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TDMS Study 97013-97 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                       WATER DISINFECTION MODEL (BROMODICHLOROMETHANE)                   DATE: 11/04/03       
EXPERIMENT: 97013 TEST: 97                                                                                     TIME: 14:15:14       
TEST TYPE:  26-39 WEEKS                         CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-65406                              ROUTE: GAVAGE                                                  NTP C#: 97013K       
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: 11/04/03       
EXPERIMENT: 97013 TEST: 97                                                                                     TIME: 14:15:14       
TEST TYPE:  26-39 WEEKS                         CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-65406                              ROUTE: GAVAGE                                                  NTP C#: 97013K       
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.                                                                                      
                                                 ---------------                                                                    
                                                 Salivary Glands                                                                    
                                                                                                                                   
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                       WATER DISINFECTION MODEL (BROMODICHLOROMETHANE)                   DATE: 11/04/03       
EXPERIMENT: 97013 TEST: 97                                                                                     TIME: 14:15:14       
TEST TYPE:  26-39 WEEKS                         CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-65406                              ROUTE: GAVAGE                                                  NTP C#: 97013K       
PATHOLOGIST: MISSING                                                                                           CAS: 75-27-4         
                                                                                                                                    
                                                                                                                                    
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS                                                                               
IN THE ANALYSIS OF     WATER DISINFECTION MODEL (BROMODICHLOR                                                                       
===============================================================                                                                     
Male Mice                                                                                                                           
------------                                                                                                                        
Organ                                 Morphology                                                                                    
-----                                 ----------                                                                                    
Stomach, Forestomach                   Squamous Cell Papilloma                                                                      
===============================================================                                                                     
Female Mice                                                                                                                         
------------                                                                                                                        
Organ                                  Morphology                                                                                   
-----                                  ----------                                                                                   
                                       Squamous Cell Papilloma                                                                      
All Organs                             Malignant Tumors                                                                             
===============================================================                                                                     
                                                                                                                                   
