                                                 Toxicology Data Management System                                     Page: 1
 Version: 11/09/04                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ORAL                                      Date of
 Species: RATS                                           Vehicle: WATER                                   Input File: 9-NOV-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  058803105  03/31/97   729       50(3)      23  (662)    519.6     DIPROPYLENE GLYCOL                         |
|BATTELLE COLUMBUS  058800705  08/14/95   729       50(3)      29  (665)    502.2     SODIUM NITRITE                             |
|SOUTHERN RESEARCH  059601003  09/16/98   729       50(3)      36  (687)    514.1     SODIUM DICHLORATE                          |
|________________________________________________________________________________________________________________________________|
|                                                                                                                                |
|                                                       FEMALE                                                                   |
|________________________________________________________________________________________________________________________________|
|                                                                                                                                |
|BATTELLE COLUMBUS  058803105  03/31/97   729       50(5)      30  (683)    350.8     DIPROPYLENE GLYCOL                         |
|BATTELLE COLUMBUS  058800705  08/14/95   730       50(5)      33  (695)    350.1     SODIUM NITRITE                             |
|SOUTHERN RESEARCH  059601003  09/16/98   734       50(5)      37  (699)    341.7     SODIUM DICHLORATE                          |
|________________________________________________________________________________________________________________________________|

























                                                                                  

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                                                 Toxicology Data Management System                                     Page: 3
 Version: 11/09/04                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ORAL                                       Date of
 Species: RATS                                           Vehicle: WATER                                    Input File: 9-NOV-2004 
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|#All Organs:                                                                                                                      |
|   Benign Tumors                       47/50 (94%)   47/50 (94%)   48/50 (96%)         44/50 (88%)   42/50 (84%)   46/50 (92%)    |
| Overall Incidence               Total 142/150 (94.67%)Mean 94.67%  SD 1.15%     Total 132/150 (88%)    Mean 88%     SD 4%        |
 __________________________________________________________________________________________________________________________________
|#All Organs:                                                                                                                      |
|   Malignant Tumors                    35/50 (70%)   30/50 (60%)   27/50 (54%)         25/50 (50%)   23/50 (46%)   21/50 (42%)    |
| Overall Incidence               Total 92/150 (61.33%) Mean 61.33%  SD 8.08%     Total 69/150 (46%)     Mean 46%     SD 4%        |
 __________________________________________________________________________________________________________________________________
|#All Organs:                                                                                                                      |
|   Malignant and Benign Tumors         49/50 (98%)   49/50 (98%)   49/50 (98%)         50/50 (100%)  45/50 (90%)   49/50 (98%)    |
| Overall Incidence               Total 147/150 (98%)   Mean 98%     SD 0%        Total 144/150 (96%)    Mean 96%     SD 5.29%     |
 __________________________________________________________________________________________________________________________________
|#All Organs:                                                                                                                      |
|   Histiocytic Sarcoma                  0/50 (0%)     0/50 (0%)     1/50 (2%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/150 (0.67%)   Mean 0.67%   SD 1.15%     Total 0/150 (0%)       Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#All Organs:                                                                                                                      |
|   Leukemia: Lymphocytic, Monocytic,   16/50 (32%)   17/50 (34%)   13/50 (26%)         10/50 (20%)   15/50 (30%)   11/50 (22%)    |
|      Mononuclear, or Undifferentiated                                                                                            |
| Overall Incidence               Total 46/150 (30.67%) Mean 30.67%  SD 4.16%     Total 36/150 (24%)     Mean 24%     SD 5.29%     |
 __________________________________________________________________________________________________________________________________
|#All Organs:                                                                                                                      |
|   Malignant Lymphoma: Histiocytic,     1/50 (2%)     0/50 (0%)     1/50 (2%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|      Lymphocytic, Mixed, NOS, or                                                                                                 |
|      Undifferentiated Cell Type                                                                                                  |
| Overall Incidence               Total 2/150 (1.33%)   Mean 1.33%   SD 1.15%     Total 0/150 (0%)       Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#All Organs:                                                                                                                      |
|   Mesothelioma: Benign                 1/50 (2%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/150 (0.67%)   Mean 0.67%   SD 1.15%     Total 0/150 (0%)       Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#All Organs:                                                                                                                      |
|   Mesothelioma: Benign, Malignant,     6/50 (12%)    3/50 (6%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|      NOS                                                                                                                         |
| Overall Incidence               Total 9/150 (6%)      Mean 6%      SD 6%        Total 0/150 (0%)       Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#All Organs:                                                                                                                      |
|   Mesothelioma: Malignant              6/50 (12%)    3/50 (6%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 9/150 (6%)      Mean 6%      SD 6%        Total 0/150 (0%)       Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#All Organs:                                                                                                                      |
|   Osteosarcoma                         0/50 (0%)     1/50 (2%)     3/50 (6%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 4/150 (2.67%)   Mean 2.67%   SD 3.06%     Total 0/150 (0%)       Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#All Organs:                                                                                                                      |
|   Osteosarcoma or Osteoma              0/50 (0%)     1/50 (2%)     3/50 (6%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 4/150 (2.67%)   Mean 2.67%   SD 3.06%     Total 0/150 (0%)       Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|*Adrenal Cortex:                                                                                                                  |
