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TDMS Study 97013-08 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                       WATER DISINFECTION MODEL (BROMODICHLOROMETHANE)                   DATE: 06/11/04       
EXPERIMENT: 97013 TEST: 08                                                                                     TIME: 10:50:01       
TEST TYPE:  SUBCHRON 26-WEEK                    CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-65406                              ROUTE: GAVAGE                                                  NTP C#: 97013G       
PATHOLOGIST: MISSING                                                                                           CAS: 75-27-4         
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                            FINAL#1 MICE                                                            
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 001    0 MG/KG                                                                       
                                       INCLUDE 002    0 MG/KG                                                                       
                                       INCLUDE 003    25 MG/KG                                                                      
                                       INCLUDE 004    25 MG/KG                                                                      
                                       INCLUDE 005    50 MG/KG                                                                      
                                       INCLUDE 006    50 MG/KG                                                                      
                                       INCLUDE 007    100     MG/KG                                                                 
                                       INCLUDE 008    100     MG/KG                                                                 
                                                                                                                                   
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                       WATER DISINFECTION MODEL (BROMODICHLOROMETHANE)                   DATE: 06/11/04       
EXPERIMENT: 97013 TEST: 08                                                                                     TIME: 10:50:01       
TEST TYPE:  SUBCHRON 26-WEEK                    CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-65406                              ROUTE: GAVAGE                                                  NTP C#: 97013G       
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: 06/11/04       
EXPERIMENT: 97013 TEST: 08                                                                                     TIME: 10:50:01       
TEST TYPE:  SUBCHRON 26-WEEK                    CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-65406                              ROUTE: GAVAGE                                                  NTP C#: 97013G       
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                                                                                    
-----                                 ----------                                                                                    
Skin                                   Squamous Cell Papilloma                                                                      
Stomach, Forestomach                   Squamous Cell Papilloma                                                                      
All Organs                             Benign Tumors                                                                                
                                       Malignant and Benign Tumors                                                                  
===============================================================                                                                     
Female Mice                                                                                                                         
------------                                                                                                                        
Organ                                  Morphology                                                                                   
-----                                  ----------                                                                                   
Stomach, Forestomach                   Squamous Cell Papilloma                                                                      
