National Toxicology Program

National Toxicology Program
https://ntp.niehs.nih.gov/go/11593

TDMS Study 97013-92 Pathology Tables

NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                          WATER DISINFECTION MODEL (SODIUM BROMATE)                      DATE: 12/08/03       
EXPERIMENT: 97013 TEST: 92                                                                                     TIME: 14:32:25       
TEST TYPE:  26-39 WEEKS                         CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-65406                              ROUTE: SKIN APPLICATION                                        NTP C#: 97013B       
PATHOLOGIST: TOFT, JOHN                                                                                        CAS: 7789-38-0       
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                            FINAL#1 MICE                                                            
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    25019 Moribund Sacrifice                                                                     
                                       25020 Natural Death                                                                          
                                       25021 Terminal Sacrifice                                                                     
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
                                                                                                                                   
NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                          WATER DISINFECTION MODEL (SODIUM BROMATE)                      DATE: 12/08/03       
EXPERIMENT: 97013 TEST: 92                                                                                     TIME: 14:32:25       
TEST TYPE:  26-39 WEEKS                         CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-65406                              ROUTE: SKIN APPLICATION                                        NTP C#: 97013B       
PATHOLOGIST: TOFT, JOHN                                                                                        CAS: 7789-38-0       
                                                                                                                                    
                                                                                                                                    
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS                                                                               
IN THE ANALYSIS OF        WATER DISINFECTION MODEL (SODIUM BR                                                                       
===============================================================                                                                     
Male Mice                                                                                                                           
------------                                                                                                                        
Organ                                 Morphology                                                                                    
-----                                 ----------                                                                                    
Epididymis                             Degeneration                                                                                 
Kidney                                 Nephropathy                                                                                  
Kidney: Renal Tubule                   Hypertrophy                                                                                  
Liver                                  Necrosis                                                                                     
Liver: Hepatocyte                      Vacuolization Cytoplasmic                                                                    
Lymph Node, Mandibular                 Hyperplasia Lymphoid                                                                         
Testes: Germinal Epithelium            Degeneration                                                                                 
Thymus                                 Cyst                                                                                         
Thyroid Gland: Follicular Cell         Hypertrophy                                                                                  
===============================================================                                                                     
Female Mice                                                                                                                         
------------                                                                                                                        
Organ                                  Morphology                                                                                   
-----                                  ----------                                                                                   
Kidney                                 Nephropathy                                                                                  
Kidney: Renal Tubule                   Hypertrophy                                                                                  
Ovary                                  Cyst                                                                                         
Spleen                                 Hematopoietic Cell Proliferation                                                             
Thymus                                 Cyst                                                                                         
Thyroid Gland                          Infiltration Cellular Lymphocyte                                                             
Thyroid Gland: Follicle                Depletion Secretory                                                                          
Thyroid Gland: Follicular Cell         Hypertrophy                                                                                  
===============================================================                                                                     
                                                                                                                                   
       Date:  12/08/03                           EXPERIMENT: 97013 TEST: 92                                            Page 1       
Statistical Analysis of Non-neoplastic Lesions in        Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -         WATER DISINFECTION MODEL (SO
DIUM BR                                                                                                                             
                                         Terminal Sacrifice at 39 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Accessory Adrenal Cortical Nodule                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/10 (0%)    0/10 (0%)    2/10 (20%)   1/10 (10%)  |2/9 (22%)    2/10 (20%)   2/10 (20%)   4/10 (40%)   | 
|POLY-3 RATE (b)    |     0/8.63       0/8.92       2/9.32       1/8.55      |2/8.79       2/7.32       2/9.54       4/9.52       | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         21.5%        11.7%       |22.8%        27.3%        21.0%        42.0%        | 
|TERMINAL (d)       |     0/8 (0%)     0/8 (0%)     2/8 (25%)    1/8 (13%)   |1/7 (14%)    2/7 (29%)    1/8 (13%)    3/8 (38%)    | 
|FIRST INCIDENCE    |     ---          ---          272 (T)      272 (T)     |217          272 (T)      127          257          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.240      (e)          P=0.232      P=0.500     |P=0.277      P=0.679      P=0.661N     P=0.403      | 
|POLY 3             |     P=0.227      (e)          P=0.243      P=0.498     |P=0.253      P=0.635      P=0.673N     P=0.356      | 
|POLY 1.5           |     P=0.224      (e)          P=0.240      P=0.495     |P=0.252      P=0.661      P=0.669N     P=0.362      | 
|POLY 6             |     P=0.230      (e)          P=0.242      P=0.500     |P=0.251      P=0.628      P=0.677N     P=0.351      | 
|LOGISTIC REGRESSION|     (e)          (e)          P=0.232      P=0.500     |P=0.219      P=0.699      P=0.547N     P=0.354      | 
|COCH-ARM / FISHERS |     P=0.239      (e)          P=0.237      P=0.500     |P=0.223      P=0.667N     P=0.667N     P=0.370      | 
