National Toxicology Program

National Toxicology Program
https://ntp.niehs.nih.gov/go/15938

TDMS Study 97013-10 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: 10                                                                                     TIME: 09:12:18       
TEST TYPE:  SUBCHRON 26-WEEK                    CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-65406                              ROUTE: DOSED WATER                                             NTP C#: 97013A       
PATHOLOGIST: TOFT, JOHN                                                                                        CAS: 7789-38-0       
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                                                           FINAL #1 MICE                                                            
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
                                                                                                                                   
NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                          WATER DISINFECTION MODEL (SODIUM BROMATE)                      DATE: 06/18/04       
EXPERIMENT: 97013 TEST: 10                                                                                     TIME: 09:12:18       
TEST TYPE:  SUBCHRON 26-WEEK                    CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-65406                              ROUTE: DOSED WATER                                             NTP C#: 97013A       
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                                                                                    
-----                                 ----------                                                                                    
Pituitary Gland: Pars Distalis         Hyperplasia                                                                                  
Thymus                                 Cyst                                                                                         
===============================================================                                                                     
Female Mice                                                                                                                         
------------                                                                                                                        
Organ                                  Morphology                                                                                   
-----                                  ----------                                                                                   
                                       Cyst                                                                                         
                                       Ectopic Thyroid                                                                              
Thyroid Gland: Follicle                Depletion Secretory                                                                          
Thyroid Gland: Follicular Cell         Hypertrophy                                                                                  
===============================================================                                                                     
                                                                                                                                   
       Date:  06/18/04                           EXPERIMENT: 97013 TEST: 10                                            Page 1       
Statistical Analysis of Non-neoplastic Lesions in        Mice(P53 Heterozygous Transgenic)  -         WATER DISINFECTION MODEL (SODI
UM BR                                                                                                                               
                                         Terminal Sacrifice at 27 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/14 (7%)    0/15 (0%)    2/15 (13%)   0/15 (0%)   |0/15 (0%)    0/15 (0%)    0/15 (0%)    0/15 (0%)    | 
|POLY-3 RATE (b)    |     1/14.00      0/14.47      2/14.34      0/14.22     |0/14.58      0/15.00      0/15.00      0/14.32      | 
|POLY-3 PERCENT (g) |     7.1%         0.0%         14.0%        0.0%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     1/14 (7%)    0/14 (0%)    2/14 (14%)   0/14 (0%)   |0/14 (0%)    0/15 (0%)    0/15 (0%)    0/14 (0%)    | 
|FIRST INCIDENCE    |     184 (T)      ---          184 (T)      ---         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.530N     P=0.500N     P=0.500      P=0.500N    |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.528N     P=0.493N     P=0.508      P=0.497N    |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.526N     P=0.490N     P=0.514      P=0.493N    |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.528N     P=0.497N     P=0.503      P=0.499N    |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.530N     (e)          P=0.500      (e)         |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.518N     P=0.483N     P=0.527      P=0.483N    |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.315N     (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex: Subcapsular                                                                                                      | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/14 (7%)    2/15 (13%)   2/15 (13%)   3/15 (20%)  |13/15 (87%)  12/15 (80%)  13/15 (87%)  14/15 (93%)  | 
|POLY-3 RATE (b)    |     1/14.00      2/14.47      2/14.34      3/14.22     |13/15.00     12/15.00     13/15.00     14/15.00     | 
|POLY-3 PERCENT (g) |     7.1%         13.8%        14.0%        21.1%       |86.7%        80.0%        86.7%        93.3%        | 
|TERMINAL (d)       |     1/14 (7%)    2/14 (14%)   2/14 (14%)   3/14 (21%)  |12/14 (86%)  12/15 (80%)  13/15 (87%)  13/14 (93%)  | 
