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TDMS Study 97013-15 Pathology Tables

NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                       WATER DISINFECTION MODEL (DICHLOROACETIC ACID)                    DATE: 01/27/05       
EXPERIMENT: 97013 TEST: 15                                                                                     TIME: 10:09:33       
TEST TYPE:  SUBCHRON 26-WEEK                    CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-65406                              ROUTE: SKIN APPLICATION                                        NTP C#: 97013D       
PATHOLOGIST: MISSING                                                                                           CAS: 79-43-6         
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                         FINAL #1 TGAC MICE                                                         
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    25019 Moribund Sacrifice                                                                     
                                       25020 Natural Death                                                                          
                                       25021 Terminal Sacrifice                                                                     
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 001    0 MG/KG                                                                       
                                       INCLUDE 002    0 MG/KG                                                                       
                                       INCLUDE 003    31.25   MG/KG                                                                 
                                       INCLUDE 004    31.25   MG/KG                                                                 
                                       INCLUDE 005    125MG/KG                                                                      
                                       INCLUDE 006    125MG/KG                                                                      
                                       INCLUDE 007    500MG/KG                                                                      
                                       INCLUDE 008    500MG/KG                                                                      
                                                                                                                                   
NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                       WATER DISINFECTION MODEL (DICHLOROACETIC ACID)                    DATE: 01/27/05       
EXPERIMENT: 97013 TEST: 15                                                                                     TIME: 10:09:33       
TEST TYPE:  SUBCHRON 26-WEEK                    CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-65406                              ROUTE: SKIN APPLICATION                                        NTP C#: 97013D       
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                                                                                    
-----                                 ----------                                                                                    
Adrenal Cortex: Subcapsular            Hyperplasia                                                                                  
Kidney                                 Nephropathy                                                                                  
Kidney: Renal Tubule                   Dilatation                                                                                   
Liver                                  Hematopoietic Cell Proliferation                                                             
                                       Inflammation Chronic                                                                         
Liver: Hepatocyte                      Vacuolization Cytoplasmic                                                                    
Pituitary Gland: Pars Distalis         Cyst                                                                                         
Skin: Site of Application - Epidermis  Hyperkeratosis                                                                               
                                       Hyperplasia                                                                                  
Spleen                                 Hematopoietic Cell Proliferation                                                             
Thymus                                 Cyst                                                                                         
Thymus: Thymocyte                      Necrosis                                                                                     
===============================================================                                                                     
Female Mice                                                                                                                         
------------                                                                                                                        
Organ                                  Morphology                                                                                   
-----                                  ----------                                                                                   
Adrenal Cortex                         Accessory Adrenal Cortical Nodule                                                            
Liver                                  Inflammation Chronic                                                                         
Liver: Hepatocyte                      Necrosis                                                                                     
                                       Vacuolization Cytoplasmic                                                                    
Skin: Site of Application - Epidermis  Hyperkeratosis                                                                               
                                       Hyperplasia                                                                                  
Thymus                                 Atrophy                                                                                      
                                       Cyst                                                                                         
Thyroid Gland: Follicle                Degeneration                                                                                 
===============================================================                                                                     
                                                                                                                                   
       Date:  01/27/05                           EXPERIMENT: 97013 TEST: 15                                            Page 1       