|   Adenoma                              0/47 (0%)     0/50 (0%)     0/49 (0%)           1/49 (2%)     1/50 (2%)     0/50 (0%)     |
| Overall Incidence               Total 0/146 (0%)      Mean 0%      SD 0%        Total 2/149 (1.34%)    Mean 1.35%   SD 1.17%     |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 4
 Version: 11/09/04                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ORAL                                       Date of
 Species: RATS                                           Vehicle: WATER                                    Input File: 9-NOV-2004 
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|*Adrenal Medulla:                                                                                                                 |
|   Ganglioneuroma                       1/47 (2%)     0/50 (0%)     0/49 (0%)           0/49 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/146 (0.68%)   Mean 0.71%   SD 1.23%     Total 0/149 (0%)       Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|*Adrenal Medulla:                                                                                                                 |
|   Pheochromocytoma Benign              4/47 (9%)     6/50 (12%)    6/49 (12%)          0/49 (0%)     4/50 (8%)     2/50 (4%)     |
| Overall Incidence               Total 16/146 (10.96%) Mean 10.92%  SD 2.09%     Total 6/149 (4.03%)    Mean 4%      SD 4%        |
 __________________________________________________________________________________________________________________________________
|*Adrenal Medulla:                                                                                                                 |
|   Pheochromocytoma Malignant           5/47 (11%)    1/50 (2%)     3/49 (6%)           2/49 (4%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 9/146 (6.16%)   Mean 6.25%   SD 4.32%     Total 2/149 (1.34%)    Mean 1.36%   SD 2.36%     |
 __________________________________________________________________________________________________________________________________
|*Adrenal Medulla:                                                                                                                 |
|   Pheochromocytoma: Benign,            9/47 (19%)    7/50 (14%)    9/49 (18%)          2/49 (4%)     4/50 (8%)     2/50 (4%)     |
|      Complex, Malignant, NOS                                                                                                     |
| Overall Incidence               Total 25/146 (17.12%) Mean 17.17%  SD 2.77%     Total 8/149 (5.37%)    Mean 5.36%   SD 2.29%     |
 __________________________________________________________________________________________________________________________________
|#Blood Vessel:                                                                                                                    |
|   Osteosarcoma                         0/50 (0%)     0/50 (0%)     1/50 (2%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/150 (0.67%)   Mean 0.67%   SD 1.15%     Total 0/150 (0%)       Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#Bone:                                                                                                                            |
|   Osteosarcoma                         0/50 (0%)     1/50 (2%)     1/50 (2%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 2/150 (1.33%)   Mean 1.33%   SD 1.15%     Total 0/150 (0%)       Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#Bone:                                                                                                                            |
|   Osteosarcoma or Osteoma              0/50 (0%)     1/50 (2%)     1/50 (2%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 2/150 (1.33%)   Mean 1.33%   SD 1.15%     Total 0/150 (0%)       Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|*Brain:                                                                                                                           |
|   Sarcoma                              1/50 (2%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/49 (0%)     |
| Overall Incidence               Total 1/150 (0.67%)   Mean 0.67%   SD 1.15%     Total 0/149 (0%)       Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|*Clitoral/Preputial Gland:                                                                                                        |
|   Adenoma                              3/50 (6%)     0/50 (0%)     1/48 (2%)           6/48 (13%)    8/46 (17%)   11/49 (22%)    |
| Overall Incidence               Total 4/148 (2.7%)    Mean 2.69%   SD 3.05%     Total 25/143 (17.48%)  Mean 17.45%  SD 4.97%     |
 __________________________________________________________________________________________________________________________________
|*Clitoral/Preputial Gland:                                                                                                        |
|   Carcinoma                            3/50 (6%)     5/50 (10%)    3/48 (6%)           5/48 (10%)    2/46 (4%)     3/49 (6%)     |
| Overall Incidence               Total 11/148 (7.43%)  Mean 7.42%   SD 2.24%     Total 10/143 (6.99%)   Mean 6.96%   SD 3.12%     |
 __________________________________________________________________________________________________________________________________
|*Clitoral/Preputial Gland:                                                                                                        |
|   Carcinoma or Adenoma                 6/50 (12%)    5/50 (10%)    4/48 (8%)          10/48 (21%)   10/46 (22%)   14/49 (29%)    |
| Overall Incidence               Total 15/148 (10.14%) Mean 10.11%  SD 1.84%     Total 34/143 (23.78%)  Mean 23.71%  SD 4.23%     |
 __________________________________________________________________________________________________________________________________
|*Clitoral/Preputial Gland:                                                                                                        |
|   Sarcoma                              1/50 (2%)     0/50 (0%)     0/48 (0%)           0/48 (0%)     0/46 (0%)     0/49 (0%)     |
| Overall Incidence               Total 1/148 (0.68%)   Mean 0.67%   SD 1.15%     Total 0/143 (0%)       Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#Harderian Gland:                                                                                                                 |
|   Carcinoma                            0/50 (0%)     0/50 (0%)     1/50 (2%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/150 (0.67%)   Mean 0.67%   SD 1.15%     Total 0/150 (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: 11/09/04                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ORAL                                       Date of
 Species: RATS                                           Vehicle: WATER                                    Input File: 9-NOV-2004 
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|#Harderian Gland:                                                                                                                 |
|   Carcinoma or Adenoma                 0/50 (0%)     0/50 (0%)     1/50 (2%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/150 (0.67%)   Mean 0.67%   SD 1.15%     Total 0/150 (0%)       Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|*Heart:                                                                                                                           |
|   Schwannoma Benign                    2/50 (4%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 2/150 (1.33%)   Mean 1.33%   SD 2.31%     Total 0/150 (0%)       Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|*Heart:                                                                                                                           |
