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TDMS Study 05044-01 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                               4-VINYL-1-CYCLOHEXENE DIEPOXIDE                           DATE: 09/06/94       
EXPERIMENT: 05044 TEST: 01                                                                                     TIME: 11:48:23       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-CP-95653          ROUTE: DERMAL,SOLUTION                                                             NTP C#: 60139A       
PATHOLOGIST: S. GRUMBEIN                     S. EUSTIS                                                         CAS: 106-87-6        
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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                               4-VINYL-1-CYCLOHEXENE DIEPOXIDE                           DATE: 09/06/94      
EXPERIMENT: 05044 TEST: 01                                                                                     TIME: 11:48:23      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01-CP-95653          ROUTE: DERMAL,SOLUTION                                                             NTP C#: 60139A      
PATHOLOGIST: S. GRUMBEIN                     S. EUSTIS                                                         CAS: 106-87-6       
 
 
 
 
 
                                                    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                               4-VINYL-1-CYCLOHEXENE DIEPOXIDE                           DATE: 09/06/94       
EXPERIMENT: 05044 TEST: 01                                                                                     TIME: 11:48:23       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-CP-95653          ROUTE: DERMAL,SOLUTION                                                             NTP C#: 60139A       
PATHOLOGIST: S. GRUMBEIN                     S. EUSTIS                                                         CAS: 106-87-6        
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                IN THE ANALYSIS OF THE STUDY OF 4-VINYL-1-CYCLOHEXENE DIEPOXIDE
 
              ====================================================================================================
 
                                                           MALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Adrenal Medulla               Pheochromocytoma Benign
                                                           Pheochromocytoma: Benign, Complex, Malignant, NOS
                             Skin                          Basal Cell Adenoma
                                                           Squamous Cell Carcinoma
                                                           Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma
                                                           Squamous Cell Papilloma
                                                           Trichoepithelioma, Basal Cell Carcinoma, or Basal Cell Adenoma
                                                           Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma,
                                                            Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma
                             Thyroid Gland: C-Cell         Carcinoma or Adenoma
                             All Organs                    Benign Tumors
                                                           Malignant Tumors
 
              ====================================================================================================
 
                                                           FEMALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Mammary Gland                 Fibroadenoma
                                                           Fibroma, Fibroadenoma, Carcinoma, or Adenoma
                             Skin                          Basal Cell Carcinoma
                                                           Squamous Cell Carcinoma
                                                           Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma
                                                           Trichoepithelioma, Basal Cell Carcinoma, or Basal Cell Adenoma
                                                           Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma,
                                                            Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma
                             Thyroid Gland: C-Cell         Adenoma
                                                           Carcinoma or Adenoma
                             Uterus                        Polyp Stromal
                                                           Sarcoma Stromal or Polyp Stromal
                             All Organs                    Malignant Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
         DATE: 09/06/94                     EXPERIMENT: 05044 TEST: 01                                                 PAGE   1
                     STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4-VINYL-1-CYCLOHEXENE DIEPOXIDE
 
                                                 TERMINAL SACRIFICE AT 107 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 MG/ML         50 MG/ML        100 MG/       |      0 MG/ML         50 MG/ML        100 MG/       |
|                       |                                      ML            |                                      ML            |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     8/50 (16%)     15/50 (30%)      0/50 (0%)      |     2/50 (4%)       3/48 (6%)       1/50 (2%)      |
|ADJUSTED (b)           |     46.1%           64.7%            0.0%          |      6.3%           13.0%            4.3%          |
|TERMINAL (d)           |     1/7 (14%)       2/8 (25%)       0/4 (0%)       |     1/27 (4%)       3/23 (13%)      0/15 (0%)      |
|FIRST INCIDENCE (DAYS) |      571             569             ---           |      698             743 (T)         684           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.065N        P=0.239         P=0.020N*      |     P=0.568         P=0.406         P=0.711N       |
|INCIDENTAL TUMOR       |     P=0.015N*       P=0.104         P=0.005N**     |     P=0.513N        P=0.374         P=0.519N       |
|LOGISTIC REGRESSION    |     P=0.021N*       P=0.112         P=0.006N**     |     P=0.577N        P=0.379         P=0.594N       |
|COCHRAN-ARMITAGE       |     P=0.019N*                                      |     P=0.400N                                       |
|FISHER EXACT           |                     P=0.077         P=0.003N**     |                     P=0.480         P=0.500N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Malignant                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       0/50 (0%)       2/50 (4%)      |     1/50 (2%)       0/48 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      0.0%            0.0%            7.8%          |      3.7%            0.0%            0.0%          |
|TERMINAL (d)           |     0/7 (0%)        0/8 (0%)        0/4 (0%)       |     1/27 (4%)       0/23 (0%)       0/15 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             350           |      743 (T)         ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.079           (e)           P=0.209        |     P=0.343N        P=0.532N        P=0.617N       |
|INCIDENTAL TUMOR       |     P=0.175           (e)           P=0.487        |     P=0.343N        P=0.532N        P=0.617N       |
|LOGISTIC REGRESSION    |     P=0.098           (e)           P=0.288        |     P=0.343N        P=0.532N        P=0.617N       |
|COCHRAN-ARMITAGE       |     P=0.095                                        |     P=0.271N                                       |
|FISHER EXACT           |                       (e)           P=0.247        |                     P=0.510N        P=0.500N       |
|=================================================================================================================================|
 
         DATE: 09/06/94                     EXPERIMENT: 05044 TEST: 01                                                 PAGE   2
                     STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4-VINYL-1-CYCLOHEXENE DIEPOXIDE
 
                                                 TERMINAL SACRIFICE AT 107 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 MG/ML         50 MG/ML        100 MG/       |      0 MG/ML         50 MG/ML        100 MG/       |
|                       |                                      ML            |                                      ML            |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     8/50 (16%)     15/50 (30%)      2/50 (4%)      |     3/50 (6%)       3/48 (6%)       1/50 (2%)      |
|ADJUSTED (b)           |     46.1%           64.7%            7.8%          |      9.9%           13.0%            4.3%          |
|TERMINAL (d)           |     1/7 (14%)       2/8 (25%)       0/4 (0%)       |     2/27 (7%)       3/23 (13%)      0/15 (0%)      |
|FIRST INCIDENCE (DAYS) |      571             569             350           |      698             743 (T)         684           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.187N        P=0.239         P=0.126N       |     P=0.472N        P=0.569         P=0.542N       |
|INCIDENTAL TUMOR       |     P=0.042N*       P=0.104         P=0.018N*      |     P=0.362N        P=0.540         P=0.371N       |
|LOGISTIC REGRESSION    |     P=0.080N        P=0.112         P=0.052N       |     P=0.419N        P=0.535         P=0.431N       |
|COCHRAN-ARMITAGE       |     P=0.070N                                       |     P=0.240N                                       |
|FISHER EXACT           |                     P=0.077         P=0.046N*      |                     P=0.641         P=0.309N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/49 (0%)       3/49 (6%)       1/50 (2%)      |     2/45 (4%)       7/50 (14%)      3/49 (6%)      |
|ADJUSTED (b)           |      0.0%           14.0%            2.6%          |      8.0%           25.7%           12.2%          |
|TERMINAL (d)           |     0/6 (0%)        0/8 (0%)        0/4 (0%)       |     2/25 (8%)       4/23 (17%)      0/14 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             538             568           |      743 (T)         534             675           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.349         P=0.158         P=0.511        |     P=0.174         P=0.061         P=0.283        |
|INCIDENTAL TUMOR       |     P=0.393         P=0.104         P=0.569        |     P=0.426         P=0.055         P=0.475        |
|LOGISTIC REGRESSION    |     P=0.385         P=0.121         P=0.519        |     P=0.305         P=0.059         P=0.411        |
|COCHRAN-ARMITAGE       |     P=0.385                                        |     P=0.475                                        |
|FISHER EXACT           |                     P=0.121         P=0.505        |                     P=0.107         P=0.541        |
|=================================================================================================================================|
 