Statistical Analysis of Non-neoplastic Lesions in        Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -      WATER DISINFECTION MODEL (DICHL
OROACET                                                                                                                             
                                         Terminal Sacrifice at 26 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      31.25        125MG/KG     500MG/KG    |0 MG/KG      31.25        125MG/KG     500MG/KG     | 
|                   |                  MG/KG                                 |             MG/KG                                  | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Accessory Adrenal Cortical Nodule                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/15 (0%)    0/15 (0%)    0/15 (0%)    0/15 (0%)   |0/15 (0%)    2/15 (13%)   7/15 (47%)   4/15 (27%)   | 
|POLY-3 RATE (b)    |     0/13.83      0/14.51      0/14.08      0/12.44     |0/11.79      2/12.90      7/14.15      4/15.00      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |0.0%         15.5%        49.5%        26.7%        | 
|TERMINAL (d)       |     0/13 (0%)    0/14 (0%)    0/14 (0%)    0/12 (0%)   |0/11 (0%)    2/12 (17%)   7/14 (50%)   4/15 (27%)   | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |---          183 (T)      183 (T)      183 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.298      P=0.254      P=0.012 *    P=0.099      | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.304      P=0.251      P=0.004 **   P=0.081      | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.253      P=0.249      P=0.003 **   P=0.070      | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.345      P=0.249      P=0.005 **   P=0.089      | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |(e)          P=0.254      P=0.012 *    P=0.099      | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.166      P=0.241      P=0.003 **   P=0.050      | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |P=0.012 *    (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      31.25        125MG/KG     500MG/KG    |0 MG/KG      31.25        125MG/KG     500MG/KG     | 
|                   |                  MG/KG                                 |             MG/KG                                  | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     11/15 (73%)  7/15 (47%)   7/15 (47%)   7/15 (47%)  |0/15 (0%)    0/15 (0%)    0/15 (0%)    0/15 (0%)    | 
|POLY-3 RATE (b)    |     11/13.83     7/14.51      7/14.08      7/12.44     |0/11.79      0/12.90      0/14.15      0/15.00      | 
|POLY-3 PERCENT (g) |     79.6%        48.3%        49.7%        56.3%       |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     11/13 (85%)  7/14 (50%)   7/14 (50%)   7/12 (58%)  |0/11 (0%)    0/12 (0%)    0/14 (0%)    0/15 (0%)    | 
|FIRST INCIDENCE    |     182 (T)      182 (T)      182 (T)      182 (T)     |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.407N     P=0.071N     P=0.071N     P=0.160N    |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.418N     P=0.081N     P=0.098N     P=0.189N    |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.402N     P=0.097N     P=0.114N     P=0.193N    |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.420N     P=0.070N     P=0.079N     P=0.175N    |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.407N     P=0.071N     P=0.071N     P=0.160N    |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.271N     P=0.132N     P=0.132N     P=0.132N    |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.111N     (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  01/27/05                           EXPERIMENT: 97013 TEST: 15                                            Page 2       
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -      WATER DISINFECTION MODEL (DICHLO
ROACET                                                                                                                              
                                         Terminal Sacrifice at 26 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      31.25        125MG/KG     500MG/KG    |0 MG/KG      31.25        125MG/KG     500MG/KG     | 
|                   |                  MG/KG                                 |             MG/KG                                  | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex: Subcapsular                                                                                                      | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     4/15 (27%)   1/15 (7%)    2/15 (13%)   0/15 (0%)   |5/15 (33%)   8/15 (53%)   6/15 (40%)   9/15 (60%)   | 
|POLY-3 RATE (b)    |     4/13.83      1/14.51      2/14.08      0/12.44     |5/11.79      8/12.90      6/14.15      9/15.00      | 
|POLY-3 PERCENT (g) |     28.9%        6.9%         14.2%        0.0%        |42.4%        62.0%        42.4%        60.0%        | 
|TERMINAL (d)       |     4/13 (31%)   1/14 (7%)    2/14 (14%)   0/12 (0%)   |5/11 (46%)   8/12 (67%)   6/14 (43%)   9/15 (60%)   | 
|FIRST INCIDENCE    |     182 (T)      182 (T)      182 (T)      ---         |183 (T)      183 (T)      183 (T)      183 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.101N     P=0.144N     P=0.289N     P=0.064N    |P=0.431      P=0.277      P=0.607N     P=0.371      | 
|POLY 3             |     P=0.106N     P=0.146N     P=0.316N     P=0.057N    |P=0.352      P=0.283      P=0.650N     P=0.307      | 
|POLY 1.5           |     P=0.103N     P=0.152N     P=0.325N     P=0.057N    |P=0.294      P=0.279      P=0.613      P=0.252      | 
|POLY 6             |     P=0.107N     P=0.141N     P=0.303N     P=0.055N    |P=0.397      P=0.275      P=0.625N     P=0.346      | 
|LOGISTIC REGRESSION|     P=0.101N     P=0.144N     P=0.289N     (e)         |P=0.431      P=0.277      P=0.607N     P=0.371      | 
|COCH-ARM / FISHERS |     P=0.085N     P=0.165N     P=0.326N     P=0.050N    |P=0.175      P=0.231      P=0.500      P=0.136      | 
|ORDER RESTRICTED   |     P=0.018N*    (e)          (e)          (e)         |P=0.297      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      31.25        125MG/KG     500MG/KG    |0 MG/KG      31.25        125MG/KG     500MG/KG     | 
|                   |                  MG/KG                                 |             MG/KG                                  | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Epididymis                                                                                                                       | 
|     Degeneration                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/15 (13%)   1/15 (7%)    1/15 (7%)    1/15 (7%)   |                                                    | 
|POLY-3 RATE (b)    |     2/13.83      1/14.51      1/14.08      1/12.44     |                                                    | 
|POLY-3 PERCENT (g) |     14.5%        6.9%         7.1%         8.0%        |                                                    | 
|TERMINAL (d)       |     2/13 (15%)   1/14 (7%)    1/14 (7%)    1/12 (8%)   |                                                    | 