|   Schwannoma Malignant                 0/50 (0%)     1/50 (2%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/150 (0.67%)   Mean 0.67%   SD 1.15%     Total 0/150 (0%)       Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#Intestine Large: Colon/Rectum                                                                                                    |
|   Leiomyosarcoma                       0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     1/50 (2%)     |
| Overall Incidence               Total 0/150 (0%)      Mean 0%      SD 0%        Total 1/150 (0.67%)    Mean 0.67%   SD 1.15%     |
 __________________________________________________________________________________________________________________________________
|*Islets, Pancreatic:                                                                                                              |
|   Adenoma                              2/44 (5%)     4/50 (8%)     3/50 (6%)           0/47 (0%)     0/50 (0%)     2/50 (4%)     |
| Overall Incidence               Total 9/144 (6.25%)   Mean 6.18%   SD 1.73%     Total 2/147 (1.36%)    Mean 1.33%   SD 2.31%     |
 __________________________________________________________________________________________________________________________________
|*Islets, Pancreatic:                                                                                                              |
|   Carcinoma                            0/44 (0%)     1/50 (2%)     2/50 (4%)           0/47 (0%)     0/50 (0%)     1/50 (2%)     |
| Overall Incidence               Total 3/144 (2.08%)   Mean 2%      SD 2%        Total 1/147 (0.68%)    Mean 0.67%   SD 1.15%     |
 __________________________________________________________________________________________________________________________________
|*Islets, Pancreatic:                                                                                                              |
|   Carcinoma or Adenoma                 2/44 (5%)     5/50 (10%)    5/50 (10%)          0/47 (0%)     0/50 (0%)     3/50 (6%)     |
| Overall Incidence               Total 12/144 (8.33%)  Mean 8.18%   SD 3.15%     Total 3/147 (2.04%)    Mean 2%      SD 3.46%     |
 __________________________________________________________________________________________________________________________________
|*Kidney: Renal Tubule                                                                                                             |
|   Adenoma                              1/47 (2%)     0/50 (0%)     0/47 (0%)           0/49 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/144 (0.69%)   Mean 0.71%   SD 1.23%     Total 0/149 (0%)       Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|*Kidney: Renal Tubule                                                                                                             |
|   Carcinoma or Adenoma                 1/47 (2%)     0/50 (0%)     0/47 (0%)           0/49 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/144 (0.69%)   Mean 0.71%   SD 1.23%     Total 0/149 (0%)       Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|*Kidney: Renal Tubule                                                                                                             |
|   Stromal Nephroma                     1/47 (2%)     0/50 (0%)     0/47 (0%)           0/49 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/144 (0.69%)   Mean 0.71%   SD 1.23%     Total 0/149 (0%)       Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|*Lung:                                                                                                                            |
|   Alveolar/Bronchiolar Adenoma         2/50 (4%)     2/50 (4%)     1/50 (2%)           0/50 (0%)     3/50 (6%)     1/50 (2%)     |
| Overall Incidence               Total 5/150 (3.33%)   Mean 3.33%   SD 1.15%     Total 4/150 (2.67%)    Mean 2.67%   SD 3.06%     |
 __________________________________________________________________________________________________________________________________
|*Lung:                                                                                                                            |
|   Alveolar/Bronchiolar Carcinoma       1/50 (2%)     0/50 (0%)     3/50 (6%)           1/50 (2%)     0/50 (0%)     1/50 (2%)     |
| Overall Incidence               Total 4/150 (2.67%)   Mean 2.67%   SD 3.06%     Total 2/150 (1.33%)    Mean 1.33%   SD 1.15%     |
 __________________________________________________________________________________________________________________________________
|*Lung:                                                                                                                            |
|   Alveolar/Bronchiolar Carcinoma or    3/50 (6%)     2/50 (4%)     4/50 (8%)           1/50 (2%)     3/50 (6%)     2/50 (4%)     |
|      Alveolar/Bronchiolar Adenoma                                                                                                |
| Overall Incidence               Total 9/150 (6%)      Mean 6%      SD 2%        Total 6/150 (4%)       Mean 4%      SD 2%        |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 6
 Version: 11/09/04                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ORAL                                       Date of
 Species: RATS                                           Vehicle: WATER                                    Input File: 9-NOV-2004 
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|#Mammary Gland:                                                                                                                   |
|   Adenoma                              0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     2/50 (4%)     3/50 (6%)     |
| Overall Incidence               Total 0/150 (0%)      Mean 0%      SD 0%        Total 5/150 (3.33%)    Mean 3.33%   SD 3.06%     |
 __________________________________________________________________________________________________________________________________
|#Mammary Gland:                                                                                                                   |
|   Carcinoma                            0/50 (0%)     0/50 (0%)     0/50 (0%)           4/50 (8%)     1/50 (2%)     3/50 (6%)     |
| Overall Incidence               Total 0/150 (0%)      Mean 0%      SD 0%        Total 8/150 (5.33%)    Mean 5.33%   SD 3.06%     |
 __________________________________________________________________________________________________________________________________
|#Mammary Gland:                                                                                                                   |
|   Carcinoma or Adenoma                 0/50 (0%)     0/50 (0%)     0/50 (0%)           4/50 (8%)     2/50 (4%)     6/50 (12%)    |
| Overall Incidence               Total 0/150 (0%)      Mean 0%      SD 0%        Total 12/150 (8%)      Mean 8%      SD 4%        |
 __________________________________________________________________________________________________________________________________
|#Mammary Gland:                                                                                                                   |
|   Fibroadenoma                         1/50 (2%)     3/50 (6%)     2/50 (4%)          36/50 (72%)   21/50 (42%)   33/50 (66%)    |
| Overall Incidence               Total 6/150 (4%)      Mean 4%      SD 2%        Total 90/150 (60%)     Mean 60%     SD 15.87%    |
 __________________________________________________________________________________________________________________________________
|#Mammary Gland:                                                                                                                   |
|   Fibroma, Fibroadenoma or Adenoma     1/50 (2%)     3/50 (6%)     2/50 (4%)          36/50 (72%)   23/50 (46%)   35/50 (70%)    |
| Overall Incidence               Total 6/150 (4%)      Mean 4%      SD 2%        Total 94/150 (62.67%)  Mean 62.67%  SD 14.47%    |
 __________________________________________________________________________________________________________________________________
|#Mammary Gland:                                                                                                                   |
