Share This:
https://ntp.niehs.nih.gov/go/15962

TDMS Study 97013-11 Pathology Tables

NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                          WATER DISINFECTION MODEL (SODIUM BROMATE)                      DATE: 06/18/04       
EXPERIMENT: 97013 TEST: 11                                                                                     TIME: 09:20:07       
TEST TYPE:  SUBCHRON 26-WEEK                    CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-65406                              ROUTE: SKIN APPLICATION                                        NTP C#: 97013B       
PATHOLOGIST: TOFT, JOHN                                                                                        CAS: 7789-38-0       
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                            FINAL#1 MICE                                                            
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 001    0 MG/KG                                                                       
                                       INCLUDE 002    0 MG/KG                                                                       
                                       INCLUDE 003    64 MG/KG                                                                      
                                       INCLUDE 004    64 MG/KG                                                                      
                                       INCLUDE 005    128     MG/KG                                                                 
                                       INCLUDE 006    128     MG/KG                                                                 
                                       INCLUDE 007    256     MG/KG                                                                 
                                       INCLUDE 008    256     MG/KG                                                                 
                                                                                                                                   
NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                          WATER DISINFECTION MODEL (SODIUM BROMATE)                      DATE: 06/18/04       
EXPERIMENT: 97013 TEST: 11                                                                                     TIME: 09:20:07       
TEST TYPE:  SUBCHRON 26-WEEK                    CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-65406                              ROUTE: SKIN APPLICATION                                        NTP C#: 97013B       
PATHOLOGIST: TOFT, JOHN                                                                                        CAS: 7789-38-0       
                                                                                                                                    
                                                                                                                                    
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS                                                                               
IN THE ANALYSIS OF        WATER DISINFECTION MODEL (SODIUM BR                                                                       
===============================================================                                                                     
Male Mice                                                                                                                           
------------                                                                                                                        
Organ                                 Morphology                                                                                    
-----                                 ----------                                                                                    
Adrenal Cortex                         Hypertrophy                                                                                  
Kidney                                 Nephropathy                                                                                  
Thyroid Gland: Follicle                Depletion Secretory                                                                          
Thyroid Gland: Follicular Cell         Hypertrophy                                                                                  
===============================================================                                                                     
Female Mice                                                                                                                         
------------                                                                                                                        
Organ                                  Morphology                                                                                   
-----                                  ----------                                                                                   
Kidney                                 Nephropathy                                                                                  
Ovary                                  Cyst                                                                                         
Spleen                                 Hematopoietic Cell Proliferation                                                             
Thyroid Gland                          Infiltration Cellular Lymphocyte                                                             
Thyroid Gland: Follicle                Depletion Secretory                                                                          
Thyroid Gland: Follicular Cell         Hypertrophy                                                                                  
===============================================================                                                                     
                                                                                                                                   
       Date:  06/18/04                           EXPERIMENT: 97013 TEST: 11                                            Page 1       
Statistical Analysis of Non-neoplastic Lesions in        Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -         WATER DISINFECTION MODEL (SO
DIUM BR                                                                                                                             
                                         Terminal Sacrifice at 26 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Accessory Adrenal Cortical Nodule                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/15 (7%)    0/15 (0%)    0/15 (0%)    0/15 (0%)   |3/15 (20%)   3/15 (20%)   1/15 (7%)    1/15 (7%)    | 
|POLY-3 RATE (b)    |     1/12.62      0/12.43      0/13.58      0/15.00     |3/14.75      3/11.53      1/12.60      1/11.71      | 