         DATE: 09/06/94                     EXPERIMENT: 05044 TEST: 01                                                 PAGE   3
                     STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4-VINYL-1-CYCLOHEXENE DIEPOXIDE
 
                                                 TERMINAL SACRIFICE AT 107 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 MG/ML         50 MG/ML        100 MG/       |      0 MG/ML         50 MG/ML        100 MG/       |
|                       |                                      ML            |                                      ML            |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/49 (0%)       3/49 (6%)       1/50 (2%)      |     3/45 (7%)       7/50 (14%)      3/49 (6%)      |
|ADJUSTED (b)           |      0.0%           14.0%            2.6%          |     10.6%           25.7%           12.2%          |
|TERMINAL (d)           |     0/6 (0%)        0/8 (0%)        0/4 (0%)       |     2/25 (8%)       4/23 (17%)      0/14 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             538             568           |      698             534             675           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.349         P=0.158         P=0.511        |     P=0.263         P=0.116         P=0.395        |
|INCIDENTAL TUMOR       |     P=0.393         P=0.104         P=0.569        |     P=0.555N        P=0.095         P=0.667N       |
|LOGISTIC REGRESSION    |     P=0.385         P=0.121         P=0.519        |     P=0.447         P=0.127         P=0.586        |
|COCHRAN-ARMITAGE       |     P=0.385                                        |     P=0.520N                                       |
|FISHER EXACT           |                     P=0.121         P=0.505        |                     P=0.205         P=0.620N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/49 (0%)       2/49 (4%)       0/50 (0%)      |     0/45 (0%)       0/50 (0%)       0/49 (0%)      |
|ADJUSTED (b)           |      0.0%            8.9%            0.0%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/6 (0%)        0/8 (0%)        0/4 (0%)       |     0/25 (0%)       0/23 (0%)       0/14 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             609             ---           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.650         P=0.306           (e)          |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.627N        P=0.204           (e)          |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.669         P=0.245           (e)          |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.664N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.247           (e)          |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/06/94                     EXPERIMENT: 05044 TEST: 01                                                 PAGE   4
                     STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4-VINYL-1-CYCLOHEXENE DIEPOXIDE
 
                                                 TERMINAL SACRIFICE AT 107 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 MG/ML         50 MG/ML        100 MG/       |      0 MG/ML         50 MG/ML        100 MG/       |
|                       |                                      ML            |                                      ML            |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       2/50 (4%)       3/46 (7%)      |     0/48 (0%)       1/48 (2%)       1/48 (2%)      |
|ADJUSTED (b)           |      2.5%            7.2%           16.7%          |      0.0%            4.3%            6.7%          |
|TERMINAL (d)           |     0/7 (0%)        0/8 (0%)        0/4 (0%)       |     0/27 (0%)       1/23 (4%)       1/15 (7%)      |
|FIRST INCIDENCE (DAYS) |      548             642             591           |      ---             743 (T)         743 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.188         P=0.572         P=0.287        |     P=0.214         P=0.468         P=0.383        |
|INCIDENTAL TUMOR       |     P=0.286         P=0.425         P=0.370        |     P=0.214         P=0.468         P=0.383        |
|LOGISTIC REGRESSION    |     P=0.196         P=0.500         P=0.276        |     P=0.214         P=0.468         P=0.383        |
|COCHRAN-ARMITAGE       |     P=0.196                                        |     P=0.331                                        |
|FISHER EXACT           |                     P=0.500         P=0.278        |                     P=0.500         P=0.500        |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       2/50 (4%)       0/46 (0%)      |     0/48 (0%)       0/48 (0%)       0/48 (0%)      |
|ADJUSTED (b)           |      0.0%           20.5%            0.0%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/7 (0%)        1/8 (13%)       0/4 (0%)       |     0/27 (0%)       0/23 (0%)       0/15 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             730             ---           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.569         P=0.277           (e)          |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.618         P=0.280           (e)          |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.605         P=0.284           (e)          |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.652                                        |       (e)                                          |
|FISHER EXACT           |                     P=0.247           (e)          |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/06/94                     EXPERIMENT: 05044 TEST: 01                                                 PAGE   5
                     STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4-VINYL-1-CYCLOHEXENE DIEPOXIDE
 
                                                 TERMINAL SACRIFICE AT 107 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 MG/ML         50 MG/ML        100 MG/       |      0 MG/ML         50 MG/ML        100 MG/       |
|                       |                                      ML            |                                      ML            |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       4/50 (8%)       3/46 (7%)      |     0/48 (0%)       1/48 (2%)       1/48 (2%)      |
|ADJUSTED (b)           |      2.5%           26.2%           16.7%          |      0.0%            4.3%            6.7%          |
|TERMINAL (d)           |     0/7 (0%)        1/8 (13%)       0/4 (0%)       |     0/27 (0%)       1/23 (4%)       1/15 (7%)      |
|FIRST INCIDENCE (DAYS) |      548             642             591           |      ---             743 (T)         743 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.178         P=0.246         P=0.287        |     P=0.214         P=0.468         P=0.383        |
|INCIDENTAL TUMOR       |     P=0.282         P=0.163         P=0.370        |     P=0.214         P=0.468         P=0.383        |
|LOGISTIC REGRESSION    |     P=0.216         P=0.195         P=0.276        |     P=0.214         P=0.468         P=0.383        |
|COCHRAN-ARMITAGE       |     P=0.220                                        |     P=0.331                                        |
|FISHER EXACT           |                     P=0.181         P=0.278        |                     P=0.500         P=0.500        |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       2/50 (4%)       0/50 (0%)      |     2/50 (4%)       3/50 (6%)       1/50 (2%)      |
|ADJUSTED (b)           |     14.3%           25.0%            0.0%          |      7.4%           11.5%            3.2%          |
|TERMINAL (d)           |     1/7 (14%)       2/8 (25%)       0/4 (0%)       |     2/27 (7%)       2/23 (9%)       0/15 (0%)      |
|FIRST INCIDENCE (DAYS) |      743 (T)         743 (T)         ---           |      743 (T)         625             648           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.491N        P=0.550         P=0.612N       |     P=0.583N        P=0.417         P=0.660N       |
|INCIDENTAL TUMOR       |     P=0.491N        P=0.550         P=0.612N       |     P=0.518N        P=0.508         P=0.610N       |
|LOGISTIC REGRESSION    |     P=0.491N        P=0.550         P=0.612N       |     P=0.506N        P=0.414         P=0.604N       |
|COCHRAN-ARMITAGE       |     P=0.360N                                       |     P=0.399N                                       |
|FISHER EXACT           |                     P=0.500         P=0.500N       |                     P=0.500         P=0.500N       |
|=================================================================================================================================|
 