|ORDER RESTRICTED   |     P=0.169      (e)          (e)          (e)         |P=0.291      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     6/10 (60%)   5/10 (50%)   6/10 (60%)   6/10 (60%)  |0/9 (0%)     0/10 (0%)    0/10 (0%)    0/10 (0%)    | 
|POLY-3 RATE (b)    |     6/8.63       5/8.92       6/9.32       6/9.02      |0/8.29       0/7.32       0/8.64       0/9.36       | 
|POLY-3 PERCENT (g) |     69.5%        56.0%        64.4%        66.6%       |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     6/8 (75%)    5/8 (63%)    6/8 (75%)    5/8 (63%)   |0/7 (0%)     0/7 (0%)     0/8 (0%)     0/8 (0%)     | 
|FIRST INCIDENCE    |     272 (T)      272 (T)      272 (T)      221         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.529      P=0.500N     P=0.712      P=0.669N    |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.569      P=0.465N     P=0.606N     P=0.643N    |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.528      P=0.478N     P=0.620N     P=0.678N    |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.578N     P=0.454N     P=0.616N     P=0.599N    |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.518      P=0.500N     P=0.712      P=0.688     |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.522      P=0.500N     P=0.675N     P=0.675N    |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.594N     (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/08/03                           EXPERIMENT: 97013 TEST: 92                                            Page 2       
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -         WATER DISINFECTION MODEL (SOD
IUM BR                                                                                                                              
                                         Terminal Sacrifice at 39 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex: Subcapsular                                                                                                      | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)   |4/9 (44%)    7/10 (70%)   7/10 (70%)   3/10 (30%)   | 
|POLY-3 RATE (b)    |     0/8.63       0/8.92       0/9.32       0/8.55      |4/9.00       7/8.16       7/9.10       3/9.36       | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |44.4%        85.8%        76.9%        32.1%        | 
|TERMINAL (d)       |     0/8 (0%)     0/8 (0%)     0/8 (0%)     0/8 (0%)    |2/7 (29%)    6/7 (86%)    6/8 (75%)    3/8 (38%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |217          148          221          272 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.186N     P=0.192      P=0.297      P=0.425N     | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.216N     P=0.092      P=0.174      P=0.475N     | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.196N     P=0.117      P=0.193      P=0.456N     | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.257N     P=0.083      P=0.167      P=0.502N     | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.169N     P=0.153      P=0.230      P=0.441N     | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.210N     P=0.255      P=0.255      P=0.430N     | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |P=0.063N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Epididymis                                                                                                                       | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/10 (0%)    0/10 (0%)    2/10 (20%)   2/10 (20%)  |                                                    | 
|POLY-3 RATE (b)    |     0/8.63       0/8.92       2/9.32       2/8.55      |                                                    | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         21.5%        23.4%       |                                                    | 
|TERMINAL (d)       |     0/8 (0%)     0/8 (0%)     2/8 (25%)    2/8 (25%)   |                                                    | 
|FIRST INCIDENCE    |     ---          ---          272 (T)      272 (T)     |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.077      (e)          P=0.232      P=0.232     |                                                    | 
|POLY 3             |     P=0.070      (e)          P=0.243      P=0.221     |                                                    | 
|POLY 1.5           |     P=0.069      (e)          P=0.240      P=0.219     |                                                    | 
|POLY 6             |     P=0.070      (e)          P=0.242      P=0.223     |                                                    | 
|LOGISTIC REGRESSION|     (e)          (e)          P=0.232      P=0.232     |                                                    | 
|COCH-ARM / FISHERS |     P=0.077      (e)          P=0.237      P=0.237     |                                                    | 
|ORDER RESTRICTED   |     P=0.097      (e)          (e)          (e)         |                                                    | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/08/03                           EXPERIMENT: 97013 TEST: 92                                            Page 3       
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -         WATER DISINFECTION MODEL (SOD
IUM BR                                                                                                                              
                                         Terminal Sacrifice at 39 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Epididymis                                                                                                                       | 
|     Degeneration                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/10 (10%)   2/10 (20%)   3/10 (30%)   5/10 (50%)  |                                                    | 
|POLY-3 RATE (b)    |     1/8.63       2/9.79       3/9.32       5/9.54      |                                                    | 
|POLY-3 PERCENT (g) |     11.6%        20.4%        32.2%        52.4%       |                                                    | 
|TERMINAL (d)       |     1/8 (13%)    1/8 (13%)    3/8 (38%)    4/8 (50%)   |                                                    | 
|FIRST INCIDENCE    |     272 (T)      140          272 (T)      69          |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.037 *    P=0.512      P=0.288      P=0.082     |                                                    | 
|POLY 3             |     P=0.036 *    P=0.545      P=0.319      P=0.078     |                                                    | 
|POLY 1.5           |     P=0.035 *    P=0.531      P=0.313      P=0.073     |                                                    | 
|POLY 6             |     P=0.036 *    P=0.554      P=0.316      P=0.081     |                                                    | 
|LOGISTIC REGRESSION|     P=0.034 *    P=0.478      P=0.288      P=0.075     |                                                    | 
|COCH-ARM / FISHERS |     P=0.032 *    P=0.500      P=0.291      P=0.070     |                                                    | 
|ORDER RESTRICTED   |     P=0.040 *    (e)          (e)          (e)         |                                                    | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Epididymis                                                                                                                       | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/10 (0%)    0/10 (0%)    3/10 (30%)   2/10 (20%)  |                                                    | 
|POLY-3 RATE (b)    |     0/8.63       0/8.92       3/9.32       2/8.55      |                                                    | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         32.2%        23.4%       |                                                    | 
|TERMINAL (d)       |     0/8 (0%)     0/8 (0%)     3/8 (38%)    2/8 (25%)   |                                                    | 
|FIRST INCIDENCE    |     ---          ---          272 (T)      272 (T)     |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.084      (e)          P=0.107      P=0.232     |                                                    | 
|POLY 3             |     P=0.070      (e)          P=0.107      P=0.221     |                                                    | 
|POLY 1.5           |     P=0.069      (e)          P=0.104      P=0.219     |                                                    | 
|POLY 6             |     P=0.071      (e)          P=0.105      P=0.223     |                                                    | 
|LOGISTIC REGRESSION|     (e)          (e)          P=0.107      P=0.232     |                                                    | 
