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TDMS Study 05086-01 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                                  O-BENZYL-P-CHLOROPHENOL                                DATE: 09/11/94       
EXPERIMENT: 05086 TEST: 01                                                                                     TIME: 07:04:54       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-45042          ROUTE: GAVAGE                                                                      NTP C#: 61201C       
PATHOLOGIST: S. GRUMBEIN                                                                                       CAS: 120-32-1        
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               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08    
LAB: Battelle Columbus                                  O-BENZYL-P-CHLOROPHENOL                                DATE: 09/11/94      
EXPERIMENT: 05086 TEST: 01                                                                                     TIME: 07:04:54      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01-ES-45042          ROUTE: GAVAGE                                                                      NTP C#: 61201C      
PATHOLOGIST: S. GRUMBEIN                                                                                       CAS: 120-32-1       
 
 
 
 
 
                                                    RATS(FISCHER344)
                                              ----------------------------
             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 NUMBER OF ANIMALS NECROPSIED.
 
 
                                                    ----------------
 
                                                    Adrenal Gland
                                                    Bone Marrow
                                                    Brain
                                                    Clitoral Gland
                                                    Epididymis
                                                    Heart
                                                    Islets, Pancreatic
                                                    Kidney
                                                    Liver
                                                    Lung
                                                    Nose
                                                    Ovary
                                                    Pancreas
                                                    Parathyroid Gland
                                                    Pituitary Gland
                                                    Preputial Gland
                                                    Prostate
                                                    Salivary Glands
                                                    Spleen
                                                    Testes
                                                    Thymus
                                                    Thyroid Gland
                                                    Urinary Bladder
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                                  O-BENZYL-P-CHLOROPHENOL                                DATE: 09/11/94       
EXPERIMENT: 05086 TEST: 01                                                                                     TIME: 07:04:54       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-45042          ROUTE: GAVAGE                                                                      NTP C#: 61201C       
PATHOLOGIST: S. GRUMBEIN                                                                                       CAS: 120-32-1        
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                    IN THE ANALYSIS OF THE STUDY OF O-BENZYL-P-CHLOROPHENOL
 
              ====================================================================================================
 
                                                           MALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Clitoral/Preputial Gland      Adenoma
                                                           Carcinoma or Adenoma
                             Pituitary Gland: Pars Distalis or Unspecified Site
                                                           Carcinoma or Adenoma
                             Skin                          Keratoacanthoma
                                                           Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma
                                                           Squamous Cell Papilloma
                             Thyroid Gland: C-Cell         Adenoma
                                                           Carcinoma or Adenoma
                             All Organs                    Mesothelioma Benign, Malignant, NOS
                                                           Benign Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
 
                                                           FEMALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Clitoral/Preputial Gland      Carcinoma or Adenoma
                             Mammary Gland                 Fibroadenoma
                             Pituitary Gland: Pars Distalis or Unspecified Site
                                                           Carcinoma or Adenoma
                             Uterus                        Polyp Stromal
 
              ====================================================================================================
         DATE: 09/11/94                     EXPERIMENT: 05086 TEST: 01                                                 PAGE   1
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- O-BENZYL-P-CHLOROPHENOL
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0MG/KG       30MG/KG      60MG/KG      120MG/KG  |   0MG/KG       60MG/KG      120MG/KG     240MG/KG  |
|                       |   65HUCC M     65HUCC M     65HUCC M     65HUCC M  |   65HUCC F     65HUCC F     65HUCC F     65HUCC F  |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 13/70 (19%)   7/70 (10%)   9/69 (13%)  13/68 (19%) |  0/70 (0%)    3/70 (4%)    3/68 (4%)    4/70 (6%)  |
|ADJUSTED (b)           |  44.1%        26.1%        32.2%        45.6%      |   0.0%         8.3%        10.7%        12.2%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/8 (0%)     0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  7/23 (30%)   5/24 (21%)   7/25 (28%)   9/24 (38%) |  0/26 (0%)    1/30 (3%)    3/28 (11%)   2/28 (7%)  |
|FIRST INCIDENCE (DAYS) |   638          669          579          641       |   ---          649          729 (T)      661       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.404      P=0.104N     P=0.203N     P=0.562N   |  P=0.086      P=0.143      P=0.133      P=0.074    |
|INCIDENTAL TUMOR       |  P=0.320      P=0.110N     P=0.208N     P=0.501    |  P=0.101      P=0.140      P=0.133      P=0.087    |
|LOGISTIC REGRESSION    |  P=0.342      P=0.100N     P=0.245N     P=0.555    |  P=0.086      P=0.133      P=0.133      P=0.073    |
|COCHRAN-ARMITAGE       |  P=0.357                                           |  P=0.079                                           |
|FISHER EXACT           |               P=0.113N     P=0.255N     P=0.554    |               P=0.122      P=0.117      P=0.060    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Malignant                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/70 (1%)    1/70 (1%)    1/69 (1%)    2/68 (3%)  |  0/70 (0%)    1/70 (1%)    0/68 (0%)    0/70 (0%)  |
|ADJUSTED (b)           |   4.3%         4.2%         4.0%         6.8%      |   0.0%         2.4%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/8 (0%)     0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  1/23 (4%)    1/24 (4%)    1/25 (4%)    1/24 (4%)  |  0/26 (0%)    0/30 (0%)    0/28 (0%)    0/28 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      729 (T)      729 (T)      591       |   ---          633          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.353      P=0.753N     P=0.744N     P=0.498    |  P=0.555N     P=0.531        (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.338      P=0.753N     P=0.744N     P=0.477    |  P=0.564N     P=0.500        (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.336      P=0.753N     P=0.744N     P=0.484    |  P=0.563N     P=0.507        (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.341                                           |  P=0.567N                                          |
|FISHER EXACT           |               P=0.752N     P=0.748      P=0.489    |               P=0.500        (e)          (e)      |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05086 TEST: 01                                                 PAGE   2
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- O-BENZYL-P-CHLOROPHENOL
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0MG/KG       30MG/KG      60MG/KG      120MG/KG  |   0MG/KG       60MG/KG      120MG/KG     240MG/KG  |