         DATE: 09/06/94                     EXPERIMENT: 05044 TEST: 01                                                 PAGE   6
                     STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4-VINYL-1-CYCLOHEXENE DIEPOXIDE
 
                                                 TERMINAL SACRIFICE AT 107 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 MG/ML         50 MG/ML        100 MG/       |      0 MG/ML         50 MG/ML        100 MG/       |
|                       |                                      ML            |                                      ML            |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroadenoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       1/50 (2%)       1/50 (2%)      |    20/50 (40%)     11/50 (22%)      8/50 (16%)     |
|ADJUSTED (b)           |      5.9%            8.3%            7.7%          |     54.4%           37.6%           40.2%          |
|TERMINAL (d)           |     0/7 (0%)        0/8 (0%)        0/4 (0%)       |    12/27 (44%)      7/23 (30%)      4/15 (27%)     |
|FIRST INCIDENCE (DAYS) |      682             722             684           |      425             542             675           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.587         P=0.710N        P=0.722        |     P=0.117N        P=0.140N        P=0.191N       |
|INCIDENTAL TUMOR       |     P=0.631         P=0.713N        P=0.750        |     P=0.014N*       P=0.025N*       P=0.026N*      |
|LOGISTIC REGRESSION    |     P=0.610         P=0.726N        P=0.738        |     P=0.014N*       P=0.057N        P=0.023N*      |
|COCHRAN-ARMITAGE       |     P=0.640                                        |     P=0.004N**                                     |
|FISHER EXACT           |                     P=0.753N        P=0.753N       |                     P=0.041N*       P=0.007N**     |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       3/50 (6%)       1/50 (2%)      |    21/50 (42%)     14/50 (28%)      9/50 (18%)     |
|ADJUSTED (b)           |     19.3%           31.2%            7.7%          |     57.5%           47.1%           42.1%          |
|TERMINAL (d)           |     1/7 (14%)       2/8 (25%)       0/4 (0%)       |    13/27 (48%)      9/23 (39%)      4/15 (27%)     |
|FIRST INCIDENCE (DAYS) |      682             722             684           |      425             542             648           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.541N        P=0.579         P=0.603N       |     P=0.162N        P=0.283N        P=0.223N       |
|INCIDENTAL TUMOR       |     P=0.507N        P=0.579         P=0.579N       |     P=0.021N*       P=0.065N        P=0.032N*      |
|LOGISTIC REGRESSION    |     P=0.495N        P=0.616         P=0.571N       |     P=0.021N*       P=0.147N        P=0.027N*      |
|COCHRAN-ARMITAGE       |     P=0.399N                                       |     P=0.006N**                                     |
|FISHER EXACT           |                     P=0.500         P=0.500N       |                     P=0.104N        P=0.008N**     |
|=================================================================================================================================|
 
         DATE: 09/06/94                     EXPERIMENT: 05044 TEST: 01                                                 PAGE   7
                     STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4-VINYL-1-CYCLOHEXENE DIEPOXIDE
 
                                                 TERMINAL SACRIFICE AT 107 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 MG/ML         50 MG/ML        100 MG/       |      0 MG/ML         50 MG/ML        100 MG/       |
|                       |                                      ML            |                                      ML            |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip)                                                                           |
|     Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       1/50 (2%)       0/50 (0%)      |     1/50 (2%)       2/50 (4%)       1/50 (2%)      |
|ADJUSTED (b)           |      2.9%            4.5%            0.0%          |      2.1%            6.3%            3.0%          |
|TERMINAL (d)           |     0/7 (0%)        0/8 (0%)        0/4 (0%)       |     0/27 (0%)       1/23 (4%)       0/15 (0%)      |
|FIRST INCIDENCE (DAYS) |      584             676             ---           |      586             471             635           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.349N        P=0.729N        P=0.494N       |     P=0.538         P=0.468         P=0.712        |
|INCIDENTAL TUMOR       |     P=0.300N        P=0.740         P=0.431N       |     P=0.523N        P=0.668         P=0.710N       |
|LOGISTIC REGRESSION    |     P=0.333N        P=0.762N        P=0.490N       |     P=0.576N        P=0.549         P=0.729N       |
|COCHRAN-ARMITAGE       |     P=0.331N                                       |     P=0.622N                                       |
|FISHER EXACT           |                     P=0.753N        P=0.500N       |                     P=0.500         P=0.753N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Parathyroid Gland                                                                                                                |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/49 (0%)       2/45 (4%)       1/45 (2%)      |     1/47 (2%)       1/43 (2%)       0/48 (0%)      |
|ADJUSTED (b)           |      0.0%           19.6%           25.0%          |      2.6%            4.2%            0.0%          |
|TERMINAL (d)           |     0/7 (0%)        1/7 (14%)       1/4 (25%)      |     0/26 (0%)       0/21 (0%)       0/14 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             695             743 (T)       |      662             739             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.222         P=0.271         P=0.388        |     P=0.434N        P=0.706         P=0.573N       |
|INCIDENTAL TUMOR       |     P=0.251         P=0.264         P=0.388        |     P=0.312N        P=0.582         P=0.471N       |
|LOGISTIC REGRESSION    |     P=0.247         P=0.270         P=0.388        |     P=0.372N        P=0.731         P=0.492N       |
|COCHRAN-ARMITAGE       |     P=0.339                                        |     P=0.329N                                       |
|FISHER EXACT           |                     P=0.226         P=0.479        |                     P=0.730         P=0.495N       |
|=================================================================================================================================|
 
         DATE: 09/06/94                     EXPERIMENT: 05044 TEST: 01                                                 PAGE   8
                     STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4-VINYL-1-CYCLOHEXENE DIEPOXIDE
 
