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TDMS Study 97013-99 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                       WATER DISINFECTION MODEL (BROMODICHLOROMETHANE)                   DATE: 11/05/03       
EXPERIMENT: 97013 TEST: 99                                                                                     TIME: 10:06:40       
TEST TYPE:  SUBCHRON 26-WEEK                    CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-65406                              ROUTE: SKIN APPLICATION                                        NTP C#: 97013F       
PATHOLOGIST: MISSING                                                                                           CAS: 75-27-4         
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                            FINAL#1 MICE                                                            
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
                                                                                                                                   
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                       WATER DISINFECTION MODEL (BROMODICHLOROMETHANE)                   DATE: 11/05/03       
EXPERIMENT: 97013 TEST: 99                                                                                     TIME: 10:06:40       
TEST TYPE:  SUBCHRON 26-WEEK                    CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-65406                              ROUTE: SKIN APPLICATION                                        NTP C#: 97013F       
PATHOLOGIST: MISSING                                                                                           CAS: 75-27-4         
Mice(TG.AC HETEROZYGOUS TRANSGENIC)                                                                                                 
-----------------------------                                                                                                       
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE                                                                   
BASED ON NUMBER OF TISSUES EXAMINED.  IN OTHER TISSUES/ORGANS RATES                                                                 
ARE BASED ON THE NUMBER OF ANIMALS NECROPSIED.                                                                                      
                                                 ---------------                                                                    
                                                 Lung                                                                               
                                                 Salivary Glands                                                                    
                                                                                                                                   
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                       WATER DISINFECTION MODEL (BROMODICHLOROMETHANE)                   DATE: 11/05/03       
EXPERIMENT: 97013 TEST: 99                                                                                     TIME: 10:06:40       
TEST TYPE:  SUBCHRON 26-WEEK                    CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-65406                              ROUTE: SKIN APPLICATION                                        NTP C#: 97013F       
PATHOLOGIST: MISSING                                                                                           CAS: 75-27-4         
                                                                                                                                    
                                                                                                                                    
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS                                                                               
IN THE ANALYSIS OF     WATER DISINFECTION MODEL (BROMODICHLOR                                                                       
===============================================================                                                                     
Female Mice                                                                                                                         
------------                                                                                                                        