|   Fibroma, Fibroadenoma, Carcinoma,    1/50 (2%)     3/50 (6%)     2/50 (4%)          37/50 (74%)   23/50 (46%)   37/50 (74%)    |
|      or Adenoma                                                                                                                  |
| Overall Incidence               Total 6/150 (4%)      Mean 4%      SD 2%        Total 97/150 (64.67%)  Mean 64.67%  SD 16.17%    |
 __________________________________________________________________________________________________________________________________
|#Mesentery:                                                                                                                       |
|   Osteosarcoma                         0/50 (0%)     0/50 (0%)     1/50 (2%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/150 (0.67%)   Mean 0.67%   SD 1.15%     Total 0/150 (0%)       Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#Oral Cavity (Oral Mucosa, Tongue,                                                                                                |
| Pharynx, Tooth, Gingiva):                                                                                                        |
|   Squamous Cell Carcinoma              0/50 (0%)     0/50 (0%)     0/50 (0%)           1/50 (2%)     1/50 (2%)     0/50 (0%)     |
| Overall Incidence               Total 0/150 (0%)      Mean 0%      SD 0%        Total 2/150 (1.33%)    Mean 1.33%   SD 1.15%     |
 __________________________________________________________________________________________________________________________________
|#Oral Cavity (Oral Mucosa, Tongue,                                                                                                |
| Pharynx, Tooth, Gingiva):                                                                                                        |
|   Squamous Cell Carcinoma,             0/50 (0%)     0/50 (0%)     0/50 (0%)           1/50 (2%)     1/50 (2%)     0/50 (0%)     |
|      Papilloma Squamous, or Papilloma                                                                                            |
| Overall Incidence               Total 0/150 (0%)      Mean 0%      SD 0%        Total 2/150 (1.33%)    Mean 1.33%   SD 1.15%     |
 __________________________________________________________________________________________________________________________________
|#Oral Mucosa:                                                                                                                     |
|   Squamous Cell Carcinoma              0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     1/50 (2%)     0/50 (0%)     |
| Overall Incidence               Total 0/150 (0%)      Mean 0%      SD 0%        Total 1/150 (0.67%)    Mean 0.67%   SD 1.15%     |
 __________________________________________________________________________________________________________________________________
|*Ovary:                                                                                                                           |
|   Granulosa Cell Tumor Benign                                                          0/50 (0%)     0/50 (0%)     1/50 (2%)     |
| Overall Incidence                                                               Total 1/150 (0.67%)    Mean 0.67%   SD 1.15%     |
 __________________________________________________________________________________________________________________________________
|*Ovary:                                                                                                                           |
|   Granulosa Cell Tumor: Benign,                                                        0/50 (0%)     0/50 (0%)     1/50 (2%)     |
|      Malignant, NOS                                                                                                              |
| Overall Incidence                                                               Total 1/150 (0.67%)    Mean 0.67%   SD 1.15%     |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 7
 Version: 11/09/04                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ORAL                                       Date of
 Species: RATS                                           Vehicle: WATER                                    Input File: 9-NOV-2004 
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|*Ovary:                                                                                                                           |
|   Sarcoma                                                                              1/50 (2%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence                                                               Total 1/150 (0.67%)    Mean 0.67%   SD 1.15%     |
 __________________________________________________________________________________________________________________________________
|*Pancreas:                                                                                                                        |
|   Adenoma                              0/44 (0%)     0/50 (0%)     0/49 (0%)           1/47 (2%)     0/50 (0%)     2/50 (4%)     |
| Overall Incidence               Total 0/143 (0%)      Mean 0%      SD 0%        Total 3/147 (2.04%)    Mean 2.04%   SD 2%        |
 __________________________________________________________________________________________________________________________________
|*Pancreas:                                                                                                                        |
|   Carcinoma                            1/44 (2%)     0/50 (0%)     0/49 (0%)           0/47 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/143 (0.7%)    Mean 0.76%   SD 1.31%     Total 0/147 (0%)       Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|*Pancreas:                                                                                                                        |
|   Carcinoma or Adenoma                 1/44 (2%)     0/50 (0%)     0/49 (0%)           1/47 (2%)     0/50 (0%)     2/50 (4%)     |
| Overall Incidence               Total 1/143 (0.7%)    Mean 0.76%   SD 1.31%     Total 3/147 (2.04%)    Mean 2.04%   SD 2%        |
 __________________________________________________________________________________________________________________________________
|*Pancreas:                                                                                                                        |
|   Mixed Tumor Benign                   2/44 (5%)     0/50 (0%)     0/49 (0%)           0/47 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 2/143 (1.4%)    Mean 1.52%   SD 2.62%     Total 0/147 (0%)       Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|*Parathyroid Gland:                                                                                                               |
|   Adenoma                              1/45 (2%)     0/45 (0%)     0/49 (0%)           0/49 (0%)     0/46 (0%)     0/47 (0%)     |
| Overall Incidence               Total 1/139 (0.72%)   Mean 0.74%   SD 1.28%     Total 0/142 (0%)       Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#Peripheral Nerve:                                                                                                                |
|   Sarcoma                              1/50 (2%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/150 (0.67%)   Mean 0.67%   SD 1.15%     Total 0/150 (0%)       Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|*Pituitary Gland: Pars Distalis or                                                                                                |
| Unspecified Site                      15/47 (32%)   13/50 (26%)   16/48 (33%)         20/48 (42%)   24/50 (48%)   23/49 (47%)    |
|   Adenoma                                                                                                                        |
| Overall Incidence               Total 44/145 (30.34%) Mean 30.42%  SD 3.89%     Total 67/147 (45.58%)  Mean 45.54%  SD 3.39%     |