       Date:  11/04/03                           EXPERIMENT: 97013 TEST: 97                                            Page 1       
Statistical Analysis of Primary Tumors in Mice(TG.AC HETEROZYGOUS TRANSGENIC)        -      WATER DISINFECTION MODEL (BROMODICHLOR  
                                         Terminal Sacrifice at 42 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      25 MG/KG     50 MG/KG     100         |0 MG/KG      25 MG/KG     50 MG/KG     100          | 
|                   |                                            MG/KG       |                                       MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Salivary Glands                                                                                                                  | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/2 (100%)   0/0 (0%)     2/2 (100%)   1/1 (100%)  |0/0 (0%)     0/0 (0%)     0/0 (0%)     3/3 (100%)   | 
|POLY-3 RATE (b)    |     2/2.00       0/0.00       2/2.00       1/1.00      |0/0.00       0/0.00       0/0.00       3/3.00       | 
|POLY-3 PERCENT (g) |     100.0%       0.0%         100.0%       100.0%      |0.0%         0.0%         0.0%         100.0%       | 
|TERMINAL (d)       |     0/0 (0%)     0/0 (0%)     1/1 (100%)   0/0 (0%)    |0/0 (0%)     0/0 (0%)     0/0 (0%)     1/1 (100%)   | 
|FIRST INCIDENCE    |     127          ---          127          169         |---          ---          ---          168          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|POLY 3             |     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|POLY 6             |     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      25 MG/KG     50 MG/KG     100         |0 MG/KG      25 MG/KG     50 MG/KG     100          | 
|                   |                                            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)        |     5/10 (50%)   6/10 (60%)   4/10 (40%)   6/10 (60%)  |6/10 (60%)   4/10 (40%)   6/10 (60%)   7/10 (70%)   | 
|POLY-3 RATE (b)    |     5/6.94       6/6.13       4/8.03       6/8.24      |6/7.66       4/9.86       6/9.08       7/8.46       | 
|POLY-3 PERCENT (g) |     72.1%        97.9%        49.8%        72.9%       |78.4%        40.6%        66.1%        82.7%        | 
|TERMINAL (d)       |     5/6 (83%)    6/6 (100%)   3/6 (50%)    6/8 (75%)   |6/7 (86%)    4/9 (44%)    6/9 (67%)    6/7 (86%)    | 
|FIRST INCIDENCE    |     288 (T)      288 (T)      226          288 (T)     |288 (T)      288 (T)      288 (T)      261          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.360N     P=0.500      P=0.487N     P=0.607N    |P=0.195      P=0.128N     P=0.389N     P=0.516      | 
|POLY 3             |     P=0.495N     P=0.268      P=0.363N     P=0.709     |P=0.230      P=0.131N     P=0.496N     P=0.667      | 
|POLY 1.5           |     P=0.567N     P=0.216      P=0.423N     P=0.616     |P=0.258      P=0.176N     P=0.556N     P=0.629      | 
|POLY 6             |     P=0.427N     P=0.390      P=0.306N     P=0.662N    |P=0.212      P=0.107N     P=0.442N     P=0.688      | 
|LOGISTIC REGRESSION|     P=0.403N     P=0.500      P=0.405N     P=0.607N    |P=0.207      P=0.128N     P=0.389N     P=0.611      | 
|COCH-ARM / FISHERS |     P=0.479      P=0.500      P=0.500N     P=0.500     |P=0.276      P=0.328N     P=0.675N     P=0.500      | 
|ORDER RESTRICTED   |     P=0.235N     (e)          (e)          (e)         |P=0.223      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/04/03                           EXPERIMENT: 97013 TEST: 97                                            Page 2       
Statistical Analysis of Primary Tumors in Mice(TG.AC HETEROZYGOUS TRANSGENIC)       -      WATER DISINFECTION MODEL (BROMODICHLOR   
                                         Terminal Sacrifice at 42 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      25 MG/KG     50 MG/KG     100         |0 MG/KG      25 MG/KG     50 MG/KG     100          | 
|                   |                                            MG/KG       |                                       MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Squamous Cell Papilloma                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     5/10 (50%)   6/10 (60%)   4/10 (40%)   6/10 (60%)  |6/10 (60%)   4/10 (40%)   6/10 (60%)   7/10 (70%)   | 
|POLY-3 RATE (b)    |     5/6.94       6/6.13       4/8.03       6/8.24      |6/7.66       4/9.86       6/9.08       7/8.46       | 
|POLY-3 PERCENT (g) |     72.1%        97.9%        49.8%        72.9%       |78.4%        40.6%        66.1%        82.7%        | 
|TERMINAL (d)       |     5/6 (83%)    6/6 (100%)   3/6 (50%)    6/8 (75%)   |6/7 (86%)    4/9 (44%)    6/9 (67%)    6/7 (86%)    | 