Organ                                  Morphology                                                                                   
-----                                  ----------                                                                                   
Skin                                                                                                                                
Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthom
a, Trichoepitheliom                                                                                                                 
                                       Squamous Cell Papilloma                                                                      
                                       Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma               
===============================================================                                                                     
                                                                                                                                   
       Date:  11/05/03                           EXPERIMENT: 97013 TEST: 99                                            Page 1       
Statistical Analysis of Primary Tumors in Mice(TG.AC HETEROZYGOUS TRANSGENIC)        -      WATER DISINFECTION MODEL (BROMODICHLOR  
                                         Terminal Sacrifice at 40 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Alveolar/Bronchiolar Adenoma                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/10 (0%)    2/10 (20%)   0/10 (0%)    0/10 (0%)   |0/10 (0%)    0/10 (0%)    1/10 (10%)   1/10 (10%)   | 
|POLY-3 RATE (b)    |     0/7.65       2/8.19       0/9.85       0/9.08      |0/5.97       0/4.87       1/8.76       1/5.96       | 
|POLY-3 PERCENT (g) |     0.0%         24.4%        0.0%         0.0%        |0.0%         0.0%         11.4%        16.8%        | 
|TERMINAL (d)       |     0/6 (0%)     2/8 (25%)    0/9 (0%)     0/8 (0%)    |0/5 (0%)     0/4 (0%)     1/7 (14%)    1/5 (20%)    | 
|FIRST INCIDENCE    |     ---          274 (T)      ---          ---         |---          ---          274 (T)      274 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.355N     P=0.298      (e)          (e)         |P=0.243      (e)          P=0.567      P=0.500      | 
|POLY 3             |     P=0.352N     P=0.239      (e)          (e)         |P=0.251      (e)          P=0.574      P=0.500      | 
|POLY 1.5           |     P=0.375N     P=0.225      (e)          (e)         |P=0.251      (e)          P=0.564      P=0.506      | 
|POLY 6             |     P=0.323N     P=0.264      (e)          (e)         |P=0.240      (e)          P=0.569      P=0.489      | 
|LOGISTIC REGRESSION|     (e)          P=0.298      (e)          (e)         |(e)          (e)          P=0.567      P=0.500      | 
|COCH-ARM / FISHERS |     P=0.403N     P=0.237      (e)          (e)         |P=0.231      (e)          P=0.500      P=0.500      | 
|ORDER RESTRICTED   |     P=0.206N     (e)          (e)          (e)         |P=0.246      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor                                                                       | 
|     (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepitheliom                           | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     6/10 (60%)   5/10 (50%)   7/10 (70%)   3/10 (30%)  |6/10 (60%)   3/10 (30%)   7/10 (70%)   1/10 (10%)   | 
|POLY-3 RATE (b)    |     6/8.63       5/8.19       7/9.85       3/9.22      |6/6.17       3/4.87       7/9.58       1/5.96       | 
|POLY-3 PERCENT (g) |     69.5%        61.1%        71.0%        32.5%       |97.2%        61.7%        73.0%        16.8%        | 
|TERMINAL (d)       |     4/6 (67%)    5/8 (63%)    7/9 (78%)    2/8 (25%)   |5/5 (100%)   3/4 (75%)    5/7 (71%)    1/5 (20%)    | 
|FIRST INCIDENCE    |     202          274 (T)      274 (T)      260         |254          274 (T)      226          274 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.062N     P=0.289N     P=0.424N     P=0.107N    |P=0.016N*    P=0.257N     P=0.475N     P=0.020N*    | 
|POLY 3             |     P=0.083N     P=0.558N     P=0.666      P=0.131N    |P=0.003N**   P=0.185N     P=0.289N     P<0.001N**   | 
|POLY 1.5           |     P=0.100N     P=0.562N     P=0.608      P=0.149N    |P=0.005N**   P=0.132N     P=0.414N     P=0.002N**   | 
|POLY 6             |     P=0.072N     P=0.530N     P=0.682N     P=0.115N    |P=0.004N**   P=0.318N     P=0.277N     P=0.003N**   | 
