)     0/49 (0%)     |
|                                        0/56 (0%)     0/49 (0%)                         0/57 (0%)     0/48 (0%)     1/48 (2%)     |
| Overall Incidence               Total 1/1098 (0.09%)  Mean 0.1%    SD 0.46%     Total 2/1147 (0.17%)   Mean 0.15%   SD 0.5%      |
 __________________________________________________________________________________________________________________________________
|*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%)     |
|                                        0/47 (0%)     0/47 (0%)     0/47 (0%)           0/45 (0%)     0/46 (0%)     0/45 (0%)     |
|                                        1/49 (2%)     0/49 (0%)     2/97 (2%)           0/47 (0%)     0/49 (0%)     0/95 (0%)     |
|                                        0/50 (0%)     0/48 (0%)     0/48 (0%)           0/48 (0%)     0/48 (0%)     0/49 (0%)     |
|                                        0/56 (0%)     0/49 (0%)                         0/57 (0%)     0/48 (0%)     1/48 (2%)     |
| Overall Incidence               Total 4/1098 (0.36%)  Mean 0.26%   SD 0.66%     Total 3/1147 (0.26%)   Mean 0.25%   SD 0.65%     |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 42
 Version: 04/26/04                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 19-APR-2004
 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%)    |
|                                        5/49 (10%)    9/46 (20%)    3/50 (6%)           6/47 (13%)    4/47 (9%)     8/49 (16%)    |
|                                        7/50 (14%)    1/50 (2%)    15/99 (15%)          3/49 (6%)     2/50 (4%)    15/100(15%)    |
|                                        4/50 (8%)     9/48 (19%)    9/47 (19%)         12/50 (24%)    9/49 (18%)   12/47 (26%)    |
|                                       10/59 (17%)   11/50 (22%)                        9/60 (15%)    6/50 (12%)    2/49 (4%)     |
| Overall Incidence               Total 165/1140 (14.47%Mean 14.66%  SD 5.58%     Total 161/1192 (13.51%)Mean 13.19%  SD 6.31%     |
 __________________________________________________________________________________________________________________________________
|*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%)     |
|                                        1/49 (2%)     1/46 (2%)     1/50 (2%)           3/47 (6%)     3/47 (6%)     2/49 (4%)     |
|                                        2/50 (4%)     0/50 (0%)     1/99 (1%)           1/49 (2%)     1/50 (2%)     5/100(5%)     |
|                                        1/50 (2%)     1/48 (2%)     2/47 (4%)           1/50 (2%)     0/49 (0%)     1/47 (2%)     |
|                                        0/59 (0%)     0/50 (0%)                         1/60 (2%)     0/50 (0%)     1/49 (2%)     |
| Overall Incidence               Total 25/1140 (2.19%) Mean 2.17%   SD 1.63%     Total 32/1192 (2.68%)  Mean 2.71%   SD 2.12%     |
 __________________________________________________________________________________________________________________________________
|*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%)    |
|                                        6/49 (12%)   10/46 (22%)    4/50 (8%)           8/47 (17%)    7/47 (15%)    9/49 (18%)    |
|                                        9/50 (18%)    1/50 (2%)    16/99 (16%)          4/49 (8%)     3/50 (6%)    19/100(19%)    |
|                                        5/50 (10%)   10/48 (21%)   11/47 (23%)         13/50 (26%)    9/49 (18%)   13/47 (28%)    |
|                                       10/59 (17%)   11/50 (22%)                       10/60 (17%)    6/50 (12%)    3/49 (6%)     |
| Overall Incidence               Total 190/1140 (16.67%Mean 16.83%  SD 5.93%     Total 190/1192 (15.94%)Mean 15.66%  SD 5.94%     |
 __________________________________________________________________________________________________________________________________
|*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%)     |
|                                        0/49 (0%)     0/46 (0%)     0/50 (0%)           0/47 (0%)     0/47 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     1/99 (1%)           0/49 (0%)     0/50 (0%)     0/100(0%)     |
|                                        0/50 (0%)     1/48 (2%)     1/47 (2%)           0/50 (0%)     0/49 (0%)     0/47 (0%)     |
|                                        0/59 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/49 (0%)     |
| Overall Incidence               Total 12/1140 (1.05%) Mean 0.98%   SD 1.26%     Total 3/1192 (0.25%)   Mean 0.24%   SD 0.62%     |
 __________________________________________________________________________________________________________________________________
|*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%)     |
|                                        0/49 (0%)     0/46 (0%)     1/50 (2%)           1/47 (2%)     1/47 (2%)     0/49 (0%)     |
|                                        1/50 (2%)     0/50 (0%)     0/99 (0%)           0/49 (0%)     2/50 (4%)     0/100(0%)     |
|                                        1/50 (2%)     0/48 (0%)     0/47 (0%)           1/50 (2%)     1/49 (2%)     1/47 (2%)     |
|                                        1/59 (2%)     0/50 (0%)                         0/60 (0%)     1/50 (2%)     0/49 (0%)     |
| Overall Incidence               Total 11/1140 (0.96%) Mean 0.88%   SD 1.24%     Total 13/1192 (1.09%)  Mean 1.22%   SD 1.19%     |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 43
 Version: 04/26/04                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 19-APR-2004
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|*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%)     |
|                                        0/49 (0%)     0/46 (0%)     1/50 (2%)           1/47 (2%)     1/47 (2%)     0/49 (0%)     |
|                                        1/50 (2%)     0/50 (0%)     1/99 (1%)           0/49 (0%)     2/50 (4%)     0/100(0%)     |
|                                        1/50 (2%)     1/48 (2%)     1/47 (2%)           1/50 (2%)     1/49 (2%)     1/47 (2%)     |
|                                        1/59 (2%)     0/50 (0%)                         0/60 (0%)     1/50 (2%)     0/49 (0%)     |
| Overall Incidence               Total 23/1140 (2.02%) Mean 1.86%   SD 1.54%     Total 16/1192 (1.34%)  Mean 1.46%   SD 1.26%     |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 0/1159 (0%)     Mean 0%      SD 0%        Total 1/1209 (0.08%)   Mean 0.1%    SD 0.44%     |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/1159 (0.09%)  Mean 0.1%    SD 0.45%     Total 0/1209 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/1159 (0.09%)  Mean 0.1%    SD 0.45%     Total 0/1209 (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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 2/1159 (0.17%)  Mean 0.15%   SD 0.49%     Total 0/1209 (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: 44
