National Toxicology Program

National Toxicology Program
https://ntp.niehs.nih.gov/go/11161

TDMS Study 97013-91 Pathology Tables

NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                       WATER DISINFECTION MODEL (DICHLOROACETIC ACID)                    DATE: 12/05/03       
EXPERIMENT: 97013 TEST: 91                                                                                     TIME: 09:41:15       
TEST TYPE:  26-39 WEEKS                         CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-65406                              ROUTE: DOSED WATER                                             NTP C#: 97013I       
PATHOLOGIST: MISSING                                                                                           CAS: 79-43-6         
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                                                            FINAL#1 MICE                                                            
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
                                                                                                                                   
NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                       WATER DISINFECTION MODEL (DICHLOROACETIC ACID)                    DATE: 12/05/03       
EXPERIMENT: 97013 TEST: 91                                                                                     TIME: 09:41:15       
TEST TYPE:  26-39 WEEKS                         CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-65406                              ROUTE: DOSED WATER                                             NTP C#: 97013I       
PATHOLOGIST: MISSING                                                                                           CAS: 79-43-6         
                                                                                                                                    
                                                                                                                                    
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS                                                                               
IN THE ANALYSIS OF     WATER DISINFECTION MODEL (DICHLOROACET                                                                       
===============================================================                                                                     
Male Mice                                                                                                                           
------------                                                                                                                        
Organ                                 Morphology                                                                                    
-----                                 ----------                                                                                    
Epididymis                             Degeneration                                                                                 
Skin: Epidermis                        Hyperplasia                                                                                  
Stomach, Forestomach: Epithelium       Hyperplasia                                                                                  
Testes: Germinal Epithelium            Degeneration                                                                                 
Thyroid Gland: Follicle                Degeneration                                                                                 
===============================================================                                                                     
Female Mice                                                                                                                         
------------                                                                                                                        
Organ                                  Morphology                                                                                   
-----                                  ----------                                                                                   
Adrenal Cortex: Subcapsular            Hyperplasia                                                                                  
Kidney: Renal Tubule                   Dilatation                                                                                   
Liver: Hepatocyte                      Vacuolization Cytoplasmic                                                                    
Ovary                                  Cyst                                                                                         
===============================================================                                                                     
                                                                                                                                   
       Date:  12/05/03                           EXPERIMENT: 97013 TEST: 91                                            Page 1       
Statistical Analysis of Non-neoplastic Lesions in        Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -      WATER DISINFECTION MODEL (DICHL
OROACET                                                                                                                             
                                         Terminal Sacrifice at 41 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       500 MG/L     1000MG/L     2000MG/L    |0 MG/L       500 MG/L     1000MG/L     2000MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Accessory Adrenal Cortical Nodule                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/10 (10%)   1/10 (10%)   0/10 (0%)    1/10 (10%)  |2/10 (20%)   2/10 (20%)   2/10 (20%)   3/10 (30%)   | 
|POLY-3 RATE (b)    |     1/9.03       1/10.00      0/10.00      1/10.00     |2/7.24       2/9.36       2/8.38       3/8.09       | 
|POLY-3 PERCENT (g) |     11.1%        10.0%        0.0%         10.0%       |27.6%        21.4%        23.9%        37.1%        | 
|TERMINAL (d)       |     1/9 (11%)    0/9 (0%)     0/10 (0%)    1/10 (10%)  |2/7 (29%)    2/9 (22%)    1/7 (14%)    3/8 (38%)    | 
|FIRST INCIDENCE    |     281 (T)      150          ---          281 (T)     |282 (T)      282 (T)      78           282 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.589N     P=0.749N     P=0.479N     P=0.743N    |P=0.394      P=0.611N     P=0.703      P=0.570      | 