|POLY-3 PERCENT (g) |     7.9%         0.0%         0.0%         0.0%        |20.4%        26.0%        7.9%         8.5%         | 
|TERMINAL (d)       |     1/12 (8%)    0/11 (0%)    0/13 (0%)    0/15 (0%)   |0/11 (0%)    3/10 (30%)   1/11 (9%)    1/11 (9%)    | 
|FIRST INCIDENCE    |     181 (T)      ---          ---          ---         |60           182 (T)      182 (T)      182 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.277N     P=0.517N     P=0.484N     P=0.455N    |P=0.171N     P=0.615      P=0.345N     P=0.345N     | 
|POLY 3             |     P=0.316N     P=0.503N     P=0.485N     P=0.466N    |P=0.202N     P=0.547      P=0.358N     P=0.387N     | 
|POLY 1.5           |     P=0.314N     P=0.502N     P=0.488N     P=0.473N    |P=0.184N     P=0.581      P=0.334N     P=0.360N     | 
|POLY 6             |     P=0.317N     P=0.504N     P=0.484N     P=0.460N    |P=0.216N     P=0.525      P=0.383N     P=0.402N     | 
|LOGISTIC REGRESSION|     P=0.277N     (e)          (e)          (e)         |P=0.147N     P=0.633N     P=0.290N     P=0.213N     | 
|COCH-ARM / FISHERS |     P=0.305N     P=0.500N     P=0.500N     P=0.500N    |P=0.152N     P=0.674N     P=0.299N     P=0.299N     | 
|ORDER RESTRICTED   |     P=0.094N     (e)          (e)          (e)         |P=0.243N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     8/15 (53%)   4/15 (27%)   1/15 (7%)    3/15 (20%)  |0/15 (0%)    0/15 (0%)    0/15 (0%)    0/15 (0%)    | 
|POLY-3 RATE (b)    |     8/12.62      4/12.43      1/13.58      3/15.00     |0/12.95      0/11.53      0/12.60      0/11.71      | 
|POLY-3 PERCENT (g) |     63.4%        32.2%        7.4%         20.0%       |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     8/12 (67%)   4/11 (36%)   1/13 (8%)    3/15 (20%)  |0/11 (0%)    0/10 (0%)    0/11 (0%)    0/11 (0%)    | 
|FIRST INCIDENCE    |     181 (T)      181 (T)      181 (T)      181 (T)     |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.013N*    P=0.156N     P=0.005N**   P=0.022N*   |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.015N*    P=0.117N     P<0.001N**   P=0.020N*   |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.018N*    P=0.117N     P<0.001N**   P=0.026N*   |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.013N*    P=0.117N     P<0.001N**   P=0.017N*   |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.013N*    P=0.156N     P=0.005N**   P=0.022N*   |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.038N*    P=0.132N     P=0.007N**   P=0.064N    |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     P<0.001N**   (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/04                           EXPERIMENT: 97013 TEST: 11                                            Page 2       
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -         WATER DISINFECTION MODEL (SOD
IUM BR                                                                                                                              
                                         Terminal Sacrifice at 26 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex: Subcapsular                                                                                                      | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/15 (0%)    0/15 (0%)    1/15 (7%)    0/15 (0%)   |4/15 (27%)   3/15 (20%)   5/15 (33%)   3/15 (20%)   | 
|POLY-3 RATE (b)    |     0/12.62      0/12.43      1/13.58      0/15.00     |4/13.78      3/11.53      5/13.96      3/11.71      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         7.4%         0.0%        |29.0%        26.0%        35.8%        25.6%        | 
|TERMINAL (d)       |     0/12 (0%)    0/11 (0%)    1/13 (8%)    0/15 (0%)   |2/11 (18%)   3/10 (30%)   3/11 (27%)   3/11 (27%)   | 
|FIRST INCIDENCE    |     ---          ---          181 (T)      ---         |146          182 (T)      108          182 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.723      (e)          P=0.516      (e)         |P=0.490N     P=0.565N     P=0.476      P=0.533N     | 
|POLY 3             |     P=0.761      (e)          P=0.515      (e)         |P=0.549N     P=0.606N     P=0.509      P=0.596N     | 
|POLY 1.5           |     P=0.746      (e)          P=0.512      (e)         |P=0.521N     P=0.575N     P=0.517      P=0.563N     | 
|POLY 6             |     P=0.769N     (e)          P=0.516      (e)         |P=0.566N     P=0.628N     P=0.495      P=0.615N     | 
|LOGISTIC REGRESSION|     (e)          (e)          P=0.516      (e)         |P=0.499N     P=0.551N     P=0.498      P=0.542N     | 
|COCH-ARM / FISHERS |     P=0.695      (e)          P=0.500      (e)         |P=0.480N     P=0.500N     P=0.500      P=0.500N     | 
|ORDER RESTRICTED   |     P=0.395      (e)          (e)          (e)         |P=0.614N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Epididymis                                                                                                                       | 
|     Degeneration                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/15 (7%)    0/15 (0%)    0/15 (0%)    2/15 (13%)  |                                                    | 
|POLY-3 RATE (b)    |     1/13.10      0/12.43      0/13.58      2/15.00     |                                                    | 
|POLY-3 PERCENT (g) |     7.6%         0.0%         0.0%         13.3%       |                                                    | 
|TERMINAL (d)       |     0/12 (0%)    0/11 (0%)    0/13 (0%)    2/15 (13%)  |                                                    | 
|FIRST INCIDENCE    |     146          ---          ---          181 (T)     |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.303      P=0.516N     P=0.485N     P=0.569     |                                                    | 
|POLY 3             |     P=0.270      P=0.510N     P=0.493N     P=0.548     |                                                    | 
|POLY 1.5           |     P=0.263      P=0.506N     P=0.492N     P=0.540     |                                                    | 
|POLY 6             |     P=0.275      P=0.516N     P=0.496N     P=0.550     |                                                    | 
|LOGISTIC REGRESSION|     P=0.237      P=0.499N     P=0.531N     P=0.482     |                                                    | 
|COCH-ARM / FISHERS |     P=0.242      P=0.500N     P=0.500N     P=0.500     |                                                    | 
|ORDER RESTRICTED   |     P=0.160      (e)          (e)          (e)         |                                                    | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/04                           EXPERIMENT: 97013 TEST: 11                                            Page 3       
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -         WATER DISINFECTION MODEL (SOD
IUM BR                                                                                                                              