|                       |   65HUCC M     65HUCC M     65HUCC M     65HUCC M  |   65HUCC F     65HUCC F     65HUCC F     65HUCC F  |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 14/70 (20%)   7/70 (10%)  10/69 (14%)  15/68 (22%) |  0/70 (0%)    4/70 (6%)    3/68 (4%)    4/70 (6%)  |
|ADJUSTED (b)           |  47.6%        26.1%        35.9%        50.6%      |   0.0%        10.5%        10.7%        12.2%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/8 (0%)     0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  8/23 (35%)   5/24 (21%)   8/25 (32%)  10/24 (42%) |  0/26 (0%)    1/30 (3%)    3/28 (11%)   2/28 (7%)  |
|FIRST INCIDENCE (DAYS) |   638          669          579          591       |   ---          633          729 (T)      661       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.283      P=0.069N     P=0.202N     P=0.523    |  P=0.128      P=0.083      P=0.133      P=0.074    |
|INCIDENTAL TUMOR       |  P=0.204      P=0.072N     P=0.207N     P=0.400    |  P=0.145      P=0.075      P=0.133      P=0.087    |
|LOGISTIC REGRESSION    |  P=0.219      P=0.064N     P=0.252N     P=0.444    |  P=0.127      P=0.071      P=0.133      P=0.073    |
|COCHRAN-ARMITAGE       |  P=0.246                                           |  P=0.116                                           |
|FISHER EXACT           |               P=0.077N     P=0.263N     P=0.465    |               P=0.060      P=0.117      P=0.060    |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  7/69 (10%)   4/68 (6%)    2/69 (3%)    2/69 (3%)  |  8/69 (12%)   7/68 (10%)   4/66 (6%)    4/67 (6%)  |
|ADJUSTED (b)           |  21.2%        13.3%         8.0%         8.3%      |  28.1%        21.1%        12.8%        13.6%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/8 (0%)     0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  1/10 (10%)   1/10 (10%)   0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  3/23 (13%)   2/24 (8%)    2/25 (8%)    2/24 (8%)  |  6/25 (24%)   5/29 (17%)   3/28 (11%)   3/27 (11%) |
|FIRST INCIDENCE (DAYS) |   457          456 (I)      729 (T)      729 (T)   |   583          632          582          676       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.048N*    P=0.265N     P=0.082N     P=0.089N   |  P=0.093N     P=0.387N     P=0.144N     P=0.146N   |
|INCIDENTAL TUMOR       |  P=0.050N     P=0.267N     P=0.085N     P=0.092N   |  P=0.094N     P=0.409N     P=0.135N     P=0.144N   |
|LOGISTIC REGRESSION    |  P=0.050N*    P=0.273N     P=0.082N     P=0.088N   |  P=0.097N     P=0.425N     P=0.175N     P=0.148N   |
|COCHRAN-ARMITAGE       |  P=0.048N*                                         |  P=0.124N                                          |
|FISHER EXACT           |               P=0.274N     P=0.083N     P=0.083N   |               P=0.512N     P=0.205N     P=0.197N   |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05086 TEST: 01                                                 PAGE   3
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- O-BENZYL-P-CHLOROPHENOL
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0MG/KG       30MG/KG      60MG/KG      120MG/KG  |   0MG/KG       60MG/KG      120MG/KG     240MG/KG  |
|                       |   65HUCC M     65HUCC M     65HUCC M     65HUCC M  |   65HUCC F     65HUCC F     65HUCC F     65HUCC F  |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/69 (3%)    3/68 (4%)    3/69 (4%)    0/69 (0%)  |  5/69 (7%)    2/68 (3%)    2/66 (3%)    2/67 (3%)  |
|ADJUSTED (b)           |   5.2%         8.5%         7.6%         0.0%      |  18.5%         6.6%         7.1%         7.4%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/8 (0%)     0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    1/10 (10%)   0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  0/23 (0%)    1/24 (4%)    0/25 (0%)    0/24 (0%)  |  4/25 (16%)   1/29 (3%)    2/28 (7%)    2/27 (7%)  |
|FIRST INCIDENCE (DAYS) |   543          457 (I)      562          ---       |   680          724          729 (T)      729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.183N     P=0.499      P=0.495      P=0.255N   |  P=0.172N     P=0.173N     P=0.188N     P=0.189N   |
|INCIDENTAL TUMOR       |  P=0.192N     P=0.502      P=0.503      P=0.244N   |  P=0.164N     P=0.176N     P=0.189N     P=0.179N   |
|LOGISTIC REGRESSION    |  P=0.178N     P=0.494      P=0.591      P=0.241N   |  P=0.179N     P=0.175N     P=0.213N     P=0.194N   |
|COCHRAN-ARMITAGE       |  P=0.165N                                          |  P=0.199N                                          |
|FISHER EXACT           |               P=0.493      P=0.500      P=0.248N   |               P=0.226N     P=0.239N     P=0.233N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  9/69 (13%)   7/68 (10%)   5/69 (7%)    2/69 (3%)  | 13/69 (19%)   9/68 (13%)   6/66 (9%)    6/67 (9%)  |
|ADJUSTED (b)           |  25.3%        21.0%        15.0%         8.3%      |  44.9%        26.9%        19.8%        20.8%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/8 (0%)     0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  1/10 (10%)   2/10 (20%)   0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  3/23 (13%)   3/24 (13%)   2/25 (8%)    2/24 (8%)  | 10/25 (40%)   6/29 (21%)   5/28 (18%)   5/27 (19%) |
|FIRST INCIDENCE (DAYS) |   457          456 (I)      562          729 (T)   |   583          632          582          676       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.021N*    P=0.395N     P=0.203N     P=0.035N*  |  P=0.033N*    P=0.142N     P=0.041N*    P=0.042N*  |
|INCIDENTAL TUMOR       |  P=0.021N*    P=0.394N     P=0.188N     P=0.034N*  |  P=0.031N*    P=0.152N     P=0.038N*    P=0.038N*  |
|LOGISTIC REGRESSION    |  P=0.018N*    P=0.407N     P=0.173N     P=0.031N*  |  P=0.034N*    P=0.156N     P=0.057N     P=0.042N*  |
|COCHRAN-ARMITAGE       |  P=0.018N*                                         |  P=0.055N                                          |
|FISHER EXACT           |               P=0.408N     P=0.199N     P=0.028N*  |               P=0.255N     P=0.083N     P=0.078N   |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05086 TEST: 01                                                 PAGE   4
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- O-BENZYL-P-CHLOROPHENOL
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0MG/KG       30MG/KG      60MG/KG      120MG/KG  |   0MG/KG       60MG/KG      120MG/KG     240MG/KG  |
|                       |   65HUCC M     65HUCC M     65HUCC M     65HUCC M  |   65HUCC F     65HUCC F     65HUCC F     65HUCC F  |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/69 (3%)    0/67 (0%)    2/68 (3%)    2/68 (3%)  |  0/70 (0%)    0/70 (0%)    1/67 (1%)    0/70 (0%)  |
|ADJUSTED (b)           |   8.0%         0.0%         8.0%         7.5%      |   0.0%         0.0%         3.4%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/8 (0%)     0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  0/23 (0%)    0/24 (0%)    2/25 (8%)    1/24 (4%)  |  0/26 (0%)    0/30 (0%)    0/28 (0%)    0/28 (0%)  |
|FIRST INCIDENCE (DAYS) |   724          ---          729 (T)      716       |   ---          ---          680          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.453      P=0.240N     P=0.667N     P=0.685N   |  P=0.693        (e)        P=0.468        (e)      |
|INCIDENTAL TUMOR       |  P=0.408      P=0.273N     P=0.680      P=0.629    |  P=0.714        (e)        P=0.455        (e)      |
|LOGISTIC REGRESSION    |  P=0.442      P=0.234N     P=0.697N     P=0.695    |  P=0.699        (e)        P=0.498        (e)      |
|COCHRAN-ARMITAGE       |  P=0.442                                           |  P=0.693                                           |
|FISHER EXACT           |               P=0.256N     P=0.685      P=0.685    |                 (e)        P=0.489        (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/69 (3%)    1/67 (1%)    2/68 (3%)    2/68 (3%)  |  0/70 (0%)    0/70 (0%)    2/67 (3%)    0/70 (0%)  |
|ADJUSTED (b)           |   8.0%         2.9%         8.0%         7.5%      |   0.0%         0.0%         6.9%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/8 (0%)     0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  0/23 (0%)    0/24 (0%)    2/25 (8%)    1/24 (4%)  |  0/26 (0%)    0/30 (0%)    1/28 (4%)    0/28 (0%)  |
|FIRST INCIDENCE (DAYS) |   724          656          729 (T)      716       |   ---          ---          680          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.531      P=0.500N     P=0.667N     P=0.685N   |  P=0.599        (e)        P=0.230        (e)      |
|INCIDENTAL TUMOR       |  P=0.479      P=0.560N     P=0.680      P=0.629    |  P=0.619        (e)        P=0.223        (e)      |
|LOGISTIC REGRESSION    |  P=0.514      P=0.507N     P=0.697N     P=0.695    |  P=0.604        (e)        P=0.234        (e)      |
|COCHRAN-ARMITAGE       |  P=0.523                                           |  P=0.593                                           |
|FISHER EXACT           |               P=0.511N     P=0.685      P=0.685    |                 (e)        P=0.237        (e)      |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05086 TEST: 01                                                 PAGE   5