|FIRST INCIDENCE    |     184 (T)      184 (T)      184 (T)      184 (T)     |154          185 (T)      185 (T)      127          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.235      P=0.500      P=0.500      P=0.298     |P=0.238      P=0.359N     P=0.526N     P=0.494      | 
|POLY 3             |     P=0.237      P=0.512      P=0.508      P=0.303     |P=0.270      P=0.500N     P=0.698      P=0.500      | 
|POLY 1.5           |     P=0.243      P=0.517      P=0.514      P=0.310     |P=0.270      P=0.500N     P=0.698      P=0.500      | 
|POLY 6             |     P=0.234      P=0.506      P=0.503      P=0.299     |P=0.270      P=0.500N     P=0.698      P=0.500      | 
|LOGISTIC REGRESSION|     P=0.235      P=0.500      P=0.500      P=0.298     |(e)          P=0.359N     P=0.526N     (e)          | 
|COCH-ARM / FISHERS |     P=0.251      P=0.527      P=0.527      P=0.326     |P=0.265      P=0.500N     P=0.701N     P=0.500      | 
|ORDER RESTRICTED   |     P=0.237      (e)          (e)          (e)         |P=0.343      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/04                           EXPERIMENT: 97013 TEST: 10                                            Page 2       
Statistical Analysis of Non-neoplastic Lesions in       Mice(P53 Heterozygous Transgenic)  -         WATER DISINFECTION MODEL (SODIU
M BR                                                                                                                                
                                         Terminal Sacrifice at 27 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Nephropathy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     5/15 (33%)   7/15 (47%)   3/15 (20%)   3/15 (20%)  |0/15 (0%)    0/15 (0%)    2/15 (13%)   2/15 (13%)   | 
|POLY-3 RATE (b)    |     5/14.83      7/14.47      3/14.34      3/14.22     |0/14.58      0/15.00      2/15.00      2/14.32      | 
|POLY-3 PERCENT (g) |     33.7%        48.4%        20.9%        21.1%       |0.0%         0.0%         13.3%        14.0%        | 
|TERMINAL (d)       |     5/14 (36%)   7/14 (50%)   3/14 (21%)   3/14 (21%)  |0/14 (0%)    0/15 (0%)    2/15 (13%)   2/14 (14%)   | 
|FIRST INCIDENCE    |     184 (T)      184 (T)      184 (T)      184 (T)     |---          ---          185 (T)      185 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.104N     P=0.354      P=0.341N     P=0.341N    |P=0.062      (e)          P=0.251      P=0.236      | 
|POLY 3             |     P=0.117N     P=0.336      P=0.363N     P=0.368N    |P=0.060      (e)          P=0.238      P=0.227      | 
|POLY 1.5           |     P=0.114N     P=0.344      P=0.356N     P=0.361N    |P=0.061      (e)          P=0.235      P=0.228      | 
|POLY 6             |     P=0.117N     P=0.329      P=0.366N     P=0.369N    |P=0.059      (e)          P=0.242      P=0.227      | 
|LOGISTIC REGRESSION|     P=0.104N     P=0.354      P=0.341N     P=0.341N    |(e)          (e)          P=0.251      P=0.236      | 
|COCH-ARM / FISHERS |     P=0.105N     P=0.355      P=0.341N     P=0.341N    |P=0.065      (e)          P=0.241      P=0.241      | 
|ORDER RESTRICTED   |     P=0.191N     (e)          (e)          (e)         |P=0.105      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     12/15 (80%)  12/15 (80%)  10/15 (67%)  14/15 (93%) |14/15 (93%)  13/15 (87%)  14/15 (93%)  14/15 (93%)  | 
|POLY-3 RATE (b)    |     12/14.83     12/14.47     10/15.00     14/14.22    |14/14.58     13/15.00     14/15.00     14/15.00     | 
|POLY-3 PERCENT (g) |     80.9%        82.9%        66.7%        98.5%       |96.0%        86.7%        93.3%        93.3%        | 
|TERMINAL (d)       |     12/14 (86%)  12/14 (86%)  9/14 (64%)   14/14 (100%)|14/14 (100%) 13/15 (87%)  14/15 (93%)  13/14 (93%)  | 
|FIRST INCIDENCE    |     184 (T)      184 (T)      128          184 (T)     |185 (T)      185 (T)      185 (T)      127          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.256      P=0.702      P=0.347N     P=0.236     |P=0.391      P=0.251N     P=0.514N     P=0.760      | 
|POLY 3             |     P=0.204      P=0.632      P=0.322N     P=0.160     |P=0.550      P=0.398N     P=0.696N     P=0.696N     | 
|POLY 1.5           |     P=0.220      P=0.647      P=0.332N     P=0.200     |P=0.517      P=0.445N     P=0.730N     P=0.730N     | 
|POLY 6             |     P=0.204      P=0.619      P=0.305N     P=0.143     |P=0.594      P=0.332N     P=0.634N     P=0.634N     | 
|LOGISTIC REGRESSION|     P=0.182      P=0.702      P=0.325N     P=0.236     |P=0.402      P=0.251N     P=0.514N     P=0.721      | 
|COCH-ARM / FISHERS |     P=0.269      P=0.674N     P=0.341N     P=0.299     |P=0.476      P=0.500N     P=0.759N     P=0.759N     | 
|ORDER RESTRICTED   |     P=0.088      (e)          (e)          (e)         |P=0.486N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/04                           EXPERIMENT: 97013 TEST: 10                                            Page 3       
Statistical Analysis of Non-neoplastic Lesions in       Mice(P53 Heterozygous Transgenic)  -         WATER DISINFECTION MODEL (SODIU
M BR                                                                                                                                
                                         Terminal Sacrifice at 27 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Hepatocyte                                                                                                                | 
|     Fatty Change                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     10/15 (67%)  13/15 (87%)  10/15 (67%)  8/15 (53%)  |1/15 (7%)    0/15 (0%)    0/15 (0%)    0/15 (0%)    | 
|POLY-3 RATE (b)    |     10/14.83     13/14.47     10/14.34     8/14.22     |1/15.00      0/15.00      0/15.00      0/14.32      | 
|POLY-3 PERCENT (g) |     67.4%        89.8%        69.8%        56.3%       |6.7%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     10/14 (71%)  13/14 (93%)  10/14 (71%)  8/14 (57%)  |0/14 (0%)    0/15 (0%)    0/15 (0%)    0/14 (0%)    | 
|FIRST INCIDENCE    |     184 (T)      184 (T)      184 (T)      184 (T)     |154          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.080N     P=0.166      P=0.659      P=0.349N    |P=0.360N     P=0.500N     P=0.500N     P=0.514N     | 