                                         Terminal Sacrifice at 26 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Nephropathy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     8/15 (53%)   8/15 (53%)   14/15 (93%)  14/15 (93%) |8/15 (53%)   7/15 (47%)   13/15 (87%)  15/15 (100%) | 
|POLY-3 RATE (b)    |     8/12.62      8/12.51      14/14.53     14/15.00    |8/13.21      7/13.38      13/14.51     15/15.00     | 
|POLY-3 PERCENT (g) |     63.4%        63.9%        96.4%        93.3%       |60.6%        52.3%        89.6%        100.0%       | 
|TERMINAL (d)       |     8/12 (67%)   7/11 (64%)   13/13 (100%) 14/15 (93%) |7/11 (64%)   5/10 (50%)   10/11 (91%)  11/11 (100%) | 
|FIRST INCIDENCE    |     181 (T)      176          68           181 (T)     |165          71           108          69           | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.057      P=0.554      P=0.026 *    P=0.106     |P=0.004 **   P=0.589N     P=0.077      P=0.017 *    | 
|POLY 3             |     P=0.013 *    P=0.649      P=0.030 *    P=0.060     |P<0.001 **   P=0.485N     P=0.076      P=0.005 **   | 
|POLY 1.5           |     P=0.007 **   P=0.649      P=0.026 *    P=0.040 *   |P<0.001 **   P=0.489N     P=0.068      P=0.003 **   | 
|POLY 6             |     P=0.019 *    P=0.652      P=0.028 *    P=0.079     |P<0.001 **   P=0.481N     P=0.083      P=0.009 **   | 
|LOGISTIC REGRESSION|     P=0.012 *    P=0.642      P=0.023 *    P=0.106     |P<0.001 **   P=0.535N     P=0.048 *    P=0.003 **   | 
|COCH-ARM / FISHERS |     P=0.003 **   P=0.642N     P=0.018 *    P=0.018 *   |P<0.001 **   P=0.500N     P=0.054      P=0.003 **   | 
|ORDER RESTRICTED   |     P=0.016 *    (e)          (e)          (e)         |P<0.001 **   (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Renal Tubule                                                                                                             | 
|     Dilatation                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/15 (7%)    0/15 (0%)    0/15 (0%)    2/15 (13%)  |1/15 (7%)    0/15 (0%)    0/15 (0%)    0/15 (0%)    | 
|POLY-3 RATE (b)    |     1/12.62      0/12.43      0/13.58      2/15.00     |1/13.30      0/11.53      0/12.60      0/11.71      | 
|POLY-3 PERCENT (g) |     7.9%         0.0%         0.0%         13.3%       |7.5%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     1/12 (8%)    0/11 (0%)    0/13 (0%)    2/15 (13%)  |0/11 (0%)    0/10 (0%)    0/11 (0%)    0/11 (0%)    | 
|FIRST INCIDENCE    |     181 (T)      ---          ---          181 (T)     |158          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.308      P=0.517N     P=0.484N     P=0.580     |P=0.326N     P=0.533N     P=0.533N     P=0.533N     | 
|POLY 3             |     P=0.272      P=0.503N     P=0.485N     P=0.561     |P=0.283N     P=0.528N     P=0.511N     P=0.525N     | 
|POLY 1.5           |     P=0.264      P=0.502N     P=0.488N     P=0.547     |P=0.288N     P=0.521N     P=0.504N     P=0.517N     | 
|POLY 6             |     P=0.278      P=0.504N     P=0.484N     P=0.570     |P=0.284N     P=0.532N     P=0.518N     P=0.528N     | 
|LOGISTIC REGRESSION|     P=0.308      (e)          (e)          P=0.580     |P=0.302N     P=0.492N     P=0.507N     P=0.491N     | 
|COCH-ARM / FISHERS |     P=0.242      P=0.500N     P=0.500N     P=0.500     |P=0.305N     P=0.500N     P=0.500N     P=0.500N     | 
|ORDER RESTRICTED   |     P=0.169      (e)          (e)          (e)         |P=0.144N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/04                           EXPERIMENT: 97013 TEST: 11                                            Page 4       
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -         WATER DISINFECTION MODEL (SOD
IUM BR                                                                                                                              
                                         Terminal Sacrifice at 26 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/15 (0%)    0/15 (0%)    1/15 (7%)    1/15 (7%)   |2/15 (13%)   2/15 (13%)   2/15 (13%)   3/15 (20%)   | 
|POLY-3 RATE (b)    |     0/12.62      0/12.43      1/13.58      1/15.00     |2/13.21      2/11.53      2/12.60      3/11.71      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         7.4%         6.7%        |15.1%        17.4%        15.9%        25.6%        | 
|TERMINAL (d)       |     0/12 (0%)    0/11 (0%)    1/13 (8%)    1/15 (7%)   |1/11 (9%)    2/10 (20%)   2/11 (18%)   3/11 (27%)   | 
|FIRST INCIDENCE    |     ---          ---          181 (T)      181 (T)     |165          182 (T)      182 (T)      182 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.288      (e)          P=0.516      P=0.545     |P=0.390      P=0.664      P=0.690      P=0.492      | 
|POLY 3             |     P=0.292      (e)          P=0.515      P=0.534     |P=0.341      P=0.650      P=0.684      P=0.442      | 
|POLY 1.5           |     P=0.279      (e)          P=0.512      P=0.527     |P=0.357      P=0.663      P=0.694      P=0.460      | 
|POLY 6             |     P=0.302      (e)          P=0.516      P=0.539     |P=0.335      P=0.644      P=0.671      P=0.437      | 
|LOGISTIC REGRESSION|     (e)          (e)          P=0.516      P=0.545     |P=0.351      P=0.664      P=0.694      P=0.452      | 
|COCH-ARM / FISHERS |     P=0.233      (e)          P=0.500      P=0.500     |P=0.380      P=0.701N     P=0.701N     P=0.500      | 
|ORDER RESTRICTED   |     P=0.269      (e)          (e)          (e)         |P=0.402      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     10/15 (67%)  6/15 (40%)   9/15 (60%)   11/15 (73%) |13/15 (87%)  12/15 (80%)  12/15 (80%)  12/15 (80%)  | 
|POLY-3 RATE (b)    |     10/13.54     6/12.43      9/14.53      11/15.00    |13/14.04     12/12.72     12/13.09     12/12.66     | 
|POLY-3 PERCENT (g) |     73.9%        48.3%        62.0%        73.3%       |92.6%        94.3%        91.7%        94.8%        | 
|TERMINAL (d)       |     9/12 (75%)   6/11 (55%)   8/13 (62%)   11/15 (73%) |10/11 (91%)  10/10 (100%) 11/11 (100%) 11/11 (100%) | 
|FIRST INCIDENCE    |     79           181 (T)      68           181 (T)     |146          71           145          69           | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.552N     P=0.181N     P=0.398N     P=0.459N    |P=0.393N     P=0.629      P=0.558N     P=0.538N     | 
|POLY 3             |     P=0.415      P=0.171N     P=0.394N     P=0.649N    |P=0.597      P=0.744      P=0.764N     P=0.743      | 
|POLY 1.5           |     P=0.369      P=0.156N     P=0.408N     P=0.636     |P=0.541N     P=0.732N     P=0.598N     P=0.707N     | 
|POLY 6             |     P=0.453      P=0.178N     P=0.389N     P=0.619N    |P=0.373      P=0.658      P=0.688      P=0.590      | 
|LOGISTIC REGRESSION|     P=0.361      P=0.129N     P=0.473N     P=0.648     |P=0.611      P=0.699      P=0.738N     P=0.723      | 
|COCH-ARM / FISHERS |     P=0.238      P=0.136N     P=0.500N     P=0.500     |P=0.433N     P=0.500N     P=0.500N     P=0.500N     | 