|POLY 3             |     P=0.608N     P=0.738N     P=0.480N     P=0.738N    |P=0.382      P=0.605N     P=0.652N     P=0.557      | 
|POLY 1.5           |     P=0.609N     P=0.741N     P=0.483N     P=0.741N    |P=0.376      P=0.626N     P=0.660N     P=0.538      | 
|POLY 6             |     P=0.607N     P=0.737N     P=0.479N     P=0.737N    |P=0.389      P=0.603N     P=0.655N     P=0.567      | 
|LOGISTIC REGRESSION|     P=0.562      P=0.741      (e)          P=0.749N    |P=0.374      P=0.611N     P=0.711      P=0.570      | 
|COCH-ARM / FISHERS |     P=0.620N     P=0.763N     P=0.500N     P=0.763N    |P=0.374      P=0.709N     P=0.709N     P=0.500      | 
|ORDER RESTRICTED   |     P=0.502N     (e)          (e)          (e)         |P=0.470      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       500 MG/L     1000MG/L     2000MG/L    |0 MG/L       500 MG/L     1000MG/L     2000MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     8/10 (80%)   6/10 (60%)   9/10 (90%)   7/10 (70%)  |0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)    | 
|POLY-3 RATE (b)    |     8/9.03       6/9.15       9/10.00      7/10.00     |0/7.24       0/9.36       0/7.40       0/8.09       | 
|POLY-3 PERCENT (g) |     88.6%        65.6%        90.0%        70.0%       |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     8/9 (89%)    6/9 (67%)    9/10 (90%)   7/10 (70%)  |0/7 (0%)     0/9 (0%)     0/7 (0%)     0/8 (0%)     | 
|FIRST INCIDENCE    |     281 (T)      281 (T)      281 (T)      281 (T)     |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.348N     P=0.291N     P=0.743      P=0.333N    |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.365N     P=0.271N     P=0.730      P=0.338N    |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.402N     P=0.262N     P=0.697      P=0.362N    |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.351N     P=0.286N     P=0.737      P=0.333N    |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.348N     P=0.291N     P=0.743      P=0.333N    |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.549N     P=0.314N     P=0.500      P=0.500N    |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.261N     (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/05/03                           EXPERIMENT: 97013 TEST: 91                                            Page 2       
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -      WATER DISINFECTION MODEL (DICHLO
ROACET                                                                                                                              
                                         Terminal Sacrifice at 41 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       500 MG/L     1000MG/L     2000MG/L    |0 MG/L       500 MG/L     1000MG/L     2000MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex: Subcapsular                                                                                                      | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/10 (20%)   1/10 (10%)   1/10 (10%)   0/10 (0%)   |3/10 (30%)   5/10 (50%)   4/10 (40%)   8/10 (80%)   | 
|POLY-3 RATE (b)    |     2/9.03       1/10.00      1/10.00      0/10.00     |3/8.11       5/9.36       4/7.40       8/10.00      | 
|POLY-3 PERCENT (g) |     22.2%        10.0%        10.0%        0.0%        |37.0%        53.4%        54.1%        80.0%        | 
|TERMINAL (d)       |     2/9 (22%)    0/9 (0%)     1/10 (10%)   0/10 (0%)   |2/7 (29%)    5/9 (56%)    4/7 (57%)    6/8 (75%)    | 
|FIRST INCIDENCE    |     281 (T)      150          281 (T)      ---         |141          282 (T)      282 (T)      89           | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.132N     P=0.488N     P=0.461N     P=0.210N    |P=0.038 *    P=0.498      P=0.500      P=0.095      | 
|POLY 3             |     P=0.140N     P=0.463N     P=0.463N     P=0.202N    |P=0.048 *    P=0.421      P=0.437      P=0.076      | 
|POLY 1.5           |     P=0.141N     P=0.469N     P=0.469N     P=0.206N    |P=0.039 *    P=0.409      P=0.461      P=0.059      | 
|POLY 6             |     P=0.140N     P=0.462N     P=0.462N     P=0.202N    |P=0.054      P=0.412      P=0.416      P=0.082      | 
|LOGISTIC REGRESSION|     P=0.199N     P=0.536N     P=0.461N     P=0.204N    |P=0.026 *    P=0.403      P=0.513      P=0.034 *    | 
|COCH-ARM / FISHERS |     P=0.143N     P=0.500N     P=0.500N     P=0.237N    |P=0.027 *    P=0.325      P=0.500      P=0.035 *    | 
|ORDER RESTRICTED   |     P=0.094N     (e)          (e)          (e)         |P=0.042 *    (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       500 MG/L     1000MG/L     2000MG/L    |0 MG/L       500 MG/L     1000MG/L     2000MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Epididymis                                                                                                                       | 
|     Degeneration                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/10 (0%)    1/10 (10%)   1/10 (10%)   3/10 (30%)  |                                                    | 
|POLY-3 RATE (b)    |     0/9.03       1/9.15       1/10.00      3/10.00     |                                                    | 
|POLY-3 PERCENT (g) |     0.0%         10.9%        10.0%        30.0%       |                                                    | 
|TERMINAL (d)       |     0/9 (0%)     1/9 (11%)    1/10 (10%)   3/10 (30%)  |                                                    | 
|FIRST INCIDENCE    |     ---          281 (T)      281 (T)      281 (T)     |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.058      P=0.500      P=0.521      P=0.129     |                                                    | 
|POLY 3             |     P=0.055      P=0.503      P=0.520      P=0.115     |                                                    | 
|POLY 1.5           |     P=0.053      P=0.505      P=0.517      P=0.111     |                                                    | 
|POLY 6             |     P=0.056      P=0.500      P=0.521      P=0.115     |                                                    | 
|LOGISTIC REGRESSION|     (e)          P=0.500      P=0.521      P=0.129     |                                                    | 
|COCH-ARM / FISHERS |     P=0.045 *    P=0.500      P=0.500      P=0.105     |                                                    | 
|ORDER RESTRICTED   |     P=0.036 *    (e)          (e)          (e)         |                                                    | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/05/03                           EXPERIMENT: 97013 TEST: 91                                            Page 3       