|POLY 3             |     P=0.113N     P=0.145      P=0.602      P=0.408N    |P=0.347N     P=0.500N     P=0.500N     P=0.509N     | 
|POLY 1.5           |     P=0.109N     P=0.164      P=0.617      P=0.393N    |P=0.349N     P=0.500N     P=0.500N     P=0.506N     | 
|POLY 6             |     P=0.111N     P=0.128      P=0.594      P=0.411N    |P=0.346N     P=0.500N     P=0.500N     P=0.512N     | 
|LOGISTIC REGRESSION|     P=0.080N     P=0.166      P=0.659      P=0.349N    |P=0.101N     (e)          (e)          P=0.325N     | 
|COCH-ARM / FISHERS |     P=0.096N     P=0.195      P=0.650N     P=0.355N    |P=0.350N     P=0.500N     P=0.500N     P=0.500N     | 
|ORDER RESTRICTED   |     P=0.138N     (e)          (e)          (e)         |P=0.129N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Hepatocyte                                                                                                                | 
|     Vacuolization Cytoplasmic                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     13/15 (87%)  14/15 (93%)  12/15 (80%)  14/15 (93%) |13/15 (87%)  14/15 (93%)  12/15 (80%)  12/15 (80%)  | 
|POLY-3 RATE (b)    |     13/14.83     14/14.47     12/14.34     14/14.22    |13/14.58     14/15.00     12/15.00     12/14.32     | 
|POLY-3 PERCENT (g) |     87.7%        96.8%        83.7%        98.5%       |89.2%        93.3%        80.0%        83.8%        | 
|TERMINAL (d)       |     13/14 (93%)  14/14 (100%) 12/14 (86%)  14/14 (100%)|13/14 (93%)  14/15 (93%)  12/15 (80%)  12/14 (86%)  | 
|FIRST INCIDENCE    |     184 (T)      184 (T)      184 (T)      184 (T)     |185 (T)      185 (T)      185 (T)      185 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.530      P=0.500      P=0.500N     P=0.500     |P=0.278N     P=0.749      P=0.324N     P=0.500N     | 
|POLY 3             |     P=0.381      P=0.403      P=0.589N     P=0.330     |P=0.292N     P=0.601      P=0.428N     P=0.549N     | 
|POLY 1.5           |     P=0.425      P=0.445      P=0.557N     P=0.386     |P=0.278N     P=0.555      P=0.460N     P=0.534N     | 
|POLY 6             |     P=0.371      P=0.359      P=0.609N     P=0.306     |P=0.297N     P=0.664      P=0.384N     P=0.546N     | 
|LOGISTIC REGRESSION|     P=0.530      P=0.500      P=0.500N     P=0.500     |P=0.278N     P=0.749      P=0.324N     P=0.500N     | 
|COCH-ARM / FISHERS |     P=0.520      P=0.500      P=0.500N     P=0.500     |P=0.245N     P=0.500      P=0.500N     P=0.500N     | 
|ORDER RESTRICTED   |     P=0.202      (e)          (e)          (e)         |P=0.364N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/04                           EXPERIMENT: 97013 TEST: 10                                            Page 4       
Statistical Analysis of Non-neoplastic Lesions in       Mice(P53 Heterozygous Transgenic)  -         WATER DISINFECTION MODEL (SODIU
M BR                                                                                                                                
                                         Terminal Sacrifice at 27 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/15 (13%)   1/15 (7%)    0/15 (0%)    0/15 (0%)   |1/15 (7%)    0/15 (0%)    0/15 (0%)    0/15 (0%)    | 
|POLY-3 RATE (b)    |     2/14.83      1/15.00      0/14.34      0/14.22     |1/14.58      0/15.00      0/15.00      0/14.32      | 
|POLY-3 PERCENT (g) |     13.5%        6.7%         0.0%         0.0%        |6.9%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     2/14 (14%)   0/14 (0%)    0/14 (0%)    0/14 (0%)   |1/14 (7%)    0/15 (0%)    0/15 (0%)    0/14 (0%)    | 
|FIRST INCIDENCE    |     184 (T)      143          ---          ---         |185 (T)      ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.108N     P=0.500N     P=0.236N     P=0.236N    |P=0.353N     P=0.486N     P=0.486N     P=0.500N     | 
|POLY 3             |     P=0.105N     P=0.496N     P=0.239N     P=0.241N    |P=0.352N     P=0.494N     P=0.494N     P=0.503N     | 
|POLY 1.5           |     P=0.103N     P=0.498N     P=0.237N     P=0.238N    |P=0.352N     P=0.497N     P=0.497N     P=0.503N     | 
|POLY 6             |     P=0.106N     P=0.493N     P=0.241N     P=0.242N    |P=0.353N     P=0.491N     P=0.491N     P=0.503N     | 
|LOGISTIC REGRESSION|     P=0.057N     P=0.305N     (e)          (e)         |P=0.353N     (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.100N     P=0.500N     P=0.241N     P=0.241N    |P=0.350N     P=0.500N     P=0.500N     P=0.500N     | 
|ORDER RESTRICTED   |     P=0.076N     (e)          (e)          (e)         |P=0.123N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mandibular                                                                                                           | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/15 (7%)    2/15 (13%)   1/15 (7%)    0/15 (0%)   |0/15 (0%)    2/15 (13%)   1/15 (7%)    1/15 (7%)    | 
|POLY-3 RATE (b)    |     1/14.83      2/14.47      1/14.34      0/14.22     |0/14.58      2/15.00      1/15.00      1/14.32      | 
|POLY-3 PERCENT (g) |     6.7%         13.8%        7.0%         0.0%        |0.0%         13.3%        6.7%         7.0%         | 
|TERMINAL (d)       |     1/14 (7%)    2/14 (14%)   1/14 (7%)    0/14 (0%)   |0/14 (0%)    2/15 (13%)   1/15 (7%)    1/14 (7%)    | 
|FIRST INCIDENCE    |     184 (T)      184 (T)      184 (T)      ---         |---          185 (T)      185 (T)      185 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.198N     P=0.500      P=0.764      P=0.500N    |P=0.571      P=0.251      P=0.514      P=0.500      | 
|POLY 3             |     P=0.209N     P=0.491      P=0.753      P=0.508N    |P=0.570      P=0.238      P=0.506      P=0.496      | 
|POLY 1.5           |     P=0.206N     P=0.495      P=0.755      P=0.506N    |P=0.572      P=0.235      P=0.503      P=0.497      | 
|POLY 6             |     P=0.209N     P=0.488      P=0.752      P=0.509N    |P=0.571      P=0.242      P=0.509      P=0.497      | 