|ORDER RESTRICTED   |     P=0.397N     (e)          (e)          (e)         |P=0.603      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/04                           EXPERIMENT: 97013 TEST: 11                                            Page 5       
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -         WATER DISINFECTION MODEL (SOD
IUM BR                                                                                                                              
                                         Terminal Sacrifice at 26 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Hepatocyte                                                                                                                | 
|     Necrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/15 (7%)    2/15 (13%)   0/15 (0%)    0/15 (0%)   |1/15 (7%)    2/15 (13%)   1/15 (7%)    1/15 (7%)    | 
|POLY-3 RATE (b)    |     1/13.54      2/13.36      0/13.58      0/15.00     |1/12.95      2/11.53      1/12.60      1/12.66      | 
|POLY-3 PERCENT (g) |     7.4%         15.0%        0.0%         0.0%        |7.7%         17.4%        7.9%         7.9%         | 
|TERMINAL (d)       |     0/12 (0%)    1/11 (9%)    0/13 (0%)    0/15 (0%)   |1/11 (9%)    2/10 (20%)   1/11 (9%)    0/11 (0%)    | 
|FIRST INCIDENCE    |     79           74           ---          ---         |182 (T)      182 (T)      182 (T)      69           | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.170N     P=0.481      P=0.500N     P=0.486N    |P=0.517N     P=0.465      P=0.766      P=0.753N     | 
|POLY 3             |     P=0.172N     P=0.495      P=0.499N     P=0.480N    |P=0.536N     P=0.458      P=0.756      P=0.757      | 
|POLY 1.5           |     P=0.174N     P=0.498      P=0.498N     P=0.484N    |P=0.532N     P=0.467      P=0.760      P=0.759      | 
|POLY 6             |     P=0.170N     P=0.493      P=0.500N     P=0.476N    |P=0.532N     P=0.458      P=0.752      P=0.761      | 
|LOGISTIC REGRESSION|     P=0.362N     P=0.505      P=0.669N     P=0.960N    |P=0.526N     P=0.465      P=0.766      P=0.726N     | 
|COCH-ARM / FISHERS |     P=0.184N     P=0.500      P=0.500N     P=0.500N    |P=0.531N     P=0.500      P=0.759N     P=0.759N     | 
|ORDER RESTRICTED   |     P=0.141N     (e)          (e)          (e)         |P=0.561N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Hepatocyte                                                                                                                | 
|     Vacuolization Cytoplasmic                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     6/15 (40%)   4/15 (27%)   3/15 (20%)   6/15 (40%)  |3/15 (20%)   4/15 (27%)   3/15 (20%)   3/15 (20%)   | 
|POLY-3 RATE (b)    |     6/13.61      4/12.43      3/13.58      6/15.00     |3/12.95      4/11.53      3/12.60      3/11.71      | 
|POLY-3 PERCENT (g) |     44.1%        32.2%        22.1%        40.0%       |23.2%        34.7%        23.8%        25.6%        | 
|TERMINAL (d)       |     5/12 (42%)   4/11 (36%)   3/13 (23%)   6/15 (40%)  |3/11 (27%)   4/10 (40%)   3/11 (27%)   3/11 (27%)   | 
|FIRST INCIDENCE    |     42           181 (T)      181 (T)      181 (T)     |182 (T)      182 (T)      182 (T)      182 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.428N     P=0.407N     P=0.184N     P=0.468N    |P=0.502N     P=0.440      P=0.680      P=0.680      | 
|POLY 3             |     P=0.544N     P=0.414N     P=0.209N     P=0.561N    |P=0.566N     P=0.429      P=0.662      P=0.625      | 
|POLY 1.5           |     P=0.567N     P=0.403N     P=0.212N     P=0.586N    |P=0.550N     P=0.445      P=0.671      P=0.639      | 
|POLY 6             |     P=0.524N     P=0.420N     P=0.207N     P=0.540N    |P=0.565N     P=0.428      P=0.653      P=0.629      | 
|LOGISTIC REGRESSION|     P=0.567N     P=0.351N     P=0.216N     P=0.612     |P=0.502N     P=0.440      P=0.680      P=0.680      | 
|COCH-ARM / FISHERS |     P=0.519      P=0.350N     P=0.213N     P=0.645N    |P=0.521N     P=0.500      P=0.674N     P=0.674N     | 
|ORDER RESTRICTED   |     P=0.379N     (e)          (e)          (e)         |P=0.617      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/04                           EXPERIMENT: 97013 TEST: 11                                            Page 6       
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -         WATER DISINFECTION MODEL (SOD
IUM BR                                                                                                                              
                                         Terminal Sacrifice at 26 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/15 (0%)    1/15 (7%)    0/15 (0%)    0/15 (0%)   |0/15 (0%)    2/15 (13%)   0/15 (0%)    0/15 (0%)    | 
|POLY-3 RATE (b)    |     0/12.62      1/13.36      0/13.58      0/15.00     |0/12.95      2/11.53      0/12.60      0/11.71      | 
|POLY-3 PERCENT (g) |     0.0%         7.5%         0.0%         0.0%        |0.0%         17.4%        0.0%         0.0%         | 
|TERMINAL (d)       |     0/12 (0%)    0/11 (0%)    0/13 (0%)    0/15 (0%)   |0/11 (0%)    2/10 (20%)   0/11 (0%)    0/11 (0%)    | 
|FIRST INCIDENCE    |     ---          74           ---          ---         |---          182 (T)      ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.556N     P=0.500      (e)          (e)         |P=0.399N     P=0.213      (e)          (e)          | 
|POLY 3             |     P=0.549N     P=0.511      (e)          (e)         |P=0.435N     P=0.203      (e)          (e)          | 
|POLY 1.5           |     P=0.553N     P=0.509      (e)          (e)         |P=0.426N     P=0.209      (e)          (e)          | 
|POLY 6             |     P=0.547N     P=0.512      (e)          (e)         |P=0.436N     P=0.202      (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.863      P=0.494      (e)          (e)         |(e)          P=0.213      (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.568N     P=0.500      (e)          (e)         |P=0.404N     P=0.241      (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.363N     (e)          (e)          (e)         |P=0.233N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mandibular                                                                                                           | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/15 (0%)    0/15 (0%)    0/15 (0%)    0/15 (0%)   |4/15 (27%)   2/14 (14%)   2/14 (14%)   3/15 (20%)   | 
|POLY-3 RATE (b)    |     0/12.62      0/12.43      0/13.58      0/15.00     |4/12.95      2/11.20      2/12.09      3/11.71      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |30.9%        17.9%        16.5%        25.6%        | 