|FIRST INCIDENCE    |     182 (T)      182 (T)      182 (T)      182 (T)     |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.568N     P=0.473N     P=0.473N     P=0.529N    |                                                    | 
|POLY 3             |     P=0.562N     P=0.483N     P=0.494N     P=0.538N    |                                                    | 
|POLY 1.5           |     P=0.558N     P=0.489N     P=0.499N     P=0.536N    |                                                    | 
|POLY 6             |     P=0.564N     P=0.478N     P=0.484N     P=0.535N    |                                                    | 
|LOGISTIC REGRESSION|     P=0.568N     P=0.473N     P=0.473N     P=0.529N    |                                                    | 
|COCH-ARM / FISHERS |     P=0.522N     P=0.500N     P=0.500N     P=0.500N    |                                                    | 
|ORDER RESTRICTED   |     P=0.432N     (e)          (e)          (e)         |                                                    | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  01/27/05                           EXPERIMENT: 97013 TEST: 15                                            Page 3       
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -      WATER DISINFECTION MODEL (DICHLO
ROACET                                                                                                                              
                                         Terminal Sacrifice at 26 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      31.25        125MG/KG     500MG/KG    |0 MG/KG      31.25        125MG/KG     500MG/KG     | 
|                   |                  MG/KG                                 |             MG/KG                                  | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Nephropathy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     7/15 (47%)   7/15 (47%)   11/15 (73%)  13/15 (87%) |3/15 (20%)   6/15 (40%)   5/15 (33%)   5/15 (33%)   | 
|POLY-3 RATE (b)    |     7/13.83      7/14.51      11/14.08     13/13.06    |3/12.61      6/13.51      5/14.15      5/15.00      | 
|POLY-3 PERCENT (g) |     50.6%        48.3%        78.1%        99.5%       |23.8%        44.4%        35.3%        33.3%        | 
|TERMINAL (d)       |     7/13 (54%)   7/14 (50%)   11/14 (79%)  12/12 (100%)|2/11 (18%)   5/12 (42%)   5/14 (36%)   5/15 (33%)   | 
|FIRST INCIDENCE    |     182 (T)      182 (T)      182 (T)      132         |104          134          183 (T)      183 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P<0.001 **   P=0.572N     P=0.175      P=0.008 **  |P=0.501N     P=0.271      P=0.480      P=0.524      | 
|POLY 3             |     P<0.001 **   P=0.597N     P=0.125      P=0.002 **  |P=0.585N     P=0.245      P=0.412      P=0.450      | 
|POLY 1.5           |     P<0.001 **   P=0.612N     P=0.117      P=0.002 **  |P=0.594      P=0.243      P=0.398      P=0.425      | 
|POLY 6             |     P<0.001 **   P=0.583N     P=0.145      P=0.003 **  |P=0.564N     P=0.244      P=0.423      P=0.467      | 
|LOGISTIC REGRESSION|     P<0.001 **   P=0.572N     P=0.175      P=0.004 **  |P=0.566      P=0.227      P=0.379      P=0.358      | 
|COCH-ARM / FISHERS |     P=0.012 *    P=0.642N     P=0.132      P=0.025 *   |P=0.496      P=0.213      P=0.341      P=0.341      | 
|ORDER RESTRICTED   |     P<0.001 **   (e)          (e)          (e)         |P=0.366      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      31.25        125MG/KG     500MG/KG    |0 MG/KG      31.25        125MG/KG     500MG/KG     | 
|                   |                  MG/KG                                 |             MG/KG                                  | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Renal Tubule                                                                                                             | 
|     Dilatation                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     4/15 (27%)   2/15 (13%)   2/15 (13%)   0/15 (0%)   |2/15 (13%)   3/15 (20%)   3/15 (20%)   1/15 (7%)    | 
|POLY-3 RATE (b)    |     4/13.83      2/14.51      2/14.08      0/12.44     |2/11.79      3/12.90      3/14.15      1/15.00      | 
|POLY-3 PERCENT (g) |     28.9%        13.8%        14.2%        0.0%        |17.0%        23.3%        21.2%        6.7%         | 
|TERMINAL (d)       |     4/13 (31%)   2/14 (14%)   2/14 (14%)   0/12 (0%)   |2/11 (18%)   3/12 (25%)   3/14 (21%)   1/15 (7%)    | 
|FIRST INCIDENCE    |     182 (T)      182 (T)      182 (T)      ---         |183 (T)      183 (T)      183 (T)      183 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.073N     P=0.289N     P=0.289N     P=0.064N    |P=0.184N     P=0.543      P=0.616      P=0.389N     | 
|POLY 3             |     P=0.079N     P=0.302N     P=0.316N     P=0.057N    |P=0.200N     P=0.543      P=0.587      P=0.415N     | 
|POLY 1.5           |     P=0.077N     P=0.311N     P=0.325N     P=0.057N    |P=0.222N     P=0.539      P=0.565      P=0.437N     | 
|POLY 6             |     P=0.079N     P=0.295N     P=0.303N     P=0.055N    |P=0.185N     P=0.541      P=0.601      P=0.401N     | 
|LOGISTIC REGRESSION|     P=0.073N     P=0.289N     P=0.289N     (e)         |P=0.184N     P=0.543      P=0.616      P=0.389N     | 
|COCH-ARM / FISHERS |     P=0.061N     P=0.326N     P=0.326N     P=0.050N    |P=0.281N     P=0.500      P=0.500      P=0.500N     | 
|ORDER RESTRICTED   |     P=0.027N*    (e)          (e)          (e)         |P=0.281N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  01/27/05                           EXPERIMENT: 97013 TEST: 15                                            Page 4       
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -      WATER DISINFECTION MODEL (DICHLO
ROACET                                                                                                                              
                                         Terminal Sacrifice at 26 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      31.25        125MG/KG     500MG/KG    |0 MG/KG      31.25        125MG/KG     500MG/KG     | 
|                   |                  MG/KG                                 |             MG/KG                                  | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/15 (20%)   0/15 (0%)    0/15 (0%)    0/15 (0%)   |0/15 (0%)    0/15 (0%)    0/15 (0%)    0/15 (0%)    | 
|POLY-3 RATE (b)    |     3/14.25      0/14.51      0/14.08      0/12.44     |0/11.79      0/12.90      0/14.15      0/15.00      | 
|POLY-3 PERCENT (g) |     21.1%        0.0%         0.0%         0.0%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     2/13 (15%)   0/14 (0%)    0/14 (0%)    0/12 (0%)   |0/11 (0%)    0/12 (0%)    0/14 (0%)    0/15 (0%)    | 