 Version: 04/26/04                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 19-APR-2004
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/1159 (0.09%)  Mean 0.05%   SD 0.22%     Total 0/1209 (0%)      Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 0/1159 (0%)     Mean 0%      SD 0%        Total 1/1209 (0.08%)   Mean 0.1%    SD 0.44%     |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     1/50 (2%)     0/50 (0%)     |
| Overall Incidence               Total 0/1159 (0%)     Mean 0%      SD 0%        Total 3/1209 (0.25%)   Mean 0.29%   SD 0.72%     |
 __________________________________________________________________________________________________________________________________
|#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%)     |
|                                        0/50 (0%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/100(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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     1/50 (2%)     0/50 (0%)     |
| Overall Incidence               Total 3/1159 (0.26%)  Mean 0.2%    SD 0.52%     Total 5/1209 (0.41%)   Mean 0.43%   SD 1.03%     |
 __________________________________________________________________________________________________________________________________
|#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%)     |
|                                        0/50 (0%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (0%)     0/50 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/100(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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 3/1159 (0.26%)  Mean 0.2%    SD 0.52%     Total 2/1209 (0.17%)   Mean 0.14%   SD 0.48%     |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 45
 Version: 04/26/04                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 19-APR-2004
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 0/1159 (0%)     Mean 0%      SD 0%        Total 1/1209 (0.08%)   Mean 0.1%    SD 0.44%     |
 __________________________________________________________________________________________________________________________________
|*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%)     0/48 (0%)     0/50 (0%)           0/49 (0%)     0/48 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/49 (0%)     0/99 (0%)           0/49 (0%)     1/50 (2%)     0/99 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/48 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 0/1149 (0%)     Mean 0%      SD 0%        Total 1/1204 (0.08%)   Mean 0.1%    SD 0.44%     |
 __________________________________________________________________________________________________________________________________
|*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%)     1/48 (2%)     0/50 (0%)           0/49 (0%)     1/48 (2%)     0/49 (0%)     |
|                                        0/50 (0%)     0/49 (0%)     1/99 (1%)           1/49 (2%)     1/50 (2%)     0/99 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/48 (0%)           0/50 (0%)     1/50 (2%)     0/50 (0%)     |
|                                        1/60 (2%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     1/50 (2%)     |
| Overall Incidence               Total 4/1149 (0.35%)  Mean 0.34%   SD 0.73%     Total 6/1204 (0.5%)    Mean 0.58%   SD 0.94%     |
 __________________________________________________________________________________________________________________________________
|*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%)     0/48 (0%)     0/50 (0%)           0/49 (0%)     0/48 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/49 (0%)     0/99 (0%)           1/49 (2%)     0/50 (0%)     0/99 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/48 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 0/1149 (0%)     Mean 0%      SD 0%        Total 1/1204 (0.08%)   Mean 0.1%    SD 0.45%     |
 __________________________________________________________________________________________________________________________________
|*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%)     1/48 (2%)     0/50 (0%)           0/49 (0%)     1/48 (2%)     0/49 (0%)     |
|                                        0/50 (0%)     0/49 (0%)     1/99 (1%)           1/49 (2%)     0/50 (0%)     0/99 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/48 (0%)           0/50 (0%)     1/50 (2%)     0/50 (0%)     |
|                                        1/60 (2%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     1/50 (2%)     |
| Overall Incidence               Total 4/1149 (0.35%)  Mean 0.34%   SD 0.73%     Total 5/1204 (0.42%)   Mean 0.48%   SD 0.88%     |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 46
 Version: 04/26/04                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 19-APR-2004
 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%)     0/48 (0%)     0/50 (0%)           0/49 (0%)     0/48 (0%)     0/49 (0%)     |
|                                        0/50 (0%)     0/49 (0%)     0/99 (0%)           0/49 (0%)     0/50 (0%)     0/99 (0%)     |
|                                        0/50 (0%)     0/50 (0%)     0/48 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/60 (0%)     0/50 (0%)                         0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/1149 (0.09%)  Mean 0.11%   SD 0.49%     Total 0/1204 (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%)     |
|                                                                                        0/50 (0%)     0/49 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/100(0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence                                                               Total 2/1209 (0.17%)   Mean 0.14%   SD 0.48%     |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/100(0%)     |
|                                                                                        1/50 (2%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/60 (0%)     0/50 (0%)     1/50 (2%)     |
| Overall Incidence                                                               Total 4/1209 (0.33%)   Mean 0.38%   SD 1.02%     |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/100(0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/60 (0%)     1/50 (2%)     0/50 (0%)     |
| Overall Incidence                                                               Total 2/1209 (0.17%)   Mean 0.14%   SD 0.48%     |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/100(0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/60 (0%)     0/50 (0%)     1/50 (2%)     |
| Overall Incidence                                                               Total 1/1209 (0.08%)   Mean 0.1%    SD 0.44%     |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 47