|TERMINAL (d)       |     0/12 (0%)    0/11 (0%)    0/13 (0%)    0/15 (0%)   |4/11 (36%)   0/9 (0%)     1/10 (10%)   3/11 (27%)   | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |182 (T)      152          145          182 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.479N     P=0.411N     P=0.380N     P=0.500N     | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.493N     P=0.397N     P=0.357N     P=0.561N     | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.482N     P=0.397N     P=0.354N     P=0.543N     | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.498N     P=0.376N     P=0.356N     P=0.557N     | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.497N     P=0.413N     P=0.374N     P=0.500N     | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.469N     P=0.361N     P=0.361N     P=0.500N     | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |P=0.414N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/04                           EXPERIMENT: 97013 TEST: 11                                            Page 7       
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -         WATER DISINFECTION MODEL (SOD
IUM BR                                                                                                                              
                                         Terminal Sacrifice at 26 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |0/15 (0%)    0/15 (0%)    1/15 (7%)    3/15 (20%)   | 
|POLY-3 RATE (b)    |                                                        |0/12.95      0/11.53      1/12.60      3/11.71      | 
|POLY-3 PERCENT (g) |                                                        |0.0%         0.0%         7.9%         25.6%        | 
|TERMINAL (d)       |                                                        |0/11 (0%)    0/10 (0%)    1/11 (9%)    3/11 (27%)   | 
|FIRST INCIDENCE    |                                                        |---          ---          182 (T)      182 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |P=0.020 *    (e)          P=0.500      P=0.112      | 
|POLY 3             |                                                        |P=0.013 *    (e)          P=0.494      P=0.085      | 
|POLY 1.5           |                                                        |P=0.014 *    (e)          P=0.499      P=0.090      | 
|POLY 6             |                                                        |P=0.013 *    (e)          P=0.491      P=0.085      | 
|LOGISTIC REGRESSION|                                                        |(e)          (e)          P=0.500      P=0.112      | 
|COCH-ARM / FISHERS |                                                        |P=0.018 *    (e)          P=0.500      P=0.112      | 
|ORDER RESTRICTED   |                                                        |P=0.011 *    (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis                                                                                                   | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/15 (0%)    3/14 (21%)   4/15 (27%)   3/15 (20%)  |2/15 (13%)   1/15 (7%)    2/15 (13%)   0/15 (0%)    | 
|POLY-3 RATE (b)    |     0/12.62      3/12.49      4/13.58      3/15.00     |2/13.78      1/11.78      2/12.60      0/11.71      | 
|POLY-3 PERCENT (g) |     0.0%         24.0%        29.5%        20.0%       |14.5%        8.5%         15.9%        0.0%         | 
|TERMINAL (d)       |     0/12 (0%)    2/11 (18%)   4/13 (31%)   3/15 (20%)  |0/11 (0%)    0/10 (0%)    2/11 (18%)   0/11 (0%)    | 
|FIRST INCIDENCE    |     ---          176          181 (T)      181 (T)     |146          165          182 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.251      P=0.110      P=0.064      P=0.157     |P=0.221N     P=0.547N     P=0.657      P=0.286N     | 
|POLY 3             |     P=0.241      P=0.101      P=0.052      P=0.141     |P=0.223N     P=0.556N     P=0.667      P=0.270N     | 
|POLY 1.5           |     P=0.218      P=0.100      P=0.051      P=0.132     |P=0.211N     P=0.541N     P=0.685      P=0.256N     | 
|POLY 6             |     P=0.258      P=0.101      P=0.053      P=0.147     |P=0.232N     P=0.563N     P=0.645      P=0.278N     | 
|LOGISTIC REGRESSION|     P=0.227      P=0.106      P=0.064      P=0.157     |P=0.195N     P=0.480N     P=0.704      P=0.211N     | 
|COCH-ARM / FISHERS |     P=0.154      P=0.100      P=0.050      P=0.112     |P=0.193N     P=0.500N     P=0.701N     P=0.241N     | 
|ORDER RESTRICTED   |     P=0.072      (e)          (e)          (e)         |P=0.177N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/04                           EXPERIMENT: 97013 TEST: 11                                            Page 8       
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -         WATER DISINFECTION MODEL (SOD
IUM BR                                                                                                                              
                                         Terminal Sacrifice at 26 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Hyperkeratosis                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/15 (13%)   0/15 (0%)    3/15 (20%)   4/15 (27%)  |0/15 (0%)    1/15 (7%)    0/15 (0%)    0/15 (0%)    | 
|POLY-3 RATE (b)    |     2/12.62      0/12.43      3/13.58      4/15.00     |0/12.95      1/11.94      0/12.60      0/11.71      | 
|POLY-3 PERCENT (g) |     15.9%        0.0%         22.1%        26.7%       |0.0%         8.4%         0.0%         0.0%         | 
|TERMINAL (d)       |     2/12 (17%)   0/11 (0%)    3/13 (23%)   4/15 (27%)  |0/11 (0%)    0/10 (0%)    0/11 (0%)    0/11 (0%)    | 
|FIRST INCIDENCE    |     181 (T)      ---          181 (T)      181 (T)     |---          152          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.177      P=0.254N     P=0.539      P=0.439     |P=0.591N     P=0.484      (e)          (e)          | 
|POLY 3             |     P=0.149      P=0.233N     P=0.535      P=0.414     |P=0.580N     P=0.484      (e)          (e)          | 
|POLY 1.5           |     P=0.135      P=0.232N     P=0.529      P=0.394     |P=0.577N     P=0.485      (e)          (e)          | 
|POLY 6             |     P=0.160      P=0.234N     P=0.538      P=0.428     |P=0.580N     P=0.489      (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.177      (e)          P=0.539      P=0.439     |P=0.562N     P=0.518      (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.100      P=0.241N     P=0.500      P=0.326     |P=0.568N     P=0.500      (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.145      (e)          (e)          (e)         |P=0.384N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin: Epidermis                                                                                                                  | 
|     Hyperplasia Focal                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/15 (20%)   2/15 (13%)   3/15 (20%)   4/15 (27%)  |2/15 (13%)   3/15 (20%)   3/15 (20%)   1/15 (7%)    | 
|POLY-3 RATE (b)    |     3/12.62      2/12.43      3/13.58      4/15.00     |2/12.95      3/11.53      3/12.60      1/11.71      | 
|POLY-3 PERCENT (g) |     23.8%        16.1%        22.1%        26.7%       |15.4%        26.0%        23.8%        8.5%         | 
