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TDMS Study 05044-02 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: 02                                                                                     TIME: 19:37:21       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-CP-95653          ROUTE: DERMAL,SOLUTION                                                             NTP C#: 60139A       
PATHOLOGIST: M. RYAN                                                                                           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: 02                                                                                     TIME: 19:37:21      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01-CP-95653          ROUTE: DERMAL,SOLUTION                                                             NTP C#: 60139A      
PATHOLOGIST: M. RYAN                                                                                           CAS: 106-87-6       
 
 
 
 
 
                                                    MICE(B6C3F1)
                                              ----------------------------
             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
                                                    Gallbladder
                                                    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: 02                                                                                     TIME: 19:37:21       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-CP-95653          ROUTE: DERMAL,SOLUTION                                                             NTP C#: 60139A       
PATHOLOGIST: M. RYAN                                                                                           CAS: 106-87-6        
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                IN THE ANALYSIS OF THE STUDY OF 4-VINYL-1-CYCLOHEXENE DIEPOXIDE
 
              ====================================================================================================
 
                                                           MALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Harderian Gland               Adenoma
                                                           Carcinoma or Adenoma
                             Liver                         Hemangiosarcoma
                                                           Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma
                                                           Hepatocellular Carcinoma or Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
                             Lung                          Alveolar/Bronchiolar Adenoma
                                                           Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
                             Skin                          Basosquamous Tumor Malignant
                                                           Squamous Cell Carcinoma
                                                           Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma,
                                                            Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma
                             Spleen                        Hemangiosarcoma
                             All Organs                    Hemangiosarcoma
                                                           Hemangiosarcoma or Hemangioma
                                                           Benign Tumors
                                                           Malignant Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
 
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                               4-VINYL-1-CYCLOHEXENE DIEPOXIDE                           DATE: 09/06/94       
EXPERIMENT: 05044 TEST: 02                                                                                     TIME: 19:37:21       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-CP-95653          ROUTE: DERMAL,SOLUTION                                                             NTP C#: 60139A       
PATHOLOGIST: M. RYAN                                                                                           CAS: 106-87-6        
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                IN THE ANALYSIS OF THE STUDY OF 4-VINYL-1-CYCLOHEXENE DIEPOXIDE
 
              ====================================================================================================
 
                                                           FEMALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Adrenal Gland: Non-medullary, Non-cortical
                                                           Adenoma
                             Harderian Gland               Adenoma
                                                           Carcinoma or Adenoma
                             Lung                          Alveolar/Bronchiolar Adenoma
                                                           Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
                             Mammary Gland                 Carcinoma
                             Ovary                         Granulosa Cell Tumor Benign
                                                           Granulosa Cell Tumor Malignant
                                                           Granulosa Cell Tumor, Benign, Malignant, NOS
                                                           Mixed Tumor Benign
                             Pituitary Gland: Pars Distalis or Unspecified Site
                                                           Adenoma
                                                           Carcinoma or Adenoma
                             Skin                          Squamous Cell Carcinoma
                                                           Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma,
                                                            Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma
                             All Organs                    Hemangiosarcoma or Hemangioma
                                                           Malignant Lymphoma And Histiocytic Sarcoma
                                                           Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,
                                                            NOS, or Undifferentiated Cell Type
                                                           Benign Tumors
                                                           Malignant Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
         DATE: 09/06/94                     EXPERIMENT: 05044 TEST: 02                                                 PAGE   1
                       STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4-VINYL-1-CYCLOHEXENE DIEPOXIDE
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 85 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/ML      25 MG/ML     50 MG/ML     100 MG/   |   0 MG/ML      25 MG/ML     50 MG/ML     100 MG/   |
|                       |                                          ML        |                                          ML        |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Gland: Non-medullary, Non-cortical                                                                                       |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/50 (10%)   5/50 (10%)   3/49 (6%)    1/50 (2%)  |  2/50 (4%)    1/50 (2%)    7/50 (14%)   3/50 (6%)  |
|ADJUSTED (b)           |  13.2%        14.3%        32.1%         3.7%      |   4.8%         2.6%        19.3%         8.5%      |
|TERMINAL (d)           |  5/38 (13%)   5/35 (14%)   1/4 (25%)    0/0        |  2/42 (5%)    1/39 (3%)    6/35 (17%)   0/12 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      729 (T)      520          505       |   593 (T)      593 (T)      572          487       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.055      P=0.579      P=0.104      P=0.398    |  P=0.024 *    P=0.526N     P=0.048 *    P=0.237    |
|INCIDENTAL TUMOR       |  P=0.568      P=0.579      P=0.424      P=0.974    |  P=0.194      P=0.526N     P=0.074      P=0.642    |
|LOGISTIC REGRESSION    |  P=0.626N     P=0.579      P=0.636N     P=0.829    |  P=0.173      P=0.526N     P=0.061      P=0.492    |
|COCHRAN-ARMITAGE       |  P=0.056N                                          |  P=0.264                                           |
|FISHER EXACT           |               P=0.630N     P=0.369N     P=0.102N   |               P=0.500N     P=0.080      P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/50 (6%)    7/50 (14%)   3/50 (6%)    4/50 (8%)  |  5/50 (10%)   1/50 (2%)    4/50 (8%)    8/50 (16%) |
|ADJUSTED (b)           |   7.1%        19.3%        34.2%        46.3%      |  11.9%         2.6%        10.3%        35.4%      |
|TERMINAL (d)           |  1/38 (3%)    6/35 (17%)   1/4 (25%)    0/0        |  5/42 (12%)   1/39 (3%)    2/35 (6%)    2/12 (17%) |
|FIRST INCIDENCE (DAYS) |   495          673          520          486       |   593 (T)      593 (T)      464          464       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.141      P=0.230      P=0.008 ** |  P=0.001 **   P=0.121N     P=0.595N     P=0.009 ** |
|INCIDENTAL TUMOR       |  P=0.477      P=0.187      P=0.550N     P=0.397N   |  P=0.155      P=0.121N     P=0.489N     P=0.271    |
|LOGISTIC REGRESSION    |  P=0.260      P=0.155      P=0.627      P=0.484    |  P=0.044 *    P=0.121N     P=0.528N     P=0.142    |
|COCHRAN-ARMITAGE       |  P=0.517N                                          |  P=0.078                                           |
|FISHER EXACT           |               P=0.159      P=0.661N     P=0.500    |               P=0.102N     P=0.500N     P=0.277    |
|=================================================================================================================================|
 