Tooth                                  Odontogenic Tumor                                                                            
All Organs                             Benign Tumors                                                                                
===============================================================                                                                     
                                                                                                                                   
       Date:  06/11/04                           EXPERIMENT: 97013 TEST: 08                                            Page 1       
Statistical Analysis of Primary Tumors in Mice(TG.AC HETEROZYGOUS TRANSGENIC)        -      WATER DISINFECTION MODEL (BROMODICHLOR  
                                         Terminal Sacrifice at 26 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)        |     1/15 (7%)    1/15 (7%)    0/15 (0%)    5/15 (33%)  |1/15 (7%)    3/15 (20%)   5/15 (33%)   2/15 (13%)   | 
|POLY-3 RATE (b)    |     1/13.17      1/14.49      0/12.95      5/15.00     |1/13.13      3/14.48      5/14.18      2/13.35      | 
|POLY-3 PERCENT (g) |     7.6%         6.9%         0.0%         33.3%       |7.6%         20.7%        35.3%        15.0%        | 
|TERMINAL (d)       |     1/13 (8%)    1/14 (7%)    0/12 (0%)    5/15 (33%)  |1/11 (9%)    3/14 (21%)   4/13 (31%)   2/13 (15%)   | 
|FIRST INCIDENCE    |     182 (T)      182 (T)      ---          182 (T)     |183 (T)      183 (T)      126          183 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.027 *    P=0.748N     P=0.516N     P=0.122     |P=0.480      P=0.390      P=0.126      P=0.560      | 
|POLY 3             |     P=0.015 *    P=0.739N     P=0.503N     P=0.112     |P=0.428      P=0.334      P=0.095      P=0.506      | 
|POLY 1.5           |     P=0.015 *    P=0.742N     P=0.498N     P=0.105     |P=0.423      P=0.326      P=0.091      P=0.501      | 
|POLY 6             |     P=0.016 *    P=0.741N     P=0.511N     P=0.115     |P=0.448      P=0.346      P=0.105      P=0.517      | 
|LOGISTIC REGRESSION|     P=0.027 *    P=0.748N     (e)          P=0.122     |P=0.425      P=0.390      P=0.087      P=0.560      | 
|COCH-ARM / FISHERS |     P=0.018 *    P=0.759N     P=0.500N     P=0.084     |P=0.433      P=0.299      P=0.084      P=0.500      | 
|ORDER RESTRICTED   |     P=0.011 *    (e)          (e)          (e)         |P=0.205      (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        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Squamous Cell Papilloma                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     9/15 (60%)   5/15 (33%)   11/15 (73%)  12/15 (80%) |6/15 (40%)   8/15 (53%)   10/15 (67%)  11/15 (73%)  | 
|POLY-3 RATE (b)    |     9/13.17      5/15.00      11/13.48     12/15.00    |6/13.47      8/14.48      10/13.51     11/13.35     | 
|POLY-3 PERCENT (g) |     68.4%        33.3%        81.6%        80.0%       |44.6%        55.3%        74.0%        82.4%        | 
|TERMINAL (d)       |     9/13 (69%)   4/14 (29%)   10/12 (83%)  12/15 (80%) |5/11 (46%)   8/14 (57%)   10/13 (77%)  11/13 (85%)  | 
|FIRST INCIDENCE    |     182 (T)      143          142          182 (T)     |160          183 (T)      183 (T)      183 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.117      P=0.104N     P=0.231      P=0.415     |P=0.062      P=0.582      P=0.247      P=0.145      | 
|POLY 3             |     P=0.057      P=0.065N     P=0.365      P=0.394     |P=0.020 *    P=0.427      P=0.115      P=0.041 *    | 
|POLY 1.5           |     P=0.055      P=0.075N     P=0.388      P=0.353     |P=0.024 *    P=0.417      P=0.127      P=0.045 *    | 
|POLY 6             |     P=0.059      P=0.061N     P=0.336      P=0.413     |P=0.020 *    P=0.440      P=0.112      P=0.041 *    | 
|LOGISTIC REGRESSION|     P=0.083      P=0.090N     P=0.288      P=0.415     |P=0.030 *    P=0.471      P=0.140      P=0.064      | 
|COCH-ARM / FISHERS |     P=0.048 *    P=0.136N     P=0.350      P=0.213     |P=0.042 *    P=0.358      P=0.136      P=0.070      | 
|ORDER RESTRICTED   |     P=0.047 *    (e)          (e)          (e)         |P=0.025 *    (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/11/04                           EXPERIMENT: 97013 TEST: 08                                            Page 2       
Statistical Analysis of Primary Tumors in Mice(TG.AC HETEROZYGOUS TRANSGENIC)       -      WATER DISINFECTION MODEL (BROMODICHLOR   
