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TDMS Study 97013-09 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                          WATER DISINFECTION MODEL (SODIUM BROMATE)                      DATE: 04/22/05       
EXPERIMENT: 97013 TEST: 09                                                                                     TIME: 09:11:40       
TEST TYPE:  SUBCHRON 26-WEEK                    CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-65406                              ROUTE: DOSED WATER                                             NTP C#: 97013A       
PATHOLOGIST: TOFT, JOHN                                                                                        CAS: 7789-38-0       
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                                                        FINAL #1 TG/AC MICE                                                         
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    25019 Moribund Sacrifice                                                                     
                                       25020 Natural Death                                                                          
                                       25021 Terminal Sacrifice                                                                     
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 001    0 MG/L                                                                        
                                       INCLUDE 002    0 MG/L                                                                        
                                       INCLUDE 003    80 MG/L                                                                       
                                       INCLUDE 004    80 MG/L                                                                       
                                       INCLUDE 005    400 MG/L                                                                      
                                       INCLUDE 006    400 MG/L                                                                      
                                       INCLUDE 007    800 MG/L                                                                      
                                       INCLUDE 008    800 MG/L                                                                      
                                                                                                                                   
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                          WATER DISINFECTION MODEL (SODIUM BROMATE)                      DATE: 04/22/05       
EXPERIMENT: 97013 TEST: 09                                                                                     TIME: 09:11:40       
TEST TYPE:  SUBCHRON 26-WEEK                    CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-65406                              ROUTE: DOSED WATER                                             NTP C#: 97013A       
PATHOLOGIST: TOFT, JOHN                                                                                        CAS: 7789-38-0       
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 (SODIUM BROMATE)                      DATE: 04/22/05       
EXPERIMENT: 97013 TEST: 09                                                                                     TIME: 09:11:40       
TEST TYPE:  SUBCHRON 26-WEEK                    CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-65406                              ROUTE: DOSED WATER                                             NTP C#: 97013A       
PATHOLOGIST: TOFT, JOHN                                                                                        CAS: 7789-38-0       
                                                                                                                                    
                                                                                                                                    
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS                                                                               
IN THE ANALYSIS OF        WATER DISINFECTION MODEL (SODIUM BR                                                                       
===============================================================                                                                     
Male Mice                                                                                                                           
------------                                                                                                                        
Organ                                 Morphology                                                                                    
-----                                 ----------                                                                                    
Lung                                   Alveolar/Bronchiolar Adenoma                                                                 
Stomach, Forestomach                   Squamous Cell Papilloma                                                                      
===============================================================                                                                     