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -      WATER DISINFECTION MODEL (DICHLO
ROACET                                                                                                                              
                                         Terminal Sacrifice at 41 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       500 MG/L     1000MG/L     2000MG/L    |0 MG/L       500 MG/L     1000MG/L     2000MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Nephropathy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     9/10 (90%)   8/10 (80%)   7/10 (70%)   10/10 (100%)|3/10 (30%)   5/10 (50%)   2/10 (20%)   7/10 (70%)   | 
|POLY-3 RATE (b)    |     9/9.03       8/9.15       7/10.00      10/10.00    |3/7.24       5/9.36       2/7.40       7/9.06       | 
|POLY-3 PERCENT (g) |     99.7%        87.4%        70.0%        100.0%      |41.4%        53.4%        27.0%        77.3%        | 
|TERMINAL (d)       |     9/9 (100%)   8/9 (89%)    7/10 (70%)   10/10 (100%)|3/7 (43%)    5/9 (56%)    2/7 (29%)    6/8 (75%)    | 
|FIRST INCIDENCE    |     281 (T)      281 (T)      281 (T)      281 (T)     |282 (T)      282 (T)      282 (T)      89           | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.602      P=0.500N     P=0.129N     P=1.000     |P=0.093      P=0.500      P=0.500N     P=0.138      | 
|POLY 3             |     P=0.563      P=0.455N     P=0.119N     P=1.000     |P=0.113      P=0.504      P=0.488N     P=0.166      | 
|POLY 1.5           |     P=0.508      P=0.426N     P=0.139N     P=1.000     |P=0.100      P=0.465      P=0.488N     P=0.132      | 
|POLY 6             |     P=0.584      P=0.492N     P=0.116N     P=1.000     |P=0.123      P=0.508      P=0.496N     P=0.183      | 
|LOGISTIC REGRESSION|     P=0.602      P=0.500N     P=0.129N     P=1.000     |P=0.078      P=0.500      P=0.500N     P=0.099      | 
|COCH-ARM / FISHERS |     P=0.327      P=0.500N     P=0.291N     P=0.500     |P=0.088      P=0.325      P=0.500N     P=0.089      | 
|ORDER RESTRICTED   |     P=0.218      (e)          (e)          (e)         |P=0.113      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       500 MG/L     1000MG/L     2000MG/L    |0 MG/L       500 MG/L     1000MG/L     2000MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Glomerulus                                                                                                               | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)   |3/10 (30%)   0/10 (0%)    1/10 (10%)   1/10 (10%)   | 
|POLY-3 RATE (b)    |     0/9.03       0/9.15       0/10.00      0/10.00     |3/10.00      0/9.36       1/8.28       1/9.03       | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |30.0%        0.0%         12.1%        11.1%        | 
|TERMINAL (d)       |     0/9 (0%)     0/9 (0%)     0/10 (0%)    0/10 (0%)   |0/7 (0%)     0/9 (0%)     0/7 (0%)     0/8 (0%)     | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |94           ---          139          108          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.322N     P=0.105N     P=0.307N     P=0.328N     | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.297N     P=0.107N     P=0.366N     P=0.331N     | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.296N     P=0.102N     P=0.348N     P=0.325N     | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.294N     P=0.112N     P=0.377N     P=0.333N     | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.157N     (e)          P=0.287N     P=0.290N     | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.286N     P=0.105N     P=0.291N     P=0.291N     | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |P=0.111N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/05/03                           EXPERIMENT: 97013 TEST: 91                                            Page 4       
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -      WATER DISINFECTION MODEL (DICHLO
ROACET                                                                                                                              
                                         Terminal Sacrifice at 41 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       500 MG/L     1000MG/L     2000MG/L    |0 MG/L       500 MG/L     1000MG/L     2000MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Renal Tubule                                                                                                             | 
|     Dilatation                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     4/10 (40%)   6/10 (60%)   6/10 (60%)   5/10 (50%)  |3/10 (30%)   1/10 (10%)   2/10 (20%)   0/10 (0%)    | 
|POLY-3 RATE (b)    |     4/9.03       6/9.15       6/10.00      5/10.00     |3/7.24       1/9.36       2/7.40       0/8.09       | 
|POLY-3 PERCENT (g) |     44.3%        65.6%        60.0%        50.0%       |41.4%        10.7%        27.0%        0.0%         | 
|TERMINAL (d)       |     4/9 (44%)    6/9 (67%)    6/10 (60%)   5/10 (50%)  |3/7 (43%)    1/9 (11%)    2/7 (29%)    0/8 (0%)     | 
|FIRST INCIDENCE    |     281 (T)      281 (T)      281 (T)      281 (T)     |282 (T)      282 (T)      282 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.575N     P=0.322      P=0.416      P=0.584     |P=0.079N     P=0.199N     P=0.500N     P=0.085N     | 
|POLY 3             |     P=0.576N     P=0.334      P=0.415      P=0.579     |P=0.092N     P=0.193N     P=0.488N     P=0.068N     | 
|POLY 1.5           |     P=0.578      P=0.344      P=0.401      P=0.567     |P=0.092N     P=0.212N     P=0.488N     P=0.075N     | 
|POLY 6             |     P=0.569N     P=0.325      P=0.417      P=0.582     |P=0.089N     P=0.191N     P=0.496N     P=0.065N     | 
|LOGISTIC REGRESSION|     P=0.575N     P=0.322      P=0.416      P=0.586     |P=0.079N     P=0.199N     P=0.500N     (e)          | 
|COCH-ARM / FISHERS |     P=0.479      P=0.328      P=0.328      P=0.500     |P=0.089N     P=0.291N     P=0.500N     P=0.105N     | 
|ORDER RESTRICTED   |     P=0.441      (e)          (e)          (e)         |P=0.027N*    (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       500 MG/L     1000MG/L     2000MG/L    |0 MG/L       500 MG/L     1000MG/L     2000MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     9/10 (90%)   7/10 (70%)   5/10 (50%)   7/10 (70%)  |7/10 (70%)   10/10 (100%) 9/10 (90%)   8/10 (80%)   | 
|POLY-3 RATE (b)    |     9/10.00      7/9.15       5/10.00      7/10.00     |7/7.24       10/10.00     9/9.12       8/8.09       | 
|POLY-3 PERCENT (g) |     90.0%        76.5%        50.0%        70.0%       |96.7%        100.0%       98.7%        98.9%        | 