|TERMINAL (d)       |     3/12 (25%)   2/11 (18%)   3/13 (23%)   4/15 (27%)  |2/11 (18%)   3/10 (30%)   3/11 (27%)   1/11 (9%)    | 
|FIRST INCIDENCE    |     181 (T)      181 (T)      181 (T)      181 (T)     |182 (T)      182 (T)      182 (T)      182 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.485      P=0.543N     P=0.636N     P=0.632     |P=0.318N     P=0.453      P=0.500      P=0.500N     | 
|POLY 3             |     P=0.441      P=0.507N     P=0.638N     P=0.600     |P=0.376N     P=0.443      P=0.486      P=0.536N     | 
|POLY 1.5           |     P=0.415      P=0.504N     P=0.643N     P=0.578     |P=0.363N     P=0.456      P=0.497      P=0.526N     | 
|POLY 6             |     P=0.460      P=0.510N     P=0.635N     P=0.616     |P=0.373N     P=0.443      P=0.477      P=0.534N     | 
|LOGISTIC REGRESSION|     P=0.485      P=0.543N     P=0.636N     P=0.632     |P=0.318N     P=0.453      P=0.500      P=0.500N     | 
|COCH-ARM / FISHERS |     P=0.331      P=0.500N     P=0.674N     P=0.500     |P=0.334N     P=0.500      P=0.500      P=0.500N     | 
|ORDER RESTRICTED   |     P=0.533      (e)          (e)          (e)         |P=0.325N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/04                           EXPERIMENT: 97013 TEST: 11                                            Page 9       
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -         WATER DISINFECTION MODEL (SOD
IUM BR                                                                                                                              
                                         Terminal Sacrifice at 26 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/15 (0%)    0/15 (0%)    1/15 (7%)    2/15 (13%)  |3/15 (20%)   5/15 (33%)   9/15 (60%)   10/15 (67%)  | 
|POLY-3 RATE (b)    |     0/12.62      0/12.43      1/13.58      2/15.00     |3/13.78      5/11.53      9/13.09      10/12.66     | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         7.4%         13.3%       |21.8%        43.4%        68.8%        79.0%        | 
|TERMINAL (d)       |     0/12 (0%)    0/11 (0%)    1/13 (8%)    2/15 (13%)  |1/11 (9%)    5/10 (50%)   8/11 (73%)   9/11 (82%)   | 
|FIRST INCIDENCE    |     ---          ---          181 (T)      181 (T)     |146          182 (T)      145          69           | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.101      (e)          P=0.516      P=0.286     |P=0.006 **   P=0.285      P=0.035 *    P=0.018 *    | 
|POLY 3             |     P=0.091      (e)          P=0.515      P=0.273     |P<0.001 **   P=0.234      P=0.012 *    P<0.001 **   | 
|POLY 1.5           |     P=0.085      (e)          P=0.512      P=0.263     |P<0.001 **   P=0.264      P=0.017 *    P=0.003 **   | 
|POLY 6             |     P=0.096      (e)          P=0.516      P=0.280     |P<0.001 **   P=0.212      P=0.008 **   P<0.001 **   | 
|LOGISTIC REGRESSION|     (e)          (e)          P=0.516      P=0.286     |P=0.002 **   P=0.282      P=0.028 *    P=0.010 *    | 
|COCH-ARM / FISHERS |     P=0.067      (e)          P=0.500      P=0.241     |P=0.005 **   P=0.341      P=0.030 *    P=0.013 *    | 
|ORDER RESTRICTED   |     P=0.097      (e)          (e)          (e)         |P<0.001 **   (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach: Epithelium                                                                                                 | 
|     Hyperkeratosis                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/15 (0%)    0/15 (0%)    0/15 (0%)    0/15 (0%)   |1/15 (7%)    2/15 (13%)   1/15 (7%)    1/15 (7%)    | 
|POLY-3 RATE (b)    |     0/12.62      0/12.43      0/13.58      0/15.00     |1/13.44      2/12.69      1/13.39      1/12.47      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |7.4%         15.8%        7.5%         8.0%         | 
|TERMINAL (d)       |     0/12 (0%)    0/11 (0%)    0/13 (0%)    0/15 (0%)   |0/11 (0%)    0/10 (0%)    0/11 (0%)    0/11 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |146          81           108          113          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.550N     P=0.464      P=0.742      P=0.725      | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.550N     P=0.480      P=0.761      P=0.745      | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.543N     P=0.483      P=0.758N     P=0.750      | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.551N     P=0.482      P=0.756      P=0.746      | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.499N     P=0.602      P=0.732      P=0.729N     | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.531N     P=0.500      P=0.759N     P=0.759N     | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |P=0.588N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/04                           EXPERIMENT: 97013 TEST: 11                                            Page 10      
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -         WATER DISINFECTION MODEL (SOD
IUM BR                                                                                                                              
                                         Terminal Sacrifice at 26 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach: Epithelium                                                                                                 | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/15 (7%)    2/15 (13%)   1/15 (7%)    0/15 (0%)   |2/15 (13%)   2/15 (13%)   1/15 (7%)    2/15 (13%)   | 
|POLY-3 RATE (b)    |     1/13.61      2/13.09      1/13.58      0/15.00     |2/14.40      2/12.69      1/13.39      2/13.31      | 
|POLY-3 PERCENT (g) |     7.4%         15.3%        7.4%         0.0%        |13.9%        15.8%        7.5%         15.0%        | 
|TERMINAL (d)       |     0/12 (0%)    0/11 (0%)    1/13 (8%)    0/15 (0%)   |0/11 (0%)    0/10 (0%)    0/11 (0%)    0/11 (0%)    | 
|FIRST INCIDENCE    |     42           136          181 (T)      ---         |60           81           108          99           | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.215N     P=0.500      P=0.751N     P=0.500N    |P=0.590N     P=0.663      P=0.520N     P=0.664      | 
|POLY 3             |     P=0.220N     P=0.486      P=0.761      P=0.481N    |P=0.595N     P=0.652      P=0.526N     P=0.670      | 
|POLY 1.5           |     P=0.228N     P=0.484      P=0.760      P=0.486N    |P=0.591N     P=0.661      P=0.516N     P=0.675      | 
|POLY 6             |     P=0.215N     P=0.492      P=0.761      P=0.476N    |P=0.595N     P=0.653      P=0.536N     P=0.675      | 
|LOGISTIC REGRESSION|     P=0.389N     P=0.504      P=0.691      (e)         |P=0.513N     P=0.539N     P=0.234N     P=0.493N     | 
|COCH-ARM / FISHERS |     P=0.242N     P=0.500      P=0.759N     P=0.500N    |P=0.581N     P=0.701N     P=0.500N     P=0.701N     | 