                                                 TERMINAL SACRIFICE AT 107 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 MG/ML         50 MG/ML        100 MG/       |      0 MG/ML         50 MG/ML        100 MG/       |
|                       |                                      ML            |                                      ML            |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    24/50 (48%)     26/50 (52%)     27/48 (56%)     |    19/47 (40%)     14/49 (29%)     17/48 (35%)     |
|ADJUSTED (b)           |     74.8%           89.8%           90.4%          |     55.9%           43.0%           67.6%          |
|TERMINAL (d)           |     3/7 (43%)       6/8 (75%)       2/4 (50%)      |    12/26 (46%)      7/23 (30%)      8/15 (53%)     |
|FIRST INCIDENCE (DAYS) |      458             389             394           |      586             534             519           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.167         P=0.453N        P=0.223        |     P=0.153         P=0.382N        P=0.116        |
|INCIDENTAL TUMOR       |     P=0.155         P=0.357         P=0.229        |     P=0.486N        P=0.174N        P=0.571        |
|LOGISTIC REGRESSION    |     P=0.226         P=0.422         P=0.261        |     P=0.514         P=0.230N        P=0.471        |
|COCHRAN-ARMITAGE       |     P=0.237                                        |     P=0.345N                                       |
|FISHER EXACT           |                     P=0.421         P=0.269        |                     P=0.157N        P=0.385N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       1/50 (2%)       0/48 (0%)      |    14/47 (30%)     15/49 (31%)     11/48 (23%)     |
|ADJUSTED (b)           |     28.6%            2.8%            0.0%          |     40.4%           46.9%           34.6%          |
|TERMINAL (d)           |     2/7 (29%)       0/8 (0%)        0/4 (0%)       |     7/26 (27%)      7/23 (30%)      2/15 (13%)     |
|FIRST INCIDENCE (DAYS) |      743 (T)         596             ---           |      626             584             396           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.183N        P=0.455N        P=0.362N       |     P=0.323         P=0.275         P=0.375        |
|INCIDENTAL TUMOR       |     P=0.167N        P=0.519N        P=0.362N       |     P=0.230N        P=0.285         P=0.200N       |
|LOGISTIC REGRESSION    |     P=0.151N        P=0.448N        P=0.362N       |     P=0.317N        P=0.304         P=0.302N       |
|COCHRAN-ARMITAGE       |     P=0.148N                                       |     P=0.262N                                       |
|FISHER EXACT           |                     P=0.500N        P=0.258N       |                     P=0.554         P=0.299N       |
|=================================================================================================================================|
 
         DATE: 09/06/94                     EXPERIMENT: 05044 TEST: 01                                                 PAGE   9
                     STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4-VINYL-1-CYCLOHEXENE DIEPOXIDE
 
                                                 TERMINAL SACRIFICE AT 107 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 MG/ML         50 MG/ML        100 MG/       |      0 MG/ML         50 MG/ML        100 MG/       |
|                       |                                      ML            |                                      ML            |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    26/50 (52%)     27/50 (54%)     27/48 (56%)     |    33/47 (70%)     29/49 (59%)     28/48 (58%)     |
|ADJUSTED (b)           |     87.4%           90.1%           90.4%          |     82.0%           75.5%           82.6%          |
|TERMINAL (d)           |     5/7 (71%)       6/8 (75%)       2/4 (50%)      |    19/26 (73%)     14/23 (61%)     10/15 (67%)     |
|FIRST INCIDENCE (DAYS) |      458             389             394           |      586             534             396           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.240         P=0.383N        P=0.290        |     P=0.107         P=0.471         P=0.086        |
|INCIDENTAL TUMOR       |     P=0.258         P=0.426         P=0.328        |     P=0.194N        P=0.423N        P=0.226N       |
|LOGISTIC REGRESSION    |     P=0.358         P=0.502         P=0.397        |     P=0.320N        P=0.341N        P=0.360N       |
|COCHRAN-ARMITAGE       |     P=0.374                                        |     P=0.139N                                       |
|FISHER EXACT           |                     P=0.500         P=0.413        |                     P=0.180N        P=0.160N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Basal Cell Adenoma                                                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       0/50 (0%)       4/50 (8%)      |     1/50 (2%)       1/50 (2%)       0/50 (0%)      |
|ADJUSTED (b)           |      4.2%            0.0%           42.5%          |      3.7%            4.3%            0.0%          |
|TERMINAL (d)           |     0/7 (0%)        0/8 (0%)        1/4 (25%)      |     1/27 (4%)       1/23 (4%)       0/15 (0%)      |
|FIRST INCIDENCE (DAYS) |      620             ---             668           |      743 (T)         743 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.044 *       P=0.443N        P=0.118        |     P=0.453N        P=0.726         P=0.617N       |
|INCIDENTAL TUMOR       |     P=0.070         P=0.587N        P=0.155        |     P=0.453N        P=0.726         P=0.617N       |
|LOGISTIC REGRESSION    |     P=0.063         P=0.500N        P=0.143        |     P=0.453N        P=0.726         P=0.617N       |
|COCHRAN-ARMITAGE       |     P=0.082                                        |     P=0.331N                                       |
|FISHER EXACT           |                     P=0.500N        P=0.181        |                     P=0.753N        P=0.500N       |
|=================================================================================================================================|
 
         DATE: 09/06/94                     EXPERIMENT: 05044 TEST: 01                                                 PAGE  10
                     STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4-VINYL-1-CYCLOHEXENE DIEPOXIDE
 
                                                 TERMINAL SACRIFICE AT 107 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 MG/ML         50 MG/ML        100 MG/       |      0 MG/ML         50 MG/ML        100 MG/       |
|                       |                                      ML            |                                      ML            |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Basal Cell Carcinoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       2/50 (4%)       3/50 (6%)      |     0/50 (0%)       3/50 (6%)       4/50 (8%)      |
|ADJUSTED (b)           |      3.8%            8.4%           20.1%          |      0.0%           12.5%           20.0%          |
|TERMINAL (d)           |     0/7 (0%)        0/8 (0%)        0/4 (0%)       |     0/27 (0%)       2/23 (9%)       2/15 (13%)     |
|FIRST INCIDENCE (DAYS) |      619             642             595           |      ---             739             654           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.170         P=0.597         P=0.266        |     P=0.012 *       P=0.098         P=0.020 *      |
|INCIDENTAL TUMOR       |     P=0.281         P=0.425         P=0.356        |     P=0.032 *       P=0.066         P=0.040 *      |
|LOGISTIC REGRESSION    |     P=0.208         P=0.508         P=0.291        |     P=0.015 *       P=0.081         P=0.032 *      |
|COCHRAN-ARMITAGE       |     P=0.222                                        |     P=0.049 *                                      |
|FISHER EXACT           |                     P=0.500         P=0.309        |                     P=0.121         P=0.059        |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Keratoacanthoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       2/50 (4%)       3/50 (6%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      0.0%            8.6%           29.4%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/7 (0%)        0/8 (0%)        1/4 (25%)      |     0/27 (0%)       0/23 (0%)       0/15 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             647             558           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.055         P=0.305         P=0.101        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.089         P=0.287         P=0.125        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.075         P=0.250         P=0.116        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.082                                        |       (e)                                          |
|FISHER EXACT           |                     P=0.247         P=0.121        |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/06/94                     EXPERIMENT: 05044 TEST: 01                                                 PAGE  11
                     STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4-VINYL-1-CYCLOHEXENE DIEPOXIDE
 