|FIRST INCIDENCE    |     288 (T)      288 (T)      226          288 (T)     |288 (T)      288 (T)      288 (T)      261          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.360N     P=0.500      P=0.487N     P=0.607N    |P=0.195      P=0.128N     P=0.389N     P=0.516      | 
|POLY 3             |     P=0.495N     P=0.268      P=0.363N     P=0.709     |P=0.230      P=0.131N     P=0.496N     P=0.667      | 
|POLY 1.5           |     P=0.567N     P=0.216      P=0.423N     P=0.616     |P=0.258      P=0.176N     P=0.556N     P=0.629      | 
|POLY 6             |     P=0.427N     P=0.390      P=0.306N     P=0.662N    |P=0.212      P=0.107N     P=0.442N     P=0.688      | 
|LOGISTIC REGRESSION|     P=0.403N     P=0.500      P=0.405N     P=0.607N    |P=0.207      P=0.128N     P=0.389N     P=0.611      | 
|COCH-ARM / FISHERS |     P=0.479      P=0.500      P=0.500N     P=0.500     |P=0.276      P=0.328N     P=0.675N     P=0.500      | 
|ORDER RESTRICTED   |     P=0.235N     (e)          (e)          (e)         |P=0.223      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      25 MG/KG     50 MG/KG     100         |0 MG/KG      25 MG/KG     50 MG/KG     100          | 
|                   |                                            MG/KG       |                                       MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Squamous Cell Papilloma, Papilloma, Squamous Cell                                                                           | 
|     Carcinoma or Keratoacanthoma                                                                                                | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     5/10 (50%)   6/10 (60%)   4/10 (40%)   6/10 (60%)  |6/10 (60%)   4/10 (40%)   6/10 (60%)   7/10 (70%)   | 
|POLY-3 RATE (b)    |     5/6.94       6/6.13       4/8.03       6/8.24      |6/7.66       4/9.86       6/9.08       7/8.46       | 
|POLY-3 PERCENT (g) |     72.1%        97.9%        49.8%        72.9%       |78.4%        40.6%        66.1%        82.7%        | 
|TERMINAL (d)       |     5/6 (83%)    6/6 (100%)   3/6 (50%)    6/8 (75%)   |6/7 (86%)    4/9 (44%)    6/9 (67%)    6/7 (86%)    | 
|FIRST INCIDENCE    |     288 (T)      288 (T)      226          288 (T)     |288 (T)      288 (T)      288 (T)      261          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.360N     P=0.500      P=0.487N     P=0.607N    |P=0.195      P=0.128N     P=0.389N     P=0.516      | 
|POLY 3             |     P=0.495N     P=0.268      P=0.363N     P=0.709     |P=0.230      P=0.131N     P=0.496N     P=0.667      | 
|POLY 1.5           |     P=0.567N     P=0.216      P=0.423N     P=0.616     |P=0.258      P=0.176N     P=0.556N     P=0.629      | 
|POLY 6             |     P=0.427N     P=0.390      P=0.306N     P=0.662N    |P=0.212      P=0.107N     P=0.442N     P=0.688      | 
|LOGISTIC REGRESSION|     P=0.403N     P=0.500      P=0.405N     P=0.607N    |P=0.207      P=0.128N     P=0.389N     P=0.611      | 
|COCH-ARM / FISHERS |     P=0.479      P=0.500      P=0.500N     P=0.500     |P=0.276      P=0.328N     P=0.675N     P=0.500      | 
|ORDER RESTRICTED   |     P=0.235N     (e)          (e)          (e)         |P=0.223      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/04/03                           EXPERIMENT: 97013 TEST: 97                                            Page 3       
Statistical Analysis of Primary Tumors in Mice(TG.AC HETEROZYGOUS TRANSGENIC)       -      WATER DISINFECTION MODEL (BROMODICHLOR   
                                         Terminal Sacrifice at 42 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      25 MG/KG     50 MG/KG     100         |0 MG/KG      25 MG/KG     50 MG/KG     100          | 
|                   |                                            MG/KG       |                                       MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Squamous Cell Papilloma                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     8/10 (80%)   6/10 (60%)   9/10 (90%)   6/10 (60%)  |4/10 (40%)   7/10 (70%)   8/10 (80%)   10/10 (100%) | 
|POLY-3 RATE (b)    |     8/8.17       6/6.13       9/9.48       6/8.24      |4/8.13       7/10.00      8/9.08       10/10.00     | 
|POLY-3 PERCENT (g) |     97.9%        97.9%        94.9%        72.9%       |49.2%        70.0%        88.1%        100.0%       | 
|TERMINAL (d)       |     6/6 (100%)   6/6 (100%)   6/6 (100%)   6/8 (75%)   |3/7 (43%)    6/9 (67%)    8/9 (89%)    7/7 (100%)   | 
|FIRST INCIDENCE    |     189          288 (T)      127          288 (T)     |233          274          288 (T)      168          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.058N     P=0.289N     P=0.526      P=0.077N    |P=0.006 **   P=0.406      P=0.233      P=0.036 *    | 