|COCH-ARM / FISHERS |     P=0.085      (e)          P=0.105      P=0.237     |                                                    | 
|ORDER RESTRICTED   |     P=0.066      (e)          (e)          (e)         |                                                    | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/08/03                           EXPERIMENT: 97013 TEST: 92                                            Page 4       
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -         WATER DISINFECTION MODEL (SOD
IUM BR                                                                                                                              
                                         Terminal Sacrifice at 39 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Nephropathy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     7/10 (70%)   10/10 (100%) 9/10 (90%)   10/10 (100%)|5/9 (56%)    6/10 (60%)   8/10 (80%)   10/10 (100%) | 
|POLY-3 RATE (b)    |     7/8.63       10/10.00     9/9.79       10/10.00    |5/8.29       6/8.16       8/9.10       10/10.00     | 
|POLY-3 PERCENT (g) |     81.1%        100.0%       92.0%        100.0%      |60.3%        73.5%        87.9%        100.0%       | 
|TERMINAL (d)       |     7/8 (88%)    8/8 (100%)   8/8 (100%)   8/8 (100%)  |5/7 (71%)    5/7 (71%)    7/8 (88%)    8/8 (100%)   | 
|FIRST INCIDENCE    |     272 (T)      140          221          69          |272 (T)      148          221          218          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.135      P=0.138      P=0.264      P=0.131     |P=0.038 *    P=0.488      P=0.273      P=0.069      | 
|POLY 3             |     P=0.208      P=0.242      P=0.500      P=0.242     |P=0.016 *    P=0.482      P=0.210      P=0.031 *    | 
|POLY 1.5           |     P=0.141      P=0.163      P=0.420      P=0.163     |P=0.011 *    P=0.487      P=0.208      P=0.025 *    | 
|POLY 6             |     P=0.283      P=0.346      P=0.565      P=0.346     |P=0.026 *    P=0.522      P=0.250      P=0.047 *    | 
|LOGISTIC REGRESSION|     P=0.053      P=0.091      P=0.439      P=0.072     |P=0.017 *    P=0.405      P=0.161      P=0.031 *    | 
|COCH-ARM / FISHERS |     P=0.077      P=0.105      P=0.291      P=0.105     |P=0.013 *    P=0.605      P=0.259      P=0.033 *    | 
|ORDER RESTRICTED   |     P=0.045 *    (e)          (e)          (e)         |P=0.012 *    (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Cortex                                                                                                                   | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/10 (0%)    3/10 (30%)   1/10 (10%)   0/10 (0%)   |1/9 (11%)    0/10 (0%)    0/10 (0%)    0/10 (0%)    | 
|POLY-3 RATE (b)    |     0/8.63       3/8.92       1/9.32       0/8.55      |1/8.29       0/7.32       0/8.64       0/9.36       | 
|POLY-3 PERCENT (g) |     0.0%         33.6%        10.7%        0.0%        |12.1%        0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/8 (0%)     3/8 (38%)    1/8 (13%)    0/8 (0%)    |1/7 (14%)    0/7 (0%)     0/8 (0%)     0/8 (0%)     | 
|FIRST INCIDENCE    |     ---          272 (T)      272 (T)      ---         |272 (T)      ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.361N     P=0.107      P=0.500      (e)         |P=0.287N     P=0.500N     P=0.473N     P=0.473N     | 
|POLY 3             |     P=0.350N     P=0.097      P=0.515      (e)         |P=0.274N     P=0.525N     P=0.492N     P=0.476N     | 
|POLY 1.5           |     P=0.358N     P=0.096      P=0.512      (e)         |P=0.277N     P=0.517N     P=0.490N     P=0.477N     | 
|POLY 6             |     P=0.346N     P=0.098      P=0.515      (e)         |P=0.275N     P=0.522N     P=0.489N     P=0.474N     | 
|LOGISTIC REGRESSION|     (e)          P=0.107      P=0.500      (e)         |P=0.287N     (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.361N     P=0.105      P=0.500      (e)         |P=0.292N     P=0.474N     P=0.474N     P=0.474N     | 
|ORDER RESTRICTED   |     P=0.196N     (e)          (e)          (e)         |P=0.101N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/08/03                           EXPERIMENT: 97013 TEST: 92                                            Page 5       
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -         WATER DISINFECTION MODEL (SOD
IUM BR                                                                                                                              
                                         Terminal Sacrifice at 39 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Renal Tubule                                                                                                             | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/10 (0%)    0/10 (0%)    0/10 (0%)    2/10 (20%)  |0/9 (0%)     0/10 (0%)    0/10 (0%)    4/10 (40%)   | 
|POLY-3 RATE (b)    |     0/8.63       0/8.92       0/9.32       2/8.55      |0/8.29       0/7.32       0/8.64       4/10.00      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         23.4%       |0.0%         0.0%         0.0%         40.0%        | 
|TERMINAL (d)       |     0/8 (0%)     0/8 (0%)     0/8 (0%)     2/8 (25%)   |0/7 (0%)     0/7 (0%)     0/8 (0%)     2/8 (25%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          272 (T)     |---          ---          ---          218          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.044 *    (e)          (e)          P=0.232     |P=0.006 **   (e)          (e)          P=0.089      | 
|POLY 3             |     P=0.036 *    (e)          (e)          P=0.221     |P<0.001 **   (e)          (e)          P=0.055      | 
|POLY 1.5           |     P=0.036 *    (e)          (e)          P=0.219     |P<0.001 **   (e)          (e)          P=0.050      | 
|POLY 6             |     P=0.036 *    (e)          (e)          P=0.223     |P<0.001 **   (e)          (e)          P=0.063      | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          P=0.232     |P=0.003 **   (e)          (e)          P=0.044 *    | 
|COCH-ARM / FISHERS |     P=0.043 *    (e)          (e)          P=0.237     |P=0.003 **   (e)          (e)          P=0.054      | 
|ORDER RESTRICTED   |     P=0.021 *    (e)          (e)          (e)         |P<0.001 **   (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/10 (0%)    1/10 (10%)   1/10 (10%)   1/10 (10%)  |2/9 (22%)    2/10 (20%)   2/10 (20%)   2/10 (20%)   | 
|POLY-3 RATE (b)    |     0/8.63       1/8.92       1/9.32       1/9.02      |2/8.29       2/7.32       2/9.54       2/9.52       | 
|POLY-3 PERCENT (g) |     0.0%         11.2%        10.7%        11.1%       |24.1%        27.3%        21.0%        21.0%        | 
|TERMINAL (d)       |     0/8 (0%)     1/8 (13%)    1/8 (13%)    0/8 (0%)    |2/7 (29%)    2/7 (29%)    1/8 (13%)    1/8 (13%)    | 
|FIRST INCIDENCE    |     ---          272 (T)      272 (T)      221         |272 (T)      272 (T)      127          257          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.391      P=0.500      P=0.500      P=0.523     |P=0.529N     P=0.716      P=0.654N     P=0.640N     | 
|POLY 3             |     P=0.400      P=0.507      P=0.515      P=0.509     |P=0.521N     P=0.660      P=0.652N     P=0.653N     | 
|POLY 1.5           |     P=0.386      P=0.504      P=0.512      P=0.501     |P=0.532N     P=0.675      P=0.657N     P=0.658N     | 
|POLY 6             |     P=0.416      P=0.508      P=0.515      P=0.517     |P=0.511N     P=0.667      P=0.642N     P=0.643N     | 
|LOGISTIC REGRESSION|     P=0.380      P=0.500      P=0.500      P=0.521     |P=0.567N     P=0.716      P=0.584N     P=0.664N     | 
|COCH-ARM / FISHERS |     P=0.380      P=0.500      P=0.500      P=0.500     |P=0.569N     P=0.667N     P=0.667N     P=0.667N     | 
|ORDER RESTRICTED   |     P=0.334      (e)          (e)          (e)         |P=0.639N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/08/03                           EXPERIMENT: 97013 TEST: 92                                            Page 6       
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -         WATER DISINFECTION MODEL (SOD
IUM BR                                                                                                                              
                                         Terminal Sacrifice at 39 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     8/10 (80%)   8/10 (80%)   6/10 (60%)   6/10 (60%)  |7/9 (78%)    9/10 (90%)   10/10 (100%) 9/10 (90%)   | 
|POLY-3 RATE (b)    |     8/9.52       8/8.92       6/9.79       6/9.02      |7/8.79       9/9.15       10/10.00     9/10.00      | 