 __________________________________________________________________________________________________________________________________
|*Pituitary Gland: Pars Distalis or                                                                                                |
| Unspecified Site                       0/47 (0%)     0/50 (0%)     0/48 (0%)           1/48 (2%)     0/50 (0%)     1/49 (2%)     |
|   Carcinoma                                                                                                                      |
| Overall Incidence               Total 0/145 (0%)      Mean 0%      SD 0%        Total 2/147 (1.36%)    Mean 1.37%   SD 1.19%     |
 __________________________________________________________________________________________________________________________________
|*Pituitary Gland: Pars Distalis or                                                                                                |
| Unspecified Site                      15/47 (32%)   13/50 (26%)   16/48 (33%)         21/48 (44%)   24/50 (48%)   24/49 (49%)    |
|   Carcinoma or Adenoma                                                                                                           |
| Overall Incidence               Total 44/145 (30.34%) Mean 30.42%  SD 3.89%     Total 69/147 (46.94%)  Mean 46.91%  SD 2.78%     |
 __________________________________________________________________________________________________________________________________
|*Pituitary Gland: Pars Intermedia                                                                                                 |
|   Adenoma                              0/47 (0%)     0/50 (0%)     0/48 (0%)           0/48 (0%)     0/50 (0%)     1/49 (2%)     |
| Overall Incidence               Total 0/145 (0%)      Mean 0%      SD 0%        Total 1/147 (0.68%)    Mean 0.68%   SD 1.18%     |
 __________________________________________________________________________________________________________________________________
|*Pituitary Gland: Pars Intermedia                                                                                                 |
|   Carcinoma or Adenoma                 0/47 (0%)     0/50 (0%)     0/48 (0%)           0/48 (0%)     0/50 (0%)     1/49 (2%)     |
| Overall Incidence               Total 0/145 (0%)      Mean 0%      SD 0%        Total 1/147 (0.68%)    Mean 0.68%   SD 1.18%     |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 8
 Version: 11/09/04                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ORAL                                       Date of
 Species: RATS                                           Vehicle: WATER                                    Input File: 9-NOV-2004 
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|*Prostate:                                                                                                                        |
|   Adenoma                              1/48 (2%)     0/50 (0%)     0/50 (0%)                                                     |
| Overall Incidence               Total 1/148 (0.68%)   Mean 0.69%   SD 1.2%                                                       |
 __________________________________________________________________________________________________________________________________
|*Prostate:                                                                                                                        |
|   Carcinoma or Adenoma                 1/48 (2%)     0/50 (0%)     0/50 (0%)                                                     |
| Overall Incidence               Total 1/148 (0.68%)   Mean 0.69%   SD 1.2%                                                       |
 __________________________________________________________________________________________________________________________________
|#Skin: Sebaceous Gland                                                                                                            |
|   Adenoma                              1/50 (2%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/150 (0.67%)   Mean 0.67%   SD 1.15%     Total 0/150 (0%)       Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#Skin: Sebaceous Gland                                                                                                            |
|   Carcinoma or Adenoma                 1/50 (2%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/150 (0.67%)   Mean 0.67%   SD 1.15%     Total 0/150 (0%)       Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#Skin:                                                                                                                            |
|   Basal Cell Adenoma, Basosquamous     0/50 (0%)     0/50 (0%)     1/50 (2%)           0/50 (0%)     1/50 (2%)     2/50 (4%)     |
|      Tumor Benign, or                                                                                                            |
|      Trichoepithelioma                                                                                                           |
| Overall Incidence               Total 1/150 (0.67%)   Mean 0.67%   SD 1.15%     Total 3/150 (2%)       Mean 2%      SD 2%        |
 __________________________________________________________________________________________________________________________________
|#Skin:                                                                                                                            |
|   Basal Cell Carcinoma                 0/50 (0%)     1/50 (2%)     0/50 (0%)           0/50 (0%)     1/50 (2%)     1/50 (2%)     |
| Overall Incidence               Total 1/150 (0.67%)   Mean 0.67%   SD 1.15%     Total 2/150 (1.33%)    Mean 1.33%   SD 1.15%     |
 __________________________________________________________________________________________________________________________________
|#Skin:                                                                                                                            |
|   Basal Cell Carcinoma or              0/50 (0%)     1/50 (2%)     0/50 (0%)           0/50 (0%)     1/50 (2%)     1/50 (2%)     |
|      Basosquamous Tumor (malignant or                                                                                            |
|      NOS)                                                                                                                        |
| Overall Incidence               Total 1/150 (0.67%)   Mean 0.67%   SD 1.15%     Total 2/150 (1.33%)    Mean 1.33%   SD 1.15%     |
 __________________________________________________________________________________________________________________________________
|#Skin:                                                                                                                            |
|   Basal Cell Carcinoma, Basal Cell     0/50 (0%)     1/50 (2%)     1/50 (2%)           0/50 (0%)     2/50 (4%)     3/50 (6%)     |
|      Adenoma, Basosquamous Tumor                                                                                                 |
|      (benign, malignant or NOS), or                                                                                              |
|      Trichoepithelioma                                                                                                           |
| Overall Incidence               Total 2/150 (1.33%)   Mean 1.33%   SD 1.15%     Total 5/150 (3.33%)    Mean 3.33%   SD 3.06%     |
 __________________________________________________________________________________________________________________________________
|#Skin:                                                                                                                            |
|   Basal or Sq. Cell Carcinoma,         1/50 (2%)     3/50 (6%)     5/50 (10%)          0/50 (0%)     3/50 (6%)     3/50 (6%)     |
|      Carcinoma, Basosq. Tumor (M or                                                                                              |