Female Mice                                                                                                                         
------------                                                                                                                        
Organ                                  Morphology                                                                                   
-----                                  ----------                                                                                   
Skin                                   Squamous Cell Papilloma                                                                      
All Organs                             Benign Tumors                                                                                
===============================================================                                                                     
                                                                                                                                   
       Date:  04/22/05                           EXPERIMENT: 97013 TEST: 09                                            Page 1       
Statistical Analysis of Primary Tumors in Mice(TG.AC HETEROZYGOUS TRANSGENIC)        -         WATER DISINFECTION MODEL (SODIUM BR  
                                         Terminal Sacrifice at 27 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Alveolar/Bronchiolar Adenoma                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/15 (0%)    0/15 (0%)    0/15 (0%)    2/15 (13%)  |0/15 (0%)    0/15 (0%)    1/15 (7%)    2/15 (13%)   | 
|POLY-3 RATE (b)    |     0/13.82      0/14.58      0/14.49      2/14.62     |0/12.01      0/10.24      1/12.33      2/13.00      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         13.7%       |0.0%         0.0%         8.1%         15.4%        | 
|TERMINAL (d)       |     0/13 (0%)    0/13 (0%)    0/14 (0%)    2/14 (14%)  |0/10 (0%)    0/9 (0%)     1/10 (10%)   1/12 (8%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          183 (T)     |---          ---          184 (T)      142          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.047 *    (e)          (e)          P=0.252     |P=0.085      (e)          P=0.500      P=0.269      | 
|POLY 3             |     P=0.040 *    (e)          (e)          P=0.244     |P=0.075      (e)          P=0.505      P=0.249      | 
|POLY 1.5           |     P=0.040 *    (e)          (e)          P=0.245     |P=0.066      (e)          P=0.506      P=0.239      | 
|POLY 6             |     P=0.039 *    (e)          (e)          P=0.243     |P=0.083      (e)          P=0.503      P=0.259      | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          P=0.252     |P=0.060      (e)          P=0.500      P=0.232      | 
|COCH-ARM / FISHERS |     P=0.041 *    (e)          (e)          P=0.241     |P=0.057      (e)          P=0.500      P=0.241      | 
|ORDER RESTRICTED   |     P=0.030 *    (e)          (e)          (e)         |P=0.080      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Squamous Cell Papilloma                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/15 (0%)    2/15 (13%)   3/15 (20%)   2/15 (13%)  |6/15 (40%)   4/15 (27%)   1/15 (7%)    5/15 (33%)   | 
|POLY-3 RATE (b)    |     0/13.82      2/14.60      3/14.49      2/14.62     |6/12.12      4/10.24      1/12.66      5/12.46      | 
|POLY-3 PERCENT (g) |     0.0%         13.7%        20.7%        13.7%       |49.5%        39.1%        7.9%         40.1%        | 
|TERMINAL (d)       |     0/13 (0%)    1/13 (8%)    3/14 (21%)   2/14 (14%)  |5/10 (50%)   4/9 (44%)    0/10 (0%)    5/12 (42%)   | 
|FIRST INCIDENCE    |     ---          182          183 (T)      183 (T)     |177          184 (T)      161          184 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.286      P=0.248      P=0.128      P=0.252     |P=0.277N     P=0.431N     P=0.050N     P=0.356N     | 
|POLY 3             |     P=0.277      P=0.244      P=0.114      P=0.244     |P=0.347N     P=0.473N     P=0.024N*    P=0.476N     | 
|POLY 1.5           |     P=0.278      P=0.244      P=0.115      P=0.245     |P=0.374N     P=0.422N     P=0.025N*    P=0.493N     | 
|POLY 6             |     P=0.275      P=0.242      P=0.113      P=0.243     |P=0.329N     P=0.512N     P=0.023N*    P=0.465N     | 
|LOGISTIC REGRESSION|     P=0.266      P=0.242      P=0.128      P=0.252     |P=0.318N     P=0.503N     P=0.035N*    P=0.435N     | 
|COCH-ARM / FISHERS |     P=0.253      P=0.241      P=0.112      P=0.241     |P=0.426N     P=0.350N     P=0.040N*    P=0.500N     | 
|ORDER RESTRICTED   |     P=0.130      (e)          (e)          (e)         |P=0.123N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  04/22/05                           EXPERIMENT: 97013 TEST: 09                                            Page 2       
Statistical Analysis of Primary Tumors in Mice(TG.AC HETEROZYGOUS TRANSGENIC)       -         WATER DISINFECTION MODEL (SODIUM BR   
                                         Terminal Sacrifice at 27 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Squamous Cell Papilloma                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     7/15 (47%)   2/15 (13%)   8/15 (53%)   3/15 (20%)  |6/15 (40%)   3/15 (20%)   2/15 (13%)   6/15 (40%)   | 