|ORDER RESTRICTED   |     P=0.191N     (e)          (e)          (e)         |P=0.611N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Testes: Germinal Epithelium                                                                                                      | 
|     Degeneration                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/15 (13%)   0/15 (0%)    2/15 (13%)   3/15 (20%)  |                                                    | 
|POLY-3 RATE (b)    |     2/13.10      0/12.43      2/13.58      3/15.00     |                                                    | 
|POLY-3 PERCENT (g) |     15.3%        0.0%         14.7%        20.0%       |                                                    | 
|TERMINAL (d)       |     1/12 (8%)    0/11 (0%)    2/13 (15%)   3/15 (20%)  |                                                    | 
|FIRST INCIDENCE    |     146          ---          181 (T)      181 (T)     |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.326      P=0.258N     P=0.668N     P=0.596     |                                                    | 
|POLY 3             |     P=0.289      P=0.242N     P=0.687N     P=0.564     |                                                    | 
|POLY 1.5           |     P=0.275      P=0.237N     P=0.685N     P=0.553     |                                                    | 
|POLY 6             |     P=0.298      P=0.248N     P=0.693N     P=0.567     |                                                    | 
|LOGISTIC REGRESSION|     P=0.269      P=0.232N     P=0.693N     P=0.522     |                                                    | 
|COCH-ARM / FISHERS |     P=0.227      P=0.241N     P=0.701N     P=0.500     |                                                    | 
|ORDER RESTRICTED   |     P=0.267      (e)          (e)          (e)         |                                                    | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/04                           EXPERIMENT: 97013 TEST: 11                                            Page 11      
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -         WATER DISINFECTION MODEL (SOD
IUM BR                                                                                                                              
                                         Terminal Sacrifice at 26 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thymus                                                                                                                           | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/14 (7%)    4/15 (27%)   1/15 (7%)    4/15 (27%)  |1/15 (7%)    3/14 (21%)   4/15 (27%)   2/15 (13%)   | 
|POLY-3 RATE (b)    |     1/13.08      4/14.02      1/14.05      4/15.00     |1/13.21      3/12.81      4/14.46      2/13.31      | 
|POLY-3 PERCENT (g) |     7.6%         28.5%        7.1%         26.7%       |7.6%         23.4%        27.7%        15.0%        | 
|TERMINAL (d)       |     0/12 (0%)    1/11 (9%)    0/13 (0%)    4/15 (27%)  |0/11 (0%)    1/10 (10%)   1/11 (9%)    0/11 (0%)    | 
|FIRST INCIDENCE    |     146          74           146          181 (T)     |165          67           108          99           | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.313      P=0.176      P=0.748N     P=0.242     |P=0.443      P=0.292      P=0.175      P=0.481      | 
|POLY 3             |     P=0.252      P=0.183      P=0.745N     P=0.208     |P=0.468      P=0.284      P=0.190      P=0.503      | 
|POLY 1.5           |     P=0.245      P=0.180      P=0.746N     P=0.202     |P=0.465      P=0.279      P=0.183      P=0.501      | 
|POLY 6             |     P=0.254      P=0.184      P=0.744N     P=0.210     |P=0.482      P=0.291      P=0.198      P=0.510      | 
|LOGISTIC REGRESSION|     P=0.143      P=0.237      P=0.754N     P=0.156     |P=0.545      P=0.386      P=0.138      P=0.599      | 
|COCH-ARM / FISHERS |     P=0.225      P=0.186      P=0.741N     P=0.186     |P=0.465      P=0.272      P=0.165      P=0.500      | 
|ORDER RESTRICTED   |     P=0.147      (e)          (e)          (e)         |P=0.273      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thymus                                                                                                                           | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/14 (14%)   2/15 (13%)   2/15 (13%)   5/15 (33%)  |2/15 (13%)   4/14 (29%)   2/15 (13%)   3/15 (20%)   | 
|POLY-3 RATE (b)    |     2/12.61      2/12.43      2/13.58      5/15.00     |2/12.95      4/11.88      2/13.14      3/12.55      | 
|POLY-3 PERCENT (g) |     15.9%        16.1%        14.7%        33.3%       |15.4%        33.7%        15.2%        23.9%        | 
|TERMINAL (d)       |     2/12 (17%)   2/11 (18%)   2/13 (15%)   5/15 (33%)  |2/11 (18%)   3/10 (30%)   1/11 (9%)    2/11 (18%)   | 
|FIRST INCIDENCE    |     181 (T)      181 (T)      181 (T)      181 (T)     |182 (T)      71           140          99           | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.184      P=0.672      P=0.673N     P=0.298     |P=0.527      P=0.290      P=0.691      P=0.500      | 
|POLY 3             |     P=0.149      P=0.696      P=0.673N     P=0.274     |P=0.519      P=0.279      P=0.696N     P=0.485      | 
|POLY 1.5           |     P=0.137      P=0.701      P=0.674N     P=0.258     |P=0.523      P=0.278      P=0.694N     P=0.487      | 
|POLY 6             |     P=0.158      P=0.694      P=0.672N     P=0.287     |P=0.529      P=0.292      P=0.695N     P=0.495      | 
|LOGISTIC REGRESSION|     P=0.184      P=0.672      P=0.673N     P=0.298     |P=0.542      P=0.287      P=0.704      P=0.496      | 
|COCH-ARM / FISHERS |     P=0.109      P=0.674N     P=0.674N     P=0.224     |P=0.535      P=0.291      P=0.701N     P=0.500      | 
|ORDER RESTRICTED   |     P=0.196      (e)          (e)          (e)         |P=0.478      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/04                           EXPERIMENT: 97013 TEST: 11                                            Page 12      
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -         WATER DISINFECTION MODEL (SOD
IUM BR                                                                                                                              
                                         Terminal Sacrifice at 26 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland                                                                                                                    | 
|     Infiltration Cellular Lymphocyte                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/15 (0%)    0/15 (0%)    1/15 (7%)    0/15 (0%)   |0/15 (0%)    6/15 (40%)   3/15 (20%)   12/15 (80%)  | 
|POLY-3 RATE (b)    |     0/12.62      0/12.43      1/14.53      0/15.00     |0/12.95      6/11.53      3/12.60      12/12.66     | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         6.9%         0.0%        |0.0%         52.1%        23.8%        94.8%        | 
|TERMINAL (d)       |     0/12 (0%)    0/11 (0%)    0/13 (0%)    0/15 (0%)   |0/11 (0%)    6/10 (60%)   3/11 (27%)   11/11 (100%) | 