|      B), Basal Cell Adenoma, Adenoma,                                                                                            |
|      Papilloma, Sq Papilloma,                                                                                                    |
|      Keratoacanthoma,                                                                                                            |
|      Trichoepithelioma                                                                                                           |
| Overall Incidence               Total 9/150 (6%)      Mean 6%      SD 4%        Total 6/150 (4%)       Mean 4%      SD 3.46%     |
 __________________________________________________________________________________________________________________________________
|#Skin:                                                                                                                            |
|   Hemangiopericytoma                   0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     1/50 (2%)     0/50 (0%)     |
| Overall Incidence               Total 0/150 (0%)      Mean 0%      SD 0%        Total 1/150 (0.67%)    Mean 0.67%   SD 1.15%     |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 9
 Version: 11/09/04                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ORAL                                       Date of
 Species: RATS                                           Vehicle: WATER                                    Input File: 9-NOV-2004 
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|#Skin:                                                                                                                            |
|   Keratoacanthoma                      1/50 (2%)     2/50 (4%)     4/50 (8%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 7/150 (4.67%)   Mean 4.67%   SD 3.06%     Total 0/150 (0%)       Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#Skin:                                                                                                                            |
|   Lipoma                               1/50 (2%)     1/50 (2%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     1/50 (2%)     |
| Overall Incidence               Total 2/150 (1.33%)   Mean 1.33%   SD 1.15%     Total 1/150 (0.67%)    Mean 0.67%   SD 1.15%     |
 __________________________________________________________________________________________________________________________________
|#Skin:                                                                                                                            |
|   Neural Crest Tumor                   0/50 (0%)     0/50 (0%)     1/50 (2%)           0/50 (0%)     0/50 (0%)     1/50 (2%)     |
| Overall Incidence               Total 1/150 (0.67%)   Mean 0.67%   SD 1.15%     Total 1/150 (0.67%)    Mean 0.67%   SD 1.15%     |
 __________________________________________________________________________________________________________________________________
|#Skin:                                                                                                                            |
|   Squamous Cell Carcinoma              0/50 (0%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     1/50 (2%)     0/50 (0%)     |
| Overall Incidence               Total 0/150 (0%)      Mean 0%      SD 0%        Total 1/150 (0.67%)    Mean 0.67%   SD 1.15%     |
 __________________________________________________________________________________________________________________________________
|#Skin:                                                                                                                            |
|   Squamous Cell Carcinoma, Basal       0/50 (0%)     1/50 (2%)     0/50 (0%)           0/50 (0%)     2/50 (4%)     1/50 (2%)     |
|      Cell Carcinoma, Basosquamous                                                                                                |
|      Tumor (malignant or NOS), or                                                                                                |
|      Carcinoma                                                                                                                   |
| Overall Incidence               Total 1/150 (0.67%)   Mean 0.67%   SD 1.15%     Total 3/150 (2%)       Mean 2%      SD 2%        |
 __________________________________________________________________________________________________________________________________
|#Skin:                                                                                                                            |
|   Squamous Cell Papilloma,             1/50 (2%)     2/50 (4%)     4/50 (8%)           0/50 (0%)     1/50 (2%)     0/50 (0%)     |
|      Papilloma, Squamous Cell                                                                                                    |
|      Carcinoma or Keratoacanthoma                                                                                                |
| Overall Incidence               Total 7/150 (4.67%)   Mean 4.67%   SD 3.06%     Total 1/150 (0.67%)    Mean 0.67%   SD 1.15%     |
 __________________________________________________________________________________________________________________________________
|#Skin:                                                                                                                            |
|   Squamous Cell Papilloma,             1/50 (2%)     2/50 (4%)     4/50 (8%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|      Papilloma, or Keratoacanthoma                                                                                               |
| Overall Incidence               Total 7/150 (4.67%)   Mean 4.67%   SD 3.06%     Total 0/150 (0%)       Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#Skin:                                                                                                                            |
|   Trichoepithelioma                    0/50 (0%)     0/50 (0%)     1/50 (2%)           0/50 (0%)     1/50 (2%)     2/50 (4%)     |
| Overall Incidence               Total 1/150 (0.67%)   Mean 0.67%   SD 1.15%     Total 3/150 (2%)       Mean 2%      SD 2%        |
 __________________________________________________________________________________________________________________________________
|#Skin:                                                                                                                            |
|   Fibroma                              6/50 (12%)    0/50 (0%)     9/50 (18%)          1/50 (2%)     1/50 (2%)     4/50 (8%)     |
| Overall Incidence               Total 15/150 (10%)    Mean 10%     SD 9.17%     Total 6/150 (4%)       Mean 4%      SD 3.46%     |
 __________________________________________________________________________________________________________________________________
|#Skin:                                                                                                                            |
|   Fibroma, Fibrosarcoma, Sarcoma,      9/50 (18%)    1/50 (2%)    10/50 (20%)          1/50 (2%)     1/50 (2%)     4/50 (8%)     |
|      Myxoma, Myxosarcoma, or Fibrous                                                                                             |
|      Histiocytoma                                                                                                                |
| Overall Incidence               Total 20/150 (13.33%) Mean 13.33%  SD 9.87%     Total 6/150 (4%)       Mean 4%      SD 3.46%     |
 __________________________________________________________________________________________________________________________________
|#Skin:                                                                                                                            |
|   Fibrosarcoma                         0/50 (0%)     1/50 (2%)     1/50 (2%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 2/150 (1.33%)   Mean 1.33%   SD 1.15%     Total 0/150 (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: 10