|POLY-3 RATE (b)    |     7/14.00      2/14.58      8/14.49      3/14.62     |6/12.01      3/10.24      2/12.33      6/13.00      | 
|POLY-3 PERCENT (g) |     50.0%        13.7%        55.2%        20.5%       |49.9%        29.3%        16.2%        46.1%        | 
|TERMINAL (d)       |     6/13 (46%)   2/13 (15%)   8/14 (57%)   3/14 (21%)  |6/10 (60%)   3/9 (33%)    2/10 (20%)   5/12 (42%)   | 
|FIRST INCIDENCE    |     171          183 (T)      183 (T)      183 (T)     |184 (T)      184 (T)      184 (T)      142          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.292N     P=0.062N     P=0.573      P=0.107N    |P=0.541N     P=0.247N     P=0.091N     P=0.494N     | 
|POLY 3             |     P=0.327N     P=0.039N*    P=0.537      P=0.100N    |P=0.549      P=0.290N     P=0.083N     P=0.581N     | 
|POLY 1.5           |     P=0.326N     P=0.038N*    P=0.548      P=0.098N    |P=0.498      P=0.255N     P=0.085N     P=0.617N     | 
|POLY 6             |     P=0.331N     P=0.042N*    P=0.518      P=0.106N    |P=0.578N     P=0.313N     P=0.083N     P=0.544N     | 
|LOGISTIC REGRESSION|     P=0.324N     P=0.045N*    P=0.545      P=0.101N    |P=0.533      P=0.247N     P=0.091N     P=0.628N     | 
|COCH-ARM / FISHERS |     P=0.351N     P=0.054N     P=0.500      P=0.123N    |P=0.428      P=0.213N     P=0.107N     P=0.645N     | 
|ORDER RESTRICTED   |     P=0.062N     (e)          (e)          (e)         |P=0.241N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Tooth                                                                                                                            | 
|     Odontogenic Tumor                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/15 (20%)   3/15 (20%)   4/15 (27%)   1/15 (7%)   |1/15 (7%)    2/15 (13%)   2/15 (13%)   4/15 (27%)   | 
|POLY-3 RATE (b)    |     3/14.00      3/14.60      4/15.00      1/14.62     |1/12.01      2/10.24      2/12.66      4/12.46      | 
|POLY-3 PERCENT (g) |     21.4%        20.6%        26.7%        6.8%        |8.3%         19.5%        15.8%        32.1%        | 
|TERMINAL (d)       |     2/13 (15%)   2/13 (15%)   3/14 (21%)   1/14 (7%)   |1/10 (10%)   2/9 (22%)    1/10 (10%)   4/12 (33%)   | 
|FIRST INCIDENCE    |     171          182          144          183 (T)     |184 (T)      184 (T)      161          184 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.218N     P=0.659N     P=0.535      P=0.283N    |P=0.177      P=0.461      P=0.500      P=0.220      | 
|POLY 3             |     P=0.224N     P=0.651N     P=0.540      P=0.282N    |P=0.129      P=0.442      P=0.519      P=0.168      | 
|POLY 1.5           |     P=0.223N     P=0.647N     P=0.538      P=0.279N    |P=0.119      P=0.464      P=0.516      P=0.161      | 
|POLY 6             |     P=0.227N     P=0.660N     P=0.540      P=0.287N    |P=0.137      P=0.429      P=0.522      P=0.174      | 
|LOGISTIC REGRESSION|     P=0.236N     P=0.654N     P=0.497      P=0.280N    |P=0.140      P=0.461      P=0.509      P=0.220      | 
|COCH-ARM / FISHERS |     P=0.236N     P=0.674N     P=0.500      P=0.299N    |P=0.108      P=0.500      P=0.500      P=0.165      | 
|ORDER RESTRICTED   |     P=0.223N     (e)          (e)          (e)         |P=0.099      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  04/22/05                           EXPERIMENT: 97013 TEST: 09                                            Page 3       
Statistical Analysis of Primary Tumors in Mice(TG.AC HETEROZYGOUS TRANSGENIC)       -         WATER DISINFECTION MODEL (SODIUM BR   
                                         Terminal Sacrifice at 27 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Leukemia: Erythrocytic                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/15 (0%)    0/15 (0%)    0/15 (0%)    0/15 (0%)   |1/15 (7%)    2/15 (13%)   3/15 (20%)   1/15 (7%)    | 
|POLY-3 RATE (b)    |     0/13.82      0/14.58      0/14.49      0/14.62     |1/12.72      2/11.64      3/13.96      1/13.00      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |7.9%         17.2%        21.5%        7.7%         | 
|TERMINAL (d)       |     0/13 (0%)    0/13 (0%)    0/14 (0%)    0/14 (0%)   |0/10 (0%)    0/9 (0%)     0/10 (0%)    0/12 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |123          91           92           142          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.517N     P=0.460      P=0.322      P=0.751N     | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.531N     P=0.468      P=0.332      P=0.757N     | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.547N     P=0.481      P=0.325      P=0.761N     | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.518N     P=0.463      P=0.339      P=0.752N     | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.573N     P=0.536      P=0.264      P=0.766N     | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.561N     P=0.500      P=0.299      P=0.759N     | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |P=0.445N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Benign Tumors                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     7/15 (47%)   4/15 (27%)   8/15 (53%)   5/15 (33%)  |9/15 (60%)   5/15 (33%)   4/15 (27%)   9/15 (60%)   | 