|FIRST INCIDENCE    |     ---          ---          68           ---         |---          182 (T)      182 (T)      69           | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.704      (e)          P=0.514      (e)         |P<0.001 **   P=0.006 **   P=0.112      P<0.001 **   | 
|POLY 3             |     P=0.761      (e)          P=0.528      (e)         |P<0.001 **   P=0.002 **   P=0.098      P<0.001 **   | 
|POLY 1.5           |     P=0.745      (e)          P=0.523      (e)         |P<0.001 **   P=0.002 **   P=0.103      P<0.001 **   | 
|POLY 6             |     P=0.769N     (e)          P=0.530      (e)         |P<0.001 **   P=0.002 **   P=0.093      P<0.001 **   | 
|LOGISTIC REGRESSION|     P=0.401      (e)          P=0.296      (e)         |P<0.001 **   P=0.006 **   P=0.112      P<0.001 **   | 
|COCH-ARM / FISHERS |     P=0.695      (e)          P=0.500      (e)         |P<0.001 **   P=0.008 **   P=0.112      P<0.001 **   | 
|ORDER RESTRICTED   |     P=0.406      (e)          (e)          (e)         |P<0.001 **   (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: Follicle                                                                                                          | 
|     Depletion Secretory                                                                                                         | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     7/15 (47%)   4/15 (27%)   5/15 (33%)   11/15 (73%) |6/15 (40%)   11/15 (73%)  13/15 (87%)  14/15 (93%)  | 
|POLY-3 RATE (b)    |     7/12.62      4/12.43      5/14.53      11/15.00    |6/13.21      11/12.85     13/13.88     14/14.16     | 
|POLY-3 PERCENT (g) |     55.5%        32.2%        34.4%        73.3%       |45.4%        85.6%        93.7%        98.9%        | 
|TERMINAL (d)       |     7/12 (58%)   4/11 (36%)   4/13 (31%)   11/15 (73%) |5/11 (46%)   9/10 (90%)   11/11 (100%) 11/11 (100%) | 
|FIRST INCIDENCE    |     181 (T)      181 (T)      68           181 (T)     |165          81           108          69           | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.156      P=0.267N     P=0.294N     P=0.343     |P=0.004 **   P=0.044 *    P=0.013 *    P=0.007 **   | 
|POLY 3             |     P=0.086      P=0.220N     P=0.240N     P=0.283     |P<0.001 **   P=0.029 *    P=0.003 **   P<0.001 **   | 
|POLY 1.5           |     P=0.071      P=0.219N     P=0.261N     P=0.240     |P<0.001 **   P=0.034 *    P=0.004 **   P<0.001 **   | 
|POLY 6             |     P=0.098      P=0.222N     P=0.231N     P=0.316     |P<0.001 **   P=0.029 *    P=0.002 **   P<0.001 **   | 
|LOGISTIC REGRESSION|     P=0.084      P=0.267N     P=0.328N     P=0.343     |P<0.001 **   P=0.032 *    P=0.007 **   P=0.002 **   | 
|COCH-ARM / FISHERS |     P=0.044 *    P=0.225N     P=0.355N     P=0.132     |P=0.002 **   P=0.070      P=0.010 *    P=0.003 **   | 
|ORDER RESTRICTED   |     P=0.053      (e)          (e)          (e)         |P<0.001 **   (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/04                           EXPERIMENT: 97013 TEST: 11                                            Page 13      
Statistical Analysis of Non-neoplastic Lesions in       Mice(TG.AC HETEROZYGOUS TRANSGENIC)  -         WATER DISINFECTION MODEL (SOD
IUM BR                                                                                                                              
                                         Terminal Sacrifice at 26 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: Follicular Cell                                                                                                   | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/15 (0%)    7/15 (47%)   10/15 (67%)  14/15 (93%) |1/15 (7%)    9/15 (60%)   12/15 (80%)  13/15 (87%)  | 
|POLY-3 RATE (b)    |     0/12.62      7/13.41      10/14.53     14/15.00    |1/12.95      9/11.94      12/13.14     13/13.40     | 
|POLY-3 PERCENT (g) |     0.0%         52.2%        68.9%        93.3%       |7.7%         75.4%        91.3%        97.0%        | 
|TERMINAL (d)       |     0/12 (0%)    6/11 (55%)   9/13 (69%)   14/15 (93%) |1/11 (9%)    8/10 (80%)   11/11 (100%) 11/11 (100%) | 
|FIRST INCIDENCE    |     ---          48           68           181 (T)     |182 (T)      152          140          69           | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P<0.001 **   P=0.004 **   P<0.001 **   P<0.001 **  |P<0.001 **   P=0.002 **   P<0.001 **   P<0.001 **   | 
|POLY 3             |     P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **  |P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   | 
|POLY 1.5           |     P<0.001 **   P=0.002 **   P<0.001 **   P<0.001 **  |P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   | 
|POLY 6             |     P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **  |P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   | 
|LOGISTIC REGRESSION|     P<0.001 **   P=0.005 **   P<0.001 **   P<0.001 **  |P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   | 
|COCH-ARM / FISHERS |     P<0.001 **   P=0.003 **   P<0.001 **   P<0.001 **  |P<0.001 **   P=0.003 **   P<0.001 **   P<0.001 **   | 
|ORDER RESTRICTED   |     P<0.001 **   (e)          (e)          (e)         |P<0.001 **   (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus: Endometrium                                                                                                              | 
|     Hyperplasia Cystic                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |11/15 (73%)  9/15 (60%)   10/15 (67%)  10/15 (67%)  | 
|POLY-3 RATE (b)    |                                                        |11/13.21     9/12.47      10/12.60     10/11.71     | 
|POLY-3 PERCENT (g) |                                                        |83.3%        72.2%        79.4%        85.4%        | 
|TERMINAL (d)       |                                                        |10/11 (91%)  8/10 (80%)   10/11 (91%)  10/11 (91%)  | 
|FIRST INCIDENCE    |                                                        |165          71           182 (T)      182 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |P=0.434N     P=0.482N     P=0.510N     P=0.510N     | 
|POLY 3             |                                                        |P=0.468      P=0.416N     P=0.610N     P=0.673      | 
|POLY 1.5           |                                                        |P=0.545      P=0.395N     P=0.533N     P=0.676N     | 
|POLY 6             |                                                        |P=0.431      P=0.422N     P=0.715N     P=0.667      | 
|LOGISTIC REGRESSION|                                                        |P=0.473      P=0.515N     P=0.677N     P=0.733N     | 
|COCH-ARM / FISHERS |                                                        |P=0.500N     P=0.350N     P=0.500N     P=0.500N     | 
|ORDER RESTRICTED   |                                                        |P=0.484      (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).