                                                 TERMINAL SACRIFICE AT 107 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 MG/ML         50 MG/ML        100 MG/       |      0 MG/ML         50 MG/ML        100 MG/       |
|                       |                                      ML            |                                      ML            |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Carcinoma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)      33/50 (66%)     36/50 (72%)     |     0/50 (0%)      16/50 (32%)     34/50 (68%)     |
|ADJUSTED (b)           |      0.0%          100.0%          100.0%          |      0.0%           63.6%          100.0%          |
|TERMINAL (d)           |     0/7 (0%)        8/8 (100%)      4/4 (100%)     |     0/27 (0%)      14/23 (61%)     15/15 (100%)    |
|FIRST INCIDENCE (DAYS) |      ---             596             543           |      ---             625             601           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P<0.001 **      P<0.001 **      P<0.001 **     |     P<0.001 **      P<0.001 **      P<0.001 **     |
|INCIDENTAL TUMOR       |     P<0.001 **      P<0.001 **      P<0.001 **     |     P<0.001 **      P<0.001 **      P<0.001 **     |
|LOGISTIC REGRESSION    |     P<0.001 **      P<0.001 **      P<0.001 **     |     P<0.001 **      P<0.001 **      P<0.001 **     |
|COCHRAN-ARMITAGE       |     P<0.001 **                                     |     P<0.001 **                                     |
|FISHER EXACT           |                     P<0.001 **      P<0.001 **     |                     P<0.001 **      P<0.001 **     |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)      33/50 (66%)     36/50 (72%)     |     0/50 (0%)      16/50 (32%)     34/50 (68%)     |
|ADJUSTED (b)           |      0.0%          100.0%          100.0%          |      0.0%           63.6%          100.0%          |
|TERMINAL (d)           |     0/7 (0%)        8/8 (100%)      4/4 (100%)     |     0/27 (0%)      14/23 (61%)     15/15 (100%)    |
|FIRST INCIDENCE (DAYS) |      ---             596             543           |      ---             625             601           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P<0.001 **      P<0.001 **      P<0.001 **     |     P<0.001 **      P<0.001 **      P<0.001 **     |
|INCIDENTAL TUMOR       |     P<0.001 **      P<0.001 **      P<0.001 **     |     P<0.001 **      P<0.001 **      P<0.001 **     |
|LOGISTIC REGRESSION    |     P<0.001 **      P<0.001 **      P<0.001 **     |     P<0.001 **      P<0.001 **      P<0.001 **     |
|COCHRAN-ARMITAGE       |     P<0.001 **                                     |     P<0.001 **                                     |
|FISHER EXACT           |                     P<0.001 **      P<0.001 **     |                     P<0.001 **      P<0.001 **     |
|=================================================================================================================================|
 
         DATE: 09/06/94                     EXPERIMENT: 05044 TEST: 01                                                 PAGE  12
                     STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4-VINYL-1-CYCLOHEXENE DIEPOXIDE
 
                                                 TERMINAL SACRIFICE AT 107 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 MG/ML         50 MG/ML        100 MG/       |      0 MG/ML         50 MG/ML        100 MG/       |
|                       |                                      ML            |                                      ML            |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       3/50 (6%)       6/50 (12%)     |     0/50 (0%)       0/50 (0%)       1/50 (2%)      |
|ADJUSTED (b)           |      0.0%           25.2%           39.3%          |      0.0%            0.0%            4.5%          |
|TERMINAL (d)           |     0/7 (0%)        1/8 (13%)       0/4 (0%)       |     0/27 (0%)       0/23 (0%)       0/15 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             688             595           |      ---             ---             689           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.004 **      P=0.174         P=0.014 *      |     P=0.204           (e)           P=0.396        |
|INCIDENTAL TUMOR       |     P=0.012 *       P=0.158         P=0.026 *      |     P=0.324           (e)           P=0.541        |
|LOGISTIC REGRESSION    |     P=0.006 **      P=0.159         P=0.015 *      |     P=0.248           (e)           P=0.476        |
|COCHRAN-ARMITAGE       |     P=0.010 *                                      |     P=0.269                                        |
|FISHER EXACT           |                     P=0.121         P=0.013 *      |                       (e)           P=0.500        |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Trichoepithelioma, Basal Cell Carcinoma, or Basal Cell Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       2/50 (4%)       7/50 (14%)     |     1/50 (2%)       4/50 (8%)       4/50 (8%)      |
|ADJUSTED (b)           |      7.9%            8.4%           51.2%          |      3.7%           16.7%           20.0%          |
|TERMINAL (d)           |     0/7 (0%)        0/8 (0%)        1/4 (25%)      |     1/27 (4%)       3/23 (13%)      2/15 (13%)     |
|FIRST INCIDENCE (DAYS) |      619             642             595           |      743 (T)         739             654           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.022 *       P=0.587N        P=0.055        |     P=0.040 *       P=0.137         P=0.064        |
|INCIDENTAL TUMOR       |     P=0.060         P=0.597         P=0.096        |     P=0.080         P=0.105         P=0.106        |
|LOGISTIC REGRESSION    |     P=0.034 *       P=0.691N        P=0.066        |     P=0.047 *       P=0.119         P=0.091        |
|COCHRAN-ARMITAGE       |     P=0.042 *                                      |     P=0.146                                        |
|FISHER EXACT           |                     P=0.691N        P=0.080        |                     P=0.181         P=0.181        |
|=================================================================================================================================|
 
         DATE: 09/06/94                     EXPERIMENT: 05044 TEST: 01                                                 PAGE  13
                     STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4-VINYL-1-CYCLOHEXENE DIEPOXIDE
 
                                                 TERMINAL SACRIFICE AT 107 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 MG/ML         50 MG/ML        100 MG/       |      0 MG/ML         50 MG/ML        100 MG/       |
|                       |                                      ML            |                                      ML            |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma,                                                                |
|     Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)      33/50 (66%)     37/50 (74%)     |     1/50 (2%)      17/50 (34%)     34/50 (68%)     |
|ADJUSTED (b)           |      7.9%          100.0%          100.0%          |      3.7%           65.1%          100.0%          |
|TERMINAL (d)           |     0/7 (0%)        8/8 (100%)      4/4 (100%)     |     1/27 (4%)      14/23 (61%)     15/15 (100%)    |
|FIRST INCIDENCE (DAYS) |      619             596             543           |      743 (T)         625             601           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P<0.001 **      P<0.001 **      P<0.001 **     |     P<0.001 **      P<0.001 **      P<0.001 **     |
|INCIDENTAL TUMOR       |     P<0.001 **      P<0.001 **      P<0.001 **     |     P<0.001 **      P<0.001 **      P<0.001 **     |
|LOGISTIC REGRESSION    |     P<0.001 **      P<0.001 **      P<0.001 **     |     P<0.001 **      P<0.001 **      P<0.001 **     |
|COCHRAN-ARMITAGE       |     P<0.001 **                                     |     P<0.001 **                                     |
|FISHER EXACT           |                     P<0.001 **      P<0.001 **     |                     P<0.001 **      P<0.001 **     |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       2/50 (4%)       0/50 (0%)      |     2/50 (4%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |     14.3%           15.4%            0.0%          |      6.1%            0.0%            0.0%          |
|TERMINAL (d)           |     1/7 (14%)       1/8 (13%)       0/4 (0%)       |     1/27 (4%)       0/23 (0%)       0/15 (0%)      |
|FIRST INCIDENCE (DAYS) |      743 (T)         642             ---           |      635             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.455N        P=0.563         P=0.612N       |     P=0.140N        P=0.289N        P=0.330N       |
|INCIDENTAL TUMOR       |     P=0.407N        P=0.481         P=0.612N       |     P=0.097N        P=0.173N        P=0.271N       |
|LOGISTIC REGRESSION    |     P=0.404N        P=0.571         P=0.612N       |     P=0.104N        P=0.245N        P=0.256N       |
|COCHRAN-ARMITAGE       |     P=0.360N                                       |     P=0.095N                                       |
|FISHER EXACT           |                     P=0.500         P=0.500N       |                     P=0.247N        P=0.247N       |
|=================================================================================================================================|
 