|TERMINAL (d)       |     8/9 (89%)    7/9 (78%)    5/10 (50%)   7/10 (70%)  |7/7 (100%)   9/9 (100%)   7/7 (100%)   8/8 (100%)   | 
|FIRST INCIDENCE    |     87           281 (T)      281 (T)      281 (T)     |282 (T)      200          78           282 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.142N     P=0.300N     P=0.055N     P=0.195N    |P=0.616N     P=0.571      P=0.254      P=1.000N     | 
|POLY 3             |     P=0.203N     P=0.430N     P=0.061N     P=0.292N    |P=0.996      P=1.000      P=1.000      P=1.000      | 
|POLY 1.5           |     P=0.213N     P=0.383N     P=0.061N     P=0.292N    |P=0.748      P=0.562      P=0.743      P=0.807      | 
|POLY 6             |     P=0.199N     P=0.457N     P=0.061N     P=0.292N    |P=1.000      P=1.000      P=1.000      P=1.000      | 
|LOGISTIC REGRESSION|     P=0.216N     P=0.265N     P=0.055N     P=0.195N    |P=0.525      (e)          P=0.287      P=1.000N     | 
|COCH-ARM / FISHERS |     P=0.242N     P=0.291N     P=0.070N     P=0.291N    |P=0.559      P=0.105      P=0.291      P=0.500      | 
|ORDER RESTRICTED   |     P=0.099N     (e)          (e)          (e)         |P=0.158      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/05/03                           EXPERIMENT: 97013 TEST: 91                                            Page 5       
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -      WATER DISINFECTION MODEL (DICHLO
ROACET                                                                                                                              
                                         Terminal Sacrifice at 41 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       500 MG/L     1000MG/L     2000MG/L    |0 MG/L       500 MG/L     1000MG/L     2000MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Hepatocyte                                                                                                                | 
|     Necrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/10 (10%)   1/10 (10%)   1/10 (10%)   3/10 (30%)  |1/10 (10%)   1/10 (10%)   1/10 (10%)   4/10 (40%)   | 
|POLY-3 RATE (b)    |     1/10.00      1/9.15       1/10.00      3/10.00     |1/7.24       1/9.36       1/7.40       4/9.06       | 
|POLY-3 PERCENT (g) |     10.0%        10.9%        10.0%        30.0%       |13.8%        10.7%        13.5%        44.2%        | 
|TERMINAL (d)       |     0/9 (0%)     1/9 (11%)    1/10 (10%)   3/10 (30%)  |1/7 (14%)    1/9 (11%)    1/7 (14%)    3/8 (38%)    | 
|FIRST INCIDENCE    |     87           281 (T)      281 (T)      281 (T)     |282 (T)      282 (T)      282 (T)      89           | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.180      P=0.760      P=0.749N     P=0.330     |P=0.061      P=0.710N     P=0.769      P=0.197      | 
|POLY 3             |     P=0.160      P=0.741      P=0.760      P=0.292     |P=0.058      P=0.702N     P=0.761N     P=0.221      | 
|POLY 1.5           |     P=0.158      P=0.747      P=0.760      P=0.292     |P=0.055      P=0.715N     P=0.760N     P=0.199      | 
|POLY 6             |     P=0.161      P=0.737      P=0.760      P=0.292     |P=0.061      P=0.701N     P=0.764N     P=0.232      | 
|LOGISTIC REGRESSION|     P=0.061      P=0.733      P=0.749N     P=0.330     |P=0.052      P=0.710N     P=0.769      P=0.153      | 
|COCH-ARM / FISHERS |     P=0.147      P=0.763N     P=0.763N     P=0.291     |P=0.053      P=0.763N     P=0.763N     P=0.152      | 
|ORDER RESTRICTED   |     P=0.170      (e)          (e)          (e)         |P=0.090      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       500 MG/L     1000MG/L     2000MG/L    |0 MG/L       500 MG/L     1000MG/L     2000MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Hepatocyte                                                                                                                | 
|     Vacuolization Cytoplasmic                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     9/10 (90%)   10/10 (100%) 9/10 (90%)   10/10 (100%)|7/10 (70%)   9/10 (90%)   9/10 (90%)   10/10 (100%) | 
|POLY-3 RATE (b)    |     9/9.03       10/10.00     9/10.00      10/10.00    |7/7.24       9/9.36       9/9.12       10/10.00     | 
|POLY-3 PERCENT (g) |     99.7%        100.0%       90.0%        100.0%      |96.7%        96.2%        98.7%        100.0%       | 
|TERMINAL (d)       |     9/9 (100%)   9/9 (100%)   9/10 (90%)   10/10 (100%)|7/7 (100%)   9/9 (100%)   7/7 (100%)   8/8 (100%)   | 
|FIRST INCIDENCE    |     281 (T)      150          281 (T)      281 (T)     |282 (T)      282 (T)      78           89           | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.504N     P=0.521      P=0.521N     P=1.000N    |P=0.086      P=1.000      P=0.254      P=0.240      | 
|POLY 3             |     P=0.732N     P=1.000      P=0.533N     P=1.000     |P=0.706      P=0.988N     P=1.000      P=1.000      | 
|POLY 1.5           |     P=0.728      P=1.000      P=0.586N     P=1.000     |P=0.251      P=0.778      P=0.743      P=0.562      | 
|POLY 6             |     P=0.722N     P=1.000      P=0.521N     P=1.000     |P=1.000      P=1.000N     P=1.000      P=1.000      | 
|LOGISTIC REGRESSION|     P=0.759N     (e)          P=0.521N     P=1.000N    |P=0.021 *    P=1.000      P=0.287      P=0.063      | 
|COCH-ARM / FISHERS |     P=0.403      P=0.500      P=0.763N     P=0.500     |P=0.062      P=0.291      P=0.291      P=0.105      | 
|ORDER RESTRICTED   |     P=0.409N     (e)          (e)          (e)         |P=0.256      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/05/03                           EXPERIMENT: 97013 TEST: 91                                            Page 6       
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -      WATER DISINFECTION MODEL (DICHLO
ROACET                                                                                                                              
                                         Terminal Sacrifice at 41 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       500 MG/L     1000MG/L     2000MG/L    |0 MG/L       500 MG/L     1000MG/L     2000MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/10 (20%)   1/10 (10%)   0/10 (0%)    0/10 (0%)   |0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)    | 
|POLY-3 RATE (b)    |     2/9.03       1/9.15       0/10.00      0/10.00     |0/7.24       0/9.36       0/7.40       0/8.09       | 
|POLY-3 PERCENT (g) |     22.2%        10.9%        0.0%         0.0%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     2/9 (22%)    1/9 (11%)    0/10 (0%)    0/10 (0%)   |0/7 (0%)     0/9 (0%)     0/7 (0%)     0/8 (0%)     | 