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- O-BENZYL-P-CHLOROPHENOL
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0MG/KG       30MG/KG      60MG/KG      120MG/KG  |   0MG/KG       60MG/KG      120MG/KG     240MG/KG  |
|                       |   65HUCC M     65HUCC M     65HUCC M     65HUCC M  |   65HUCC F     65HUCC F     65HUCC F     65HUCC F  |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/70 (3%)    0/70 (0%)    1/70 (1%)    0/69 (0%)  |  0/70 (0%)    0/70 (0%)    0/68 (0%)    0/70 (0%)  |
|ADJUSTED (b)           |   7.6%         0.0%         4.0%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/8 (0%)     0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  1/23 (4%)    0/24 (0%)    1/25 (4%)    0/24 (0%)  |  0/26 (0%)    0/30 (0%)    0/28 (0%)    0/28 (0%)  |
|FIRST INCIDENCE (DAYS) |   696          ---          729 (T)      ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.184N     P=0.231N     P=0.481N     P=0.235N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.196N     P=0.253N     P=0.500N     P=0.263N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.192N     P=0.239N     P=0.507N     P=0.245N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.191N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.248N     P=0.500N     P=0.252N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/70 (3%)    1/70 (1%)    1/70 (1%)    0/69 (0%)  |  0/70 (0%)    1/70 (1%)    0/68 (0%)    0/70 (0%)  |
|ADJUSTED (b)           |   7.6%         4.2%         4.0%         0.0%      |   0.0%         2.8%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/8 (0%)     0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  1/23 (4%)    1/24 (4%)    1/25 (4%)    0/24 (0%)  |  0/26 (0%)    0/30 (0%)    0/28 (0%)    0/28 (0%)  |
|FIRST INCIDENCE (DAYS) |   696          729 (T)      729 (T)      ---       |   ---          674          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.147N     P=0.486N     P=0.481N     P=0.235N   |  P=0.565N     P=0.506        (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.157N     P=0.509N     P=0.500N     P=0.263N   |  P=0.530N     P=0.519        (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.155N     P=0.503N     P=0.507N     P=0.245N   |  P=0.560N     P=0.513        (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.156N                                          |  P=0.567N                                          |
|FISHER EXACT           |               P=0.500N     P=0.500N     P=0.252N   |               P=0.500        (e)          (e)      |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05086 TEST: 01                                                 PAGE   6
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- O-BENZYL-P-CHLOROPHENOL
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0MG/KG       30MG/KG      60MG/KG      120MG/KG  |   0MG/KG       60MG/KG      120MG/KG     240MG/KG  |
|                       |   65HUCC M     65HUCC M     65HUCC M     65HUCC M  |   65HUCC F     65HUCC F     65HUCC F     65HUCC F  |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/70 (0%)    0/70 (0%)    0/70 (0%)    0/69 (0%)  |  0/70 (0%)    2/70 (3%)    0/68 (0%)    0/70 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   0.0%         6.7%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/8 (0%)     0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  0/23 (0%)    0/24 (0%)    0/25 (0%)    0/24 (0%)  |  0/26 (0%)    2/30 (7%)    0/28 (0%)    0/28 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   ---          729 (T)      ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.397N     P=0.270        (e)          (e)      |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.397N     P=0.270        (e)          (e)      |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.397N     P=0.270        (e)          (e)      |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.406N                                          |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.248        (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/70 (0%)    0/70 (0%)    0/70 (0%)    0/69 (0%)  |  2/70 (3%)    0/70 (0%)    1/68 (1%)    2/70 (3%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   7.0%         0.0%         2.5%         6.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/8 (0%)     0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  0/23 (0%)    0/24 (0%)    0/25 (0%)    0/24 (0%)  |  0/26 (0%)    0/30 (0%)    0/28 (0%)    1/28 (4%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   717          ---          598          649       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.483      P=0.221N     P=0.497N     P=0.672N   |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.523      P=0.213N     P=0.491N     P=0.617N   |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.486      P=0.214N     P=0.499N     P=0.666N   |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.469                                           |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.248N     P=0.511N     P=0.690N   |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05086 TEST: 01                                                 PAGE   7
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- O-BENZYL-P-CHLOROPHENOL
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0MG/KG       30MG/KG      60MG/KG      120MG/KG  |   0MG/KG       60MG/KG      120MG/KG     240MG/KG  |
|                       |   65HUCC M     65HUCC M     65HUCC M     65HUCC M  |   65HUCC F     65HUCC F     65HUCC F     65HUCC F  |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/70 (0%)    0/70 (0%)    0/70 (0%)    0/69 (0%)  |  2/70 (3%)    2/70 (3%)    1/68 (1%)    2/70 (3%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   7.0%         6.7%         2.5%         6.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/8 (0%)     0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  0/23 (0%)    0/24 (0%)    0/25 (0%)    0/24 (0%)  |  0/26 (0%)    2/30 (7%)    0/28 (0%)    1/28 (4%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   717          729 (T)      598          649       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.562N     P=0.651N     P=0.497N     P=0.672N   |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.528N     P=0.651N     P=0.491N     P=0.617N   |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.558N     P=0.661N     P=0.499N     P=0.666N   |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.578N                                          |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.690N     P=0.511N     P=0.690N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroadenoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/70 (3%)    2/70 (3%)    2/70 (3%)    1/69 (1%)  | 13/70 (19%)  13/70 (19%)  17/68 (25%)  21/70 (30%) |
|ADJUSTED (b)           |   6.8%         5.9%         6.7%         4.2%      |  38.8%        35.0%        48.5%        55.8%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/8 (0%)     0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/9 (0%)     2/10 (20%) |
|TERMINAL (d)           |  0/23 (0%)    0/24 (0%)    1/25 (4%)    1/24 (4%)  |  7/26 (27%)   8/30 (27%)  11/28 (39%)  13/28 (46%) |
|FIRST INCIDENCE (DAYS) |   670          525          661          729 (T)   |   583          629          562          456 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.383N     P=0.687      P=0.686N     P=0.503N   |  P=0.057      P=0.441N     P=0.308      P=0.130    |
|INCIDENTAL TUMOR       |  P=0.417N     P=0.664      P=0.659      P=0.556N   |  P=0.058      P=0.467N     P=0.329      P=0.143    |
|LOGISTIC REGRESSION    |  P=0.390N     P=0.694      P=0.687      P=0.514N   |  P=0.063      P=0.484N     P=0.325      P=0.116    |
|COCHRAN-ARMITAGE       |  P=0.378N                                          |  P=0.041 *                                         |
|FISHER EXACT           |               P=0.690N     P=0.690N     P=0.505N   |               P=0.586N     P=0.239      P=0.084    |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05086 TEST: 01                                                 PAGE   8
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- O-BENZYL-P-CHLOROPHENOL
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0MG/KG       30MG/KG      60MG/KG      120MG/KG  |   0MG/KG       60MG/KG      120MG/KG     240MG/KG  |
|                       |   65HUCC M     65HUCC M     65HUCC M     65HUCC M  |   65HUCC F     65HUCC F     65HUCC F     65HUCC F  |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma or Adenoma                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/70 (3%)    2/70 (3%)    2/70 (3%)    1/69 (1%)  | 13/70 (19%)  15/70 (21%)  17/68 (25%)  21/70 (30%) |
|ADJUSTED (b)           |   6.8%         5.9%         6.7%         4.2%      |  38.8%        40.9%        48.5%        55.8%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/8 (0%)     0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/9 (0%)     2/10 (20%) |