|POLY-3 PERCENT (g) |     84.1%        89.7%        61.3%        66.6%       |79.7%        98.4%        100.0%       90.0%        | 
|TERMINAL (d)       |     7/8 (88%)    8/8 (100%)   5/8 (63%)    5/8 (63%)   |6/7 (86%)    7/7 (100%)   8/8 (100%)   7/8 (88%)    | 
|FIRST INCIDENCE    |     134          272 (T)      221          221         |217          62           127          218          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.173N     P=0.760      P=0.313N     P=0.329N    |P=0.526      P=0.285      P=0.316      P=0.528      | 
|POLY 3             |     P=0.175N     P=0.638      P=0.269N     P=0.369N    |P=0.466      P=0.290      P=0.226      P=0.509      | 
|POLY 1.5           |     P=0.198N     P=0.655      P=0.288N     P=0.385N    |P=0.412      P=0.337      P=0.213      P=0.486      | 
|POLY 6             |     P=0.140N     P=0.641      P=0.249N     P=0.331N    |P=0.539      P=0.287      P=0.255      P=0.550      | 
|LOGISTIC REGRESSION|     P=0.183N     P=0.701N     P=0.314N     P=0.332N    |P=0.361      P=0.355      P=0.209      P=0.459      | 
|COCH-ARM / FISHERS |     P=0.175N     P=0.709N     P=0.314N     P=0.314N    |P=0.336      P=0.458      P=0.211      P=0.458      | 
|ORDER RESTRICTED   |     P=0.192N     (e)          (e)          (e)         |P=0.131      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Necrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/10 (0%)    0/10 (0%)    0/10 (0%)    2/10 (20%)  |2/9 (22%)    1/10 (10%)   1/10 (10%)   2/10 (20%)   | 
|POLY-3 RATE (b)    |     0/8.63       0/8.92       0/9.32       2/8.55      |2/8.29       1/7.32       1/8.64       2/9.84       | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         23.4%       |24.1%        13.7%        11.6%        20.3%        | 
|TERMINAL (d)       |     0/8 (0%)     0/8 (0%)     0/8 (0%)     2/8 (25%)   |2/7 (29%)    1/7 (14%)    1/8 (13%)    1/8 (13%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          272 (T)     |272 (T)      272 (T)      272 (T)      218          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.044 *    (e)          (e)          P=0.232     |P=0.606N     P=0.500N     P=0.450N     P=0.643N     | 
|POLY 3             |     P=0.036 *    (e)          (e)          P=0.221     |P=0.590N     P=0.546N     P=0.485N     P=0.639N     | 
|POLY 1.5           |     P=0.036 *    (e)          (e)          P=0.219     |P=0.604N     P=0.531N     P=0.481N     P=0.649N     | 
|POLY 6             |     P=0.036 *    (e)          (e)          P=0.223     |P=0.580N     P=0.541N     P=0.481N     P=0.624N     | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          P=0.232     |P=0.617      P=0.500N     P=0.450N     P=0.687N     | 
|COCH-ARM / FISHERS |     P=0.043 *    (e)          (e)          P=0.237     |P=0.592      P=0.458N     P=0.458N     P=0.667N     | 
|ORDER RESTRICTED   |     P=0.021 *    (e)          (e)          (e)         |P=0.502N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/08/03                           EXPERIMENT: 97013 TEST: 92                                            Page 7       
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -         WATER DISINFECTION MODEL (SOD
IUM BR                                                                                                                              
                                         Terminal Sacrifice at 39 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Hepatocyte                                                                                                                | 
|     Vacuolization Cytoplasmic                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     5/10 (50%)   8/10 (80%)   6/10 (60%)   2/10 (20%)  |7/9 (78%)    4/10 (40%)   7/10 (70%)   8/10 (80%)   | 
|POLY-3 RATE (b)    |     5/9.12       8/10.00      6/9.32       2/8.55      |7/8.29       4/8.16       7/9.10       8/9.84       | 
|POLY-3 PERCENT (g) |     54.8%        80.0%        64.4%        23.4%       |84.4%        49.0%        76.9%        81.3%        | 
|TERMINAL (d)       |     4/8 (50%)    6/8 (75%)    6/8 (75%)    2/8 (25%)   |7/7 (100%)   3/7 (43%)    6/8 (75%)    7/8 (88%)    | 
|FIRST INCIDENCE    |     218          140          272 (T)      272 (T)     |272 (T)      148          221          218          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.058N     P=0.238      P=0.509      P=0.186N    |P=0.388      P=0.168N     P=0.518N     P=0.751N     | 
|POLY 3             |     P=0.058N     P=0.249      P=0.522      P=0.193N    |P=0.444      P=0.146N     P=0.585N     P=0.676N     | 
|POLY 1.5           |     P=0.054N     P=0.225      P=0.529      P=0.190N    |P=0.398      P=0.154N     P=0.599N     P=0.708N     | 
|POLY 6             |     P=0.066N     P=0.261      P=0.487      P=0.202N    |P=0.484      P=0.112N     P=0.516N     P=0.623N     | 
|LOGISTIC REGRESSION|     P=0.050N     P=0.176      P=0.583      P=0.175N    |P=0.378      P=0.217N     P=0.686N     P=0.726      | 
|COCH-ARM / FISHERS |     P=0.049N*    P=0.175      P=0.500      P=0.175N    |P=0.295      P=0.115N     P=0.556N     P=0.667      | 
|ORDER RESTRICTED   |     P=0.036N*    (e)          (e)          (e)         |P=0.378      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/10 (0%)    2/10 (20%)   1/10 (10%)   1/10 (10%)  |0/9 (0%)     1/10 (10%)   1/10 (10%)   0/10 (0%)    | 
|POLY-3 RATE (b)    |     0/8.63       2/8.92       1/9.32       1/8.55      |0/8.29       1/7.32       1/8.64       0/9.36       | 
|POLY-3 PERCENT (g) |     0.0%         22.4%        10.7%        11.7%       |0.0%         13.7%        11.6%        0.0%         | 
|TERMINAL (d)       |     0/8 (0%)     2/8 (25%)    1/8 (13%)    1/8 (13%)   |0/7 (0%)     1/7 (14%)    1/8 (13%)    0/8 (0%)     | 
|FIRST INCIDENCE    |     ---          272 (T)      272 (T)      272 (T)     |---          272 (T)      272 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.500      P=0.232      P=0.500      P=0.500     |P=0.564N     P=0.500      P=0.527      (e)          | 
|POLY 3             |     P=0.497      P=0.232      P=0.515      P=0.498     |P=0.580N     P=0.475      P=0.508      (e)          | 
|POLY 1.5           |     P=0.491      P=0.230      P=0.512      P=0.495     |P=0.580N     P=0.483      P=0.510      (e)          | 
|POLY 6             |     P=0.502      P=0.234      P=0.515      P=0.500     |P=0.576N     P=0.478      P=0.510      (e)          | 
|LOGISTIC REGRESSION|     (e)          P=0.232      P=0.500      P=0.500     |(e)          P=0.500      P=0.527      (e)          | 
|COCH-ARM / FISHERS |     P=0.500      P=0.237      P=0.500      P=0.500     |P=0.580N     P=0.526      P=0.526      (e)          | 
|ORDER RESTRICTED   |     P=0.274      (e)          (e)          (e)         |P=0.369N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/08/03                           EXPERIMENT: 97013 TEST: 92                                            Page 8       
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -         WATER DISINFECTION MODEL (SOD
IUM BR                                                                                                                              
                                         Terminal Sacrifice at 39 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mandibular                                                                                                           | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/10 (10%)   0/10 (0%)    0/10 (0%)    3/10 (30%)  |1/9 (11%)    3/10 (30%)   2/10 (20%)   2/10 (20%)   | 
|POLY-3 RATE (b)    |     1/8.63       0/8.92       0/9.32       3/9.02      |1/8.79       3/7.32       2/10.00      2/9.52       | 
|POLY-3 PERCENT (g) |     11.6%        0.0%         0.0%         33.3%       |11.4%        41.0%        20.0%        21.0%        | 
|TERMINAL (d)       |     1/8 (13%)    0/8 (0%)     0/8 (0%)     2/8 (25%)   |0/7 (0%)     3/7 (43%)    0/8 (0%)     1/8 (13%)    | 
|FIRST INCIDENCE    |     272 (T)      ---          ---          221         |217          272 (T)      127          257          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.085      P=0.500N     P=0.500N     P=0.310     |P=0.573      P=0.274      P=0.526      P=0.556      | 
|POLY 3             |     P=0.069      P=0.493N     P=0.485N     P=0.305     |P=0.539      P=0.218      P=0.546      P=0.529      | 
|POLY 1.5           |     P=0.068      P=0.496N     P=0.488N     P=0.291     |P=0.542      P=0.241      P=0.542      P=0.532      | 
|POLY 6             |     P=0.071      P=0.492N     P=0.485N     P=0.321     |P=0.536      P=0.210      P=0.553      P=0.526      | 