|FIRST INCIDENCE    |     281 (T)      281 (T)      ---          ---         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.084N     P=0.500N     P=0.210N     P=0.210N    |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.088N     P=0.495N     P=0.202N     P=0.202N    |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.089N     P=0.491N     P=0.206N     P=0.206N    |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.087N     P=0.499N     P=0.202N     P=0.202N    |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.084N     P=0.500N     P=0.204N     P=0.204N    |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.094N     P=0.500N     P=0.237N     P=0.237N    |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.052N     (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       500 MG/L     1000MG/L     2000MG/L    |0 MG/L       500 MG/L     1000MG/L     2000MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mesentery: Fat                                                                                                                   | 
|     Fibrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/1 (0%)     0/0 (0%)     2/3 (67%)    1/1 (100%)  |0/0 (0%)     0/0 (0%)     0/0 (0%)     0/0 (0%)     | 
|POLY-3 RATE (b)    |     0/1.00       0/0.00       2/3.00       1/1.00      |0/0.00       0/0.00       0/0.00       0/0.00       | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         66.7%        100.0%      |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/1 (0%)     0/0 (0%)     2/3 (67%)    1/1 (100%)  |0/0 (0%)     0/0 (0%)     0/0 (0%)     0/0 (0%)     | 
|FIRST INCIDENCE    |     ---          ---          281 (T)      281 (T)     |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.259      (e)          P=0.500      P=0.500     |(e)          (e)          (e)          (e)          | 
|POLY 3             |     (e)          (e)          P=0.500      P=1.000N    |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     (e)          (e)          P=0.500      P=1.000N    |(e)          (e)          (e)          (e)          | 
|POLY 6             |     (e)          (e)          P=0.500      P=1.000N    |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     (e)          (e)          P=0.500      P=0.250     |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.235      (e)          P=0.500      P=0.500     |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/05/03                           EXPERIMENT: 97013 TEST: 91                                            Page 7       
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -      WATER DISINFECTION MODEL (DICHLO
ROACET                                                                                                                              
                                         Terminal Sacrifice at 41 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       500 MG/L     1000MG/L     2000MG/L    |0 MG/L       500 MG/L     1000MG/L     2000MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mesentery: Fat                                                                                                                   | 
|     Necrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/1 (100%)   0/0 (0%)     3/3 (100%)   1/1 (100%)  |0/0 (0%)     0/0 (0%)     0/0 (0%)     0/0 (0%)     | 
|POLY-3 RATE (b)    |     1/1.00       0/0.00       3/3.00       1/1.00      |0/0.00       0/0.00       0/0.00       0/0.00       | 
|POLY-3 PERCENT (g) |     100.0%       0.0%         100.0%       100.0%      |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     1/1 (100%)   0/0 (0%)     3/3 (100%)   1/1 (100%)  |0/0 (0%)     0/0 (0%)     0/0 (0%)     0/0 (0%)     | 
|FIRST INCIDENCE    |     281 (T)      ---          281 (T)      281 (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/L       500 MG/L     1000MG/L     2000MG/L    |0 MG/L       500 MG/L     1000MG/L     2000MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |0/10 (0%)    7/10 (70%)   4/10 (40%)   1/10 (10%)   | 
|POLY-3 RATE (b)    |                                                        |0/7.24       7/9.36       4/7.40       1/8.09       | 
|POLY-3 PERCENT (g) |                                                        |0.0%         74.8%        54.1%        12.4%        | 
|TERMINAL (d)       |                                                        |0/7 (0%)     7/9 (78%)    4/7 (57%)    1/8 (13%)    | 
|FIRST INCIDENCE    |                                                        |---          282 (T)      282 (T)      282 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |P=0.375N     P=0.006 **   P=0.044 *    P=0.527      | 
|POLY 3             |                                                        |P=0.269N     P<0.001 **   P=0.026 *    P=0.522      | 
|POLY 1.5           |                                                        |P=0.305N     P<0.001 **   P=0.027 *    P=0.515      | 
|POLY 6             |                                                        |P=0.249N     P<0.001 **   P=0.024 *    P=0.526      | 
|LOGISTIC REGRESSION|                                                        |(e)          P=0.006 **   P=0.044 *    P=0.527      | 
|COCH-ARM / FISHERS |                                                        |P=0.408N     P=0.002 **   P=0.043 *    P=0.500      | 
|ORDER RESTRICTED   |                                                        |P=0.016 *    (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/05/03                           EXPERIMENT: 97013 TEST: 91                                            Page 8       
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -      WATER DISINFECTION MODEL (DICHLO
ROACET                                                                                                                              
                                         Terminal Sacrifice at 41 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       500 MG/L     1000MG/L     2000MG/L    |0 MG/L       500 MG/L     1000MG/L     2000MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis                                                                                                   | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/10 (0%)    2/10 (20%)   1/10 (10%)   1/10 (10%)  |2/10 (20%)   2/10 (20%)   2/10 (20%)   2/10 (20%)   | 
|POLY-3 RATE (b)    |     0/9.03       2/9.15       1/10.00      1/10.00     |2/8.11       2/10.00      2/7.40       2/8.09       | 
|POLY-3 PERCENT (g) |     0.0%         21.9%        10.0%        10.0%       |24.7%        20.0%        27.0%        24.7%        | 
|TERMINAL (d)       |     0/9 (0%)     2/9 (22%)    1/10 (10%)   1/10 (10%)  |1/7 (14%)    1/9 (11%)    2/7 (29%)    2/8 (25%)    | 