|POLY-3 RATE (b)    |     7/14.00      4/14.60      8/14.49      5/14.62     |9/12.12      5/10.24      4/12.66      9/13.00      | 
|POLY-3 PERCENT (g) |     50.0%        27.4%        55.2%        34.2%       |74.2%        48.8%        31.6%        69.2%        | 
|TERMINAL (d)       |     6/13 (46%)   3/13 (23%)   8/14 (57%)   5/14 (36%)  |8/10 (80%)   5/9 (56%)    3/10 (30%)   8/12 (67%)   | 
|FIRST INCIDENCE    |     171          182          183 (T)      183 (T)     |177          184 (T)      161          142          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.438N     P=0.237N     P=0.573      P=0.307N    |P=0.499N     P=0.168N     P=0.068N     P=0.417N     | 
|POLY 3             |     P=0.491N     P=0.197N     P=0.537      P=0.320N    |P=0.558      P=0.205N     P=0.033N*    P=0.564N     | 
|POLY 1.5           |     P=0.488N     P=0.193N     P=0.548      P=0.315N    |P=0.480      P=0.162N     P=0.037N*    P=0.617N     | 
|POLY 6             |     P=0.499N     P=0.207N     P=0.518      P=0.333N    |P=0.547N     P=0.242N     P=0.030N*    P=0.514N     | 
|LOGISTIC REGRESSION|     P=0.482N     P=0.191N     P=0.545      P=0.308N    |P=0.529      P=0.218N     P=0.048N*    P=0.623N     | 
|COCH-ARM / FISHERS |     P=0.513N     P=0.225N     P=0.500      P=0.355N    |P=0.383      P=0.136N     P=0.070N     P=0.645N     | 
|ORDER RESTRICTED   |     P=0.314N     (e)          (e)          (e)         |P=0.150N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  04/22/05                           EXPERIMENT: 97013 TEST: 09                                            Page 4       
Statistical Analysis of Primary Tumors in Mice(TG.AC HETEROZYGOUS TRANSGENIC)       -         WATER DISINFECTION MODEL (SODIUM BR   
                                         Terminal Sacrifice at 27 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant Tumors                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/15 (0%)    0/15 (0%)    0/15 (0%)    1/15 (7%)   |3/15 (20%)   3/15 (20%)   4/15 (27%)   1/15 (7%)    | 
|POLY-3 RATE (b)    |     0/13.82      0/14.58      0/14.49      1/14.62     |3/12.83      3/12.48      4/14.00      1/13.00      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         6.8%        |23.4%        24.0%        28.6%        7.7%         | 
|TERMINAL (d)       |     0/13 (0%)    0/13 (0%)    0/14 (0%)    1/14 (7%)   |1/10 (10%)   0/9 (0%)     0/10 (0%)    0/12 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          183 (T)     |123          91           92           142          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.197      (e)          (e)          P=0.515     |P=0.210N     P=0.602      P=0.519      P=0.278N     | 
|POLY 3             |     P=0.191      (e)          (e)          P=0.511     |P=0.219N     P=0.661      P=0.552      P=0.291N     | 
|POLY 1.5           |     P=0.191      (e)          (e)          P=0.511     |P=0.230N     P=0.669      P=0.542      P=0.297N     | 
|POLY 6             |     P=0.191      (e)          (e)          P=0.510     |P=0.209N     P=0.657      P=0.560      P=0.285N     | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          P=0.515     |P=0.244N     P=0.647N     P=0.489      P=0.295N     | 
|COCH-ARM / FISHERS |     P=0.185      (e)          (e)          P=0.500     |P=0.236N     P=0.674N     P=0.500      P=0.299N     | 
|ORDER RESTRICTED   |     P=0.131      (e)          (e)          (e)         |P=0.219N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       80 MG/L      400 MG/L     800 MG/L    |0 MG/L       80 MG/L      400 MG/L     800 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant and Benign Tumors                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     8/15 (53%)   6/15 (40%)   11/15 (73%)  7/15 (47%)  |10/15 (67%)  8/15 (53%)   7/15 (47%)   10/15 (67%)  | 
|POLY-3 RATE (b)    |     8/14.00      6/14.60      11/15.00     7/14.62     |10/12.83     8/12.48      7/14.00      10/13.00     | 
|POLY-3 PERCENT (g) |     57.1%        41.1%        73.3%        47.9%       |78.0%        64.1%        50.0%        76.9%        | 
|TERMINAL (d)       |     7/13 (54%)   5/13 (39%)   10/14 (71%)  7/14 (50%)  |8/10 (80%)   5/9 (56%)    3/10 (30%)   9/12 (75%)   | 
|FIRST INCIDENCE    |     171          182          144          183 (T)     |123          91           92           142          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.540N     P=0.363N     P=0.324      P=0.427N    |P=0.381N     P=0.500N     P=0.263N     P=0.406N     | 
|POLY 3             |     P=0.527      P=0.318N     P=0.303      P=0.453N    |P=0.554      P=0.370N     P=0.133N     P=0.654N     | 
|POLY 1.5           |     P=0.530      P=0.311N     P=0.298      P=0.446N    |P=0.514      P=0.350N     P=0.148N     P=0.672      | 
|POLY 6             |     P=0.516      P=0.332N     P=0.303      P=0.470N    |P=0.566N     P=0.381N     P=0.121N     P=0.632N     | 
|LOGISTIC REGRESSION|     P=0.531      P=0.307N     P=0.268      P=0.442N    |P=0.540      P=0.434N     P=0.205N     P=0.652N     | 
|COCH-ARM / FISHERS |     P=0.487      P=0.358N     P=0.225      P=0.500N    |P=0.487      P=0.355N     P=0.231N     P=0.650N     | 
|ORDER RESTRICTED   |     P=0.418      (e)          (e)          (e)         |P=0.331N     (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).