         DATE: 09/06/94                     EXPERIMENT: 05044 TEST: 01                                                 PAGE  14
                     STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4-VINYL-1-CYCLOHEXENE DIEPOXIDE
 
                                                 TERMINAL SACRIFICE AT 107 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 MG/ML         50 MG/ML        100 MG/       |      0 MG/ML         50 MG/ML        100 MG/       |
|                       |                                      ML            |                                      ML            |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,                                                                                   |
|     Neurofibroma, or Fibroma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       2/50 (4%)       1/50 (2%)      |     2/50 (4%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |     16.4%           15.4%           25.0%          |      6.1%            0.0%            0.0%          |
|TERMINAL (d)           |     1/7 (14%)       1/8 (13%)       1/4 (25%)      |     1/27 (4%)       0/23 (0%)       0/15 (0%)      |
|FIRST INCIDENCE (DAYS) |      548             642             743 (T)       |      635             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.498N        P=0.649N        P=0.622N       |     P=0.140N        P=0.289N        P=0.330N       |
|INCIDENTAL TUMOR       |     P=0.432N        P=0.643         P=0.591N       |     P=0.097N        P=0.173N        P=0.271N       |
|LOGISTIC REGRESSION    |     P=0.420N        P=0.674N        P=0.536N       |     P=0.104N        P=0.245N        P=0.256N       |
|COCHRAN-ARMITAGE       |     P=0.390N                                       |     P=0.095N                                       |
|FISHER EXACT           |                     P=0.691N        P=0.500N       |                     P=0.247N        P=0.247N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    44/50 (88%)     40/50 (80%)     39/50 (78%)     |                                                    |
|ADJUSTED (b)           |    100.0%          100.0%          100.0%          |                                                    |
|TERMINAL (d)           |     7/7 (100%)      8/8 (100%)      4/4 (100%)     |                                                    |
|FIRST INCIDENCE (DAYS) |      379             387             543           |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.430         P=0.116N        P=0.449        |                                                    |
|INCIDENTAL TUMOR       |     P=0.149N        P=0.211N        P=0.162N       |                                                    |
|LOGISTIC REGRESSION    |     P=0.139N        P=0.248N        P=0.143N       |                                                    |
|COCHRAN-ARMITAGE       |     P=0.121N                                       |                                                    |
|FISHER EXACT           |                     P=0.207N        P=0.143N       |                                                    |
|=================================================================================================================================|
 
         DATE: 09/06/94                     EXPERIMENT: 05044 TEST: 01                                                 PAGE  15
                     STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4-VINYL-1-CYCLOHEXENE DIEPOXIDE
 
                                                 TERMINAL SACRIFICE AT 107 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 MG/ML         50 MG/ML        100 MG/       |      0 MG/ML         50 MG/ML        100 MG/       |
|                       |                                      ML            |                                      ML            |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     7/48 (15%)      6/50 (12%)      2/43 (5%)      |     6/46 (13%)     14/48 (29%)      9/49 (18%)     |
|ADJUSTED (b)           |     39.0%           22.4%           27.3%          |     21.4%           45.8%           39.0%          |
|TERMINAL (d)           |     1/7 (14%)       0/8 (0%)        1/4 (25%)      |     5/27 (19%)      8/23 (35%)      4/15 (27%)     |
|FIRST INCIDENCE (DAYS) |      379             538             595           |      736             471             404           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.122N        P=0.388N        P=0.174N       |     P=0.040 *       P=0.018 *       P=0.053        |
|INCIDENTAL TUMOR       |     P=0.121N        P=0.373N        P=0.199N       |     P=0.224         P=0.022 *       P=0.202        |
|LOGISTIC REGRESSION    |     P=0.089N        P=0.468N        P=0.108N       |     P=0.208         P=0.027 *       P=0.223        |
|COCHRAN-ARMITAGE       |     P=0.088N                                       |     P=0.315                                        |
|FISHER EXACT           |                     P=0.468N        P=0.108N       |                     P=0.048 *       P=0.335        |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/48 (4%)       0/50 (0%)       0/43 (0%)      |     0/46 (0%)       3/48 (6%)       1/49 (2%)      |
|ADJUSTED (b)           |      9.1%            0.0%            0.0%          |      0.0%            8.7%            6.7%          |
|TERMINAL (d)           |     0/7 (0%)        0/8 (0%)        0/4 (0%)       |     0/27 (0%)       1/23 (4%)       1/15 (7%)      |
|FIRST INCIDENCE (DAYS) |      607             ---             ---           |      ---             542             743 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.096N        P=0.202N        P=0.261N       |     P=0.268         P=0.106         P=0.383        |
|INCIDENTAL TUMOR       |     P=0.096N        P=0.260N        P=0.236N       |     P=0.414         P=0.216         P=0.383        |
|LOGISTIC REGRESSION    |     P=0.102N        P=0.227N        P=0.263N       |     P=0.411         P=0.144         P=0.383        |
|COCHRAN-ARMITAGE       |     P=0.102N                                       |     P=0.398                                        |
|FISHER EXACT           |                     P=0.237N        P=0.275N       |                     P=0.129         P=0.516        |
|=================================================================================================================================|
 
         DATE: 09/06/94                     EXPERIMENT: 05044 TEST: 01                                                 PAGE  16
                     STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4-VINYL-1-CYCLOHEXENE DIEPOXIDE
 