|FIRST INCIDENCE    |     152          ---          ---          ---         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.205N     P=0.112N     P=0.112N     P=0.140N    |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.184N     P=0.102N     P=0.107N     P=0.132N    |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.182N     P=0.103N     P=0.108N     P=0.128N    |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.184N     P=0.103N     P=0.106N     P=0.134N    |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.174N     P=0.125N     P=0.110N     P=0.117N    |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.183N     P=0.112N     P=0.112N     P=0.112N    |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.009N**   (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      31.25        125MG/KG     500MG/KG    |0 MG/KG      31.25        125MG/KG     500MG/KG     | 
|                   |                  MG/KG                                 |             MG/KG                                  | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/15 (13%)   8/15 (53%)   4/15 (27%)   2/15 (13%)  |11/15 (73%)  13/15 (87%)  14/15 (93%)  11/15 (73%)  | 
|POLY-3 RATE (b)    |     2/13.83      8/14.51      4/14.08      2/12.44     |11/11.79     13/13.77     14/14.15     11/15.00     | 
|POLY-3 PERCENT (g) |     14.5%        55.2%        28.4%        16.1%       |93.3%        94.4%        98.9%        73.3%        | 
|TERMINAL (d)       |     2/13 (15%)   8/14 (57%)   4/14 (29%)   2/12 (17%)  |11/11 (100%) 12/12 (100%) 14/14 (100%) 11/15 (73%)  | 
|FIRST INCIDENCE    |     182 (T)      182 (T)      182 (T)      182 (T)     |183 (T)      93           183 (T)      183 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.206N     P=0.035 *    P=0.362      P=0.673     |P=0.003N**   P=0.529      P=1.000N     P=0.099N     | 
|POLY 3             |     P=0.202N     P=0.023 *    P=0.334      P=0.661     |P=0.016N*    P=0.850      P=0.676      P=0.197N     | 
|POLY 1.5           |     P=0.199N     P=0.021 *    P=0.327      P=0.662     |P=0.067N     P=0.655      P=0.381      P=0.320N     | 
|POLY 6             |     P=0.199N     P=0.024 *    P=0.347      P=0.664     |P=0.003N**   P=0.993      P=0.989      P=0.130N     | 
|LOGISTIC REGRESSION|     P=0.206N     P=0.035 *    P=0.362      P=0.673     |P=0.015N*    P=0.541      P=1.000N     P=0.099N     | 
|COCH-ARM / FISHERS |     P=0.157N     P=0.025 *    P=0.326      P=0.701N    |P=0.372N     P=0.326      P=0.165      P=0.659N     | 
|ORDER RESTRICTED   |     P=0.206      (e)          (e)          (e)         |P=0.025N*    (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  01/27/05                           EXPERIMENT: 97013 TEST: 15                                            Page 5       
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -      WATER DISINFECTION MODEL (DICHLO
ROACET                                                                                                                              
                                         Terminal Sacrifice at 26 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      31.25        125MG/KG     500MG/KG    |0 MG/KG      31.25        125MG/KG     500MG/KG     | 
|                   |                  MG/KG                                 |             MG/KG                                  | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Hepatocyte                                                                                                                | 
|     Necrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/15 (7%)    2/15 (13%)   0/15 (0%)    2/15 (13%)  |1/15 (7%)    0/15 (0%)    0/15 (0%)    3/15 (20%)   | 
|POLY-3 RATE (b)    |     1/14.58      2/14.51      0/14.08      2/13.44     |1/11.79      0/12.90      0/14.15      3/15.00      | 
|POLY-3 PERCENT (g) |     6.9%         13.8%        0.0%         14.9%       |8.5%         0.0%         0.0%         20.0%        | 
|TERMINAL (d)       |     0/13 (0%)    2/14 (14%)   0/14 (0%)    1/12 (8%)   |1/11 (9%)    0/12 (0%)    0/14 (0%)    3/15 (20%)   | 
|FIRST INCIDENCE    |     114          182 (T)      ---          4           |183 (T)      ---          ---          183 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.413      P=0.517      P=0.514N     P=0.474     |P=0.076      P=0.483N     P=0.452N     P=0.418      | 
|POLY 3             |     P=0.425      P=0.498      P=0.507N     P=0.471     |P=0.052      P=0.482N     P=0.464N     P=0.392      | 
|POLY 1.5           |     P=0.431      P=0.499      P=0.507N     P=0.478     |P=0.048 *    P=0.484N     P=0.473N     P=0.367      | 
|POLY 6             |     P=0.422      P=0.498      P=0.505N     P=0.469     |P=0.056      P=0.483N     P=0.457N     P=0.409      | 
|LOGISTIC REGRESSION|     P=0.601N     P=0.346      P=0.339N     P=0.737N    |P=0.076      (e)          (e)          P=0.418      | 
|COCH-ARM / FISHERS |     P=0.449      P=0.500      P=0.500N     P=0.500     |P=0.044 *    P=0.500N     P=0.500N     P=0.299      | 
|ORDER RESTRICTED   |     P=0.367      (e)          (e)          (e)         |P=0.063      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      31.25        125MG/KG     500MG/KG    |0 MG/KG      31.25        125MG/KG     500MG/KG     | 
|                   |                  MG/KG                                 |             MG/KG                                  | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Hepatocyte                                                                                                                | 
|     Vacuolization Cytoplasmic                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/15 (20%)   4/15 (27%)   14/15 (93%)  15/15 (100%)|6/15 (40%)   4/15 (27%)   14/15 (93%)  15/15 (100%) | 
|POLY-3 RATE (b)    |     3/13.83      4/14.51      14/14.08     15/15.00    |6/11.79      4/12.90      14/14.15     15/15.00     | 
|POLY-3 PERCENT (g) |     21.7%        27.6%        99.4%        100.0%      |50.9%        31.0%        98.9%        100.0%       | 
|TERMINAL (d)       |     3/13 (23%)   4/14 (29%)   14/14 (100%) 12/12 (100%)|6/11 (55%)   4/12 (33%)   14/14 (100%) 15/15 (100%) | 
|FIRST INCIDENCE    |     182 (T)      182 (T)      182 (T)      4           |183 (T)      183 (T)      183 (T)      183 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P<0.001 **   P=0.545      P<0.001 **   P<0.001 **  |P<0.001 **   P=0.277N     P=0.012 *    P=0.009 **   | 
|POLY 3             |     P<0.001 **   P=0.528      P<0.001 **   P<0.001 **  |P<0.001 **   P=0.277N     P=0.002 **   P<0.001 **   | 
|POLY 1.5           |     P<0.001 **   P=0.518      P<0.001 **   P<0.001 **  |P<0.001 **   P=0.287N     P<0.001 **   P<0.001 **   | 
|POLY 6             |     P<0.001 **   P=0.537      P<0.001 **   P<0.001 **  |P<0.001 **   P=0.279N     P=0.003 **   P=0.002 **   | 
|LOGISTIC REGRESSION|     P<0.001 **   P=0.545      P<0.001 **   P<0.001 **  |P<0.001 **   P=0.277N     P=0.012 *    P=0.009 **   | 
|COCH-ARM / FISHERS |     P<0.001 **   P=0.500      P<0.001 **   P<0.001 **  |P<0.001 **   P=0.350N     P=0.003 **   P<0.001 **   | 
|ORDER RESTRICTED   |     P<0.001 **   (e)          (e)          (e)         |P<0.001 **   (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  01/27/05                           EXPERIMENT: 97013 TEST: 15                                            Page 6       