                                         Terminal Sacrifice at 26 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        | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Tooth                                                                                                                            | 
|     Odontogenic Tumor                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/15 (13%)   2/15 (13%)   3/15 (20%)   2/15 (13%)  |4/15 (27%)   0/15 (0%)    3/15 (20%)   2/15 (13%)   | 
|POLY-3 RATE (b)    |     2/13.17      2/15.00      3/15.00      2/15.00     |4/13.36      0/14.48      3/13.51      2/14.01      | 
|POLY-3 PERCENT (g) |     15.2%        13.3%        20.0%        13.3%       |29.9%        0.0%         22.2%        14.3%        | 
|TERMINAL (d)       |     2/13 (15%)   1/14 (7%)    0/12 (0%)    2/15 (13%)  |3/11 (27%)   0/14 (0%)    3/13 (23%)   1/13 (8%)    | 
|FIRST INCIDENCE    |     182 (T)      143          113          182 (T)     |168          ---          183 (T)      127          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.563N     P=0.663N     P=0.511      P=0.648N    |P=0.393N     P=0.037N*    P=0.410N     P=0.278N     | 
|POLY 3             |     P=0.573N     P=0.650N     P=0.562      P=0.650N    |P=0.435N     P=0.035N*    P=0.493N     P=0.302N     | 
|POLY 1.5           |     P=0.581N     P=0.660N     P=0.550      P=0.660N    |P=0.438N     P=0.037N*    P=0.489N     P=0.313N     | 
|POLY 6             |     P=0.570N     P=0.646N     P=0.567      P=0.646N    |P=0.427N     P=0.033N*    P=0.489N     P=0.285N     | 
|LOGISTIC REGRESSION|     P=0.407      P=0.704      P=0.443      P=0.648N    |P=0.430N     P=0.044N*    P=0.477N     P=0.324N     | 
|COCH-ARM / FISHERS |     P=0.573      P=0.701N     P=0.500      P=0.701N    |P=0.427N     P=0.050N     P=0.500N     P=0.326N     | 
|ORDER RESTRICTED   |     P=0.649N     (e)          (e)          (e)         |P=0.153N     (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                                                                                                                       | 
|     Leukemia: Erythrocytic                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/15 (7%)    0/15 (0%)    0/15 (0%)    1/15 (7%)   |2/15 (13%)   2/15 (13%)   1/15 (7%)    0/15 (0%)    | 
|POLY-3 RATE (b)    |     1/14.01      0/14.49      0/12.95      1/15.00     |2/13.47      2/15.00      1/14.18      0/13.35      | 
|POLY-3 PERCENT (g) |     7.1%         0.0%         0.0%         6.7%        |14.9%        13.3%        7.1%         0.0%         | 
|TERMINAL (d)       |     0/13 (0%)    0/14 (0%)    0/12 (0%)    1/15 (7%)   |1/11 (9%)    1/14 (7%)    0/13 (0%)    0/13 (0%)    | 
|FIRST INCIDENCE    |     98           ---          ---          182 (T)     |160          143          126          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.611      P=0.486N     P=0.486N     P=0.737N    |P=0.126N     P=0.644N     P=0.489N     P=0.229N     | 
|POLY 3             |     P=0.599      P=0.493N     P=0.516N     P=0.745N    |P=0.125N     P=0.659N     P=0.482N     P=0.232N     | 
|POLY 1.5           |     P=0.598      P=0.492N     P=0.506N     P=0.747N    |P=0.124N     P=0.668N     P=0.484N     P=0.233N     | 
|POLY 6             |     P=0.601      P=0.497N     P=0.525N     P=0.745N    |P=0.124N     P=0.647N     P=0.474N     P=0.229N     | 
|LOGISTIC REGRESSION|     P=0.427      P=0.828N     P=0.689N     P=0.642     |P=0.110N     P=0.667      P=0.536N     P=0.232N     | 
|COCH-ARM / FISHERS |     P=0.596      P=0.500N     P=0.500N     P=0.759N    |P=0.118N     P=0.701N     P=0.500N     P=0.241N     | 
|ORDER RESTRICTED   |     P=0.388N     (e)          (e)          (e)         |P=0.149N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/11/04                           EXPERIMENT: 97013 TEST: 08                                            Page 3       
Statistical Analysis of Primary Tumors in Mice(TG.AC HETEROZYGOUS TRANSGENIC)       -      WATER DISINFECTION MODEL (BROMODICHLOR   
                                         Terminal Sacrifice at 26 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)        |     9/15 (60%)   5/15 (33%)   11/15 (73%)  13/15 (87%) |7/15 (47%)   9/15 (60%)   12/15 (80%)  12/15 (80%)  | 
|POLY-3 RATE (b)    |     9/13.17      5/15.00      11/13.48     13/15.00    |7/13.47      9/14.48      12/14.18     12/13.35     | 
|POLY-3 PERCENT (g) |     68.4%        33.3%        81.6%        86.7%       |52.0%        62.2%        84.6%        89.9%        | 
|TERMINAL (d)       |     9/13 (69%)   4/14 (29%)   10/12 (83%)  13/15 (87%) |6/11 (55%)   9/14 (64%)   11/13 (85%)  12/13 (92%)  | 