                                                 TERMINAL SACRIFICE AT 107 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 MG/ML         50 MG/ML        100 MG/       |      0 MG/ML         50 MG/ML        100 MG/       |
|                       |                                      ML            |                                      ML            |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     9/48 (19%)      6/50 (12%)      2/43 (5%)      |     6/46 (13%)     15/48 (31%)     10/49 (20%)     |
|ADJUSTED (b)           |     44.6%           22.4%           27.3%          |     21.4%           49.4%           44.5%          |
|TERMINAL (d)           |     1/7 (14%)       0/8 (0%)        1/4 (25%)      |     5/27 (19%)      9/23 (39%)      5/15 (33%)     |
|FIRST INCIDENCE (DAYS) |      379             538             595           |      736             471             404           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.044N*       P=0.203N        P=0.076N       |     P=0.020 *       P=0.010 **      P=0.026 *      |
|INCIDENTAL TUMOR       |     P=0.039N*       P=0.199N        P=0.077N       |     P=0.136         P=0.012 *       P=0.118        |
|LOGISTIC REGRESSION    |     P=0.029N*       P=0.259N        P=0.041N*      |     P=0.131         P=0.015 *       P=0.137        |
|COCHRAN-ARMITAGE       |     P=0.029N*                                      |     P=0.239                                        |
|FISHER EXACT           |                     P=0.259N        P=0.038N*      |                     P=0.030 *       P=0.248        |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/48 (2%)       3/50 (6%)       3/43 (7%)      |     2/46 (4%)       0/48 (0%)       1/49 (2%)      |
|ADJUSTED (b)           |      4.5%           19.2%           29.7%          |      7.4%            0.0%            3.7%          |
|TERMINAL (d)           |     0/7 (0%)        1/8 (13%)       1/4 (25%)      |     2/27 (7%)       0/23 (0%)       0/15 (0%)      |
|FIRST INCIDENCE (DAYS) |      667             569             503           |      743 (T)         ---             670           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.161         P=0.374         P=0.236        |     P=0.497N        P=0.274N        P=0.672N       |
|INCIDENTAL TUMOR       |     P=0.171         P=0.319         P=0.207        |     P=0.411N        P=0.274N        P=0.582N       |
|LOGISTIC REGRESSION    |     P=0.197         P=0.333         P=0.265        |     P=0.440N        P=0.274N        P=0.605N       |
|COCHRAN-ARMITAGE       |     P=0.199                                        |     P=0.343N                                       |
|FISHER EXACT           |                     P=0.324         P=0.268        |                     P=0.237N        P=0.476N       |
|=================================================================================================================================|
 
         DATE: 09/06/94                     EXPERIMENT: 05044 TEST: 01                                                 PAGE  17
                     STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4-VINYL-1-CYCLOHEXENE DIEPOXIDE
 
                                                 TERMINAL SACRIFICE AT 107 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 MG/ML         50 MG/ML        100 MG/       |      0 MG/ML         50 MG/ML        100 MG/       |
|                       |                                      ML            |                                      ML            |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/48 (4%)       4/50 (8%)       3/43 (7%)      |     2/46 (4%)       0/48 (0%)       1/49 (2%)      |
|ADJUSTED (b)           |      7.1%           27.3%           29.7%          |      7.4%            0.0%            3.7%          |
|TERMINAL (d)           |     0/7 (0%)        1/8 (13%)       1/4 (25%)      |     2/27 (7%)       0/23 (0%)       0/15 (0%)      |
|FIRST INCIDENCE (DAYS) |      571             569             503           |      743 (T)         ---             670           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.312         P=0.417         P=0.425        |     P=0.497N        P=0.274N        P=0.672N       |
|INCIDENTAL TUMOR       |     P=0.346         P=0.332         P=0.407        |     P=0.411N        P=0.274N        P=0.582N       |
|LOGISTIC REGRESSION    |     P=0.359         P=0.369         P=0.450        |     P=0.440N        P=0.274N        P=0.605N       |
|COCHRAN-ARMITAGE       |     P=0.363                                        |     P=0.343N                                       |
|FISHER EXACT           |                     P=0.359         P=0.447        |                     P=0.237N        P=0.476N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Urinary Bladder                                                                                                                  |
|     Papilloma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/49 (0%)       0/50 (0%)       0/49 (0%)      |     0/50 (0%)       2/50 (4%)       0/48 (0%)      |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |      0.0%            8.0%            0.0%          |
|TERMINAL (d)           |     0/6 (0%)        0/8 (0%)        0/4 (0%)       |     0/27 (0%)       1/23 (4%)       0/14 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      ---             676             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.553         P=0.183           (e)          |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.626         P=0.144           (e)          |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.602         P=0.205           (e)          |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.661                                        |
|FISHER EXACT           |                       (e)             (e)          |                     P=0.247           (e)          |
|=================================================================================================================================|
 
         DATE: 09/06/94                     EXPERIMENT: 05044 TEST: 01                                                 PAGE  18
                     STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4-VINYL-1-CYCLOHEXENE DIEPOXIDE
 
                                                 TERMINAL SACRIFICE AT 107 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 MG/ML         50 MG/ML        100 MG/       |      0 MG/ML         50 MG/ML        100 MG/       |
|                       |                                      ML            |                                      ML            |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |     3/50 (6%)       8/50 (16%)      6/50 (12%)     |
|ADJUSTED (b)           |                                                    |      7.8%           30.8%           26.2%          |
|TERMINAL (d)           |                                                    |     0/27 (0%)       6/23 (26%)      2/15 (13%)     |
|FIRST INCIDENCE (DAYS) |                                                    |      626             600             404           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.044 *       P=0.053         P=0.070        |
|INCIDENTAL TUMOR       |                                                    |     P=0.215         P=0.056         P=0.398        |
|LOGISTIC REGRESSION    |                                                    |     P=0.163         P=0.060         P=0.272        |
|COCHRAN-ARMITAGE       |                                                    |     P=0.215                                        |
|FISHER EXACT           |                                                    |                     P=0.100         P=0.243        |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal or Polyp Stromal                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |     3/50 (6%)       9/50 (18%)      6/50 (12%)     |
|ADJUSTED (b)           |                                                    |      7.8%           32.3%           26.2%          |
|TERMINAL (d)           |                                                    |     0/27 (0%)       6/23 (26%)      2/15 (13%)     |
|FIRST INCIDENCE (DAYS) |                                                    |      626             534             404           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.048 *       P=0.032 *       P=0.070        |
|INCIDENTAL TUMOR       |                                                    |     P=0.265         P=0.044 *       P=0.398        |
|LOGISTIC REGRESSION    |                                                    |     P=0.189         P=0.045 *       P=0.272        |
|COCHRAN-ARMITAGE       |                                                    |     P=0.221                                        |
|FISHER EXACT           |                                                    |                     P=0.061         P=0.243        |
|=================================================================================================================================|
 
         DATE: 09/06/94                     EXPERIMENT: 05044 TEST: 01                                                 PAGE  19
                     STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4-VINYL-1-CYCLOHEXENE DIEPOXIDE
 