|LOGISTIC REGRESSION|     P=0.066N     P=0.460N     P=0.665N     P=0.132N    |P=0.006N**   P=0.324N     P=0.326N     P=0.011N*    | 
|COCH-ARM / FISHERS |     P=0.155N     P=0.500N     P=0.500      P=0.185N    |P=0.047N*    P=0.185N     P=0.500      P=0.029N*    | 
|ORDER RESTRICTED   |     P=0.081N     (e)          (e)          (e)         |P<0.001N**   (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/05/03                           EXPERIMENT: 97013 TEST: 99                                            Page 2       
Statistical Analysis of Primary Tumors in Mice(TG.AC HETEROZYGOUS TRANSGENIC)       -      WATER DISINFECTION MODEL (BROMODICHLOR   
                                         Terminal Sacrifice at 40 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Squamous Cell Papilloma                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     6/10 (60%)   5/10 (50%)   7/10 (70%)   3/10 (30%)  |6/10 (60%)   3/10 (30%)   7/10 (70%)   1/10 (10%)   | 
|POLY-3 RATE (b)    |     6/8.63       5/8.19       7/9.85       3/9.22      |6/6.17       3/4.87       7/9.58       1/5.96       | 
|POLY-3 PERCENT (g) |     69.5%        61.1%        71.0%        32.5%       |97.2%        61.7%        73.0%        16.8%        | 
|TERMINAL (d)       |     4/6 (67%)    5/8 (63%)    7/9 (78%)    2/8 (25%)   |5/5 (100%)   3/4 (75%)    5/7 (71%)    1/5 (20%)    | 
|FIRST INCIDENCE    |     202          274 (T)      274 (T)      260         |254          274 (T)      226          274 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.062N     P=0.289N     P=0.424N     P=0.107N    |P=0.016N*    P=0.257N     P=0.475N     P=0.020N*    | 
|POLY 3             |     P=0.083N     P=0.558N     P=0.666      P=0.131N    |P=0.003N**   P=0.185N     P=0.289N     P<0.001N**   | 
|POLY 1.5           |     P=0.100N     P=0.562N     P=0.608      P=0.149N    |P=0.005N**   P=0.132N     P=0.414N     P=0.002N**   | 
|POLY 6             |     P=0.072N     P=0.530N     P=0.682N     P=0.115N    |P=0.004N**   P=0.318N     P=0.277N     P=0.003N**   | 
|LOGISTIC REGRESSION|     P=0.066N     P=0.460N     P=0.665N     P=0.132N    |P=0.006N**   P=0.324N     P=0.326N     P=0.011N*    | 
|COCH-ARM / FISHERS |     P=0.155N     P=0.500N     P=0.500      P=0.185N    |P=0.047N*    P=0.185N     P=0.500      P=0.029N*    | 
|ORDER RESTRICTED   |     P=0.081N     (e)          (e)          (e)         |P<0.001N**   (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Squamous Cell Papilloma, Papilloma, Squamous Cell                                                                           | 
|     Carcinoma or Keratoacanthoma                                                                                                | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     6/10 (60%)   5/10 (50%)   7/10 (70%)   3/10 (30%)  |6/10 (60%)   3/10 (30%)   7/10 (70%)   1/10 (10%)   | 
|POLY-3 RATE (b)    |     6/8.63       5/8.19       7/9.85       3/9.22      |6/6.17       3/4.87       7/9.58       1/5.96       | 
|POLY-3 PERCENT (g) |     69.5%        61.1%        71.0%        32.5%       |97.2%        61.7%        73.0%        16.8%        | 
|TERMINAL (d)       |     4/6 (67%)    5/8 (63%)    7/9 (78%)    2/8 (25%)   |5/5 (100%)   3/4 (75%)    5/7 (71%)    1/5 (20%)    | 
|FIRST INCIDENCE    |     202          274 (T)      274 (T)      260         |254          274 (T)      226          274 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.062N     P=0.289N     P=0.424N     P=0.107N    |P=0.016N*    P=0.257N     P=0.475N     P=0.020N*    | 
|POLY 3             |     P=0.083N     P=0.558N     P=0.666      P=0.131N    |P=0.003N**   P=0.185N     P=0.289N     P<0.001N**   | 
|POLY 1.5           |     P=0.100N     P=0.562N     P=0.608      P=0.149N    |P=0.005N**   P=0.132N     P=0.414N     P=0.002N**   | 
|POLY 6             |     P=0.072N     P=0.530N     P=0.682N     P=0.115N    |P=0.004N**   P=0.318N     P=0.277N     P=0.003N**   | 
|LOGISTIC REGRESSION|     P=0.066N     P=0.460N     P=0.665N     P=0.132N    |P=0.006N**   P=0.324N     P=0.326N     P=0.011N*    | 
|COCH-ARM / FISHERS |     P=0.155N     P=0.500N     P=0.500      P=0.185N    |P=0.047N*    P=0.185N     P=0.500      P=0.029N*    | 
|ORDER RESTRICTED   |     P=0.081N     (e)          (e)          (e)         |P<0.001N**   (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/05/03                           EXPERIMENT: 97013 TEST: 99                                            Page 3       