|LOGISTIC REGRESSION|     P=0.198N     P=0.500      P=0.764      (e)         |(e)          P=0.251      P=0.514      P=0.500      | 
|COCH-ARM / FISHERS |     P=0.196N     P=0.500      P=0.759N     P=0.500N    |P=0.578      P=0.241      P=0.500      P=0.500      | 
|ORDER RESTRICTED   |     P=0.223N     (e)          (e)          (e)         |P=0.276      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/04                           EXPERIMENT: 97013 TEST: 10                                            Page 5       
Statistical Analysis of Non-neoplastic Lesions in       Mice(P53 Heterozygous Transgenic)  -         WATER DISINFECTION MODEL (SODIU
M BR                                                                                                                                
                                         Terminal Sacrifice at 27 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |1/15 (7%)    1/15 (7%)    2/15 (13%)   1/15 (7%)    | 
|POLY-3 RATE (b)    |                                                        |1/14.58      1/15.00      2/15.00      1/14.32      | 
|POLY-3 PERCENT (g) |                                                        |6.9%         6.7%         13.3%        7.0%         | 
|TERMINAL (d)       |                                                        |1/14 (7%)    1/15 (7%)    2/15 (13%)   1/14 (7%)    | 
|FIRST INCIDENCE    |                                                        |185 (T)      185 (T)      185 (T)      185 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |P=0.563      P=0.749N     P=0.525      P=0.764      | 
|POLY 3             |                                                        |P=0.554      P=0.754N     P=0.510      P=0.757      | 
|POLY 1.5           |                                                        |P=0.559      P=0.757N     P=0.506      P=0.758      | 
|POLY 6             |                                                        |P=0.551      P=0.750N     P=0.516      P=0.757      | 
|LOGISTIC REGRESSION|                                                        |P=0.563      P=0.749N     P=0.525      P=0.764      | 
|COCH-ARM / FISHERS |                                                        |P=0.571      P=0.759N     P=0.500      P=0.759N     | 
|ORDER RESTRICTED   |                                                        |P=0.584      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis                                                                                                   | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     4/15 (27%)   1/15 (7%)    3/15 (20%)   3/15 (20%)  |0/15 (0%)    0/15 (0%)    0/15 (0%)    1/15 (7%)    | 
|POLY-3 RATE (b)    |     4/14.83      1/14.47      3/15.00      3/14.22     |0/14.58      0/15.00      0/15.00      1/14.32      | 
|POLY-3 PERCENT (g) |     27.0%        6.9%         20.0%        21.1%       |0.0%         0.0%         0.0%         7.0%         | 
|TERMINAL (d)       |     4/14 (29%)   1/14 (7%)    2/14 (14%)   3/14 (21%)  |0/14 (0%)    0/15 (0%)    0/15 (0%)    1/14 (7%)    | 
|FIRST INCIDENCE    |     184 (T)      184 (T)      128          184 (T)     |---          ---          ---          185 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.513      P=0.166N     P=0.500N     P=0.500N    |P=0.182      (e)          (e)          P=0.500      | 
|POLY 3             |     P=0.504      P=0.170N     P=0.493N     P=0.525N    |P=0.183      (e)          (e)          P=0.496      | 
|POLY 1.5           |     P=0.506      P=0.167N     P=0.497N     P=0.518N    |P=0.184      (e)          (e)          P=0.497      | 
|POLY 6             |     P=0.507      P=0.172N     P=0.488N     P=0.526N    |P=0.182      (e)          (e)          P=0.497      | 
|LOGISTIC REGRESSION|     P=0.546      P=0.166N     P=0.397N     P=0.500N    |(e)          (e)          (e)          P=0.500      | 
|COCH-ARM / FISHERS |     P=0.517      P=0.165N     P=0.500N     P=0.500N    |P=0.185      (e)          (e)          P=0.500      | 
|ORDER RESTRICTED   |     P=0.364N     (e)          (e)          (e)         |P=0.116      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/04                           EXPERIMENT: 97013 TEST: 10                                            Page 6       
Statistical Analysis of Non-neoplastic Lesions in       Mice(P53 Heterozygous Transgenic)  -         WATER DISINFECTION MODEL (SODIU
M BR                                                                                                                                
                                         Terminal Sacrifice at 27 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis                                                                                                   | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/15 (13%)   0/15 (0%)    0/15 (0%)    0/15 (0%)   |0/15 (0%)    0/15 (0%)    1/15 (7%)    1/15 (7%)    | 
|POLY-3 RATE (b)    |     2/14.83      0/14.47      0/14.34      0/14.22     |0/14.58      0/15.00      1/15.00      1/14.32      | 
|POLY-3 PERCENT (g) |     13.5%        0.0%         0.0%         0.0%        |0.0%         0.0%         6.7%         7.0%         | 
|TERMINAL (d)       |     2/14 (14%)   0/14 (0%)    0/14 (0%)    0/14 (0%)   |0/14 (0%)    0/15 (0%)    1/15 (7%)    1/14 (7%)    | 
|FIRST INCIDENCE    |     184 (T)      ---          ---          ---         |---          ---          185 (T)      185 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.159N     P=0.236N     P=0.236N     P=0.236N    |P=0.201      (e)          P=0.514      P=0.500      | 
|POLY 3             |     P=0.150N     P=0.237N     P=0.239N     P=0.241N    |P=0.200      (e)          P=0.506      P=0.496      | 
|POLY 1.5           |     P=0.151N     P=0.235N     P=0.237N     P=0.238N    |P=0.203      (e)          P=0.503      P=0.497      | 
|POLY 6             |     P=0.150N     P=0.239N     P=0.241N     P=0.242N    |P=0.198      (e)          P=0.509      P=0.497      | 
|LOGISTIC REGRESSION|     P=0.159N     (e)          (e)          (e)         |(e)          (e)          P=0.514      P=0.500      | 