|LOGISTIC REGRESSION|     P=0.075      (e)          (e)          P=0.282     |P=0.500      P=0.262      (e)          P=0.511      | 
|COCH-ARM / FISHERS |     P=0.077      P=0.500N     P=0.500N     P=0.291     |P=0.539      P=0.333      P=0.542      P=0.542      | 
|ORDER RESTRICTED   |     P=0.028 *    (e)          (e)          (e)         |P=0.363      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mesentery: Fat                                                                                                                   | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/1 (100%)   0/0 (0%)     2/2 (100%)   0/0 (0%)    |0/0 (0%)     0/0 (0%)     0/0 (0%)     0/0 (0%)     | 
|POLY-3 RATE (b)    |     1/1.00       0/0.00       2/2.00       0/0.00      |0/0.00       0/0.00       0/0.00       0/0.00       | 
|POLY-3 PERCENT (g) |     100.0%       0.0%         100.0%       0.0%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     1/1 (100%)   0/0 (0%)     2/2 (100%)   0/0 (0%)    |0/0 (0%)     0/0 (0%)     0/0 (0%)     0/0 (0%)     | 
|FIRST INCIDENCE    |     272 (T)      ---          272 (T)      ---         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|POLY 3             |     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|POLY 6             |     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/08/03                           EXPERIMENT: 97013 TEST: 92                                            Page 9       
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -         WATER DISINFECTION MODEL (SOD
IUM BR                                                                                                                              
                                         Terminal Sacrifice at 39 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mesentery: Fat                                                                                                                   | 
|     Necrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/1 (100%)   0/0 (0%)     2/2 (100%)   0/0 (0%)    |0/0 (0%)     0/0 (0%)     0/0 (0%)     0/0 (0%)     | 
|POLY-3 RATE (b)    |     1/1.00       0/0.00       2/2.00       0/0.00      |0/0.00       0/0.00       0/0.00       0/0.00       | 
|POLY-3 PERCENT (g) |     100.0%       0.0%         100.0%       0.0%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     1/1 (100%)   0/0 (0%)     2/2 (100%)   0/0 (0%)    |0/0 (0%)     0/0 (0%)     0/0 (0%)     0/0 (0%)     | 
|FIRST INCIDENCE    |     272 (T)      ---          272 (T)      ---         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|POLY 3             |     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|POLY 6             |     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |1/9 (11%)    4/10 (40%)   2/10 (20%)   5/10 (50%)   | 
|POLY-3 RATE (b)    |                                                        |1/8.29       4/7.32       2/8.64       5/9.52       | 
|POLY-3 PERCENT (g) |                                                        |12.1%        54.6%        23.2%        52.6%        | 
|TERMINAL (d)       |                                                        |1/7 (14%)    4/7 (57%)    2/8 (25%)    4/8 (50%)    | 
|FIRST INCIDENCE    |                                                        |272 (T)      272 (T)      272 (T)      257          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |P=0.124      P=0.141      P=0.550      P=0.116      | 
|POLY 3             |                                                        |P=0.102      P=0.095      P=0.515      P=0.086      | 
|POLY 1.5           |                                                        |P=0.099      P=0.109      P=0.519      P=0.084      | 
|POLY 6             |                                                        |P=0.108      P=0.096      P=0.519      P=0.091      | 
|LOGISTIC REGRESSION|                                                        |P=0.124      P=0.141      P=0.550      P=0.095      | 
|COCH-ARM / FISHERS |                                                        |P=0.099      P=0.184      P=0.542      P=0.091      | 
|ORDER RESTRICTED   |                                                        |P=0.043 *    (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/08/03                           EXPERIMENT: 97013 TEST: 92                                            Page 10      
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -         WATER DISINFECTION MODEL (SOD
IUM BR                                                                                                                              
                                         Terminal Sacrifice at 39 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis                                                                                                   | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/9 (33%)    3/10 (30%)   1/10 (10%)   3/10 (30%)  |0/9 (0%)     0/10 (0%)    0/10 (0%)    0/10 (0%)    | 
|POLY-3 RATE (b)    |     3/7.63       3/8.92       1/9.79       3/9.02      |0/8.29       0/7.32       0/8.64       0/9.36       | 
|POLY-3 PERCENT (g) |     39.3%        33.6%        10.2%        33.3%       |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     3/7 (43%)    3/8 (38%)    0/8 (0%)     2/8 (25%)   |0/7 (0%)     0/7 (0%)     0/8 (0%)     0/8 (0%)     | 
|FIRST INCIDENCE    |     272 (T)      272 (T)      221          221         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.494N     P=0.620N     P=0.243N     P=0.612N    |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.481N     P=0.603N     P=0.196N     P=0.597N    |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.495N     P=0.612N     P=0.212N     P=0.619N    |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.467N     P=0.596N     P=0.185N     P=0.571N    |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.511N     P=0.620N     P=0.238N     P=0.636N    |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.505N     P=0.630N     P=0.249N     P=0.630N    |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.351N     (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin: Epidermis                                                                                                                  | 
|     Hyperplasia Focal                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     4/10 (40%)   2/10 (20%)   1/10 (10%)   2/10 (20%)  |2/9 (22%)    2/10 (20%)   6/10 (60%)   3/10 (30%)   | 
|POLY-3 RATE (b)    |     4/9.12       2/9.14       1/9.32       2/8.55      |2/8.29       2/7.32       6/9.10       3/9.36       | 
|POLY-3 PERCENT (g) |     43.9%        21.9%        10.7%        23.4%       |24.1%        27.3%        65.9%        32.1%        | 
|TERMINAL (d)       |     3/8 (38%)    1/8 (13%)    1/8 (13%)    2/8 (25%)   |2/7 (29%)    2/7 (29%)    5/8 (63%)    3/8 (38%)    | 
|FIRST INCIDENCE    |     218          251          272 (T)      272 (T)     |272 (T)      272 (T)      221          272 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.250N     P=0.321N     P=0.158N     P=0.322N    |P=0.395      P=0.716      P=0.134      P=0.570      | 
|POLY 3             |     P=0.252N     P=0.312N     P=0.136N     P=0.346N    |P=0.423      P=0.660      P=0.092      P=0.561      | 
|POLY 1.5           |     P=0.250N     P=0.313N     P=0.135N     P=0.341N    |P=0.407      P=0.675      P=0.091      P=0.557      | 
|POLY 6             |     P=0.259N     P=0.313N     P=0.145N     P=0.357N    |P=0.429      P=0.667      P=0.106      P=0.566      | 
|LOGISTIC REGRESSION|     P=0.244N     P=0.306N     P=0.140N     P=0.318N    |P=0.410      P=0.716      P=0.090      P=0.570      | 
|COCH-ARM / FISHERS |     P=0.241N     P=0.314N     P=0.152N     P=0.314N    |P=0.350      P=0.667N     P=0.115      P=0.556      | 
|ORDER RESTRICTED   |     P=0.153N     (e)          (e)          (e)         |P=0.214      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/08/03                           EXPERIMENT: 97013 TEST: 92                                            Page 11      
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -         WATER DISINFECTION MODEL (SOD
IUM BR                                                                                                                              
                                         Terminal Sacrifice at 39 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/10 (30%)   2/10 (20%)   2/10 (20%)   3/10 (30%)  |3/9 (33%)    6/10 (60%)   8/10 (80%)   8/10 (80%)   | 
|POLY-3 RATE (b)    |     3/9.52       2/8.92       2/9.32       3/9.02      |3/8.29       6/7.32       8/9.54       8/9.52       | 
|POLY-3 PERCENT (g) |     31.5%        22.4%        21.5%        33.3%       |36.2%        82.0%        83.9%        84.1%        | 