|FIRST INCIDENCE    |     ---          281 (T)      281 (T)      281 (T)     |141          200          282 (T)      282 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.537      P=0.233      P=0.521      P=0.521     |P=0.592N     P=0.594N     P=0.703      P=0.664N     | 
|POLY 3             |     P=0.549      P=0.228      P=0.520      P=0.520     |P=0.558      P=0.623N     P=0.674      P=0.707      | 
|POLY 1.5           |     P=0.542      P=0.231      P=0.517      P=0.517     |P=0.567      P=0.640N     P=0.687      P=0.705      | 
|POLY 6             |     P=0.551      P=0.226      P=0.521      P=0.521     |P=0.556      P=0.617N     P=0.662      P=0.708      | 
|LOGISTIC REGRESSION|     (e)          P=0.233      P=0.521      P=0.521     |P=0.606      P=0.591      P=0.709N     P=0.706N     | 
|COCH-ARM / FISHERS |     P=0.500      P=0.237      P=0.500      P=0.500     |P=0.605      P=0.709N     P=0.709N     P=0.709N     | 
|ORDER RESTRICTED   |     P=0.272      (e)          (e)          (e)         |P=0.667      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       500 MG/L     1000MG/L     2000MG/L    |0 MG/L       500 MG/L     1000MG/L     2000MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Preputial Gland: Duct                                                                                                            | 
|     Ectasia                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/2 (100%)   4/4 (100%)   2/2 (100%)   0/0 (0%)    |                                                    | 
|POLY-3 RATE (b)    |     2/2.00       4/4.00       2/2.00       0/0.00      |                                                    | 
|POLY-3 PERCENT (g) |     100.0%       100.0%       100.0%       0.0%        |                                                    | 
|TERMINAL (d)       |     2/2 (100%)   4/4 (100%)   2/2 (100%)   0/0 (0%)    |                                                    | 
|FIRST INCIDENCE    |     281 (T)      281 (T)      281 (T)      ---         |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |                                                    | 
|POLY 3             |     (e)          (e)          (e)          (e)         |                                                    | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |                                                    | 
|POLY 6             |     (e)          (e)          (e)          (e)         |                                                    | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |                                                    | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |                                                    | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |                                                    | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/05/03                           EXPERIMENT: 97013 TEST: 91                                            Page 9       
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -      WATER DISINFECTION MODEL (DICHLO
ROACET                                                                                                                              
                                         Terminal Sacrifice at 41 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       500 MG/L     1000MG/L     2000MG/L    |0 MG/L       500 MG/L     1000MG/L     2000MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin: Epidermis                                                                                                                  | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     5/9 (56%)    4/9 (44%)    0/9 (0%)     1/8 (13%)   |1/6 (17%)    0/7 (0%)     2/7 (29%)    0/7 (0%)     | 
|POLY-3 RATE (b)    |     5/9.00       4/9.00       0/9.00       1/8.00      |1/6.00       0/7.00       2/7.00       0/7.00       | 
|POLY-3 PERCENT (g) |     55.6%        44.4%        0.0%         12.5%       |16.7%        0.0%         28.6%        0.0%         | 
|TERMINAL (d)       |     5/9 (56%)    4/9 (44%)    0/9 (0%)     1/8 (13%)   |1/6 (17%)    0/7 (0%)     1/6 (17%)    0/7 (0%)     | 
|FIRST INCIDENCE    |     281 (T)      281 (T)      ---          281 (T)     |282 (T)      ---          180          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.023N*    P=0.500N     P=0.020N*    P=0.096N    |P=0.438N     P=0.469N     P=0.516      P=0.469N     | 
|POLY 3             |     P=0.013N*    P=0.500N     P=0.006N**   P=0.078N    |P=0.426N     P=0.469N     P=0.556      P=0.469N     | 
|POLY 1.5           |     P=0.013N*    P=0.500N     P=0.006N**   P=0.078N    |P=0.426N     P=0.469N     P=0.556      P=0.469N     | 
|POLY 6             |     P=0.013N*    P=0.500N     P=0.006N**   P=0.078N    |P=0.426N     P=0.469N     P=0.556      P=0.469N     | 
|LOGISTIC REGRESSION|     P=0.023N*    P=0.500N     (e)          P=0.096N    |P=0.438N     (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.021N*    P=0.500N     P=0.015N*    P=0.088N    |P=0.426N     P=0.462N     P=0.563      P=0.462N     | 
|ORDER RESTRICTED   |     P=0.010N*    (e)          (e)          (e)         |P=0.278N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       500 MG/L     1000MG/L     2000MG/L    |0 MG/L       500 MG/L     1000MG/L     2000MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach: Epithelium                                                                                                 | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/10 (30%)   0/10 (0%)    0/10 (0%)    1/10 (10%)  |0/10 (0%)    1/10 (10%)   0/10 (0%)    0/10 (0%)    | 
|POLY-3 RATE (b)    |     3/9.03       0/9.15       0/10.00      1/10.00     |0/7.24       1/10.00      0/7.40       0/8.09       | 
|POLY-3 PERCENT (g) |     33.2%        0.0%         0.0%         10.0%       |0.0%         10.0%        0.0%         0.0%         | 
|TERMINAL (d)       |     3/9 (33%)    0/9 (0%)     0/10 (0%)    1/10 (10%)  |0/7 (0%)     0/9 (0%)     0/7 (0%)     0/8 (0%)     | 
|FIRST INCIDENCE    |     281 (T)      ---          ---          281 (T)     |---          200          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.213N     P=0.109N     P=0.093N     P=0.253N    |P=0.568N     P=0.571      (e)          (e)          | 
|POLY 3             |     P=0.225N     P=0.090N     P=0.076N     P=0.252N    |P=0.530N     P=0.563      (e)          (e)          | 
|POLY 1.5           |     P=0.228N     P=0.088N     P=0.079N     P=0.258N    |P=0.539N     P=0.548      (e)          (e)          | 