|COCH-ARM / FISHERS |     P=0.158N     P=0.241N     P=0.241N     P=0.241N    |P=0.206      (e)          P=0.500      P=0.500      | 
|ORDER RESTRICTED   |     P=0.029N*    (e)          (e)          (e)         |P=0.248      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/15 (0%)    1/15 (7%)    0/15 (0%)    1/15 (7%)   |1/15 (7%)    0/15 (0%)    2/15 (13%)   1/15 (7%)    | 
|POLY-3 RATE (b)    |     0/14.83      1/15.00      0/14.34      1/14.22     |1/15.00      0/15.00      2/15.00      1/15.00      | 
|POLY-3 PERCENT (g) |     0.0%         6.7%         0.0%         7.0%        |6.7%         0.0%         13.3%        6.7%         | 
|TERMINAL (d)       |     0/14 (0%)    0/14 (0%)    0/14 (0%)    1/14 (7%)   |0/14 (0%)    0/15 (0%)    2/15 (13%)   0/14 (0%)    | 
|FIRST INCIDENCE    |     ---          143          ---          184 (T)     |154          ---          185 (T)      127          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.456      P=0.500      (e)          P=0.500     |P=0.415      P=0.500N     P=0.516      P=0.753      | 
|POLY 3             |     P=0.453      P=0.502      (e)          P=0.492     |P=0.423      P=0.500N     P=0.500      P=0.760      | 
|POLY 1.5           |     P=0.456      P=0.501      (e)          P=0.494     |P=0.423      P=0.500N     P=0.500      P=0.760      | 
|POLY 6             |     P=0.452      P=0.504      (e)          P=0.491     |P=0.423      P=0.500N     P=0.500      P=0.760      | 
|LOGISTIC REGRESSION|     P=0.597      (e)          (e)          P=0.500     |(e)          (e)          P=0.516      (e)          | 
|COCH-ARM / FISHERS |     P=0.464      P=0.500      (e)          P=0.500     |P=0.422      P=0.500N     P=0.500      P=0.759N     | 
|ORDER RESTRICTED   |     P=0.243      (e)          (e)          (e)         |P=0.374      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/04                           EXPERIMENT: 97013 TEST: 10                                            Page 7       
Statistical Analysis of Non-neoplastic Lesions in       Mice(P53 Heterozygous Transgenic)  -         WATER DISINFECTION MODEL (SODIU
M BR                                                                                                                                
                                         Terminal Sacrifice at 27 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach: Epithelium                                                                                                 | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/15 (20%)   3/15 (20%)   1/15 (7%)    3/14 (21%)  |4/15 (27%)   1/15 (7%)    2/15 (13%)   2/15 (13%)   | 
|POLY-3 RATE (b)    |     3/14.83      3/15.00      1/15.00      3/14.00     |4/15.00      1/15.00      2/15.00      2/14.32      | 
|POLY-3 PERCENT (g) |     20.2%        20.0%        6.7%         21.4%       |26.7%        6.7%         13.3%        14.0%        | 
|TERMINAL (d)       |     3/14 (21%)   2/14 (14%)   0/14 (0%)    3/14 (21%)  |3/14 (21%)   1/15 (7%)    2/15 (13%)   2/14 (14%)   | 
|FIRST INCIDENCE    |     184 (T)      143          128          184 (T)     |154          185 (T)      185 (T)      185 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.524N     P=0.669      P=0.303N     P=0.674     |P=0.424N     P=0.159N     P=0.305N     P=0.337N     | 
|POLY 3             |     P=0.550N     P=0.665N     P=0.294N     P=0.643     |P=0.427N     P=0.163N     P=0.327N     P=0.350N     | 
|POLY 1.5           |     P=0.551N     P=0.668N     P=0.296N     P=0.640     |P=0.421N     P=0.163N     P=0.327N     P=0.341N     | 
|POLY 6             |     P=0.547N     P=0.661N     P=0.290N     P=0.648     |P=0.432N     P=0.163N     P=0.327N     P=0.357N     | 
|LOGISTIC REGRESSION|     P=0.551      P=0.588N     P=0.150N     P=0.674     |P=0.371N     P=0.159N     P=0.305N     P=0.306N     | 
|COCH-ARM / FISHERS |     P=0.554N     P=0.674N     P=0.299N     P=0.639     |P=0.409N     P=0.165N     P=0.326N     P=0.326N     | 
|ORDER RESTRICTED   |     P=0.516N     (e)          (e)          (e)         |P=0.199N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Testes: Germinal Epithelium                                                                                                      | 
|     Degeneration                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     6/15 (40%)   3/15 (20%)   3/15 (20%)   2/15 (13%)  |                                                    | 
|POLY-3 RATE (b)    |     6/14.83      3/14.47      3/14.34      2/14.22     |                                                    | 
|POLY-3 PERCENT (g) |     40.5%        20.7%        20.9%        14.1%       |                                                    | 
|TERMINAL (d)       |     6/14 (43%)   3/14 (21%)   3/14 (21%)   2/14 (14%)  |                                                    | 
|FIRST INCIDENCE    |     184 (T)      184 (T)      184 (T)      184 (T)     |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.114N     P=0.213N     P=0.213N     P=0.109N    |                                                    | 
|POLY 3             |     P=0.123N     P=0.227N     P=0.232N     P=0.117N    |                                                    | 
|POLY 1.5           |     P=0.122N     P=0.222N     P=0.226N     P=0.113N    |                                                    | 
|POLY 6             |     P=0.122N     P=0.230N     P=0.235N     P=0.118N    |                                                    | 
|LOGISTIC REGRESSION|     P=0.114N     P=0.213N     P=0.213N     P=0.109N    |                                                    | 
|COCH-ARM / FISHERS |     P=0.115N     P=0.213N     P=0.213N     P=0.107N    |                                                    | 
|ORDER RESTRICTED   |     P=0.073N     (e)          (e)          (e)         |                                                    | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/04                           EXPERIMENT: 97013 TEST: 10                                            Page 8       
Statistical Analysis of Non-neoplastic Lesions in       Mice(P53 Heterozygous Transgenic)  -         WATER DISINFECTION MODEL (SODIU