                                                 TERMINAL SACRIFICE AT 107 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 MG/ML         50 MG/ML        100 MG/       |      0 MG/ML         50 MG/ML        100 MG/       |
|                       |                                      ML            |                                      ML            |
|=================================================================================================================================|
|                                                                                                                                 |
|Zymbal's Gland                                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       0/50 (0%)       2/50 (4%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      0.0%            0.0%            6.2%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/7 (0%)        0/8 (0%)        0/4 (0%)       |     0/27 (0%)       0/23 (0%)       0/15 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             591           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.100           (e)           P=0.258        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.158           (e)           P=0.316        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.097           (e)           P=0.242        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.095                                        |       (e)                                          |
|FISHER EXACT           |                       (e)           P=0.247        |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Leukemia: Lymphocytic, Monocytic, Mononuclear,                                                                              |
|     or Undifferentiated                                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    16/50 (32%)     15/50 (30%)     15/50 (30%)     |    12/50 (24%)     17/50 (34%)     13/50 (26%)     |
|ADJUSTED (b)           |     60.3%           65.7%           70.3%          |     31.1%           58.7%           50.9%          |
|TERMINAL (d)           |     2/7 (29%)       3/8 (38%)       1/4 (25%)      |     2/27 (7%)      12/23 (52%)      5/15 (33%)     |
|FIRST INCIDENCE (DAYS) |      379             404             543           |      586             571             601           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.428         P=0.322N        P=0.488        |     P=0.064         P=0.081         P=0.089        |
|INCIDENTAL TUMOR       |     P=0.500N        P=0.495N        P=0.525N       |     P=0.304         P=0.073         P=0.497        |
|LOGISTIC REGRESSION    |     P=0.483N        P=0.495N        P=0.519N       |     P=0.226         P=0.103         P=0.324        |
|COCHRAN-ARMITAGE       |     P=0.457N                                       |     P=0.456                                        |
|FISHER EXACT           |                     P=0.500N        P=0.500N       |                     P=0.189         P=0.500        |
|=================================================================================================================================|
 
         DATE: 09/06/94                     EXPERIMENT: 05044 TEST: 01                                                 PAGE  20
                     STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4-VINYL-1-CYCLOHEXENE DIEPOXIDE
 
                                                 TERMINAL SACRIFICE AT 107 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 MG/ML         50 MG/ML        100 MG/       |      0 MG/ML         50 MG/ML        100 MG/       |
|                       |                                      ML            |                                      ML            |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Mesothelioma Benign, Malignant, NOS                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       2/50 (4%)       1/50 (2%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      2.1%            8.2%            2.4%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/7 (0%)        0/8 (0%)        0/4 (0%)       |     0/27 (0%)       0/23 (0%)       0/15 (0%)      |
|FIRST INCIDENCE (DAYS) |      470             626             550           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.610         P=0.571         P=0.752N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.608N        P=0.476         P=0.730        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.611N        P=0.507         P=0.714N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.622N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.500         P=0.753N       |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    50/50 (100%)    45/50 (90%)     46/50 (92%)     |    39/50 (78%)     40/50 (80%)     32/50 (64%)     |
|ADJUSTED (b)           |    100.0%          100.0%          100.0%          |     88.2%           95.1%           88.4%          |
|TERMINAL (d)           |     7/7 (100%)      8/8 (100%)      4/4 (100%)     |    22/27 (81%)     21/23 (91%)     11/15 (73%)     |
|FIRST INCIDENCE (DAYS) |      379             387             394           |      425             471             404           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.378         P=0.101N        P=0.411        |     P=0.078         P=0.130         P=0.083        |
|INCIDENTAL TUMOR       |     P=0.191N        P=0.038N*       P=0.197N       |     P=0.180N        P=0.388         P=0.231N       |
|LOGISTIC REGRESSION    |     P=0.093N        P=0.072N        P=0.116N       |     P=0.227N        P=0.332         P=0.274N       |
|COCHRAN-ARMITAGE       |     P=0.070N                                       |     P=0.069N                                       |
|FISHER EXACT           |                     P=0.028N*       P=0.059N       |                     P=0.500         P=0.093N       |
|=================================================================================================================================|
 
         DATE: 09/06/94                     EXPERIMENT: 05044 TEST: 01                                                 PAGE  21
                     STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4-VINYL-1-CYCLOHEXENE DIEPOXIDE
 
                                                 TERMINAL SACRIFICE AT 107 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 MG/ML         50 MG/ML        100 MG/       |      0 MG/ML         50 MG/ML        100 MG/       |
|                       |                                      ML            |                                      ML            |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    24/50 (48%)     40/50 (80%)     41/50 (82%)     |    25/50 (50%)     38/50 (76%)     39/50 (78%)     |
|ADJUSTED (b)           |     75.9%          100.0%          100.0%          |     61.8%           97.4%          100.0%          |
|TERMINAL (d)           |     3/7 (43%)       8/8 (100%)      4/4 (100%)     |    12/27 (44%)     22/23 (96%)     15/15 (100%)    |
|FIRST INCIDENCE (DAYS) |      379             373             242           |      586             534             396           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.001 **      P=0.105         P=0.004 **     |     P<0.001 **      P=0.002 **      P<0.001 **     |
|INCIDENTAL TUMOR       |     P<0.001 **      P<0.001 **      P=0.002 **     |     P<0.001 **      P<0.001 **      P<0.001 **     |
|LOGISTIC REGRESSION    |     P<0.001 **      P<0.001 **      P<0.001 **     |     P<0.001 **      P<0.001 **      P<0.001 **     |
|COCHRAN-ARMITAGE       |     P<0.001 **                                     |     P=0.002 **                                     |
|FISHER EXACT           |                     P<0.001 **      P<0.001 **     |                     P=0.006 **      P=0.003 **     |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    50/50 (100%)    49/50 (98%)     49/50 (98%)     |    43/50 (86%)     47/50 (94%)     44/50 (88%)     |
|ADJUSTED (b)           |    100.0%          100.0%          100.0%          |     89.6%          100.0%          100.0%          |
|TERMINAL (d)           |     7/7 (100%)      8/8 (100%)      4/4 (100%)     |    22/27 (81%)     23/23 (100%)    15/15 (100%)    |
|FIRST INCIDENCE (DAYS) |      379             373             242           |      425             471             396           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.261         P=0.210N        P=0.295        |     P=0.003 **      P=0.050         P=0.003 **     |
|INCIDENTAL TUMOR       |     P=0.485N          (e)           P=0.362N       |     P=0.207         P=0.059         P=0.339        |
|LOGISTIC REGRESSION    |     P=0.437N          (e)           P=0.626N       |     P=0.159         P=0.203         P=0.233        |
|COCHRAN-ARMITAGE       |     P=0.331N                                       |     P=0.436                                        |
|FISHER EXACT           |                     P=0.500N        P=0.500N       |                     P=0.159         P=0.500        |
|=================================================================================================================================|
 
         DATE: 09/06/94                     EXPERIMENT: 05044 TEST: 01                                                 PAGE  22
                     STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4-VINYL-1-CYCLOHEXENE DIEPOXIDE
 
                                                 TERMINAL SACRIFICE AT 107 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.
 (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).

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