Statistical Analysis of Primary Tumors in Mice(TG.AC HETEROZYGOUS TRANSGENIC)       -      WATER DISINFECTION MODEL (BROMODICHLOR   
                                         Terminal Sacrifice at 40 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Squamous Cell Papilloma                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/10 (30%)   6/10 (60%)   5/10 (50%)   6/10 (60%)  |1/10 (10%)   4/10 (40%)   5/10 (50%)   4/10 (40%)   | 
|POLY-3 RATE (b)    |     3/8.25       6/8.19       5/10.00      6/9.22      |1/5.97       4/5.53       5/9.58       4/5.96       | 
|POLY-3 PERCENT (g) |     36.4%        73.3%        50.0%        65.1%       |16.8%        72.3%        52.2%        67.1%        | 
|TERMINAL (d)       |     2/6 (33%)    6/8 (75%)    4/9 (44%)    5/8 (63%)   |1/5 (20%)    3/4 (75%)    3/7 (43%)    4/5 (80%)    | 
|FIRST INCIDENCE    |     202          274 (T)      260          260         |274 (T)      190          226          274 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.373      P=0.335      P=0.584      P=0.368     |P=0.178      P=0.095      P=0.187      P=0.115      | 
|POLY 3             |     P=0.290      P=0.147      P=0.458      P=0.235     |P=0.141      P=0.080      P=0.206      P=0.105      | 
|POLY 1.5           |     P=0.252      P=0.140      P=0.406      P=0.209     |P=0.157      P=0.098      P=0.168      P=0.124      | 
|POLY 6             |     P=0.339      P=0.178      P=0.515      P=0.275     |P=0.114      P=0.071      P=0.217      P=0.083      | 
|LOGISTIC REGRESSION|     P=0.320      P=0.201      P=0.406      P=0.263     |P=0.162      P=0.074      P=0.145      P=0.115      | 
|COCH-ARM / FISHERS |     P=0.196      P=0.185      P=0.325      P=0.185     |P=0.157      P=0.152      P=0.070      P=0.152      | 
|ORDER RESTRICTED   |     P=0.182      (e)          (e)          (e)         |P=0.067      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Tooth                                                                                                                            | 
|     Odontogenic Tumor                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/10 (30%)   1/10 (10%)   2/10 (20%)   2/10 (20%)  |4/10 (40%)   3/10 (30%)   3/10 (30%)   3/10 (30%)   | 
|POLY-3 RATE (b)    |     3/8.63       1/8.19       2/10.00      2/9.22      |4/6.17       3/5.82       3/9.58       3/6.66       | 
|POLY-3 PERCENT (g) |     34.8%        12.2%        20.0%        21.7%       |64.8%        51.5%        31.3%        45.0%        | 
|TERMINAL (d)       |     1/6 (17%)    1/8 (13%)    1/9 (11%)    1/8 (13%)   |3/5 (60%)    2/4 (50%)    1/7 (14%)    2/5 (40%)    | 
|FIRST INCIDENCE    |     202          274 (T)      260          260         |254          96           226          184          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.398N     P=0.253N     P=0.342N     P=0.390N    |P=0.384N     P=0.651N     P=0.318N     P=0.503N     | 
|POLY 3             |     P=0.457N     P=0.307N     P=0.427N     P=0.466N    |P=0.331N     P=0.548N     P=0.226N     P=0.441N     | 
|POLY 1.5           |     P=0.467N     P=0.311N     P=0.453N     P=0.480N    |P=0.353N     P=0.500N     P=0.268N     P=0.444N     | 
|POLY 6             |     P=0.451N     P=0.296N     P=0.404N     P=0.452N    |P=0.330N     P=0.610N     P=0.224N     P=0.468N     | 
|LOGISTIC REGRESSION|     P=0.494N     P=0.288N     P=0.654N     P=0.528N    |P=0.372N     P=0.598N     P=0.284N     P=0.496N     | 
|COCH-ARM / FISHERS |     P=0.500N     P=0.291N     P=0.500N     P=0.500N    |P=0.432N     P=0.500N     P=0.500N     P=0.500N     | 
|ORDER RESTRICTED   |     P=0.332N     (e)          (e)          (e)         |P=0.273N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/05/03                           EXPERIMENT: 97013 TEST: 99                                            Page 4       
Statistical Analysis of Primary Tumors in Mice(TG.AC HETEROZYGOUS TRANSGENIC)       -      WATER DISINFECTION MODEL (BROMODICHLOR   
                                         Terminal Sacrifice at 40 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Vagina                                                                                                                           | 
|     Squamous Cell Papilloma                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |1/10 (10%)   1/10 (10%)   2/10 (20%)   2/10 (20%)   | 
|POLY-3 RATE (b)    |                                                        |1/5.97       1/4.87       2/8.76       2/5.96       | 