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -      WATER DISINFECTION MODEL (DICHLO
ROACET                                                                                                                              
                                         Terminal Sacrifice at 26 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      31.25        125MG/KG     500MG/KG    |0 MG/KG      31.25        125MG/KG     500MG/KG     | 
|                   |                  MG/KG                                 |             MG/KG                                  | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mandibular                                                                                                           | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/15 (0%)    2/15 (13%)   0/15 (0%)    1/14 (7%)   |3/15 (20%)   1/15 (7%)    4/15 (27%)   2/15 (13%)   | 
|POLY-3 RATE (b)    |     0/13.83      2/15.00      0/14.08      1/11.44     |3/11.79      1/13.52      4/14.15      2/15.00      | 
|POLY-3 PERCENT (g) |     0.0%         13.3%        0.0%         8.7%        |25.4%        7.4%         28.3%        13.3%        | 
|TERMINAL (d)       |     0/13 (0%)    1/14 (7%)    0/14 (0%)    1/11 (9%)   |3/11 (27%)   0/12 (0%)    4/14 (29%)   2/15 (13%)   | 
|FIRST INCIDENCE    |     ---          145          ---          182 (T)     |183 (T)      132          183 (T)      183 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.585      P=0.256      (e)          P=0.467     |P=0.419N     P=0.266N     P=0.644      P=0.352N     | 
|POLY 3             |     P=0.589      P=0.250      (e)          P=0.462     |P=0.466N     P=0.245N     P=0.607      P=0.387N     | 
|POLY 1.5           |     P=0.590      P=0.243      (e)          P=0.463     |P=0.491N     P=0.256N     P=0.581      P=0.416N     | 
|POLY 6             |     P=0.591      P=0.258      (e)          P=0.463     |P=0.448N     P=0.240N     P=0.625      P=0.368N     | 
|LOGISTIC REGRESSION|     P=0.638      P=0.148      (e)          P=0.467     |P=0.487N     P=0.279N     P=0.644      P=0.352N     | 
|COCH-ARM / FISHERS |     P=0.619      P=0.241      (e)          P=0.483     |P=0.554N     P=0.299N     P=0.500      P=0.500N     | 
|ORDER RESTRICTED   |     P=0.286      (e)          (e)          (e)         |P=0.347N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      31.25        125MG/KG     500MG/KG    |0 MG/KG      31.25        125MG/KG     500MG/KG     | 
|                   |                  MG/KG                                 |             MG/KG                                  | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |3/15 (20%)   2/15 (13%)   1/15 (7%)    1/15 (7%)    | 
|POLY-3 RATE (b)    |                                                        |3/11.79      2/13.52      1/14.15      1/15.00      | 
|POLY-3 PERCENT (g) |                                                        |25.4%        14.8%        7.1%         6.7%         | 
|TERMINAL (d)       |                                                        |3/11 (27%)   1/12 (8%)    1/14 (7%)    1/15 (7%)    | 
|FIRST INCIDENCE    |                                                        |183 (T)      132          183 (T)      183 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |P=0.214N     P=0.453N     P=0.213N     P=0.192N     | 
|POLY 3             |                                                        |P=0.255N     P=0.434N     P=0.231N     P=0.213N     | 
|POLY 1.5           |                                                        |P=0.265N     P=0.448N     P=0.247N     P=0.234N     | 
|POLY 6             |                                                        |P=0.249N     P=0.427N     P=0.220N     P=0.201N     | 
|LOGISTIC REGRESSION|                                                        |P=0.260N     P=0.471N     P=0.213N     P=0.192N     | 
|COCH-ARM / FISHERS |                                                        |P=0.291N     P=0.500N     P=0.299N     P=0.299N     | 
|ORDER RESTRICTED   |                                                        |P=0.126N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  01/27/05                           EXPERIMENT: 97013 TEST: 15                                            Page 7       
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -      WATER DISINFECTION MODEL (DICHLO
ROACET                                                                                                                              
                                         Terminal Sacrifice at 26 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      31.25        125MG/KG     500MG/KG    |0 MG/KG      31.25        125MG/KG     500MG/KG     | 
|                   |                  MG/KG                                 |             MG/KG                                  | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis                                                                                                   | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/15 (0%)    1/15 (7%)    0/14 (0%)    3/15 (20%)  |3/15 (20%)   4/15 (27%)   3/15 (20%)   3/15 (20%)   | 
|POLY-3 RATE (b)    |     0/13.83      1/14.51      0/14.00      3/12.44     |3/11.79      4/13.77      3/15.00      3/15.00      | 
|POLY-3 PERCENT (g) |     0.0%         6.9%         0.0%         24.1%       |25.4%        29.1%        20.0%        20.0%        | 
|TERMINAL (d)       |     0/13 (0%)    1/14 (7%)    0/14 (0%)    3/12 (25%)  |3/11 (27%)   3/12 (25%)   2/14 (14%)   3/15 (20%)   | 
|FIRST INCIDENCE    |     ---          182 (T)      ---          182 (T)     |183 (T)      93           98           183 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.026 *    P=0.515      (e)          P=0.100     |P=0.389N     P=0.556      P=0.558N     P=0.514N     | 
|POLY 3             |     P=0.027 *    P=0.510      (e)          P=0.086     |P=0.444N     P=0.592      P=0.550N     P=0.550N     | 
|POLY 1.5           |     P=0.028 *    P=0.506      (e)          P=0.087     |P=0.468N     P=0.575      P=0.583N     P=0.583N     | 
|POLY 6             |     P=0.027 *    P=0.512      (e)          P=0.087     |P=0.426N     P=0.596      P=0.529N     P=0.529N     | 
|LOGISTIC REGRESSION|     (e)          P=0.515      (e)          P=0.100     |P=0.579N     P=0.525      P=0.678N     P=0.514N     | 
|COCH-ARM / FISHERS |     P=0.039 *    P=0.500      (e)          P=0.112     |P=0.534N     P=0.500      P=0.674N     P=0.674N     | 
|ORDER RESTRICTED   |     P=0.011 *    (e)          (e)          (e)         |P=0.528N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      31.25        125MG/KG     500MG/KG    |0 MG/KG      31.25        125MG/KG     500MG/KG     | 
|                   |                  MG/KG                                 |             MG/KG                                  | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin: Epidermis                                                                                                                  | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/15 (13%)   3/15 (20%)   2/15 (13%)   3/15 (20%)  |3/15 (20%)   1/15 (7%)    1/15 (7%)    2/15 (13%)   | 