M BR                                                                                                                                
                                         Terminal Sacrifice at 27 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thymus                                                                                                                           | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     7/14 (50%)   6/15 (40%)   2/15 (13%)   2/15 (13%)  |4/15 (27%)   7/15 (47%)   12/15 (80%)  3/15 (20%)   | 
|POLY-3 RATE (b)    |     7/14.00      6/14.47      2/14.34      2/14.22     |4/14.58      7/15.00      12/15.00     3/14.32      | 
|POLY-3 PERCENT (g) |     50.0%        41.5%        14.0%        14.1%       |27.4%        46.7%        80.0%        20.9%        | 
|TERMINAL (d)       |     7/14 (50%)   6/14 (43%)   2/14 (14%)   2/14 (14%)  |4/14 (29%)   7/15 (47%)   12/15 (80%)  3/14 (21%)   | 
|FIRST INCIDENCE    |     184 (T)      184 (T)      184 (T)      184 (T)     |185 (T)      185 (T)      185 (T)      185 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.015N*    P=0.500N     P=0.056N     P=0.056N    |P=0.404N     P=0.271      P=0.009 **   P=0.500N     | 
|POLY 3             |     P=0.012N*    P=0.469N     P=0.041N*    P=0.043N*   |P=0.412N     P=0.244      P=0.002 **   P=0.510N     | 
|POLY 1.5           |     P=0.011N*    P=0.455N     P=0.039N*    P=0.040N*   |P=0.399N     P=0.237      P=0.002 **   P=0.508N     | 
|POLY 6             |     P=0.012N*    P=0.485N     P=0.044N*    P=0.045N*   |P=0.418N     P=0.255      P=0.003 **   P=0.509N     | 
|LOGISTIC REGRESSION|     P=0.015N*    P=0.500N     P=0.056N     P=0.056N    |P=0.404N     P=0.271      P=0.009 **   P=0.500N     | 
|COCH-ARM / FISHERS |     P=0.013N*    P=0.434N     P=0.041N*    P=0.041N*   |P=0.383N     P=0.225      P=0.005 **   P=0.500N     | 
|ORDER RESTRICTED   |     P=0.021N*    (e)          (e)          (e)         |P=0.051N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thymus                                                                                                                           | 
|     Ectopic Parathyroid Gland                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/14 (7%)    0/15 (0%)    0/15 (0%)    0/15 (0%)   |0/15 (0%)    2/15 (13%)   1/15 (7%)    2/15 (13%)   | 
|POLY-3 RATE (b)    |     1/14.00      0/14.47      0/14.34      0/14.22     |0/14.58      2/15.00      1/15.00      2/14.32      | 
|POLY-3 PERCENT (g) |     7.1%         0.0%         0.0%         0.0%        |0.0%         13.3%        6.7%         14.0%        | 
|TERMINAL (d)       |     1/14 (7%)    0/14 (0%)    0/14 (0%)    0/14 (0%)   |0/14 (0%)    2/15 (13%)   1/15 (7%)    2/14 (14%)   | 
|FIRST INCIDENCE    |     184 (T)      ---          ---          ---         |---          185 (T)      185 (T)      185 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.352N     P=0.500N     P=0.500N     P=0.500N    |P=0.289      P=0.251      P=0.514      P=0.236      | 
|POLY 3             |     P=0.339N     P=0.493N     P=0.495N     P=0.497N    |P=0.293      P=0.238      P=0.506      P=0.227      | 
|POLY 1.5           |     P=0.341N     P=0.490N     P=0.492N     P=0.493N    |P=0.295      P=0.235      P=0.503      P=0.228      | 
|POLY 6             |     P=0.336N     P=0.497N     P=0.498N     P=0.499N    |P=0.294      P=0.242      P=0.509      P=0.227      | 
|LOGISTIC REGRESSION|     P=0.352N     (e)          (e)          (e)         |(e)          P=0.251      P=0.514      P=0.236      | 
|COCH-ARM / FISHERS |     P=0.344N     P=0.483N     P=0.483N     P=0.483N    |P=0.297      P=0.241      P=0.500      P=0.241      | 
|ORDER RESTRICTED   |     P=0.117N     (e)          (e)          (e)         |P=0.146      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/04                           EXPERIMENT: 97013 TEST: 10                                            Page 9       
Statistical Analysis of Non-neoplastic Lesions in       Mice(P53 Heterozygous Transgenic)  -         WATER DISINFECTION MODEL (SODIU
M BR                                                                                                                                
                                         Terminal Sacrifice at 27 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thymus                                                                                                                           | 
|     Ectopic Thyroid                                                                                                             | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/14 (7%)    0/15 (0%)    0/15 (0%)    0/15 (0%)   |0/15 (0%)    0/15 (0%)    0/15 (0%)    2/15 (13%)   | 
|POLY-3 RATE (b)    |     1/14.00      0/14.47      0/14.34      0/14.22     |0/14.58      0/15.00      0/15.00      2/14.32      | 
|POLY-3 PERCENT (g) |     7.1%         0.0%         0.0%         0.0%        |0.0%         0.0%         0.0%         14.0%        | 
|TERMINAL (d)       |     1/14 (7%)    0/14 (0%)    0/14 (0%)    0/14 (0%)   |0/14 (0%)    0/15 (0%)    0/15 (0%)    2/14 (14%)   | 
|FIRST INCIDENCE    |     184 (T)      ---          ---          ---         |---          ---          ---          185 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.352N     P=0.500N     P=0.500N     P=0.500N    |P=0.040 *    (e)          (e)          P=0.236      | 
|POLY 3             |     P=0.339N     P=0.493N     P=0.495N     P=0.497N    |P=0.037 *    (e)          (e)          P=0.227      | 
|POLY 1.5           |     P=0.341N     P=0.490N     P=0.492N     P=0.493N    |P=0.037 *    (e)          (e)          P=0.228      | 
|POLY 6             |     P=0.336N     P=0.497N     P=0.498N     P=0.499N    |P=0.037 *    (e)          (e)          P=0.227      | 
|LOGISTIC REGRESSION|     P=0.352N     (e)          (e)          (e)         |(e)          (e)          (e)          P=0.236      | 
|COCH-ARM / FISHERS |     P=0.344N     P=0.483N     P=0.483N     P=0.483N    |P=0.041 *    (e)          (e)          P=0.241      | 