|TERMINAL (d)           |  0/23 (0%)    0/24 (0%)    1/25 (4%)    1/24 (4%)  |  7/26 (27%)  10/30 (33%)  11/28 (39%)  13/28 (46%) |
|FIRST INCIDENCE (DAYS) |   670          525          661          729 (T)   |   583          629          562          456 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.383N     P=0.687      P=0.686N     P=0.503N   |  P=0.077      P=0.569      P=0.308      P=0.130    |
|INCIDENTAL TUMOR       |  P=0.417N     P=0.664      P=0.659      P=0.556N   |  P=0.080      P=0.545      P=0.329      P=0.143    |
|LOGISTIC REGRESSION    |  P=0.390N     P=0.694      P=0.687      P=0.514N   |  P=0.086      P=0.528      P=0.325      P=0.116    |
|COCHRAN-ARMITAGE       |  P=0.378N                                          |  P=0.057                                           |
|FISHER EXACT           |               P=0.690N     P=0.690N     P=0.505N   |               P=0.416      P=0.239      P=0.084    |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/70 (3%)    2/70 (3%)    2/70 (3%)    1/69 (1%)  | 14/70 (20%)  15/70 (21%)  18/68 (26%)  21/70 (30%) |
|ADJUSTED (b)           |   6.8%         5.9%         6.7%         4.2%      |  40.9%        40.9%        49.8%        55.8%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/8 (0%)     0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/9 (0%)     2/10 (20%) |
|TERMINAL (d)           |  0/23 (0%)    0/24 (0%)    1/25 (4%)    1/24 (4%)  |  7/26 (27%)  10/30 (33%)  11/28 (39%)  13/28 (46%) |
|FIRST INCIDENCE (DAYS) |   670          525          661          729 (T)   |   583          629          562          456 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.383N     P=0.687      P=0.686N     P=0.503N   |  P=0.104      P=0.511N     P=0.314      P=0.180    |
|INCIDENTAL TUMOR       |  P=0.417N     P=0.664      P=0.659      P=0.556N   |  P=0.110      P=0.540N     P=0.338      P=0.205    |
|LOGISTIC REGRESSION    |  P=0.390N     P=0.694      P=0.687      P=0.514N   |  P=0.118      P=0.556N     P=0.342      P=0.167    |
|COCHRAN-ARMITAGE       |  P=0.378N                                          |  P=0.078                                           |
|FISHER EXACT           |               P=0.690N     P=0.690N     P=0.505N   |               P=0.500      P=0.242      P=0.121    |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05086 TEST: 01                                                 PAGE   9
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- O-BENZYL-P-CHLOROPHENOL
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0MG/KG       30MG/KG      60MG/KG      120MG/KG  |   0MG/KG       60MG/KG      120MG/KG     240MG/KG  |
|                       |   65HUCC M     65HUCC M     65HUCC M     65HUCC M  |   65HUCC F     65HUCC F     65HUCC F     65HUCC F  |
|=================================================================================================================================|
|                                                                                                                                 |
|Pancreas                                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/69 (1%)    1/67 (1%)    2/68 (3%)    1/67 (1%)  |  0/70 (0%)    0/70 (0%)    0/67 (0%)    0/70 (0%)  |
|ADJUSTED (b)           |   4.3%         4.2%         8.0%         4.2%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/8 (0%)     0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  1/23 (4%)    1/24 (4%)    2/25 (8%)    1/24 (4%)  |  0/26 (0%)    0/30 (0%)    0/28 (0%)    0/28 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      729 (T)      729 (T)      729 (T)   |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.605      P=0.753N     P=0.529      P=0.753N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.605      P=0.753N     P=0.529      P=0.753N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.605      P=0.753N     P=0.529      P=0.753N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.583                                           |    (e)                                             |
|FISHER EXACT           |               P=0.744      P=0.494      P=0.744    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 18/68 (26%)  12/70 (17%)  18/69 (26%)  13/69 (19%) | 20/70 (29%)  14/70 (20%)  13/67 (19%)  19/70 (27%) |
|ADJUSTED (b)           |  48.1%        31.7%        52.4%        42.7%      |  56.9%        39.3%        36.2%        46.8%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/8 (0%)     0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  2/10 (20%)   1/10 (10%)   0/10 (0%)    0/9 (0%)   |  1/10 (10%)   0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  6/22 (27%)   4/24 (17%)   9/24 (38%)   8/24 (33%) | 12/26 (46%)   9/30 (30%)   7/28 (25%)   9/28 (32%) |
|FIRST INCIDENCE (DAYS) |   456 (I)      456          521          459       |   457 (I)      633          582          471       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.294N     P=0.163N     P=0.543N     P=0.210N   |  P=0.499N     P=0.091N     P=0.103N     P=0.390N   |
|INCIDENTAL TUMOR       |  P=0.361N     P=0.098N     P=0.556      P=0.254N   |  P=0.478N     P=0.093N     P=0.101N     P=0.424N   |
|LOGISTIC REGRESSION    |  P=0.390N     P=0.108N     P=0.549      P=0.215N   |  P=0.427N     P=0.082N     P=0.106N     P=0.323N   |
|COCHRAN-ARMITAGE       |  P=0.279N                                          |  P=0.512                                           |
|FISHER EXACT           |               P=0.131N     P=0.557N     P=0.194N   |               P=0.162N     P=0.146N     P=0.500N   |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05086 TEST: 01                                                 PAGE  10
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- O-BENZYL-P-CHLOROPHENOL
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0MG/KG       30MG/KG      60MG/KG      120MG/KG  |   0MG/KG       60MG/KG      120MG/KG     240MG/KG  |
|                       |   65HUCC M     65HUCC M     65HUCC M     65HUCC M  |   65HUCC F     65HUCC F     65HUCC F     65HUCC F  |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/68 (3%)    0/70 (0%)    0/69 (0%)    0/69 (0%)  |  2/70 (3%)    0/70 (0%)    0/67 (0%)    0/70 (0%)  |
|ADJUSTED (b)           |   7.5%         0.0%         0.0%         0.0%      |   6.1%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/8 (0%)     0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  1/22 (5%)    0/24 (0%)    0/24 (0%)    0/24 (0%)  |  1/26 (4%)    0/30 (0%)    0/28 (0%)    0/28 (0%)  |
|FIRST INCIDENCE (DAYS) |   687          ---          ---          ---       |   521          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.112N     P=0.237N     P=0.237N     P=0.227N   |  P=0.109N     P=0.212N     P=0.227N     P=0.220N   |
|INCIDENTAL TUMOR       |  P=0.123N     P=0.248N     P=0.248N     P=0.258N   |  P=0.152N     P=0.385N     P=0.304N     P=0.304N   |
|LOGISTIC REGRESSION    |  P=0.116N     P=0.233N     P=0.242N     P=0.239N   |  P=0.114N     P=0.231N     P=0.243N     P=0.230N   |
|COCHRAN-ARMITAGE       |  P=0.114N                                          |  P=0.117N                                          |
|FISHER EXACT           |               P=0.241N     P=0.245N     P=0.245N   |               P=0.248N     P=0.259N     P=0.248N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 20/68 (29%)  12/70 (17%)  18/69 (26%)  13/69 (19%) | 22/70 (31%)  14/70 (20%)  13/67 (19%)  19/70 (27%) |
|ADJUSTED (b)           |  52.9%        31.7%        52.4%        42.7%      |  60.9%        39.3%        36.2%        46.8%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/8 (0%)     0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  2/10 (20%)   1/10 (10%)   0/10 (0%)    0/9 (0%)   |  1/10 (10%)   0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  7/22 (32%)   4/24 (17%)   9/24 (38%)   8/24 (33%) | 13/26 (50%)   9/30 (30%)   7/28 (25%)   9/28 (32%) |
|FIRST INCIDENCE (DAYS) |   456 (I)      456          521          459       |   457 (I)      633          582          471       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.194N     P=0.092N     P=0.402N     P=0.120N   |  P=0.372N     P=0.043N*    P=0.052N     P=0.260N   |
|INCIDENTAL TUMOR       |  P=0.240N     P=0.047N*    P=0.448N     P=0.145N   |  P=0.353N     P=0.055N     P=0.054N     P=0.299N   |
|LOGISTIC REGRESSION    |  P=0.263N     P=0.051N     P=0.453N     P=0.116N   |  P=0.294N     P=0.037N*    P=0.037N*    P=0.191N   |
|COCHRAN-ARMITAGE       |  P=0.179N                                          |  P=0.432N                                          |
|FISHER EXACT           |               P=0.066N     P=0.404N     P=0.106N   |               P=0.088N     P=0.078N     P=0.355N   |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05086 TEST: 01                                                 PAGE  11
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- O-BENZYL-P-CHLOROPHENOL
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0MG/KG       30MG/KG      60MG/KG      120MG/KG  |   0MG/KG       60MG/KG      120MG/KG     240MG/KG  |
