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).