|ORDER RESTRICTED   |     P=0.117N     (e)          (e)          (e)         |P=0.024 *    (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland                                                                                                                    | 
|     Ectopic Thymus                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/15 (0%)    0/15 (0%)    1/15 (7%)    1/15 (7%)   |1/15 (7%)    2/15 (13%)   2/15 (13%)   0/15 (0%)    | 
|POLY-3 RATE (b)    |     0/14.83      0/14.47      1/14.34      1/14.22     |1/14.58      2/15.00      2/15.00      0/14.32      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         7.0%         7.0%        |6.9%         13.3%        13.3%        0.0%         | 
|TERMINAL (d)       |     0/14 (0%)    0/14 (0%)    1/14 (7%)    1/14 (7%)   |1/14 (7%)    2/15 (13%)   2/15 (13%)   0/14 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          184 (T)      184 (T)     |185 (T)      185 (T)      185 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.207      (e)          P=0.500      P=0.500     |P=0.263N     P=0.525      P=0.525      P=0.500N     | 
|POLY 3             |     P=0.201      (e)          P=0.493      P=0.492     |P=0.267N     P=0.510      P=0.510      P=0.503N     | 
|POLY 1.5           |     P=0.203      (e)          P=0.496      P=0.494     |P=0.265N     P=0.506      P=0.506      P=0.503N     | 
|POLY 6             |     P=0.201      (e)          P=0.492      P=0.491     |P=0.268N     P=0.516      P=0.516      P=0.503N     | 
|LOGISTIC REGRESSION|     (e)          (e)          P=0.500      P=0.500     |P=0.263N     P=0.525      P=0.525      (e)          | 
|COCH-ARM / FISHERS |     P=0.206      (e)          P=0.500      P=0.500     |P=0.257N     P=0.500      P=0.500      P=0.500N     | 
|ORDER RESTRICTED   |     P=0.242      (e)          (e)          (e)         |P=0.230N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/04                           EXPERIMENT: 97013 TEST: 10                                            Page 10      
Statistical Analysis of Non-neoplastic Lesions in       Mice(P53 Heterozygous Transgenic)  -         WATER DISINFECTION MODEL (SODIU
M BR                                                                                                                                
                                         Terminal Sacrifice at 27 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland                                                                                                                    | 
|     Infiltration Cellular Lymphocyte                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/15 (7%)    1/15 (7%)    1/15 (7%)    0/15 (0%)   |0/15 (0%)    1/15 (7%)    2/15 (13%)   0/15 (0%)    | 
|POLY-3 RATE (b)    |     1/14.83      1/14.47      1/14.34      0/14.22     |0/14.58      1/15.00      2/15.00      0/14.32      | 
|POLY-3 PERCENT (g) |     6.7%         6.9%         7.0%         0.0%        |0.0%         6.7%         13.3%        0.0%         | 
|TERMINAL (d)       |     1/14 (7%)    1/14 (7%)    1/14 (7%)    0/14 (0%)   |0/14 (0%)    1/15 (7%)    2/15 (13%)   0/14 (0%)    | 
|FIRST INCIDENCE    |     184 (T)      184 (T)      184 (T)      ---         |---          185 (T)      185 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.301N     P=0.764      P=0.764      P=0.500N    |P=0.596N     P=0.514      P=0.251      (e)          | 
|POLY 3             |     P=0.312N     P=0.755      P=0.753      P=0.508N    |P=0.598N     P=0.506      P=0.238      (e)          | 
|POLY 1.5           |     P=0.309N     P=0.757      P=0.755      P=0.506N    |P=0.596N     P=0.503      P=0.235      (e)          | 
|POLY 6             |     P=0.312N     P=0.753      P=0.752      P=0.509N    |P=0.599N     P=0.509      P=0.242      (e)          | 
|LOGISTIC REGRESSION|     P=0.301N     P=0.764      P=0.764      (e)         |(e)          P=0.514      P=0.251      (e)          | 
|COCH-ARM / FISHERS |     P=0.299N     P=0.759N     P=0.759N     P=0.500N    |P=0.589N     P=0.500      P=0.241      (e)          | 
|ORDER RESTRICTED   |     P=0.329N     (e)          (e)          (e)         |P=0.325      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: Follicle                                                                                                          | 
|     Depletion Secretory                                                                                                         | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/15 (0%)    0/15 (0%)    0/15 (0%)    0/15 (0%)   |0/15 (0%)    0/15 (0%)    0/15 (0%)    2/15 (13%)   | 
|POLY-3 RATE (b)    |     0/14.83      0/14.47      0/14.34      0/14.22     |0/14.58      0/15.00      0/15.00      2/14.32      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |0.0%         0.0%         0.0%         14.0%        | 
|TERMINAL (d)       |     0/14 (0%)    0/14 (0%)    0/14 (0%)    0/14 (0%)   |0/14 (0%)    0/15 (0%)    0/15 (0%)    2/14 (14%)   | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |---          ---          ---          185 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.040 *    (e)          (e)          P=0.236      | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.037 *    (e)          (e)          P=0.227      | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.037 *    (e)          (e)          P=0.228      | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.037 *    (e)          (e)          P=0.227      | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          P=0.236      | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.041 *    (e)          (e)          P=0.241      | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |P=0.024 *    (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/04                           EXPERIMENT: 97013 TEST: 10                                            Page 11      
Statistical Analysis of Non-neoplastic Lesions in       Mice(P53 Heterozygous Transgenic)  -         WATER DISINFECTION MODEL (SODIU