|POLY 6             |     P=0.223N     P=0.092N     P=0.076N     P=0.251N    |P=0.528N     P=0.568      (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.213N     (e)          (e)          P=0.253N    |P=0.560N     P=0.333      (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.238N     P=0.105N     P=0.105N     P=0.291N    |P=0.568N     P=0.500      (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.018N*    (e)          (e)          (e)         |P=0.421N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/05/03                           EXPERIMENT: 97013 TEST: 91                                            Page 10      
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -      WATER DISINFECTION MODEL (DICHLO
ROACET                                                                                                                              
                                         Terminal Sacrifice at 41 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       500 MG/L     1000MG/L     2000MG/L    |0 MG/L       500 MG/L     1000MG/L     2000MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Testes: Germinal Epithelium                                                                                                      | 
|     Degeneration                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/10 (0%)    1/10 (10%)   1/10 (10%)   3/10 (30%)  |                                                    | 
|POLY-3 RATE (b)    |     0/9.03       1/9.15       1/10.00      3/10.00     |                                                    | 
|POLY-3 PERCENT (g) |     0.0%         10.9%        10.0%        30.0%       |                                                    | 
|TERMINAL (d)       |     0/9 (0%)     1/9 (11%)    1/10 (10%)   3/10 (30%)  |                                                    | 
|FIRST INCIDENCE    |     ---          281 (T)      281 (T)      281 (T)     |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.058      P=0.500      P=0.521      P=0.129     |                                                    | 
|POLY 3             |     P=0.055      P=0.503      P=0.520      P=0.115     |                                                    | 
|POLY 1.5           |     P=0.053      P=0.505      P=0.517      P=0.111     |                                                    | 
|POLY 6             |     P=0.056      P=0.500      P=0.521      P=0.115     |                                                    | 
|LOGISTIC REGRESSION|     (e)          P=0.500      P=0.521      P=0.129     |                                                    | 
|COCH-ARM / FISHERS |     P=0.045 *    P=0.500      P=0.500      P=0.105     |                                                    | 
|ORDER RESTRICTED   |     P=0.036 *    (e)          (e)          (e)         |                                                    | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       500 MG/L     1000MG/L     2000MG/L    |0 MG/L       500 MG/L     1000MG/L     2000MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thymus                                                                                                                           | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/10 (20%)   1/10 (10%)   1/9 (11%)    0/10 (0%)   |3/10 (30%)   1/10 (10%)   1/9 (11%)    1/10 (10%)   | 
|POLY-3 RATE (b)    |     2/10.00      1/9.15       1/9.00       0/10.00     |3/10.00      1/10.00      1/8.02       1/9.03       | 
|POLY-3 PERCENT (g) |     20.0%        10.9%        11.1%        0.0%        |30.0%        10.0%        12.5%        11.1%        | 
|TERMINAL (d)       |     1/9 (11%)    1/9 (11%)    1/9 (11%)    0/10 (0%)   |0/7 (0%)     0/9 (0%)     0/7 (0%)     0/8 (0%)     | 
|FIRST INCIDENCE    |     87           281 (T)      281 (T)      ---         |94           200          139          108          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.139N     P=0.500N     P=0.500N     P=0.228N    |P=0.264N     P=0.250N     P=0.319N     P=0.328N     | 
|POLY 3             |     P=0.147N     P=0.532N     P=0.538N     P=0.227N    |P=0.265N     P=0.292N     P=0.379N     P=0.331N     | 
|POLY 1.5           |     P=0.148N     P=0.523N     P=0.538N     P=0.227N    |P=0.260N     P=0.292N     P=0.373N     P=0.325N     | 
|POLY 6             |     P=0.146N     P=0.537N     P=0.538N     P=0.227N    |P=0.265N     P=0.292N     P=0.380N     P=0.333N     | 
|LOGISTIC REGRESSION|     P=0.255N     P=0.563N     P=0.500N     (e)         |P=0.123N     (e)          P=0.377N     P=0.290N     | 
|COCH-ARM / FISHERS |     P=0.147N     P=0.500N     P=0.542N     P=0.237N    |P=0.233N     P=0.291N     P=0.333N     P=0.291N     | 
|ORDER RESTRICTED   |     P=0.109N     (e)          (e)          (e)         |P=0.212N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/05/03                           EXPERIMENT: 97013 TEST: 91                                            Page 11      
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -      WATER DISINFECTION MODEL (DICHLO
ROACET                                                                                                                              
                                         Terminal Sacrifice at 41 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       500 MG/L     1000MG/L     2000MG/L    |0 MG/L       500 MG/L     1000MG/L     2000MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thymus                                                                                                                           | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/10 (20%)   3/10 (30%)   4/9 (44%)    3/10 (30%)  |3/10 (30%)   4/10 (40%)   2/9 (22%)    5/10 (50%)   | 
|POLY-3 RATE (b)    |     2/9.03       3/9.15       4/9.00       3/10.00     |3/7.24       4/9.36       2/7.14       5/8.09       | 
|POLY-3 PERCENT (g) |     22.2%        32.8%        44.4%        30.0%       |41.4%        42.8%        28.0%        61.8%        | 
|TERMINAL (d)       |     2/9 (22%)    3/9 (33%)    4/9 (44%)    3/10 (30%)  |3/7 (43%)    4/9 (44%)    2/7 (29%)    5/8 (63%)    | 
|FIRST INCIDENCE    |     281 (T)      281 (T)      281 (T)      281 (T)     |282 (T)      282 (T)      282 (T)      282 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.475      P=0.500      P=0.314      P=0.553     |P=0.301      P=0.667      P=0.500N     P=0.408      | 
|POLY 3             |     P=0.485      P=0.507      P=0.312      P=0.550     |P=0.287      P=0.663      P=0.507N     P=0.391      | 
|POLY 1.5           |     P=0.469      P=0.512      P=0.303      P=0.543     |P=0.278      P=0.631      P=0.523N     P=0.363      | 