|TERMINAL (d)       |     2/8 (25%)    2/8 (25%)    2/8 (25%)    2/8 (25%)   |3/7 (43%)    6/7 (86%)    7/8 (88%)    7/8 (88%)    | 
|FIRST INCIDENCE    |     134          272 (T)      272 (T)      221         |272 (T)      272 (T)      127          257          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.547      P=0.500N     P=0.500N     P=0.669N    |P=0.041 *    P=0.141      P=0.062      P=0.066      | 
|POLY 3             |     P=0.532      P=0.532N     P=0.510N     P=0.654     |P=0.028 *    P=0.079      P=0.039 *    P=0.038 *    | 
|POLY 1.5           |     P=0.526      P=0.524N     P=0.505N     P=0.649     |P=0.028 *    P=0.105      P=0.040 *    P=0.040 *    | 
|POLY 6             |     P=0.545      P=0.535N     P=0.520N     P=0.667     |P=0.030 *    P=0.078      P=0.040 *    P=0.039 *    | 
|LOGISTIC REGRESSION|     P=0.553      P=0.512N     P=0.592N     P=0.677N    |P=0.047 *    P=0.141      P=0.050      P=0.048 *    | 
|COCH-ARM / FISHERS |     P=0.549      P=0.500N     P=0.500N     P=0.686N    |P=0.033 *    P=0.242      P=0.055      P=0.055      | 
|ORDER RESTRICTED   |     P=0.555      (e)          (e)          (e)         |P=0.008 **   (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach: Epithelium                                                                                                 | 
|     Hyperkeratosis                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/10 (0%)    2/10 (20%)   0/10 (0%)    1/10 (10%)  |1/9 (11%)    1/10 (10%)   2/10 (20%)   1/10 (10%)   | 
|POLY-3 RATE (b)    |     0/8.63       2/8.92       0/9.32       1/9.02      |1/8.29       1/7.32       2/9.54       1/9.36       | 
|POLY-3 PERCENT (g) |     0.0%         22.4%        0.0%         11.1%       |12.1%        13.7%        21.0%        10.7%        | 
|TERMINAL (d)       |     0/8 (0%)     2/8 (25%)    0/8 (0%)     0/8 (0%)    |1/7 (14%)    1/7 (14%)    1/8 (13%)    1/8 (13%)    | 
|FIRST INCIDENCE    |     ---          272 (T)      ---          221         |272 (T)      272 (T)      127          272 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.548      P=0.232      (e)          P=0.523     |P=0.605N     P=0.769      P=0.544      P=0.738N     | 
|POLY 3             |     P=0.560      P=0.232      (e)          P=0.509     |P=0.593N     P=0.734      P=0.550      P=0.735N     | 
|POLY 1.5           |     P=0.547      P=0.230      (e)          P=0.501     |P=0.600N     P=0.743      P=0.545      P=0.736N     | 
|POLY 6             |     P=0.574      P=0.234      (e)          P=0.517     |P=0.591N     P=0.738      P=0.560      P=0.733N     | 
|LOGISTIC REGRESSION|     P=0.541      P=0.232      (e)          P=0.521     |P=0.609      P=0.769      P=0.691      P=0.738N     | 
|COCH-ARM / FISHERS |     P=0.540      P=0.237      (e)          P=0.500     |P=0.624      P=0.737N     P=0.542      P=0.737N     | 
|ORDER RESTRICTED   |     P=0.319      (e)          (e)          (e)         |P=0.596N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/08/03                           EXPERIMENT: 97013 TEST: 92                                            Page 12      
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -         WATER DISINFECTION MODEL (SOD
IUM BR                                                                                                                              
                                         Terminal Sacrifice at 39 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach: Epithelium                                                                                                 | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/10 (0%)    2/10 (20%)   0/10 (0%)    1/10 (10%)  |1/9 (11%)    1/10 (10%)   3/10 (30%)   2/10 (20%)   | 
|POLY-3 RATE (b)    |     0/8.63       2/8.92       0/9.32       1/9.02      |1/8.29       1/7.32       3/9.54       2/9.36       | 
|POLY-3 PERCENT (g) |     0.0%         22.4%        0.0%         11.1%       |12.1%        13.7%        31.5%        21.4%        | 
|TERMINAL (d)       |     0/8 (0%)     2/8 (25%)    0/8 (0%)     0/8 (0%)    |1/7 (14%)    1/7 (14%)    2/8 (25%)    2/8 (25%)    | 
|FIRST INCIDENCE    |     ---          272 (T)      ---          221         |272 (T)      272 (T)      127          272 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.548      P=0.232      (e)          P=0.523     |P=0.372      P=0.769      P=0.346      P=0.550      | 
|POLY 3             |     P=0.560      P=0.232      (e)          P=0.509     |P=0.394      P=0.734      P=0.345      P=0.544      | 
|POLY 1.5           |     P=0.547      P=0.230      (e)          P=0.501     |P=0.384      P=0.743      P=0.339      P=0.541      | 
|POLY 6             |     P=0.574      P=0.234      (e)          P=0.517     |P=0.398      P=0.738      P=0.354      P=0.548      | 
|LOGISTIC REGRESSION|     P=0.541      P=0.232      (e)          P=0.521     |P=0.341      P=0.769      P=0.416      P=0.550      | 
|COCH-ARM / FISHERS |     P=0.540      P=0.237      (e)          P=0.500     |P=0.342      P=0.737N     P=0.333      P=0.542      | 
|ORDER RESTRICTED   |     P=0.319      (e)          (e)          (e)         |P=0.367      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Testes                                                                                                                           | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/10 (0%)    1/10 (10%)   1/10 (10%)   2/10 (20%)  |                                                    | 
|POLY-3 RATE (b)    |     0/8.63       1/9.79       1/9.32       2/9.54      |                                                    | 
|POLY-3 PERCENT (g) |     0.0%         10.2%        10.7%        21.0%       |                                                    | 
|TERMINAL (d)       |     0/8 (0%)     0/8 (0%)     1/8 (13%)    1/8 (13%)   |                                                    | 
|FIRST INCIDENCE    |     ---          140          272 (T)      69          |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.151      P=0.521      P=0.500      P=0.240     |                                                    | 
|POLY 3             |     P=0.166      P=0.525      P=0.515      P=0.249     |                                                    | 
|POLY 1.5           |     P=0.161      P=0.517      P=0.512      P=0.243     |                                                    | 
|POLY 6             |     P=0.167      P=0.530      P=0.515      P=0.253     |                                                    | 
|LOGISTIC REGRESSION|     P=0.162      P=0.451      P=0.500      P=0.268     |                                                    | 
|COCH-ARM / FISHERS |     P=0.143      P=0.500      P=0.500      P=0.237     |                                                    | 
|ORDER RESTRICTED   |     P=0.128      (e)          (e)          (e)         |                                                    | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/08/03                           EXPERIMENT: 97013 TEST: 92                                            Page 13      
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -         WATER DISINFECTION MODEL (SOD
IUM BR                                                                                                                              
                                         Terminal Sacrifice at 39 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Testes: Bilateral, Germinal Epithelium                                                                                           | 
|     Degeneration                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/10 (0%)    1/10 (10%)   1/10 (10%)   2/10 (20%)  |                                                    | 
|POLY-3 RATE (b)    |     0/8.63       1/8.92       1/9.32       2/8.55      |                                                    | 
|POLY-3 PERCENT (g) |     0.0%         11.2%        10.7%        23.4%       |                                                    | 
|TERMINAL (d)       |     0/8 (0%)     1/8 (13%)    1/8 (13%)    2/8 (25%)   |                                                    | 
|FIRST INCIDENCE    |     ---          272 (T)      272 (T)      272 (T)     |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.143      P=0.500      P=0.500      P=0.232     |                                                    | 
|POLY 3             |     P=0.143      P=0.507      P=0.515      P=0.221     |                                                    | 
|POLY 1.5           |     P=0.141      P=0.504      P=0.512      P=0.219     |                                                    | 