|                       |   65HUCC M     65HUCC M     65HUCC M     65HUCC M  |   65HUCC F     65HUCC F     65HUCC F     65HUCC F  |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Keratoacanthoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  6/70 (9%)    4/70 (6%)    2/70 (3%)    1/69 (1%)  |  0/70 (0%)    1/70 (1%)    0/68 (0%)    0/70 (0%)  |
|ADJUSTED (b)           |  19.9%        16.7%         8.0%         4.2%      |   0.0%         3.3%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/8 (0%)     0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  3/23 (13%)   4/24 (17%)   2/25 (8%)    1/24 (4%)  |  0/26 (0%)    1/30 (3%)    0/28 (0%)    0/28 (0%)  |
|FIRST INCIDENCE (DAYS) |   610          729 (T)      729 (T)      729 (T)   |   ---          729 (T)      ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.027N*    P=0.365N     P=0.130N     P=0.063N   |  P=0.563N     P=0.529        (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.029N*    P=0.332N     P=0.108N     P=0.073N   |  P=0.563N     P=0.529        (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.032N*    P=0.375N     P=0.141N     P=0.065N   |  P=0.563N     P=0.529        (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.032N*                                         |  P=0.567N                                          |
|FISHER EXACT           |               P=0.372N     P=0.137N     P=0.060N   |               P=0.500        (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/70 (0%)    5/70 (7%)    2/70 (3%)    1/69 (1%)  |  1/70 (1%)    0/70 (0%)    1/68 (1%)    1/70 (1%)  |
|ADJUSTED (b)           |   0.0%        15.4%         8.0%         4.2%      |   3.8%         0.0%         3.6%         3.6%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/8 (0%)     0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    1/10 (10%)   0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  0/23 (0%)    2/24 (8%)    2/25 (8%)    1/24 (4%)  |  1/26 (4%)    0/30 (0%)    1/28 (4%)    1/28 (4%)  |
|FIRST INCIDENCE (DAYS) |   ---          457 (I)      729 (T)      729 (T)   |   729 (T)      ---          729 (T)      729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.499N     P=0.036 *    P=0.256      P=0.508    |  P=0.548      P=0.471N     P=0.746N     P=0.746N   |
|INCIDENTAL TUMOR       |  P=0.524N     P=0.038 *    P=0.256      P=0.508    |  P=0.548      P=0.471N     P=0.746N     P=0.746N   |
|LOGISTIC REGRESSION    |  P=0.521N     P=0.034 *    P=0.256      P=0.508    |  P=0.548      P=0.471N     P=0.746N     P=0.746N   |
|COCHRAN-ARMITAGE       |  P=0.506N                                          |  P=0.538                                           |
|FISHER EXACT           |               P=0.029 *    P=0.248      P=0.496    |               P=0.500N     P=0.745      P=0.752N   |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05086 TEST: 01                                                 PAGE  12
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- O-BENZYL-P-CHLOROPHENOL
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0MG/KG       30MG/KG      60MG/KG      120MG/KG  |   0MG/KG       60MG/KG      120MG/KG     240MG/KG  |
|                       |   65HUCC M     65HUCC M     65HUCC M     65HUCC M  |   65HUCC F     65HUCC F     65HUCC F     65HUCC F  |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/70 (0%)    5/70 (7%)    1/70 (1%)    1/69 (1%)  |  0/70 (0%)    0/70 (0%)    1/68 (1%)    1/70 (1%)  |
|ADJUSTED (b)           |   0.0%        15.4%         4.0%         4.2%      |   0.0%         0.0%         3.6%         3.6%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/8 (0%)     0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    1/10 (10%)   0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  0/23 (0%)    2/24 (8%)    1/25 (4%)    1/24 (4%)  |  0/26 (0%)    0/30 (0%)    1/28 (4%)    1/28 (4%)  |
|FIRST INCIDENCE (DAYS) |   ---          457 (I)      729 (T)      729 (T)   |   ---          ---          729 (T)      729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.475N     P=0.036 *    P=0.517      P=0.508    |  P=0.239        (e)        P=0.515      P=0.515    |
|INCIDENTAL TUMOR       |  P=0.501N     P=0.038 *    P=0.517      P=0.508    |  P=0.239        (e)        P=0.515      P=0.515    |
|LOGISTIC REGRESSION    |  P=0.493N     P=0.034 *    P=0.517      P=0.508    |  P=0.239        (e)        P=0.515      P=0.515    |
|COCHRAN-ARMITAGE       |  P=0.480N                                          |  P=0.236                                           |
|FISHER EXACT           |               P=0.029 *    P=0.500      P=0.496    |                 (e)        P=0.493      P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma,                                                                |
|     Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  6/70 (9%)    9/70 (13%)   4/70 (6%)    3/69 (4%)  |  1/70 (1%)    1/70 (1%)    1/68 (1%)    1/70 (1%)  |
|ADJUSTED (b)           |  19.9%        30.8%        16.0%        10.1%      |   3.8%         3.3%         3.6%         3.6%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/8 (0%)     0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    1/10 (10%)   0/10 (0%)    1/9 (11%)  |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  3/23 (13%)   6/24 (25%)   4/25 (16%)   2/24 (8%)  |  1/26 (4%)    1/30 (3%)    1/28 (4%)    1/28 (4%)  |
|FIRST INCIDENCE (DAYS) |   610          457 (I)      729 (T)      456 (I)   |   729 (T)      729 (T)      729 (T)      729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.095N     P=0.296      P=0.348N     P=0.254N   |  P=0.626N     P=0.730N     P=0.746N     P=0.746N   |
|INCIDENTAL TUMOR       |  P=0.106N     P=0.322      P=0.315N     P=0.283N   |  P=0.626N     P=0.730N     P=0.746N     P=0.746N   |
|LOGISTIC REGRESSION    |  P=0.111N     P=0.283      P=0.384N     P=0.265N   |  P=0.626N     P=0.730N     P=0.746N     P=0.746N   |
|COCHRAN-ARMITAGE       |  P=0.105N                                          |  P=0.632                                           |
|FISHER EXACT           |               P=0.293      P=0.372N     P=0.254N   |               P=0.752N     P=0.745      P=0.752N   |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05086 TEST: 01                                                 PAGE  13
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- O-BENZYL-P-CHLOROPHENOL
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0MG/KG       30MG/KG      60MG/KG      120MG/KG  |   0MG/KG       60MG/KG      120MG/KG     240MG/KG  |
|                       |   65HUCC M     65HUCC M     65HUCC M     65HUCC M  |   65HUCC F     65HUCC F     65HUCC F     65HUCC F  |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/70 (1%)    1/70 (1%)    1/70 (1%)    2/69 (3%)  |  1/70 (1%)    0/70 (0%)    0/68 (0%)    1/70 (1%)  |
|ADJUSTED (b)           |   1.9%         2.9%         4.0%         6.6%      |   3.8%         0.0%         0.0%         3.6%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/8 (0%)     0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  0/23 (0%)    0/24 (0%)    1/25 (4%)    0/24 (0%)  |  1/26 (4%)    0/30 (0%)    0/28 (0%)    1/28 (4%)  |
|FIRST INCIDENCE (DAYS) |   457          656          729 (T)      694       |   729 (T)      ---          ---          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.352      P=0.758      P=0.755N     P=0.503    |  P=0.603      P=0.471N     P=0.485N     P=0.746N   |
|INCIDENTAL TUMOR       |  P=0.315      P=0.757      P=0.710      P=0.454    |  P=0.603      P=0.471N     P=0.485N     P=0.746N   |
|LOGISTIC REGRESSION    |  P=0.337      P=0.762N     P=0.761      P=0.488    |  P=0.603      P=0.471N     P=0.485N     P=0.746N   |
|COCHRAN-ARMITAGE       |  P=0.347                                           |  P=0.594                                           |
|FISHER EXACT           |               P=0.752N     P=0.752N     P=0.495    |               P=0.500N     P=0.507N     P=0.752N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,                                                                                   |
|     Neurofibroma, or Fibroma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/70 (3%)    2/70 (3%)    3/70 (4%)    3/69 (4%)  |  2/70 (3%)    1/70 (1%)    1/68 (1%)    1/70 (1%)  |
|ADJUSTED (b)           |   6.2%         6.9%        11.5%         9.9%      |   7.4%         3.3%         2.2%         3.6%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/8 (0%)     0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  1/23 (4%)    1/24 (4%)    2/25 (8%)    0/24 (0%)  |  1/26 (4%)    1/30 (3%)    0/28 (0%)    1/28 (4%)  |
|FIRST INCIDENCE (DAYS) |   457          656          726          694       |   726          729 (T)      508          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.379      P=0.687N     P=0.526      P=0.509    |  P=0.397N     P=0.455N     P=0.480N     P=0.479N   |
|INCIDENTAL TUMOR       |  P=0.327      P=0.688N     P=0.458      P=0.444    |  P=0.423N     P=0.456N     P=0.581N     P=0.453N   |