M BR                                                                                                                                
                                         Terminal Sacrifice at 27 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: Follicular Cell                                                                                                   | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/15 (0%)    0/15 (0%)    0/15 (0%)    0/15 (0%)   |0/15 (0%)    0/15 (0%)    0/15 (0%)    2/15 (13%)   | 
|POLY-3 RATE (b)    |     0/14.83      0/14.47      0/14.34      0/14.22     |0/14.58      0/15.00      0/15.00      2/14.32      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |0.0%         0.0%         0.0%         14.0%        | 
|TERMINAL (d)       |     0/14 (0%)    0/14 (0%)    0/14 (0%)    0/14 (0%)   |0/14 (0%)    0/15 (0%)    0/15 (0%)    2/14 (14%)   | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |---          ---          ---          185 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.040 *    (e)          (e)          P=0.236      | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.037 *    (e)          (e)          P=0.227      | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.037 *    (e)          (e)          P=0.228      | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.037 *    (e)          (e)          P=0.227      | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          P=0.236      | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.041 *    (e)          (e)          P=0.241      | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |P=0.024 *    (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus: Endometrium                                                                                                              | 
|     Hyperplasia Cystic                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |11/15 (73%)  10/15 (67%)  10/15 (67%)  10/15 (67%)  | 
|POLY-3 RATE (b)    |                                                        |11/14.58     10/15.00     10/15.00     10/14.32     | 
|POLY-3 PERCENT (g) |                                                        |75.5%        66.7%        66.7%        69.8%        | 
|TERMINAL (d)       |                                                        |11/14 (79%)  10/15 (67%)  10/15 (67%)  10/14 (71%)  | 
|FIRST INCIDENCE    |                                                        |185 (T)      185 (T)      185 (T)      185 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |P=0.497N     P=0.384N     P=0.384N     P=0.500N     | 
|POLY 3             |                                                        |P=0.503N     P=0.452N     P=0.452N     P=0.530N     | 
|POLY 1.5           |                                                        |P=0.489N     P=0.473N     P=0.473N     P=0.522N     | 
|POLY 6             |                                                        |P=0.510N     P=0.424N     P=0.424N     P=0.528N     | 
|LOGISTIC REGRESSION|                                                        |P=0.497N     P=0.384N     P=0.384N     P=0.500N     | 
|COCH-ARM / FISHERS |                                                        |P=0.458N     P=0.500N     P=0.500N     P=0.500N     | 
|ORDER RESTRICTED   |                                                        |P=0.519N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
(a)  Number of tumor-bearing animals /  number of animals examined at site.                                                         
                                                                                                                                   
(b)  Number of tumor-bearing animals / Poly-3 number                                                                                
(d)  Observed incidence at terminal kill.                                                                                           
(f)  Beneath the control incidence are the P-values associated with the trend                                                       
test.  Beneath the dosed group incidence are the P-values corresponding to                                                          
pairwise comparisons between the controls and that dosed group.  The life                                                           
table analysis regards tumors in animals dying prior to  terminal kill as                                                           
 being (directly or indirectly) the cause of death.                                                                                 
Logistic regression is an alternative                                                                                               
 method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage                                                       
and Fishers exact tests compare directly the overall incidence rates                                                                
For all tests a negative trend is indicated by N                                                                                    
(e)  Value of Statistic cannot be computed.                                                                                         
(g)  Poly-3 adjusted lifetime tumor incidence.                                                                                      
(I)  Interim sacrifice                                                                                                              
(T)  Terminal sacrifice                                                                                                             
#   Tumor rates based on number of animals necropsied.                                                                              
*   To the right of any statistical result, indicates significance at (P<=0.05).                                                    
**  To the right of any statistical result, indicates significance at (P<=0.01).                                                    
NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.