|POLY 3             |     P=0.049N*    P=1.000      P=0.919N     P=0.214N    |P=0.007 **   P=0.344      P=0.100      P=0.010 *    | 
|POLY 1.5           |     P=0.081N     P=0.947N     P=0.873N     P=0.237N    |P=0.005 **   P=0.303      P=0.090      P=0.005 **   | 
|POLY 6             |     P=0.042N*    P=1.000N     P=0.999N     P=0.217N    |P=0.008 **   P=0.358      P=0.104      P=0.013 *    | 
|LOGISTIC REGRESSION|     P=0.081N     P=0.289N     P=0.554      P=0.108N    |P=0.003 **   P=0.338      P=0.139      P=0.009 **   | 
|COCH-ARM / FISHERS |     P=0.338N     P=0.314N     P=0.500      P=0.314N    |P=0.004 **   P=0.185      P=0.085      P=0.005 **   | 
|ORDER RESTRICTED   |     P=0.030N*    (e)          (e)          (e)         |P=0.004 **   (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      25 MG/KG     50 MG/KG     100         |0 MG/KG      25 MG/KG     50 MG/KG     100          | 
|                   |                                            MG/KG       |                                       MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Tooth                                                                                                                            | 
|     Odontogenic Tumor                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     4/10 (40%)   2/10 (20%)   4/10 (40%)   4/10 (40%)  |4/10 (40%)   3/10 (30%)   3/10 (30%)   2/10 (20%)   | 
|POLY-3 RATE (b)    |     4/7.46       2/7.01       4/8.95       4/9.20      |4/9.53       3/9.86       3/9.08       2/8.94       | 
|POLY-3 PERCENT (g) |     53.7%        28.5%        44.7%        43.5%       |42.0%        30.4%        33.0%        22.4%        | 
|TERMINAL (d)       |     3/6 (50%)    1/6 (17%)    2/6 (33%)    3/8 (38%)   |2/7 (29%)    3/9 (33%)    3/9 (33%)    1/7 (14%)    | 
|FIRST INCIDENCE    |     226          143          127          93          |102          288 (T)      288 (T)      185          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.544N     P=0.349N     P=0.638N     P=0.513N    |P=0.264N     P=0.387N     P=0.396N     P=0.318N     | 
|POLY 3             |     P=0.558N     P=0.335N     P=0.552N     P=0.530N    |P=0.285N     P=0.478N     P=0.531N     P=0.347N     | 
|POLY 1.5           |     P=0.577N     P=0.379N     P=0.591N     P=0.573N    |P=0.275N     P=0.487N     P=0.530N     P=0.338N     | 
|POLY 6             |     P=0.552N     P=0.306N     P=0.532N     P=0.507N    |P=0.292N     P=0.469N     P=0.519N     P=0.354N     | 
|LOGISTIC REGRESSION|     P=0.482      P=0.380N     P=0.666N     P=0.657N    |P=0.258N     P=0.616      P=0.593N     P=0.397N     | 
|COCH-ARM / FISHERS |     P=0.455      P=0.314N     P=0.675N     P=0.675N    |P=0.242N     P=0.500N     P=0.500N     P=0.314N     | 
|ORDER RESTRICTED   |     P=0.459N     (e)          (e)          (e)         |P=0.307N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/04/03                           EXPERIMENT: 97013 TEST: 97                                            Page 4       
Statistical Analysis of Primary Tumors in Mice(TG.AC HETEROZYGOUS TRANSGENIC)       -      WATER DISINFECTION MODEL (BROMODICHLOR   
                                         Terminal Sacrifice at 42 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      25 MG/KG     50 MG/KG     100         |0 MG/KG      25 MG/KG     50 MG/KG     100          | 
|                   |                                            MG/KG       |                                       MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Benign Tumors                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     8/10 (80%)   6/10 (60%)   10/10 (100%) 7/10 (70%)  |8/10 (80%)   7/10 (70%)   9/10 (90%)   10/10 (100%) | 
|POLY-3 RATE (b)    |     8/8.17       6/6.13       10/10.00     7/8.24      |8/8.13       7/10.00      9/9.08       10/10.00     | 
|POLY-3 PERCENT (g) |     97.9%        97.9%        100.0%       85.0%       |98.4%        70.0%        99.1%        100.0%       | 
|TERMINAL (d)       |     6/6 (100%)   6/6 (100%)   6/6 (100%)   7/8 (88%)   |7/7 (100%)   6/9 (67%)    9/9 (100%)   7/7 (100%)   | 
|FIRST INCIDENCE    |     189          288 (T)      127          288 (T)     |233          274          288 (T)      168          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.155N     P=0.289N     P=0.371      P=0.132N    |P=0.088      P=0.184N     P=0.477N     P=0.351      | 
|POLY 3             |     P=0.202N     P=1.000      P=1.000      P=0.478N    |P=0.185      P=0.161N     P=1.000      P=1.000      | 
|POLY 1.5           |     P=0.264N     P=0.947N     P=0.806      P=0.487N    |P=0.147      P=0.226N     P=0.935      P=0.895      | 