 Version: 11/09/04                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ORAL                                       Date of
 Species: RATS                                           Vehicle: WATER                                    Input File: 9-NOV-2004 
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|#Skin:                                                                                                                            |
|   Fibrosarcoma, Sarcoma,               3/50 (6%)     1/50 (2%)     1/50 (2%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
|      Myxosarcoma, or Fibrous                                                                                                     |
|      Histiocytoma                                                                                                                |
| Overall Incidence               Total 5/150 (3.33%)   Mean 3.33%   SD 2.31%     Total 0/150 (0%)       Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#Skin:                                                                                                                            |
|   Sarcoma                              3/50 (6%)     0/50 (0%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 3/150 (2%)      Mean 2%      SD 3.46%     Total 0/150 (0%)       Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#Stomach, Forestomach:                                                                                                            |
|   Schwannoma Malignant                 0/50 (0%)     0/50 (0%)     1/50 (2%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/150 (0.67%)   Mean 0.67%   SD 1.15%     Total 0/150 (0%)       Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#Stomach, Forestomach:                                                                                                            |
|   Squamous Cell Carcinoma or           0/50 (0%)     1/50 (2%)     0/50 (0%)           2/50 (4%)     0/50 (0%)     0/50 (0%)     |
|      Papilloma Squamous                                                                                                          |
| Overall Incidence               Total 1/150 (0.67%)   Mean 0.67%   SD 1.15%     Total 2/150 (1.33%)    Mean 1.33%   SD 2.31%     |
 __________________________________________________________________________________________________________________________________
|#Stomach, Forestomach:                                                                                                            |
|   Squamous Cell Papilloma              0/50 (0%)     1/50 (2%)     0/50 (0%)           2/50 (4%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/150 (0.67%)   Mean 0.67%   SD 1.15%     Total 2/150 (1.33%)    Mean 1.33%   SD 2.31%     |
 __________________________________________________________________________________________________________________________________
|#Stomach, Glandular:                                                                                                              |
|   Leiomyosarcoma                       0/50 (0%)     1/50 (2%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/150 (0.67%)   Mean 0.67%   SD 1.15%     Total 0/150 (0%)       Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|*Testes:                                                                                                                          |
|   Adenoma                             45/50 (90%)   47/50 (94%)   45/50 (90%)                                                    |
| Overall Incidence               Total 137/150 (91.33%)Mean 91.33%  SD 2.31%                                                      |
 __________________________________________________________________________________________________________________________________
|*Thymus:                                                                                                                          |
|   Thymoma Benign                       0/39 (0%)     0/50 (0%)     0/48 (0%)           1/48 (2%)     0/49 (0%)     0/49 (0%)     |
| Overall Incidence               Total 0/137 (0%)      Mean 0%      SD 0%        Total 1/146 (0.68%)    Mean 0.69%   SD 1.2%      |
 __________________________________________________________________________________________________________________________________
|*Thymus:                                                                                                                          |
|   Thymoma: Benign, Malignant, NOS      0/39 (0%)     0/50 (0%)     0/48 (0%)           1/48 (2%)     0/49 (0%)     0/49 (0%)     |
| Overall Incidence               Total 0/137 (0%)      Mean 0%      SD 0%        Total 1/146 (0.68%)    Mean 0.69%   SD 1.2%      |
 __________________________________________________________________________________________________________________________________
|*Thyroid Gland: C-Cell                                                                                                            |
|   Adenoma                              4/42 (10%)   12/50 (24%)    9/47 (19%)          6/45 (13%)    7/50 (14%)   12/47 (26%)    |
| Overall Incidence               Total 25/139 (17.99%) Mean 17.56%  SD 7.37%     Total 25/142 (17.61%)  Mean 17.62%  SD 6.86%     |
 __________________________________________________________________________________________________________________________________
|*Thyroid Gland: C-Cell                                                                                                            |
|   Carcinoma                            2/42 (5%)     2/50 (4%)     2/47 (4%)           1/45 (2%)     2/50 (4%)     1/47 (2%)     |
| Overall Incidence               Total 6/139 (4.32%)   Mean 4.34%   SD 0.39%     Total 4/142 (2.82%)    Mean 2.78%   SD 1.05%     |
 __________________________________________________________________________________________________________________________________
|*Thyroid Gland: C-Cell                                                                                                            |
|   Carcinoma or Adenoma                 6/42 (14%)   14/50 (28%)   11/47 (23%)          7/45 (16%)    9/50 (18%)   13/47 (28%)    |
| Overall Incidence               Total 31/139 (22.3%)  Mean 21.9%   SD 6.98%     Total 29/142 (20.42%)  Mean 20.41%  SD 6.4%      |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 11
 Version: 11/09/04                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ORAL                                       Date of
 Species: RATS                                           Vehicle: WATER                                    Input File: 9-NOV-2004 
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|*Thyroid Gland: Follicular Cell                                                                                                   |
|   Adenoma                              1/42 (2%)     1/50 (2%)     1/47 (2%)           0/45 (0%)     1/50 (2%)     0/47 (0%)     |
| Overall Incidence               Total 3/139 (2.16%)   Mean 2.17%   SD 0.19%     Total 1/142 (0.7%)     Mean 0.67%   SD 1.15%     |
 __________________________________________________________________________________________________________________________________
|*Thyroid Gland: Follicular Cell                                                                                                   |
|   Carcinoma                            0/42 (0%)     1/50 (2%)     0/47 (0%)           1/45 (2%)     1/50 (2%)     1/47 (2%)     |
| Overall Incidence               Total 1/139 (0.72%)   Mean 0.67%   SD 1.15%     Total 3/142 (2.11%)    Mean 2.12%   SD 0.11%     |
 __________________________________________________________________________________________________________________________________
|*Thyroid Gland: Follicular Cell                                                                                                   |
|   Carcinoma or Adenoma                 1/42 (2%)     2/50 (4%)     1/47 (2%)           1/45 (2%)     2/50 (4%)     1/47 (2%)     |