|POLY 6             |     P=0.145      P=0.508      P=0.515      P=0.223     |                                                    | 
|LOGISTIC REGRESSION|     (e)          P=0.500      P=0.500      P=0.232     |                                                    | 
|COCH-ARM / FISHERS |     P=0.143      P=0.500      P=0.500      P=0.237     |                                                    | 
|ORDER RESTRICTED   |     P=0.106      (e)          (e)          (e)         |                                                    | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Testes: Germinal Epithelium                                                                                                      | 
|     Degeneration                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/10 (10%)   3/10 (30%)   4/10 (40%)   8/10 (80%)  |                                                    | 
|POLY-3 RATE (b)    |     1/8.63       3/9.79       4/9.32       8/9.54      |                                                    | 
|POLY-3 PERCENT (g) |     11.6%        30.7%        42.9%        83.9%       |                                                    | 
|TERMINAL (d)       |     1/8 (13%)    2/8 (25%)    4/8 (50%)    7/8 (88%)   |                                                    | 
|FIRST INCIDENCE    |     272 (T)      140          272 (T)      69          |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P<0.001 **   P=0.309      P=0.148      P=0.004 **  |                                                    | 
|POLY 3             |     P<0.001 **   P=0.340      P=0.167      P<0.001 **  |                                                    | 
|POLY 1.5           |     P<0.001 **   P=0.325      P=0.163      P<0.001 **  |                                                    | 
|POLY 6             |     P<0.001 **   P=0.349      P=0.164      P<0.001 **  |                                                    | 
|LOGISTIC REGRESSION|     P<0.001 **   P=0.271      P=0.148      P=0.003 **  |                                                    | 
|COCH-ARM / FISHERS |     P<0.001 **   P=0.291      P=0.152      P=0.003 **  |                                                    | 
|ORDER RESTRICTED   |     P<0.001 **   (e)          (e)          (e)         |                                                    | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/08/03                           EXPERIMENT: 97013 TEST: 92                                            Page 14      
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -         WATER DISINFECTION MODEL (SOD
IUM BR                                                                                                                              
                                         Terminal Sacrifice at 39 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thymus                                                                                                                           | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/10 (30%)   2/10 (20%)   4/10 (40%)   3/9 (33%)   |1/8 (13%)    1/10 (10%)   2/10 (20%)   1/10 (10%)   | 
|POLY-3 RATE (b)    |     3/8.63       2/9.79       4/9.54       3/9.00      |1/8.00       1/8.17       2/9.54       1/9.52       | 
|POLY-3 PERCENT (g) |     34.7%        20.4%        41.9%        33.3%       |12.5%        12.2%        21.0%        10.5%        | 
|TERMINAL (d)       |     3/8 (38%)    1/8 (13%)    3/8 (38%)    1/7 (14%)   |0/7 (0%)     0/7 (0%)     1/8 (13%)    0/8 (0%)     | 
|FIRST INCIDENCE    |     272 (T)      140          251          69          |251          144          127          257          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.452      P=0.490N     P=0.510      P=0.637     |P=0.593N     P=0.746      P=0.527      P=0.719N     | 
|POLY 3             |     P=0.504      P=0.437N     P=0.564      P=0.662N    |P=0.590N     P=0.757N     P=0.563      P=0.722N     | 
|POLY 1.5           |     P=0.482      P=0.457N     P=0.545      P=0.679     |P=0.586N     P=0.749N     P=0.570      P=0.717N     | 
|POLY 6             |     P=0.526      P=0.425N     P=0.574      P=0.640N    |P=0.598N     P=0.761N     P=0.554      P=0.729N     | 
|LOGISTIC REGRESSION|     P=0.473      P=0.511N     P=0.551      P=0.669     |P=0.577      P=0.578N     P=0.712N     P=0.638N     | 
|COCH-ARM / FISHERS |     P=0.434      P=0.500N     P=0.500      P=0.630     |P=0.602N     P=0.706N     P=0.588      P=0.706N     | 
|ORDER RESTRICTED   |     P=0.514      (e)          (e)          (e)         |P=0.603N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thymus                                                                                                                           | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     7/10 (70%)   1/10 (10%)   0/10 (0%)    3/9 (33%)   |0/8 (0%)     1/10 (10%)   2/10 (20%)   5/10 (50%)   | 
|POLY-3 RATE (b)    |     7/9.12       1/8.92       0/9.32       3/7.55      |0/7.79       1/7.32       2/8.64       5/9.52       | 
|POLY-3 PERCENT (g) |     76.8%        11.2%        0.0%         39.7%       |0.0%         13.7%        23.2%        52.6%        | 
|TERMINAL (d)       |     6/8 (75%)    1/8 (13%)    0/8 (0%)     3/7 (43%)   |0/7 (0%)     1/7 (14%)    2/8 (25%)    4/8 (50%)    | 
|FIRST INCIDENCE    |     218          272 (T)      ---          272 (T)     |---          272 (T)      272 (T)      257          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.134N     P=0.014N*    P=0.003N**   P=0.138N    |P=0.008 **   P=0.500      P=0.262      P=0.038 *    | 
|POLY 3             |     P=0.074N     P=0.002N**   P<0.001N**   P=0.144N    |P=0.004 **   P=0.488      P=0.247      P=0.016 *    | 
|POLY 1.5           |     P=0.077N     P=0.002N**   P<0.001N**   P=0.139N    |P=0.004 **   P=0.500      P=0.257      P=0.017 *    | 
|POLY 6             |     P=0.075N     P=0.002N**   P<0.001N**   P=0.157N    |P=0.004 **   P=0.484      P=0.242      P=0.015 *    | 
|LOGISTIC REGRESSION|     P=0.129N     P=0.009N**   P=0.002N**   P=0.124N    |P=0.007 **   P=0.500      P=0.262      P=0.029 *    | 
|COCH-ARM / FISHERS |     P=0.129N     P=0.010N*    P=0.002N**   P=0.128N    |P=0.006 **   P=0.556      P=0.294      P=0.029 *    | 
|ORDER RESTRICTED   |     P<0.001N**   (e)          (e)          (e)         |P=0.004 **   (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/08/03                           EXPERIMENT: 97013 TEST: 92                                            Page 15      
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -         WATER DISINFECTION MODEL (SOD
IUM BR                                                                                                                              
                                         Terminal Sacrifice at 39 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland                                                                                                                    | 
|     Infiltration Cellular Lymphocyte                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/10 (0%)    0/10 (0%)    2/10 (20%)   1/10 (10%)  |0/9 (0%)     2/10 (20%)   5/10 (50%)   10/10 (100%) | 
|POLY-3 RATE (b)    |     0/8.63       0/8.92       2/9.32       1/8.55      |0/8.29       2/7.32       5/8.64       10/10.00     | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         21.5%        11.7%       |0.0%         27.3%        57.9%        100.0%       | 
|TERMINAL (d)       |     0/8 (0%)     0/8 (0%)     2/8 (25%)    1/8 (13%)   |0/7 (0%)     2/7 (29%)    5/8 (63%)    8/8 (100%)   | 
|FIRST INCIDENCE    |     ---          ---          272 (T)      272 (T)     |---          272 (T)      272 (T)      218          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.240      (e)          P=0.232      P=0.500     |P<0.001 **   P=0.231      P=0.026 *    P<0.001 **   | 
|POLY 3             |     P=0.227      (e)          P=0.243      P=0.498     |P<0.001 **   P=0.193      P=0.006 **   P<0.001 **   | 
|POLY 1.5           |     P=0.224      (e)          P=0.240      P=0.495     |P<0.001 **   P=0.203      P=0.008 **   P<0.001 **   | 
|POLY 6             |     P=0.230      (e)          P=0.242      P=0.500     |P<0.001 **   P=0.196      P=0.006 **   P<0.001 **   | 
|LOGISTIC REGRESSION|     (e)          (e)          P=0.232      P=0.500     |P<0.001 **   P=0.231      P=0.026 *    P<0.001 **   | 
|COCH-ARM / FISHERS |     P=0.239      (e)          P=0.237      P=0.500     |P<0.001 **   P=0.263      P=0.022 *    P<0.001 **   | 
|ORDER RESTRICTED   |     P=0.169      (e)          (e)          (e)         |P<0.001 **   (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: Follicle                                                                                                          | 