|POLY-3 RATE (b)    |     2/13.83      3/14.51      2/14.08      3/12.44     |3/12.76      1/12.90      1/14.15      2/15.00      | 
|POLY-3 PERCENT (g) |     14.5%        20.7%        14.2%        24.1%       |23.5%        7.8%         7.1%         13.3%        | 
|TERMINAL (d)       |     2/13 (15%)   3/14 (21%)   2/14 (14%)   3/12 (25%)  |2/11 (18%)   1/12 (8%)    1/14 (7%)    2/15 (13%)   | 
|FIRST INCIDENCE    |     182 (T)      182 (T)      182 (T)      182 (T)     |57           183 (T)      183 (T)      183 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.420      P=0.536      P=0.675N     P=0.461     |P=0.553N     P=0.279N     P=0.240N     P=0.385N     | 
|POLY 3             |     P=0.421      P=0.523      P=0.693N     P=0.449     |P=0.606N     P=0.291N     P=0.259N     P=0.423N     | 
|POLY 1.5           |     P=0.427      P=0.515      P=0.698N     P=0.451     |P=0.621N     P=0.290N     P=0.270N     P=0.446N     | 
|POLY 6             |     P=0.421      P=0.530      P=0.683N     P=0.453     |P=0.593N     P=0.295N     P=0.249N     P=0.407N     | 
|LOGISTIC REGRESSION|     P=0.420      P=0.536      P=0.675N     P=0.461     |P=0.578      P=0.338N     P=0.383N     P=0.654N     | 
|COCH-ARM / FISHERS |     P=0.489      P=0.500      P=0.701N     P=0.500     |P=0.642      P=0.299N     P=0.299N     P=0.500N     | 
|ORDER RESTRICTED   |     P=0.429      (e)          (e)          (e)         |P=0.219N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  01/27/05                           EXPERIMENT: 97013 TEST: 15                                            Page 8       
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -      WATER DISINFECTION MODEL (DICHLO
ROACET                                                                                                                              
                                         Terminal Sacrifice at 26 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      31.25        125MG/KG     500MG/KG    |0 MG/KG      31.25        125MG/KG     500MG/KG     | 
|                   |                  MG/KG                                 |             MG/KG                                  | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin: Site of Application - Epidermis                                                                                            | 
|     Hyperkeratosis                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/15 (13%)   7/15 (47%)   15/15 (100%) 14/15 (93%) |8/15 (53%)   9/15 (60%)   14/15 (93%)  14/15 (93%)  | 
|POLY-3 RATE (b)    |     2/15.00      7/15.00      15/15.00     14/14.00    |8/12.61      9/14.39      14/15.00     14/15.00     | 
|POLY-3 PERCENT (g) |     13.3%        46.7%        100.0%       100.0%      |63.4%        62.5%        93.3%        93.3%        | 
|TERMINAL (d)       |     0/13 (0%)    6/14 (43%)   14/14 (100%) 12/12 (100%)|7/11 (64%)   7/12 (58%)   13/14 (93%)  14/15 (93%)  | 
|FIRST INCIDENCE    |     114          145          79           72          |104          93           98           183 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P<0.001 **   P=0.091      P<0.001 **   P<0.001 **  |P=0.221      P=0.606      P=0.157      P=0.226      | 
|POLY 3             |     P<0.001 **   P=0.049 *    P<0.001 **   P<0.001 **  |P=0.035 *    P=0.634N     P=0.061      P=0.061      | 
|POLY 1.5           |     P<0.001 **   P=0.049 *    P<0.001 **   P<0.001 **  |P=0.024 *    P=0.638      P=0.040 *    P=0.040 *    | 
|POLY 6             |     P<0.001 **   P=0.049 *    P<0.001 **   P<0.001 **  |P=0.045 *    P=0.624N     P=0.079      P=0.079      | 
|LOGISTIC REGRESSION|     P<0.001 **   (e)          (e)          P<0.001 **  |P=0.028 *    P=0.555      P=0.039 *    P=0.072      | 
|COCH-ARM / FISHERS |     P<0.001 **   P=0.054      P<0.001 **   P<0.001 **  |P=0.014 *    P=0.500      P=0.018 *    P=0.018 *    | 
|ORDER RESTRICTED   |     P<0.001 **   (e)          (e)          (e)         |P=0.030 *    (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      31.25        125MG/KG     500MG/KG    |0 MG/KG      31.25        125MG/KG     500MG/KG     | 
|                   |                  MG/KG                                 |             MG/KG                                  | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin: Site of Application - Epidermis                                                                                            | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/15 (0%)    2/15 (13%)   11/15 (73%)  13/15 (87%) |0/15 (0%)    1/15 (7%)    10/15 (67%)  13/15 (87%)  | 
|POLY-3 RATE (b)    |     0/13.83      2/14.51      11/14.08     13/14.00    |0/11.79      1/13.51      10/14.15     13/15.00     | 
|POLY-3 PERCENT (g) |     0.0%         13.8%        78.1%        92.9%       |0.0%         7.4%         70.7%        86.7%        | 
|TERMINAL (d)       |     0/13 (0%)    2/14 (14%)   11/14 (79%)  11/12 (92%) |0/11 (0%)    0/12 (0%)    10/14 (71%)  13/15 (87%)  | 
|FIRST INCIDENCE    |     ---          182 (T)      182 (T)      72          |---          134          183 (T)      183 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P<0.001 **   P=0.252      P<0.001 **   P<0.001 **  |P<0.001 **   P=0.516      P<0.001 **   P<0.001 **   | 
|POLY 3             |     P<0.001 **   P=0.242      P<0.001 **   P<0.001 **  |P<0.001 **   P=0.527      P<0.001 **   P<0.001 **   | 
|POLY 1.5           |     P<0.001 **   P=0.238      P<0.001 **   P<0.001 **  |P<0.001 **   P=0.521      P<0.001 **   P<0.001 **   | 
|POLY 6             |     P<0.001 **   P=0.245      P<0.001 **   P<0.001 **  |P<0.001 **   P=0.530      P<0.001 **   P<0.001 **   | 
|LOGISTIC REGRESSION|     P<0.001 **   P=0.252      P<0.001 **   P<0.001 **  |P<0.001 **   P=0.427      P<0.001 **   P<0.001 **   | 
|COCH-ARM / FISHERS |     P<0.001 **   P=0.241      P<0.001 **   P<0.001 **  |P<0.001 **   P=0.500      P<0.001 **   P<0.001 **   | 
|ORDER RESTRICTED   |     P<0.001 **   (e)          (e)          (e)         |P<0.001 **   (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  01/27/05                           EXPERIMENT: 97013 TEST: 15                                            Page 9       
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -      WATER DISINFECTION MODEL (DICHLO
ROACET                                                                                                                              
                                         Terminal Sacrifice at 26 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      31.25        125MG/KG     500MG/KG    |0 MG/KG      31.25        125MG/KG     500MG/KG     | 
|                   |                  MG/KG                                 |             MG/KG                                  | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/15 (20%)   0/15 (0%)    0/15 (0%)    0/15 (0%)   |0/15 (0%)    0/15 (0%)    0/15 (0%)    0/15 (0%)    | 
|POLY-3 RATE (b)    |     3/14.25      0/14.51      0/14.08      0/12.44     |0/11.79      0/12.90      0/14.15      0/15.00      | 