| Overall Incidence               Total 4/139 (2.88%)   Mean 2.84%   SD 1.02%     Total 4/142 (2.82%)    Mean 2.78%   SD 1.05%     |
 __________________________________________________________________________________________________________________________________
|#Tissue NOS:                                                                                                                      |
|   Leiomyoma                            0/50 (0%)     0/50 (0%)     1/50 (2%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/150 (0.67%)   Mean 0.67%   SD 1.15%     Total 0/150 (0%)       Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#Tissue NOS:                                                                                                                      |
|   Paraganglioma                        0/50 (0%)     0/50 (0%)     1/50 (2%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/150 (0.67%)   Mean 0.67%   SD 1.15%     Total 0/150 (0%)       Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#Tongue:                                                                                                                          |
|   Squamous Cell Carcinoma              0/50 (0%)     0/50 (0%)     0/50 (0%)           1/50 (2%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 0/150 (0%)      Mean 0%      SD 0%        Total 1/150 (0.67%)    Mean 0.67%   SD 1.15%     |
 __________________________________________________________________________________________________________________________________
|#Tongue:                                                                                                                          |
|   Squamous Cell Carcinoma or           0/50 (0%)     0/50 (0%)     0/50 (0%)           1/50 (2%)     0/50 (0%)     0/50 (0%)     |
|      Papilloma Squamous                                                                                                          |
| Overall Incidence               Total 0/150 (0%)      Mean 0%      SD 0%        Total 1/150 (0.67%)    Mean 0.67%   SD 1.15%     |
 __________________________________________________________________________________________________________________________________
|*Urinary Bladder:                                                                                                                 |
|   Carcinoma or Papilloma               0/46 (0%)     1/49 (2%)     0/48 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/143 (0.7%)    Mean 0.68%   SD 1.18%     Total 0/150 (0%)       Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|*Urinary Bladder:                                                                                                                 |
|   Papilloma                            0/46 (0%)     1/49 (2%)     0/48 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/143 (0.7%)    Mean 0.68%   SD 1.18%     Total 0/150 (0%)       Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|*Urinary Bladder:                                                                                                                 |
|   Sarcoma                              1/46 (2%)     0/49 (0%)     0/48 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 1/143 (0.7%)    Mean 0.72%   SD 1.26%     Total 0/150 (0%)       Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#Uterus:                                                                                                                          |
|   Adenoma                                                                              1/50 (2%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence                                                               Total 1/150 (0.67%)    Mean 0.67%   SD 1.15%     |
 __________________________________________________________________________________________________________________________________
|#Uterus:                                                                                                                          |
|   Carcinoma                                                                            0/50 (0%)     2/50 (4%)     0/50 (0%)     |
| Overall Incidence                                                               Total 2/150 (1.33%)    Mean 1.33%   SD 2.31%     |
 __________________________________________________________________________________________________________________________________
|#Uterus:                                                                                                                          |
|   Polyp Stromal                                                                        8/50 (16%)    7/50 (14%)    9/50 (18%)    |
| Overall Incidence                                                               Total 24/150 (16%)     Mean 16%     SD 2%        |
 __________________________________________________________________________________________________________________________________

 *: Denominator is number of animals with tissues examined microscopically
 #: Denominator is number of animals necropsied
                                                 Toxicology Data Management System                                     Page: 12
 Version: 11/09/04                       Tumor Incidence for Selected Control Animal Groups

 Contract/Lab: All Laboratories                          Route: ORAL                                       Date of
 Species: RATS                                           Vehicle: WATER                                    Input File: 9-NOV-2004 
 Strain: FISCHER344
 Length of Study: CHRONIC                   
                                             Incidence Data for Vehicle Control Groups
 __________________________________________________________________________________________________________________________________
|                                                   Male                                              Female                       |
 __________________________________________________________________________________________________________________________________
|#Uterus:                                                                                                                          |
|   Sarcoma Stromal                                                                      1/50 (2%)     0/50 (0%)     1/50 (2%)     |
| Overall Incidence                                                               Total 2/150 (1.33%)    Mean 1.33%   SD 1.15%     |
 __________________________________________________________________________________________________________________________________
|#Uterus:                                                                                                                          |
|   Sarcoma Stromal or Polyp Stromal                                                     9/50 (18%)    7/50 (14%)   10/50 (20%)    |
| Overall Incidence                                                               Total 26/150 (17.33%)  Mean 17.33%  SD 3.06%     |
 __________________________________________________________________________________________________________________________________
|#Zymbal's Gland:                                                                                                                  |
|   Carcinoma                            3/50 (6%)     1/50 (2%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 4/150 (2.67%)   Mean 2.67%   SD 3.06%     Total 0/150 (0%)       Mean 0%      SD 0%        |
 __________________________________________________________________________________________________________________________________
|#Zymbal's Gland:                                                                                                                  |
|   Carcinoma or Adenoma                 3/50 (6%)     1/50 (2%)     0/50 (0%)           0/50 (0%)     0/50 (0%)     0/50 (0%)     |
| Overall Incidence               Total 4/150 (2.67%)   Mean 2.67%   SD 3.06%     Total 0/150 (0%)       Mean 0%      SD 0%        |
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