|     Depletion Secretory                                                                                                         | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     8/10 (80%)   7/10 (70%)   9/10 (90%)   9/10 (90%)  |5/9 (56%)    8/10 (80%)   10/10 (100%) 10/10 (100%) | 
|POLY-3 RATE (b)    |     8/9.12       7/9.14       9/9.79       9/10.00     |5/8.29       8/8.16       10/10.00     10/10.00     | 
|POLY-3 PERCENT (g) |     87.7%        76.6%        92.0%        90.0%       |60.3%        98.0%        100.0%       100.0%       | 
|TERMINAL (d)       |     7/8 (88%)    6/8 (75%)    8/8 (100%)   7/8 (88%)   |5/7 (71%)    7/7 (100%)   8/8 (100%)   8/8 (100%)   | 
|FIRST INCIDENCE    |     218          251          221          69          |272 (T)      148          127          218          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.308      P=0.489N     P=0.538      P=0.511     |P=0.054      P=0.111      P=0.062      P=0.069      | 
|POLY 3             |     P=0.455      P=0.497N     P=0.679      P=0.710     |P=0.005 **   P=0.073      P=0.031 *    P=0.031 *    | 
|POLY 1.5           |     P=0.394      P=0.496N     P=0.636      P=0.655     |P=0.003 **   P=0.095      P=0.025 *    P=0.025 *    | 
|POLY 6             |     P=0.485      P=0.499N     P=0.678      P=0.734     |P=0.013 *    P=0.082      P=0.047 *    P=0.047 *    | 
|LOGISTIC REGRESSION|     P=0.222      P=0.447N     P=0.712      P=0.473     |P=0.009 **   P=0.056      P=0.029 *    P=0.031 *    | 
|COCH-ARM / FISHERS |     P=0.263      P=0.500N     P=0.500      P=0.500     |P=0.010 *    P=0.259      P=0.033 *    P=0.033 *    | 
|ORDER RESTRICTED   |     P=0.451      (e)          (e)          (e)         |P<0.001 **   (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/08/03                           EXPERIMENT: 97013 TEST: 92                                            Page 16      
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -         WATER DISINFECTION MODEL (SOD
IUM BR                                                                                                                              
                                         Terminal Sacrifice at 39 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: Follicular Cell                                                                                                   | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/10 (0%)    9/10 (90%)   8/10 (80%)   8/10 (80%)  |1/9 (11%)    9/10 (90%)   9/10 (90%)   10/10 (100%) | 
|POLY-3 RATE (b)    |     0/8.63       9/9.14       8/9.79       8/9.02      |1/8.29       9/9.15       9/9.10       10/10.00     | 
|POLY-3 PERCENT (g) |     0.0%         98.5%        81.8%        88.7%       |12.1%        98.4%        98.9%        100.0%       | 
|TERMINAL (d)       |     0/8 (0%)     8/8 (100%)   7/8 (88%)    7/8 (88%)   |1/7 (14%)    7/7 (100%)   8/8 (100%)   8/8 (100%)   | 
|FIRST INCIDENCE    |     ---          251          221          221         |272 (T)      62           221          218          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.005 **   P<0.001 **   P<0.001 **   P<0.001 **  |P=0.004 **   P=0.002 **   P=0.002 **   P<0.001 **   | 
|POLY 3             |     P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **  |P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   | 
|POLY 1.5           |     P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **  |P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   | 
|POLY 6             |     P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **  |P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   | 
|LOGISTIC REGRESSION|     P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **  |P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   | 
|COCH-ARM / FISHERS |     P=0.003 **   P<0.001 **   P<0.001 **   P<0.001 **  |P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   | 
|ORDER RESTRICTED   |     P<0.001 **   (e)          (e)          (e)         |P<0.001 **   (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus: Endometrium                                                                                                              | 
|     Hyperplasia Cystic                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |8/9 (89%)    7/10 (70%)   8/10 (80%)   10/10 (100%) | 
|POLY-3 RATE (b)    |                                                        |8/8.79       7/8.16       8/8.64       10/10.00     | 
|POLY-3 PERCENT (g) |                                                        |91.1%        85.8%        92.6%        100.0%       | 
|TERMINAL (d)       |                                                        |7/7 (100%)   6/7 (86%)    8/8 (100%)   8/8 (100%)   | 
|FIRST INCIDENCE    |                                                        |217          148          272 (T)      218          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |P=0.347      P=0.542N     P=0.500N     P=0.567      | 
|POLY 3             |                                                        |P=0.274      P=0.667N     P=0.808      P=0.582      | 
|POLY 1.5           |                                                        |P=0.246      P=0.597N     P=0.759N     P=0.528      | 
|POLY 6             |                                                        |P=0.315      P=0.674N     P=0.835      P=0.704      | 
|LOGISTIC REGRESSION|                                                        |P=0.313      P=0.696N     P=0.782N     P=0.492      | 
|COCH-ARM / FISHERS |                                                        |P=0.202      P=0.333N     P=0.542N     P=0.474      | 
|ORDER RESTRICTED   |                                                        |P=0.218      (e)          (e)          (e)          | 
|=================================================================================================================================| 
(a)  Number of tumor-bearing animals /  number of animals examined at site.                                                         
                                                                                                                                   
(b)  Number of tumor-bearing animals / Poly-3 number                                                                                
(d)  Observed incidence at terminal kill.                                                                                           
(f)  Beneath the control incidence are the P-values associated with the trend                                                       
test.  Beneath the dosed group incidence are the P-values corresponding to                                                          
pairwise comparisons between the controls and that dosed group.  The life                                                           
table analysis regards tumors in animals dying prior to  terminal kill as                                                           
 being (directly or indirectly) the cause of death.                                                                                 
Logistic regression is an alternative                                                                                               
 method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage                                                       
and Fishers exact tests compare directly the overall incidence rates                                                                
For all tests a negative trend is indicated by N                                                                                    
(e)  Value of Statistic cannot be computed.                                                                                         
(g)  Poly-3 adjusted lifetime tumor incidence.                                                                                      
(I)  Interim sacrifice                                                                                                              
(T)  Terminal sacrifice                                                                                                             
#   Tumor rates based on number of animals necropsied.                                                                              
*   To the right of any statistical result, indicates significance at (P<=0.05).                                                    
**  To the right of any statistical result, indicates significance at (P<=0.01).                                                    
NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.