|POLY 6             |     P=0.203N     P=1.000N     P=1.000      P=0.490N    |P=0.201      P=0.143N     P=1.000      P=1.000      | 
|LOGISTIC REGRESSION|     P=0.247N     P=0.289N     P=0.155      P=0.232N    |P=0.097      P=0.130N     P=0.477N     (e)          | 
|COCH-ARM / FISHERS |     P=0.576N     P=0.314N     P=0.237      P=0.500N    |P=0.089      P=0.500N     P=0.500      P=0.237      | 
|ORDER RESTRICTED   |     P=0.090N     (e)          (e)          (e)         |P=0.122      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      25 MG/KG     50 MG/KG     100         |0 MG/KG      25 MG/KG     50 MG/KG     100          | 
|                   |                                            MG/KG       |                                       MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant Tumors                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/10 (20%)   0/10 (0%)    3/10 (30%)   1/10 (10%)  |0/10 (0%)    1/10 (10%)   0/10 (0%)    4/10 (40%)   | 
|POLY-3 RATE (b)    |     2/8.77       0/6.13       3/9.34       1/9.03      |0/7.66       1/10.00      0/9.08       4/10.00      | 
|POLY-3 PERCENT (g) |     22.8%        0.0%         32.1%        11.1%       |0.0%         10.0%        0.0%         40.0%        | 
|TERMINAL (d)       |     0/6 (0%)     0/6 (0%)     1/6 (17%)    0/8 (0%)    |0/7 (0%)     0/9 (0%)     0/9 (0%)     1/7 (14%)    | 
|FIRST INCIDENCE    |     127          ---          127          169         |---          274          ---          168          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.518N     P=0.309N     P=0.489      P=0.499N    |P=0.012 *    P=0.571      (e)          P=0.083      | 
|POLY 3             |     P=0.465N     P=0.316N     P=0.532      P=0.489N    |P=0.008 **   P=0.552      (e)          P=0.070      | 
|POLY 1.5           |     P=0.482N     P=0.316N     P=0.521      P=0.502N    |P=0.007 **   P=0.538      (e)          P=0.057      | 
|POLY 6             |     P=0.446N     P=0.306N     P=0.539      P=0.471N    |P=0.009 **   P=0.561      (e)          P=0.080      | 
|LOGISTIC REGRESSION|     P=0.556      P=0.077N     P=0.362      P=0.641N    |P=0.007 **   P=0.521      (e)          P=0.025 *    | 
|COCH-ARM / FISHERS |     P=0.559N     P=0.237N     P=0.500      P=0.500N    |P=0.010 *    P=0.500      (e)          P=0.043 *    | 
|ORDER RESTRICTED   |     P=0.404N     (e)          (e)          (e)         |P=0.007 **   (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/04/03                           EXPERIMENT: 97013 TEST: 97                                            Page 5       
Statistical Analysis of Primary Tumors in Mice(TG.AC HETEROZYGOUS TRANSGENIC)       -      WATER DISINFECTION MODEL (BROMODICHLOR   
                                         Terminal Sacrifice at 42 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/KG      25 MG/KG     50 MG/KG     100         |0 MG/KG      25 MG/KG     50 MG/KG     100          | 
|                   |                                            MG/KG       |                                       MG/KG        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant and Benign Tumors                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     10/10 (100%) 7/10 (70%)   10/10 (100%) 10/10 (100%)|10/10 (100%) 7/10 (70%)   9/10 (90%)   10/10 (100%) | 
|POLY-3 RATE (b)    |     10/10.00     7/7.01       10/10.00     10/10.00    |10/10.00     7/10.00      9/9.08       10/10.00     | 
|POLY-3 PERCENT (g) |     100.0%       99.9%        100.0%       100.0%      |100.0%       70.0%        99.1%        100.0%       | 
|TERMINAL (d)       |     6/6 (100%)   6/6 (100%)   6/6 (100%)   8/8 (100%)  |7/7 (100%)   6/9 (67%)    9/9 (100%)   7/7 (100%)   | 
|FIRST INCIDENCE    |     127          143          127          93          |102          274          288 (T)      168          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.342N     P=0.262N     (e)          (e)         |P=0.342      P=0.060N     P=0.117N     (e)          | 
|POLY 3             |     P=1.000      P=1.000N     (e)          (e)         |P=0.301      P=0.095N     P=1.000N     (e)          | 
|POLY 1.5           |     P=1.000      P=1.000N     (e)          (e)         |P=0.310      P=0.095N     P=0.991N     (e)          | 
|POLY 6             |     P=1.000      P=1.000N     (e)          (e)         |P=0.298      P=0.095N     P=1.000N     (e)          | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.382      (e)          P=0.291N     (e)          | 
|COCH-ARM / FISHERS |     P=0.306      P=0.105N     (e)          (e)         |P=0.361      P=0.105N     P=0.500N     (e)          | 
|ORDER RESTRICTED   |     P=0.318      (e)          (e)          (e)         |P=0.129      (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).