|POLY-3 PERCENT (g) |     21.1%        0.0%         0.0%         0.0%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     2/13 (15%)   0/14 (0%)    0/14 (0%)    0/12 (0%)   |0/11 (0%)    0/12 (0%)    0/14 (0%)    0/15 (0%)    | 
|FIRST INCIDENCE    |     152          ---          ---          ---         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.205N     P=0.112N     P=0.112N     P=0.140N    |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.184N     P=0.102N     P=0.107N     P=0.132N    |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.182N     P=0.103N     P=0.108N     P=0.128N    |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.184N     P=0.103N     P=0.106N     P=0.134N    |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.174N     P=0.125N     P=0.110N     P=0.117N    |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.183N     P=0.112N     P=0.112N     P=0.112N    |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.009N**   (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      31.25        125MG/KG     500MG/KG    |0 MG/KG      31.25        125MG/KG     500MG/KG     | 
|                   |                  MG/KG                                 |             MG/KG                                  | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Testes: Germinal Epithelium                                                                                                      | 
|     Degeneration                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/15 (13%)   1/15 (7%)    1/15 (7%)    2/15 (13%)  |                                                    | 
|POLY-3 RATE (b)    |     2/13.83      1/14.51      1/14.08      2/12.44     |                                                    | 
|POLY-3 PERCENT (g) |     14.5%        6.9%         7.1%         16.1%       |                                                    | 
|TERMINAL (d)       |     2/13 (15%)   1/14 (7%)    1/14 (7%)    2/12 (17%)  |                                                    | 
|FIRST INCIDENCE    |     182 (T)      182 (T)      182 (T)      182 (T)     |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.463      P=0.473N     P=0.473N     P=0.673     |                                                    | 
|POLY 3             |     P=0.460      P=0.483N     P=0.494N     P=0.661     |                                                    | 
|POLY 1.5           |     P=0.465      P=0.489N     P=0.499N     P=0.662     |                                                    | 
|POLY 6             |     P=0.459      P=0.478N     P=0.484N     P=0.664     |                                                    | 
|LOGISTIC REGRESSION|     P=0.463      P=0.473N     P=0.473N     P=0.673     |                                                    | 
|COCH-ARM / FISHERS |     P=0.513      P=0.500N     P=0.500N     P=0.701N    |                                                    | 
|ORDER RESTRICTED   |     P=0.476      (e)          (e)          (e)         |                                                    | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  01/27/05                           EXPERIMENT: 97013 TEST: 15                                            Page 10      
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -      WATER DISINFECTION MODEL (DICHLO
ROACET                                                                                                                              
                                         Terminal Sacrifice at 26 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      31.25        125MG/KG     500MG/KG    |0 MG/KG      31.25        125MG/KG     500MG/KG     | 
|                   |                  MG/KG                                 |             MG/KG                                  | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thymus                                                                                                                           | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/15 (7%)    1/15 (7%)    0/15 (0%)    2/15 (13%)  |3/15 (20%)   1/15 (7%)    1/15 (7%)    0/15 (0%)    | 
|POLY-3 RATE (b)    |     1/14.25      1/15.00      0/14.08      2/13.06     |3/13.08      1/13.52      1/15.00      0/15.00      | 
|POLY-3 PERCENT (g) |     7.0%         6.7%         0.0%         15.3%       |22.9%        7.4%         6.7%         0.0%         | 
|TERMINAL (d)       |     0/13 (0%)    0/14 (0%)    0/14 (0%)    1/12 (8%)   |1/11 (9%)    0/12 (0%)    0/14 (0%)    0/15 (0%)    | 
|FIRST INCIDENCE    |     152          145          ---          132         |104          132          98           ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.273      P=0.753N     P=0.500N     P=0.465     |P=0.116N     P=0.281N     P=0.256N     P=0.087N     | 
|POLY 3             |     P=0.288      P=0.749N     P=0.502N     P=0.469     |P=0.119N     P=0.284N     P=0.248N     P=0.082N     | 
|POLY 1.5           |     P=0.289      P=0.753N     P=0.503N     P=0.468     |P=0.123N     P=0.280N     P=0.257N     P=0.086N     | 
|POLY 6             |     P=0.289      P=0.746N     P=0.501N     P=0.472     |P=0.116N     P=0.291N     P=0.246N     P=0.081N     | 
|LOGISTIC REGRESSION|     P=0.438      P=0.627      P=0.466N     P=0.552     |P=0.310N     P=0.376N     P=0.503N     P=0.190N     | 
|COCH-ARM / FISHERS |     P=0.313      P=0.759N     P=0.500N     P=0.500     |P=0.132N     P=0.299N     P=0.299N     P=0.112N     | 
|ORDER RESTRICTED   |     P=0.232      (e)          (e)          (e)         |P=0.022N*    (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      31.25        125MG/KG     500MG/KG    |0 MG/KG      31.25        125MG/KG     500MG/KG     | 
|                   |                  MG/KG                                 |             MG/KG                                  | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thymus                                                                                                                           | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     6/15 (40%)   1/15 (7%)    4/15 (27%)   2/15 (13%)  |3/15 (20%)   8/15 (53%)   7/15 (47%)   9/15 (60%)   | 
|POLY-3 RATE (b)    |     6/13.83      1/14.51      4/14.08      2/12.44     |3/11.79      8/12.90      7/14.15      9/15.00      | 
|POLY-3 PERCENT (g) |     43.4%        6.9%         28.4%        16.1%       |25.4%        62.0%        49.5%        60.0%        | 
|TERMINAL (d)       |     6/13 (46%)   1/14 (7%)    4/14 (29%)   2/12 (17%)  |3/11 (27%)   8/12 (67%)   7/14 (50%)   9/15 (60%)   | 
|FIRST INCIDENCE    |     182 (T)      182 (T)      182 (T)      182 (T)     |183 (T)      183 (T)      183 (T)      183 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.317N     P=0.033N*    P=0.296N     P=0.130N    |P=0.278      P=0.075      P=0.234      P=0.109      | 
|POLY 3             |     P=0.331N     P=0.027N*    P=0.336N     P=0.135N    |P=0.230      P=0.069      P=0.201      P=0.078      | 
|POLY 1.5           |     P=0.321N     P=0.029N*    P=0.349N     P=0.135N    |P=0.181      P=0.070      P=0.176      P=0.058      | 