|LOGISTIC REGRESSION    |  P=0.349      P=0.694N     P=0.491      P=0.480    |  P=0.394N     P=0.462N     P=0.500N     P=0.486N   |
|COCHRAN-ARMITAGE       |  P=0.365                                           |  P=0.411N                                          |
|FISHER EXACT           |               P=0.690N     P=0.500      P=0.493    |               P=0.500N     P=0.511N     P=0.500N   |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05086 TEST: 01                                                 PAGE  14
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- O-BENZYL-P-CHLOROPHENOL
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0MG/KG       30MG/KG      60MG/KG      120MG/KG  |   0MG/KG       60MG/KG      120MG/KG     240MG/KG  |
|                       |   65HUCC M     65HUCC M     65HUCC M     65HUCC M  |   65HUCC F     65HUCC F     65HUCC F     65HUCC F  |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, or Sarcoma                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/70 (1%)    1/70 (1%)    2/70 (3%)    1/69 (1%)  |  1/70 (1%)    1/70 (1%)    1/68 (1%)    0/70 (0%)  |
|ADJUSTED (b)           |   4.3%         4.2%         7.7%         3.6%      |   3.7%         3.3%         2.2%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/8 (0%)     0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  1/23 (4%)    1/24 (4%)    1/25 (4%)    0/24 (0%)  |  0/26 (0%)    1/30 (3%)    0/28 (0%)    0/28 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      729 (T)      726          717       |   726          729 (T)      508          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.600      P=0.753N     P=0.529      P=0.752N   |  P=0.303N     P=0.733N     P=0.749N     P=0.493N   |
|INCIDENTAL TUMOR       |  P=0.568      P=0.753N     P=0.500      P=0.737    |  P=0.338N     P=0.734N     P=0.673      P=0.448N   |
|LOGISTIC REGRESSION    |  P=0.591      P=0.753N     P=0.506      P=0.761    |  P=0.304N     P=0.741N     P=0.760      P=0.491N   |
|COCHRAN-ARMITAGE       |  P=0.586                                           |  P=0.313N                                          |
|FISHER EXACT           |               P=0.752N     P=0.500      P=0.748    |               P=0.752N     P=0.745      P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 45/70 (64%)  42/68 (62%)  39/70 (56%)  46/69 (67%) |                                                    |
|ADJUSTED (b)           |  97.7%       100.0%        97.4%        97.8%      |                                                    |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |                                                    |
|INTERIM SACRIFICE 2 (c)|  7/10 (70%)   1/10 (10%)   0/10 (0%)    4/9 (44%)  |                                                    |
|TERMINAL (d)           | 22/23 (96%)  24/24 (100%) 24/25 (96%)  23/24 (96%) |                                                    |
|FIRST INCIDENCE (DAYS) |   456 (I)      439          463          431       |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.429      P=0.326N     P=0.139N     P=0.477    |                                                    |
|INCIDENTAL TUMOR       |  P=0.222      P=0.416N     P=0.136N     P=0.295    |                                                    |
|LOGISTIC REGRESSION    |  P=0.173      P=0.405N     P=0.152N     P=0.273    |                                                    |
|COCHRAN-ARMITAGE       |  P=0.418                                           |                                                    |
|FISHER EXACT           |               P=0.448N     P=0.194N     P=0.454    |                                                    |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05086 TEST: 01                                                 PAGE  15
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- O-BENZYL-P-CHLOROPHENOL
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0MG/KG       30MG/KG      60MG/KG      120MG/KG  |   0MG/KG       60MG/KG      120MG/KG     240MG/KG  |
|                       |   65HUCC M     65HUCC M     65HUCC M     65HUCC M  |   65HUCC F     65HUCC F     65HUCC F     65HUCC F  |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  9/69 (13%)  10/70 (14%)   5/67 (7%)    4/68 (6%)  |  9/70 (13%)   6/70 (9%)    6/68 (9%)    7/70 (10%) |
|ADJUSTED (b)           |  32.7%        33.4%        16.4%        16.7%      |  29.8%        19.0%        19.5%        18.8%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/8 (0%)     0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/9 (0%)     1/10 (10%) |
|TERMINAL (d)           |  6/23 (26%)   6/24 (25%)   2/25 (8%)    4/24 (17%) |  6/26 (23%)   5/30 (17%)   4/28 (14%)   2/28 (7%)  |
|FIRST INCIDENCE (DAYS) |   624          493          515          729 (T)   |   659          674          645          456 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.050N*    P=0.518      P=0.177N     P=0.110N   |  P=0.368N     P=0.215N     P=0.276N     P=0.345N   |
|INCIDENTAL TUMOR       |  P=0.058N     P=0.521      P=0.223N     P=0.124N   |  P=0.314N     P=0.198N     P=0.273N     P=0.286N   |
|LOGISTIC REGRESSION    |  P=0.058N     P=0.491      P=0.218N     P=0.124N   |  P=0.350N     P=0.211N     P=0.284N     P=0.329N   |
|COCHRAN-ARMITAGE       |  P=0.058N                                          |  P=0.397N                                          |
|FISHER EXACT           |               P=0.514      P=0.216N     P=0.127N   |               P=0.293N     P=0.314N     P=0.396N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/69 (4%)    0/70 (0%)    3/67 (4%)    0/68 (0%)  |  1/70 (1%)    1/70 (1%)    0/68 (0%)    1/70 (1%)  |
|ADJUSTED (b)           |  13.0%         0.0%        10.6%         0.0%      |   3.8%         3.3%         0.0%         3.6%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/8 (0%)     0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  3/23 (13%)   0/24 (0%)    2/25 (8%)    0/24 (0%)  |  1/26 (4%)    1/30 (3%)    0/28 (0%)    1/28 (4%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      ---          654          ---       |   729 (T)      729 (T)      ---          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.157N     P=0.111N     P=0.631N     P=0.111N   |  P=0.609N     P=0.730N     P=0.485N     P=0.746N   |
|INCIDENTAL TUMOR       |  P=0.163N     P=0.111N     P=0.652N     P=0.111N   |  P=0.609N     P=0.730N     P=0.485N     P=0.746N   |
|LOGISTIC REGRESSION    |  P=0.169N     P=0.111N     P=0.645      P=0.111N   |  P=0.609N     P=0.730N     P=0.485N     P=0.746N   |
|COCHRAN-ARMITAGE       |  P=0.170N                                          |  P=0.616N                                          |
|FISHER EXACT           |               P=0.120N     P=0.646      P=0.125N   |               P=0.752N     P=0.507N     P=0.752N   |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05086 TEST: 01                                                 PAGE  16
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- O-BENZYL-P-CHLOROPHENOL
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0MG/KG       30MG/KG      60MG/KG      120MG/KG  |   0MG/KG       60MG/KG      120MG/KG     240MG/KG  |
|                       |   65HUCC M     65HUCC M     65HUCC M     65HUCC M  |   65HUCC F     65HUCC F     65HUCC F     65HUCC F  |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 11/69 (16%)  10/70 (14%)   8/67 (12%)   4/68 (6%)  | 10/70 (14%)   7/70 (10%)   6/68 (9%)    8/70 (11%) |
|ADJUSTED (b)           |  40.6%        33.4%        25.8%        16.7%      |  33.3%        22.2%        19.5%        22.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/8 (0%)     0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/9 (0%)     1/10 (10%) |
|TERMINAL (d)           |  8/23 (35%)   6/24 (25%)   4/25 (16%)   4/24 (17%) |  7/26 (27%)   6/30 (20%)   4/28 (14%)   3/28 (11%) |
|FIRST INCIDENCE (DAYS) |   624          493          515          729 (T)   |   659          674          645          456 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.028N*    P=0.478N     P=0.268N     P=0.039N*  |  P=0.358N     P=0.213N     P=0.195N     P=0.345N   |
|INCIDENTAL TUMOR       |  P=0.033N*    P=0.475N     P=0.332N     P=0.045N*  |  P=0.306N     P=0.198N     P=0.190N     P=0.288N   |
|LOGISTIC REGRESSION    |  P=0.034N*    P=0.511N     P=0.343N     P=0.047N*  |  P=0.339N     P=0.213N     P=0.202N     P=0.326N   |
|COCHRAN-ARMITAGE       |  P=0.036N*                                         |  P=0.389N                                          |
|FISHER EXACT           |               P=0.486N     P=0.336N     P=0.052N   |               P=0.303N     P=0.232N     P=0.401N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/69 (3%)    1/70 (1%)    0/67 (0%)    1/68 (1%)  |  3/70 (4%)    1/70 (1%)    0/68 (0%)    2/70 (3%)  |
|ADJUSTED (b)           |   5.5%         2.8%         0.0%         4.2%      |  11.5%         3.3%         0.0%         5.5%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/8 (0%)     0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  0/23 (0%)    0/24 (0%)    0/25 (0%)    1/24 (4%)  |  3/26 (12%)   1/30 (3%)    0/28 (0%)    0/28 (0%)  |