|FIRST INCIDENCE    |     182 (T)      143          142          182 (T)     |160          183 (T)      126          183 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.056      P=0.104N     P=0.231      P=0.259     |P=0.055      P=0.618      P=0.163      P=0.143      | 
|POLY 3             |     P=0.018 *    P=0.065N     P=0.365      P=0.238     |P=0.011 *    P=0.437      P=0.065      P=0.029 *    | 
|POLY 1.5           |     P=0.017 *    P=0.075N     P=0.388      P=0.202     |P=0.014 *    P=0.425      P=0.065      P=0.034 *    | 
|POLY 6             |     P=0.018 *    P=0.061N     P=0.336      P=0.256     |P=0.012 *    P=0.452      P=0.072      P=0.029 *    | 
|LOGISTIC REGRESSION|     P=0.035 *    P=0.090N     P=0.288      P=0.259     |P=0.016 *    P=0.497      P=0.064      P=0.053      | 
|COCH-ARM / FISHERS |     P=0.019 *    P=0.136N     P=0.350      P=0.107     |P=0.032 *    P=0.358      P=0.064      P=0.064      | 
|ORDER RESTRICTED   |     P=0.015 *    (e)          (e)          (e)         |P=0.015 *    (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)        |     2/15 (13%)   1/15 (7%)    0/15 (0%)    1/15 (7%)   |3/15 (20%)   2/15 (13%)   1/15 (7%)    1/15 (7%)    | 
|POLY-3 RATE (b)    |     2/14.01      1/15.00      0/12.95      1/15.00     |3/13.47      2/15.00      1/14.18      1/13.35      | 
|POLY-3 PERCENT (g) |     14.3%        6.7%         0.0%         6.7%        |22.3%        13.3%        7.1%         7.5%         | 
|TERMINAL (d)       |     1/13 (8%)    0/14 (0%)    0/12 (0%)    1/15 (7%)   |2/11 (18%)   1/14 (7%)    0/13 (0%)    1/13 (8%)    | 
|FIRST INCIDENCE    |     98           143          ---          182 (T)     |160          143          126          183 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.343N     P=0.467N     P=0.241N     P=0.459N    |P=0.189N     P=0.428N     P=0.284N     P=0.265N     | 
|POLY 3             |     P=0.372N     P=0.476N     P=0.249N     P=0.476N    |P=0.202N     P=0.449N     P=0.278N     P=0.300N     | 
|POLY 1.5           |     P=0.369N     P=0.478N     P=0.238N     P=0.478N    |P=0.200N     P=0.461N     P=0.281N     P=0.300N     | 
|POLY 6             |     P=0.375N     P=0.476N     P=0.261N     P=0.476N    |P=0.202N     P=0.434N     P=0.270N     P=0.294N     | 
|LOGISTIC REGRESSION|     P=0.510N     P=0.701N     P=0.267N     P=0.642N    |P=0.181N     P=0.535N     P=0.312N     P=0.293N     | 
|COCH-ARM / FISHERS |     P=0.363N     P=0.500N     P=0.241N     P=0.500N    |P=0.188N     P=0.500N     P=0.299N     P=0.299N     | 
|ORDER RESTRICTED   |     P=0.207N     (e)          (e)          (e)         |P=0.203N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/11/04                           EXPERIMENT: 97013 TEST: 08                                            Page 4       
Statistical Analysis of Primary Tumors in Mice(TG.AC HETEROZYGOUS TRANSGENIC)       -      WATER DISINFECTION MODEL (BROMODICHLOR   
                                         Terminal Sacrifice at 26 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)        |     11/15 (73%)  6/15 (40%)   13/15 (87%)  14/15 (93%) |10/15 (67%)  10/15 (67%)  12/15 (80%)  13/15 (87%)  | 
|POLY-3 RATE (b)    |     11/14.01     6/15.00      13/15.00     14/15.00    |10/13.69     10/15.00     12/14.18     13/14.01     | 
|POLY-3 PERCENT (g) |     78.5%        40.0%        86.7%        93.3%       |73.0%        66.7%        84.6%        92.8%        | 
|TERMINAL (d)       |     10/13 (77%)  5/14 (36%)   10/12 (83%)  14/15 (93%) |8/11 (73%)   9/14 (64%)   11/13 (85%)  12/13 (92%)  | 
|FIRST INCIDENCE    |     98           143          113          182 (T)     |160          143          126          127          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.115      P=0.059N     P=0.284      P=0.453     |P=0.219      P=0.347N     P=0.587      P=0.448      | 
|POLY 3             |     P=0.023 *    P=0.035N*    P=0.465      P=0.271     |P=0.075      P=0.514N     P=0.388      P=0.185      | 
|POLY 1.5           |     P=0.022 *    P=0.038N*    P=0.450      P=0.256     |P=0.076      P=0.541N     P=0.390      P=0.173      | 
|POLY 6             |     P=0.023 *    P=0.035N*    P=0.467      P=0.273     |P=0.081      P=0.487N     P=0.398      P=0.206      | 
|LOGISTIC REGRESSION|     P=0.025 *    P=0.057N     P=0.343      P=0.275     |P=0.072      P=0.559N     P=0.357      P=0.159      | 
|COCH-ARM / FISHERS |     P=0.024 *    P=0.070N     P=0.326      P=0.165     |P=0.104      P=0.650N     P=0.341      P=0.195      | 
|ORDER RESTRICTED   |     P=0.012 *    (e)          (e)          (e)         |P=0.103      (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).