|POLY 6             |     P=0.333N     P=0.025N*    P=0.317N     P=0.131N    |P=0.270      P=0.065      P=0.219      P=0.095      | 
|LOGISTIC REGRESSION|     P=0.317N     P=0.033N*    P=0.296N     P=0.130N    |P=0.278      P=0.075      P=0.234      P=0.109      | 
|COCH-ARM / FISHERS |     P=0.258N     P=0.040N*    P=0.350N     P=0.107N    |P=0.095      P=0.064      P=0.123      P=0.030 *    | 
|ORDER RESTRICTED   |     P=0.075N     (e)          (e)          (e)         |P=0.056      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  01/27/05                           EXPERIMENT: 97013 TEST: 15                                            Page 11      
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -      WATER DISINFECTION MODEL (DICHLO
ROACET                                                                                                                              
                                         Terminal Sacrifice at 26 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      31.25        125MG/KG     500MG/KG    |0 MG/KG      31.25        125MG/KG     500MG/KG     | 
|                   |                  MG/KG                                 |             MG/KG                                  | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thymus: Thymocyte                                                                                                                | 
|     Necrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/15 (0%)    0/15 (0%)    0/15 (0%)    2/15 (13%)  |0/15 (0%)    0/15 (0%)    0/15 (0%)    0/15 (0%)    | 
|POLY-3 RATE (b)    |     0/13.83      0/14.51      0/14.08      2/14.38     |0/11.79      0/12.90      0/14.15      0/15.00      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         13.9%       |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/13 (0%)    0/14 (0%)    0/14 (0%)    0/12 (0%)   |0/11 (0%)    0/12 (0%)    0/14 (0%)    0/15 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          4           |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.040 *    (e)          (e)          P=0.232     |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.038 *    (e)          (e)          P=0.240     |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.038 *    (e)          (e)          P=0.237     |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.038 *    (e)          (e)          P=0.243     |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.040 *    (e)          (e)          P=0.241     |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.028 *    (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      31.25        125MG/KG     500MG/KG    |0 MG/KG      31.25        125MG/KG     500MG/KG     | 
|                   |                  MG/KG                                 |             MG/KG                                  | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: Follicle                                                                                                          | 
|     Degeneration                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/15 (20%)   3/15 (20%)   2/15 (13%)   1/15 (7%)   |5/15 (33%)   4/15 (27%)   2/15 (13%)   1/15 (7%)    | 
|POLY-3 RATE (b)    |     3/14.25      3/14.51      2/14.08      1/12.44     |5/11.79      4/12.90      2/14.15      1/15.00      | 
|POLY-3 PERCENT (g) |     21.1%        20.7%        14.2%        8.0%        |42.4%        31.0%        14.1%        6.7%         | 
|TERMINAL (d)       |     2/13 (15%)   3/14 (21%)   2/14 (14%)   1/12 (8%)   |5/11 (46%)   4/12 (33%)   2/14 (14%)   1/15 (7%)    | 
|FIRST INCIDENCE    |     152          182 (T)      182 (T)      182 (T)     |183 (T)      183 (T)      183 (T)      183 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.256N     P=0.639N     P=0.472N     P=0.339N    |P=0.033N*    P=0.435N     P=0.106N     P=0.035N*    | 
|POLY 3             |     P=0.265N     P=0.663N     P=0.506N     P=0.349N    |P=0.041N*    P=0.434N     P=0.119N     P=0.035N*    | 
|POLY 1.5           |     P=0.258N     P=0.664N     P=0.507N     P=0.343N    |P=0.048N*    P=0.442N     P=0.136N     P=0.044N*    | 
|POLY 6             |     P=0.268N     P=0.665N     P=0.502N     P=0.353N    |P=0.037N*    P=0.438N     P=0.109N     P=0.030N*    | 
|LOGISTIC REGRESSION|     P=0.245N     P=0.673      P=0.500N     P=0.320N    |P=0.033N*    P=0.435N     P=0.106N     P=0.035N*    | 
|COCH-ARM / FISHERS |     P=0.210N     P=0.674N     P=0.500N     P=0.299N    |P=0.071N     P=0.500N     P=0.195N     P=0.084N     | 
|ORDER RESTRICTED   |     P=0.305N     (e)          (e)          (e)         |P=0.017N*    (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  01/27/05                           EXPERIMENT: 97013 TEST: 15                                            Page 12      
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -      WATER DISINFECTION MODEL (DICHLO
ROACET                                                                                                                              
                                         Terminal Sacrifice at 26 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      31.25        125MG/KG     500MG/KG    |0 MG/KG      31.25        125MG/KG     500MG/KG     | 
|                   |                  MG/KG                                 |             MG/KG                                  | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus: Endometrium                                                                                                              | 
|     Hyperplasia Cystic                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |10/15 (67%)  12/15 (80%)  10/15 (67%)  14/15 (93%)  | 
|POLY-3 RATE (b)    |                                                        |10/11.79     12/13.77     10/14.15     14/15.00     | 
|POLY-3 PERCENT (g) |                                                        |84.8%        87.2%        70.7%        93.3%        | 
|TERMINAL (d)       |                                                        |10/11 (91%)  11/12 (92%)  10/14 (71%)  14/15 (93%)  | 
|FIRST INCIDENCE    |                                                        |183 (T)      93           183 (T)      183 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |P=0.545      P=0.496      P=0.245N     P=0.693      | 
|POLY 3             |                                                        |P=0.278      P=0.669      P=0.349N     P=0.466      | 
|POLY 1.5           |                                                        |P=0.194      P=0.583      P=0.435N     P=0.294      | 
|POLY 6             |                                                        |P=0.363      P=0.702      P=0.290N     P=0.598      | 
|LOGISTIC REGRESSION|                                                        |P=0.359      P=0.503      P=0.245N     P=0.693      | 
|COCH-ARM / FISHERS |                                                        |P=0.086      P=0.341      P=0.650N     P=0.084      | 
|ORDER RESTRICTED   |                                                        |P=0.284      (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).