|POLY 6             |     P=0.490      P=0.501      P=0.313      P=0.552     |P=0.298      P=0.667      P=0.501N     P=0.406      | 
|LOGISTIC REGRESSION|     P=0.475      P=0.500      P=0.314      P=0.555     |P=0.301      P=0.667      P=0.500N     P=0.408      | 
|COCH-ARM / FISHERS |     P=0.401      P=0.500      P=0.259      P=0.500     |P=0.282      P=0.500      P=0.556N     P=0.325      | 
|ORDER RESTRICTED   |     P=0.401      (e)          (e)          (e)         |P=0.292      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       500 MG/L     1000MG/L     2000MG/L    |0 MG/L       500 MG/L     1000MG/L     2000MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thymus                                                                                                                           | 
|     Ectopic Parathyroid Gland                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/10 (0%)    0/10 (0%)    2/9 (22%)    0/10 (0%)   |1/10 (10%)   0/10 (0%)    0/9 (0%)     0/10 (0%)    | 
|POLY-3 RATE (b)    |     0/9.03       0/9.15       2/9.00       0/10.00     |1/7.24       0/9.36       0/7.14       0/8.09       | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         22.2%        0.0%        |13.8%        0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/9 (0%)     0/9 (0%)     2/9 (22%)    0/10 (0%)   |1/7 (14%)    0/9 (0%)     0/7 (0%)     0/8 (0%)     | 
|FIRST INCIDENCE    |     ---          ---          281 (T)      ---         |282 (T)      ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.617      (e)          P=0.233      (e)         |P=0.300N     P=0.450N     P=0.500N     P=0.473N     | 
|POLY 3             |     P=0.651      (e)          P=0.224      (e)         |P=0.345N     P=0.449N     P=0.503N     P=0.478N     | 
|POLY 1.5           |     P=0.641      (e)          P=0.220      (e)         |P=0.336N     P=0.459N     P=0.509N     P=0.485N     | 
|POLY 6             |     P=0.655      (e)          P=0.225      (e)         |P=0.348N     P=0.448N     P=0.500N     P=0.474N     | 
|LOGISTIC REGRESSION|     (e)          (e)          P=0.233      (e)         |P=0.300N     (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.593      (e)          P=0.211      (e)         |P=0.307N     P=0.500N     P=0.526N     P=0.500N     | 
|ORDER RESTRICTED   |     P=0.227      (e)          (e)          (e)         |P=0.101N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/05/03                           EXPERIMENT: 97013 TEST: 91                                            Page 12      
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -      WATER DISINFECTION MODEL (DICHLO
ROACET                                                                                                                              
                                         Terminal Sacrifice at 41 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       500 MG/L     1000MG/L     2000MG/L    |0 MG/L       500 MG/L     1000MG/L     2000MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: Follicle                                                                                                          | 
|     Degeneration                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/10 (30%)   9/10 (90%)   5/10 (50%)   4/10 (40%)  |3/10 (30%)   6/10 (60%)   5/10 (50%)   5/10 (50%)   | 
|POLY-3 RATE (b)    |     3/9.03       9/10.00      5/10.00      4/10.00     |3/8.11       6/10.00      5/7.40       5/9.03       | 
|POLY-3 PERCENT (g) |     33.2%        90.0%        50.0%        40.0%       |37.0%        60.0%        67.6%        55.4%        | 
|TERMINAL (d)       |     3/9 (33%)    8/9 (89%)    5/10 (50%)   4/10 (40%)  |2/7 (29%)    5/9 (56%)    5/7 (71%)    4/8 (50%)    | 
|FIRST INCIDENCE    |     281 (T)      150          281 (T)      281 (T)     |141          200          282 (T)      108          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.332N     P=0.018 *    P=0.397      P=0.568     |P=0.385      P=0.367      P=0.324      P=0.402      | 
|POLY 3             |     P=0.318N     P=0.008 **   P=0.396      P=0.564     |P=0.397      P=0.314      P=0.244      P=0.395      | 
|POLY 1.5           |     P=0.334N     P=0.007 **   P=0.385      P=0.554     |P=0.384      P=0.283      P=0.271      P=0.376      | 
|POLY 6             |     P=0.315N     P=0.008 **   P=0.398      P=0.566     |P=0.402      P=0.324      P=0.223      P=0.402      | 
|LOGISTIC REGRESSION|     P=0.406N     P=0.012 *    P=0.397      P=0.568     |P=0.350      P=0.195      P=0.329      P=0.329      | 
|COCH-ARM / FISHERS |     P=0.436N     P=0.010 *    P=0.325      P=0.500     |P=0.354      P=0.185      P=0.325      P=0.325      | 
|ORDER RESTRICTED   |     P=0.172      (e)          (e)          (e)         |P=0.267      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       500 MG/L     1000MG/L     2000MG/L    |0 MG/L       500 MG/L     1000MG/L     2000MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus: Endometrium                                                                                                              | 
|     Hyperplasia Cystic                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |7/10 (70%)   9/10 (90%)   7/10 (70%)   7/10 (70%)   | 
|POLY-3 RATE (b)    |                                                        |7/7.24       9/9.36       7/7.40       7/8.09       | 
|POLY-3 PERCENT (g) |                                                        |96.7%        96.2%        94.6%        86.6%        | 
|TERMINAL (d)       |                                                        |7/7 (100%)   9/9 (100%)   7/7 (100%)   7/8 (88%)    | 
|FIRST INCIDENCE    |                                                        |282 (T)      282 (T)      282 (T)      282 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |P=0.203N     P=1.000N     P=1.000      P=0.527N     | 
|POLY 3             |                                                        |P=0.309N     P=0.988N     P=0.989N     P=0.587N     | 
|POLY 1.5           |                                                        |P=0.395N     P=0.778      P=0.833N     P=0.662N     | 
|POLY 6             |                                                        |P=0.228N     P=1.000N     P=1.000N     P=0.534N     | 
|LOGISTIC REGRESSION|                                                        |P=0.203N     P=1.000N     P=1.000      P=0.527N     | 
|COCH-ARM / FISHERS |                                                        |P=0.451N     P=0.291      P=0.686N     P=0.686N     | 
|ORDER RESTRICTED   |                                                        |P=0.267N     (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.