|FIRST INCIDENCE (DAYS) |   465          631          ---          729 (T)   |   729 (T)      729 (T)      ---          649       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.377N     P=0.499N     P=0.245N     P=0.508N   |  P=0.430N     P=0.254N     P=0.107N     P=0.465N   |
|INCIDENTAL TUMOR       |  P=0.399N     P=0.478N     P=0.333N     P=0.510N   |  P=0.408N     P=0.254N     P=0.107N     P=0.432N   |
|LOGISTIC REGRESSION    |  P=0.378N     P=0.496N     P=0.245N     P=0.512N   |  P=0.428N     P=0.254N     P=0.107N     P=0.463N   |
|COCHRAN-ARMITAGE       |  P=0.373N                                          |  P=0.446N                                          |
|FISHER EXACT           |               P=0.495N     P=0.256N     P=0.506N   |               P=0.310N     P=0.128N     P=0.500N   |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05086 TEST: 01                                                 PAGE  17
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- O-BENZYL-P-CHLOROPHENOL
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0MG/KG       30MG/KG      60MG/KG      120MG/KG  |   0MG/KG       60MG/KG      120MG/KG     240MG/KG  |
|                       |   65HUCC M     65HUCC M     65HUCC M     65HUCC M  |   65HUCC F     65HUCC F     65HUCC F     65HUCC F  |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/69 (4%)    2/70 (3%)    1/67 (1%)    1/68 (1%)  |  3/70 (4%)    2/70 (3%)    1/68 (1%)    2/70 (3%)  |
|ADJUSTED (b)           |   8.7%         6.0%         4.0%         4.2%      |  11.5%         5.3%         3.6%         5.5%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/8 (0%)     0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  0/23 (0%)    0/24 (0%)    1/25 (4%)    1/24 (4%)  |  3/26 (12%)   1/30 (3%)    1/28 (4%)    0/28 (0%)  |
|FIRST INCIDENCE (DAYS) |   465          631          729 (T)      729 (T)   |   729 (T)      544          729 (T)      649       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.206N     P=0.493N     P=0.308N     P=0.315N   |  P=0.386N     P=0.436N     P=0.277N     P=0.465N   |
|INCIDENTAL TUMOR       |  P=0.237N     P=0.513N     P=0.397N     P=0.337N   |  P=0.399N     P=0.582N     P=0.277N     P=0.432N   |
|LOGISTIC REGRESSION    |  P=0.212N     P=0.497N     P=0.320N     P=0.319N   |  P=0.384N     P=0.461N     P=0.277N     P=0.463N   |
|COCHRAN-ARMITAGE       |  P=0.207N                                          |  P=0.406N                                          |
|FISHER EXACT           |               P=0.493N     P=0.321N     P=0.315N   |               P=0.500N     P=0.321N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  5/70 (7%)    6/70 (9%)    3/68 (4%)   12/70 (17%) |
|ADJUSTED (b)           |                                                    |  17.9%        15.6%         9.5%        37.3%      |
|INTERIM SACRIFICE 1 (c)|                                                    |  0/10 (0%)    0/10 (0%)    0/8 (0%)     0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|                                                    |  0/10 (0%)    0/10 (0%)    0/9 (0%)     1/10 (10%) |
|TERMINAL (d)           |                                                    |  4/26 (15%)   2/30 (7%)    2/28 (7%)    9/28 (32%) |
|FIRST INCIDENCE (DAYS) |                                                    |   680          544          622          456 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.035 *    P=0.592      P=0.334N     P=0.072    |
|INCIDENTAL TUMOR       |                                                    |  P=0.035 *    P=0.476      P=0.315N     P=0.083    |
|LOGISTIC REGRESSION    |                                                    |  P=0.035 *    P=0.558      P=0.356N     P=0.076    |
|COCHRAN-ARMITAGE       |                                                    |  P=0.030 *                                         |
|FISHER EXACT           |                                                    |               P=0.500      P=0.375N     P=0.059    |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05086 TEST: 01                                                 PAGE  18
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- O-BENZYL-P-CHLOROPHENOL
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0MG/KG       30MG/KG      60MG/KG      120MG/KG  |   0MG/KG       60MG/KG      120MG/KG     240MG/KG  |
|                       |   65HUCC M     65HUCC M     65HUCC M     65HUCC M  |   65HUCC F     65HUCC F     65HUCC F     65HUCC F  |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  2/70 (3%)    1/70 (1%)    0/68 (0%)    0/70 (0%)  |
|ADJUSTED (b)           |                                                    |   5.1%         2.4%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|                                                    |  0/10 (0%)    0/10 (0%)    0/8 (0%)     0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|                                                    |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |                                                    |  0/26 (0%)    0/30 (0%)    0/28 (0%)    0/28 (0%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   500          633          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.098N     P=0.476N     P=0.252N     P=0.227N   |
|INCIDENTAL TUMOR       |                                                    |  P=0.119N     P=0.664N     P=0.327N     P=0.280N   |
|LOGISTIC REGRESSION    |                                                    |  P=0.100N     P=0.493N     P=0.242N     P=0.234N   |
|COCHRAN-ARMITAGE       |                                                    |  P=0.102N                                          |
|FISHER EXACT           |                                                    |               P=0.500N     P=0.255N     P=0.248N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal or Polyp Stromal                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  6/70 (9%)    7/70 (10%)   3/68 (4%)   12/70 (17%) |
|ADJUSTED (b)           |                                                    |  19.7%        17.6%         9.5%        37.3%      |
|INTERIM SACRIFICE 1 (c)|                                                    |  0/10 (0%)    0/10 (0%)    0/8 (0%)     0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|                                                    |  0/10 (0%)    0/10 (0%)    0/9 (0%)     1/10 (10%) |
|TERMINAL (d)           |                                                    |  4/26 (15%)   2/30 (7%)    2/28 (7%)    9/28 (32%) |
|FIRST INCIDENCE (DAYS) |                                                    |   500          544          622          456 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.082      P=0.598      P=0.225N     P=0.126    |
|INCIDENTAL TUMOR       |                                                    |  P=0.073      P=0.391      P=0.246N     P=0.122    |
|LOGISTIC REGRESSION    |                                                    |  P=0.080      P=0.549      P=0.240N     P=0.131    |
|COCHRAN-ARMITAGE       |                                                    |  P=0.069                                           |
|FISHER EXACT           |                                                    |               P=0.500      P=0.261N     P=0.103    |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05086 TEST: 01                                                 PAGE  19
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- O-BENZYL-P-CHLOROPHENOL
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0MG/KG       30MG/KG      60MG/KG      120MG/KG  |   0MG/KG       60MG/KG      120MG/KG     240MG/KG  |
|                       |   65HUCC M     65HUCC M     65HUCC M     65HUCC M  |   65HUCC F     65HUCC F     65HUCC F     65HUCC F  |
|=================================================================================================================================|
|                                                                                                                                 |
|Zymbal's Gland                                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/70 (0%)    1/70 (1%)    1/70 (1%)    2/69 (3%)  |  0/70 (0%)    0/70 (0%)    0/68 (0%)    1/70 (1%)  |
|ADJUSTED (b)           |   0.0%         4.2%         3.8%         5.3%      |   0.0%         0.0%         0.0%         2.1%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/8 (0%)     0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  0/23 (0%)    1/24 (4%)    0/25 (0%)    0/24 (0%)  |  0/26 (0%)    0/30 (0%)    0/28 (0%)    0/28 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          729 (T)      726          543       |   ---          ---          ---          554       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.149      P=0.508      P=0.516      P=0.223    |  P=0.208        (e)          (e)        P=0.522    |
|INCIDENTAL TUMOR       |  P=0.134      P=0.508      P=0.467      P=0.222    |  P=0.193        (e)          (e)        P=0.500    |
|LOGISTIC REGRESSION    |  P=0.145      P=0.508      P=0.499      P=0.234    |  P=0.199        (e)          (e)        P=0.500    |