|POLY-3 PERCENT (g) |                                                        |16.8%        20.6%        22.8%        33.5%        | 
|TERMINAL (d)       |                                                        |1/5 (20%)    1/4 (25%)    2/7 (29%)    2/5 (40%)    | 
|FIRST INCIDENCE    |                                                        |274 (T)      274 (T)      274 (T)      274 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |P=0.354      P=0.723      P=0.627      P=0.500      | 
|POLY 3             |                                                        |P=0.361      P=0.724      P=0.636      P=0.500      | 
|POLY 1.5           |                                                        |P=0.362      P=0.746      P=0.618      P=0.511      | 
|POLY 6             |                                                        |P=0.344      P=0.705      P=0.627      P=0.479      | 
|LOGISTIC REGRESSION|                                                        |P=0.354      P=0.723      P=0.627      P=0.500      | 
|COCH-ARM / FISHERS |                                                        |P=0.327      P=0.763N     P=0.500      P=0.500      | 
|ORDER RESTRICTED   |                                                        |P=0.413      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Leukemia: Erythrocytic                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/10 (0%)    1/10 (10%)   0/10 (0%)    0/10 (0%)   |2/10 (20%)   3/10 (30%)   0/10 (0%)    2/10 (20%)   | 
|POLY-3 RATE (b)    |     0/7.65       1/9.04       0/9.85       0/9.08      |2/7.88       3/7.13       0/8.76       2/7.35       | 
|POLY-3 PERCENT (g) |     0.0%         11.1%        0.0%         0.0%        |25.4%        42.1%        0.0%         27.2%        | 
|TERMINAL (d)       |     0/6 (0%)     0/8 (0%)     0/9 (0%)     0/8 (0%)    |0/5 (0%)     0/4 (0%)     0/7 (0%)     0/5 (0%)     | 
|FIRST INCIDENCE    |     ---          145          ---          ---         |96           94           ---          133          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.561N     P=0.479      (e)          (e)         |P=0.420N     P=0.461      P=0.204N     P=0.656N     | 
|POLY 3             |     P=0.530N     P=0.533      (e)          (e)         |P=0.467N     P=0.447      P=0.198N     P=0.684      | 
|POLY 1.5           |     P=0.547N     P=0.515      (e)          (e)         |P=0.464N     P=0.458      P=0.196N     P=0.689      | 
|POLY 6             |     P=0.510N     P=0.556      (e)          (e)         |P=0.477N     P=0.454      P=0.210N     P=0.683      | 
|LOGISTIC REGRESSION|     P=0.772N     P=0.695      (e)          (e)         |P=0.561N     P=0.536      P=0.958N     P=0.698      | 
|COCH-ARM / FISHERS |     P=0.568N     P=0.500      (e)          (e)         |P=0.472N     P=0.500      P=0.237N     P=0.709N     | 
|ORDER RESTRICTED   |     P=0.383N     (e)          (e)          (e)         |P=0.260N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/05/03                           EXPERIMENT: 97013 TEST: 99                                            Page 5       
Statistical Analysis of Primary Tumors in Mice(TG.AC HETEROZYGOUS TRANSGENIC)       -      WATER DISINFECTION MODEL (BROMODICHLOR   
                                         Terminal Sacrifice at 40 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Benign Tumors                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     6/10 (60%)   7/10 (70%)   9/10 (90%)   8/10 (80%)  |6/10 (60%)   5/10 (50%)   8/10 (80%)   4/10 (40%)   | 
|POLY-3 RATE (b)    |     6/8.63       7/8.19       9/10.00      8/9.22      |6/6.17       5/5.53       8/9.58       4/5.96       | 
|POLY-3 PERCENT (g) |     69.5%        85.5%        90.0%        86.8%       |97.2%        90.4%        83.5%        67.1%        | 
|TERMINAL (d)       |     4/6 (67%)    7/8 (88%)    8/9 (89%)    7/8 (88%)   |5/5 (100%)   4/4 (100%)   6/7 (86%)    4/5 (80%)    | 
|FIRST INCIDENCE    |     202          274 (T)      260          260         |254          190          226          274 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.518      P=0.579N     P=0.648      P=0.650     |P=0.161N     P=0.716      P=0.638N     P=0.260N     | 
|POLY 3             |     P=0.292      P=0.419      P=0.295      P=0.375     |P=0.105N     P=0.920N     P=0.490N     P=0.224N     | 
|POLY 1.5           |     P=0.251      P=0.416      P=0.228      P=0.345     |P=0.137N     P=0.629N     P=0.638N     P=0.217N     | 