 Version: 04/26/04                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 19-APR-2004
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     1/50 (2%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     2/100(2%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence                                                               Total 4/1209 (0.33%)   Mean 0.29%   SD 0.72%     |
 __________________________________________________________________________________________________________________________________
|#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%)    |
|                                                                                       10/50 (20%)   15/49 (31%)    5/50 (10%)    |
|                                                                                       10/50 (20%)    6/50 (12%)   13/100(13%)    |
|                                                                                       14/50 (28%)    8/50 (16%)    9/50 (18%)    |
|                                                                                       11/60 (18%)    6/50 (12%)   11/50 (22%)    |
| Overall Incidence                                                               Total 203/1209 (16.79%)Mean 17%     SD 5.25%     |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/100(0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence                                                               Total 1/1209 (0.08%)   Mean 0.1%    SD 0.44%     |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)     |
|                                                                                        1/50 (2%)     0/50 (0%)     0/100(0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     1/50 (2%)     |
|                                                                                        0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence                                                               Total 4/1209 (0.33%)   Mean 0.38%   SD 0.8%      |
 __________________________________________________________________________________________________________________________________
|#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%)    |
|                                                                                       10/50 (20%)   15/49 (31%)    5/50 (10%)    |
|                                                                                       11/50 (22%)    6/50 (12%)   13/100(13%)    |
|                                                                                       14/50 (28%)    8/50 (16%)   10/50 (20%)    |
|                                                                                       11/60 (18%)    6/50 (12%)   11/50 (22%)    |
| Overall Incidence                                                               Total 207/1209 (17.12%)Mean 17.38%  SD 5.43%     |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 48
 Version: 04/26/04                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 19-APR-2004
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     3/100(3%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/60 (0%)     1/50 (2%)     0/50 (0%)     |
| Overall Incidence                                                               Total 4/1209 (0.33%)   Mean 0.24%   SD 0.77%     |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/100(0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        1/60 (2%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence                                                               Total 1/1209 (0.08%)   Mean 0.08%   SD 0.36%     |
 __________________________________________________________________________________________________________________________________
|#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%)     |
|                                                                                        1/50 (2%)     0/49 (0%)     0/50 (0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/100(0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence                                                               Total 1/1209 (0.08%)   Mean 0.1%    SD 0.44%     |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     1/50 (2%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/100(0%)     |
|                                                                                        0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                                                                        0/60 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence                                                               Total 2/1209 (0.17%)   Mean 0.19%   SD 0.6%      |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     0/50 (0%)           0/50 (0%)     0/49 (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%)     |
|                                        0/60 (0%)     0/50 (0%)                         1/60 (2%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/1159 (0.09%)  Mean 0.1%    SD 0.45%     Total 3/1209 (0.25%)   Mean 0.22%   SD 0.58%     |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 49
 Version: 04/26/04                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ALL ROUTES                                 Date of
 Species: RATS                                           Vehicle: ALL VEHICLES                             Input File: 19-APR-2004
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     1/50 (2%)           1/50 (2%)     2/49 (4%)     2/50 (4%)     |
|                                        0/50 (0%)     0/50 (0%)     1/100(1%)           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%)     |
|                                        0/60 (0%)     2/50 (4%)                         1/60 (2%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 11/1159 (0.95%) Mean 1%      SD 1.62%     Total 7/1209 (0.58%)   Mean 0.65%   SD 1.31%     |
 __________________________________________________________________________________________________________________________________
|#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%)     0/49 (0%)     1/50 (2%)           1/50 (2%)     2/49 (4%)     2/50 (4%)     |
|                                        0/50 (0%)     0/50 (0%)     1/100(1%)           1/50 (2%)     0/50 (0%)     0/100(0%)     |
|                                        2/50 (4%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|                                        0/60 (0%)     2/50 (4%)                         2/60 (3%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 12/1159 (1.04%) Mean 1.1%    SD 1.74%     Total 10/1209 (0.83%)  Mean 0.88%   SD 1.43%     |
 __________________________________________________________________________________________________________________________________