|COCHRAN-ARMITAGE       |  P=0.150                                           |  P=0.199                                           |
|FISHER EXACT           |               P=0.500      P=0.500      P=0.245    |                 (e)          (e)        P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Leukemia: Lymphocytic, Monocytic, Mononuclear,                                                                              |
|     or Undifferentiated                                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 10/70 (14%)   9/70 (13%)  10/70 (14%)  10/69 (14%) | 14/70 (20%)  16/70 (23%)  11/68 (16%)  17/70 (24%) |
|ADJUSTED (b)           |  29.5%        30.9%        32.1%        33.0%      |  38.5%        38.9%        30.5%        42.7%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/8 (0%)     0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  1/23 (4%)    5/24 (21%)   6/25 (24%)   6/24 (25%) |  6/26 (23%)   6/30 (20%)   5/28 (18%)   7/28 (25%) |
|FIRST INCIDENCE (DAYS) |   610          603          515          508       |   416          625          402          493       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.501      P=0.499N     P=0.576N     P=0.580    |  P=0.421      P=0.555      P=0.330N     P=0.448    |
|INCIDENTAL TUMOR       |  P=0.412      P=0.540N     P=0.581      P=0.481    |  P=0.455      P=0.469      P=0.314N     P=0.423    |
|LOGISTIC REGRESSION    |  P=0.393      P=0.510N     P=0.573      P=0.459    |  P=0.490      P=0.575      P=0.321N     P=0.502    |
|COCHRAN-ARMITAGE       |  P=0.497                                           |  P=0.360                                           |
|FISHER EXACT           |               P=0.500N     P=0.595N     P=0.582    |               P=0.419      P=0.359N     P=0.342    |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05086 TEST: 01                                                 PAGE  20
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- O-BENZYL-P-CHLOROPHENOL
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0MG/KG       30MG/KG      60MG/KG      120MG/KG  |   0MG/KG       60MG/KG      120MG/KG     240MG/KG  |
|                       |   65HUCC M     65HUCC M     65HUCC M     65HUCC M  |   65HUCC F     65HUCC F     65HUCC F     65HUCC F  |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Mesothelioma Benign, Malignant, NOS                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/70 (6%)    2/70 (3%)    0/70 (0%)    0/69 (0%)  |  0/70 (0%)    0/70 (0%)    0/68 (0%)    0/70 (0%)  |
|ADJUSTED (b)           |  14.2%         7.3%         0.0%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/8 (0%)     0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  2/23 (9%)    1/24 (4%)    0/25 (0%)    0/24 (0%)  |  0/26 (0%)    0/30 (0%)    0/28 (0%)    0/28 (0%)  |
|FIRST INCIDENCE (DAYS) |   500          684          ---          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.018N*    P=0.331N     P=0.060N     P=0.068N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.021N*    P=0.344N     P=0.083N     P=0.067N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.019N*    P=0.339N     P=0.065N     P=0.069N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.019N*                                         |    (e)                                             |
|FISHER EXACT           |               P=0.340N     P=0.060N     P=0.062N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 53/70 (76%)  52/70 (74%)  44/70 (63%)  49/69 (71%) | 37/70 (53%)  33/70 (47%)  34/68 (50%)  44/70 (63%) |
|ADJUSTED (b)           |  98.1%       100.0%       100.0%       100.0%      |  89.8%        78.0%        80.6%        89.5%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/8 (0%)     0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  8/10 (80%)   4/10 (40%)   0/10 (0%)    5/9 (56%)  |  1/10 (10%)   0/10 (0%)    0/9 (0%)     3/10 (30%) |
|TERMINAL (d)           | 22/23 (96%)  24/24 (100%) 25/25 (100%) 24/24 (100%)| 22/26 (85%)  21/30 (70%)  20/28 (71%)  23/28 (82%) |
|FIRST INCIDENCE (DAYS) |   456 (I)      439          463          431       |   435          544          562          456 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.281N     P=0.459N     P=0.082N     P=0.364N   |  P=0.152      P=0.118N     P=0.303N     P=0.320    |
|INCIDENTAL TUMOR       |  P=0.303N     P=0.366N     P=0.013N*    P=0.476N   |  P=0.096      P=0.188N     P=0.235N     P=0.219    |
|LOGISTIC REGRESSION    |  P=0.429N     P=0.396N     P=0.012N*    P=0.456N   |  P=0.128      P=0.090N     P=0.208N     P=0.265    |
|COCHRAN-ARMITAGE       |  P=0.240N                                          |  P=0.081                                           |
|FISHER EXACT           |               P=0.500N     P=0.071N     P=0.332N   |               P=0.306N     P=0.434N     P=0.152    |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05086 TEST: 01                                                 PAGE  21
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- O-BENZYL-P-CHLOROPHENOL
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0MG/KG       30MG/KG      60MG/KG      120MG/KG  |   0MG/KG       60MG/KG      120MG/KG     240MG/KG  |
|                       |   65HUCC M     65HUCC M     65HUCC M     65HUCC M  |   65HUCC F     65HUCC F     65HUCC F     65HUCC F  |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 25/70 (36%)  20/70 (29%)  24/70 (34%)  15/69 (22%) | 24/70 (34%)  20/70 (29%)  17/68 (25%)  22/70 (31%) |
|ADJUSTED (b)           |  63.3%        53.1%        63.4%        44.8%      |  59.7%        46.8%        42.1%        53.1%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/8 (0%)     0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  1/10 (10%)   1/10 (10%)   0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  9/23 (39%)   8/24 (33%)  12/25 (48%)   7/24 (29%) | 11/26 (42%)   8/30 (27%)   7/28 (25%)  10/28 (36%) |
|FIRST INCIDENCE (DAYS) |   456 (I)      457 (I)      319          508       |   416          544          345          493       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.077N     P=0.251N     P=0.451N     P=0.067N   |  P=0.368N     P=0.185N     P=0.141N     P=0.321N   |
|INCIDENTAL TUMOR       |  P=0.079N     P=0.220N     P=0.505N     P=0.070N   |  P=0.349N     P=0.378N     P=0.143N     P=0.357N   |
|LOGISTIC REGRESSION    |  P=0.087N     P=0.195N     P=0.543N     P=0.070N   |  P=0.288N     P=0.158N     P=0.120N     P=0.240N   |
|COCHRAN-ARMITAGE       |  P=0.063N                                          |  P=0.426N                                          |
|FISHER EXACT           |               P=0.235N     P=0.500N     P=0.051N   |               P=0.293N     P=0.157N     P=0.429N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 54/70 (77%)  52/70 (74%)  45/70 (64%)  49/69 (71%) | 45/70 (64%)  41/70 (59%)  42/68 (62%)  50/70 (71%) |
|ADJUSTED (b)           |  98.2%       100.0%       100.0%       100.0%      |  93.6%        87.2%        87.4%        94.3%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/8 (0%)     0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  9/10 (90%)   4/10 (40%)   0/10 (0%)    5/9 (56%)  |  1/10 (10%)   0/10 (0%)    0/9 (0%)     3/10 (30%) |
|TERMINAL (d)           | 22/23 (96%)  24/24 (100%) 25/25 (100%) 24/24 (100%)| 23/26 (88%)  24/30 (80%)  22/28 (79%)  25/28 (89%) |
|FIRST INCIDENCE (DAYS) |   456 (I)      439          319          431       |   416          544          345          456 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.250N     P=0.405N     P=0.085N     P=0.313N   |  P=0.282      P=0.116N     P=0.319N     P=0.479    |
|INCIDENTAL TUMOR       |  P=0.201N     P=0.231N     P=0.015N*    P=0.335N   |  P=0.114      P=0.240N     P=0.258N     P=0.226    |
|LOGISTIC REGRESSION    |  P=0.264N     P=0.256N     P=0.013N*    P=0.303N   |  P=0.255      P=0.052N     P=0.279N     P=0.510    |
|COCHRAN-ARMITAGE       |  P=0.199N                                          |  P=0.140                                           |
|FISHER EXACT           |               P=0.422N     P=0.068N     P=0.264N   |               P=0.301N     P=0.448N     P=0.235    |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05086 TEST: 01                                                 PAGE  22
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- O-BENZYL-P-CHLOROPHENOL
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
 
 (a)  Number of tumor-bearing animals / number of animals examined at site.
 (b)  Kaplan-Meier estimated lifetime tumor incidence after adjustment for 
      intercurrent mortality.
 (c)  Observed incidence at interim kill.
          Male interim sacrifices(days):   94  456
          Female interim sacrifices(days): 94  456
 (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.  The incidental tumor 
      test regards these lesions as non-fatal.  Logistic regression is an alternative
      method for analyzing the incidence of non-fatal tumors.  The Cochran-Armitage
      and Fisher's 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. 
 (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).