|POLY 6             |     P=0.335      P=0.458      P=0.369      P=0.417     |P=0.131N     P=1.000N     P=0.486N     P=0.334N     | 
|LOGISTIC REGRESSION|     P=0.421      P=0.556      P=0.359      P=0.506     |P=0.078N     P=0.999N     P=0.517N     P=0.341N     | 
|COCH-ARM / FISHERS |     P=0.194      P=0.500      P=0.152      P=0.314     |P=0.313N     P=0.500N     P=0.314      P=0.328N     | 
|ORDER RESTRICTED   |     P=0.217      (e)          (e)          (e)         |P=0.086N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant Tumors                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/10 (10%)   1/10 (10%)   0/10 (0%)    0/10 (0%)   |4/10 (40%)   3/10 (30%)   1/10 (10%)   3/10 (30%)   | 
|POLY-3 RATE (b)    |     1/8.47       1/9.04       0/9.85       0/9.08      |4/7.88       3/7.13       1/9.18       3/8.35       | 
|POLY-3 PERCENT (g) |     11.8%        11.1%        0.0%         0.0%        |50.8%        42.1%        10.9%        35.9%        | 
|TERMINAL (d)       |     0/6 (0%)     0/8 (0%)     0/9 (0%)     0/8 (0%)    |2/5 (40%)    0/4 (0%)     0/7 (0%)     0/5 (0%)     | 
|FIRST INCIDENCE    |     153          145          ---          ---         |96           94           229          37           | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.231N     P=0.724      P=0.500N     P=0.500N    |P=0.345N     P=0.567N     P=0.107N     P=0.469N     | 
|POLY 3             |     P=0.227N     P=0.748N     P=0.470N     P=0.486N    |P=0.327N     P=0.570N     P=0.093N     P=0.461N     | 
|POLY 1.5           |     P=0.230N     P=0.760N     P=0.482N     P=0.493N    |P=0.331N     P=0.556N     P=0.098N     P=0.460N     | 
|POLY 6             |     P=0.224N     P=0.728N     P=0.455N     P=0.475N    |P=0.330N     P=0.560N     P=0.097N     P=0.461N     | 
|LOGISTIC REGRESSION|     P=0.392N     P=0.661N     (e)          (e)         |P=0.455N     P=0.481N     P=0.283N     P=0.525N     | 
|COCH-ARM / FISHERS |     P=0.231N     P=0.763N     P=0.500N     P=0.500N    |P=0.382N     P=0.500N     P=0.152N     P=0.500N     | 
|ORDER RESTRICTED   |     P=0.237N     (e)          (e)          (e)         |P=0.181N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/05/03                           EXPERIMENT: 97013 TEST: 99                                            Page 6       
Statistical Analysis of Primary Tumors in Mice(TG.AC HETEROZYGOUS TRANSGENIC)       -      WATER DISINFECTION MODEL (BROMODICHLOR   
                                         Terminal Sacrifice at 40 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      64 MG/KG     128          256         |0 MG/KG      64 MG/KG     128          256          | 
|                   |                               MG/KG        MG/KG       |                          MG/KG        MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant and Benign Tumors                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     7/10 (70%)   8/10 (80%)   9/10 (90%)   9/10 (90%)  |8/10 (80%)   8/10 (80%)   9/10 (90%)   9/10 (90%)   | 
|POLY-3 RATE (b)    |     7/9.46       8/9.04       9/10.00      9/9.22      |8/8.08       8/8.08       9/10.00      9/9.05       | 
|POLY-3 PERCENT (g) |     74.0%        88.5%        90.0%        97.6%       |99.0%        99.0%        90.0%        99.5%        | 
|TERMINAL (d)       |     4/6 (67%)    7/8 (88%)    8/9 (89%)    8/8 (100%)  |5/5 (100%)   4/4 (100%)   6/7 (86%)    5/5 (100%)   | 
|FIRST INCIDENCE    |     153          145          260          260         |96           94           226          37           | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.554      P=0.591N     P=0.519N     P=0.656N    |P=0.523      P=0.428      P=0.399N     P=0.528      | 
|POLY 3             |     P=0.125      P=0.420      P=0.371      P=0.194     |P=0.756N     P=1.000      P=0.578N     P=1.000      | 
|POLY 1.5           |     P=0.140      P=0.413      P=0.335      P=0.220     |P=0.659      P=0.983N     P=0.674N     P=0.982      | 
|POLY 6             |     P=0.126      P=0.459      P=0.419      P=0.195     |P=0.737N     P=1.000      P=0.546N     P=1.000      | 
|LOGISTIC REGRESSION|     P=0.282      P=0.484      P=0.269      P=0.379     |P=0.429      P=0.757N     P=0.657N     P=0.580      | 
|COCH-ARM / FISHERS |     P=0.180      P=0.500      P=0.291      P=0.291     |P=0.327      P=0.709N     P=0.500      P=0.500      | 
|ORDER RESTRICTED   |     P=0.087      (e)          (e)          (e)         |P=0.469N     (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).