         DATE: 09/06/94                     EXPERIMENT: 05044 TEST: 02                                                 PAGE   2
                       STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4-VINYL-1-CYCLOHEXENE DIEPOXIDE
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 85 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/ML      25 MG/ML     50 MG/ML     100 MG/   |   0 MG/ML      25 MG/ML     50 MG/ML     100 MG/   |
|                       |                                          ML        |                                          ML        |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/50 (6%)    7/50 (14%)   4/50 (8%)    4/50 (8%)  |  5/50 (10%)   2/50 (4%)    4/50 (8%)    8/50 (16%) |
|ADJUSTED (b)           |   7.1%        19.3%        37.9%        46.3%      |  11.9%         5.1%        10.3%        35.4%      |
|TERMINAL (d)           |  1/38 (3%)    6/35 (17%)   1/4 (25%)    0/0        |  5/42 (12%)   2/39 (5%)    2/35 (6%)    2/12 (17%) |
|FIRST INCIDENCE (DAYS) |   495          673          520          486       |   593 (T)      593 (T)      464          464       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.141      P=0.102      P=0.008 ** |  P=0.002 **   P=0.247N     P=0.595N     P=0.009 ** |
|INCIDENTAL TUMOR       |  P=0.452      P=0.187      P=0.550N     P=0.397N   |  P=0.171      P=0.247N     P=0.489N     P=0.271    |
|LOGISTIC REGRESSION    |  P=0.212      P=0.155      P=0.435      P=0.484    |  P=0.058      P=0.247N     P=0.528N     P=0.142    |
|COCHRAN-ARMITAGE       |  P=0.533N                                          |  P=0.103                                           |
|FISHER EXACT           |               P=0.159      P=0.500      P=0.500    |               P=0.218N     P=0.500N     P=0.277    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hemangioma                                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    5/50 (10%)   0/50 (0%)    0/50 (0%)  |  0/50 (0%)    0/50 (0%)    1/50 (2%)    1/50 (2%)  |
|ADJUSTED (b)           |   2.6%        13.8%         0.0%         0.0%      |   0.0%         0.0%         2.8%         2.5%      |
|TERMINAL (d)           |  1/38 (3%)    4/35 (11%)   0/4 (0%)     0/0        |  0/42 (0%)    0/39 (0%)    0/35 (0%)    0/12 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      698          ---          ---       |   ---          ---          584          474       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.360      P=0.089      P=0.916N       (e)      |  P=0.134        (e)        P=0.469      P=0.477    |
|INCIDENTAL TUMOR       |  P=0.655      P=0.155      P=0.916N       (e)      |  P=0.612        (e)        P=0.846      P=0.765    |
|LOGISTIC REGRESSION    |  P=0.584      P=0.098      P=0.916N       (e)      |  P=0.241        (e)        P=0.488      P=0.546    |
|COCHRAN-ARMITAGE       |  P=0.104N                                          |  P=0.236                                           |
|FISHER EXACT           |               P=0.102      P=0.500N     P=0.500N   |                 (e)        P=0.500      P=0.500    |
|=================================================================================================================================|
 
         DATE: 09/06/94                     EXPERIMENT: 05044 TEST: 02                                                 PAGE   3
                       STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4-VINYL-1-CYCLOHEXENE DIEPOXIDE
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 85 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/ML      25 MG/ML     50 MG/ML     100 MG/   |   0 MG/ML      25 MG/ML     50 MG/ML     100 MG/   |
|                       |                                          ML        |                                          ML        |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    2/50 (4%)    1/50 (2%)    0/50 (0%)  |  0/50 (0%)    0/50 (0%)    1/50 (2%)    0/50 (0%)  |
|ADJUSTED (b)           |   4.7%         5.0%         4.8%         0.0%      |   0.0%         0.0%         2.9%         0.0%      |
|TERMINAL (d)           |  0/38 (0%)    1/35 (3%)    0/4 (0%)     0/0        |  0/42 (0%)    0/39 (0%)    1/35 (3%)    0/12 (0%)  |
|FIRST INCIDENCE (DAYS) |   600          470          672          ---       |   ---          ---          593 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.545N     P=0.680      P=0.635N       (e)      |  P=0.576        (e)        P=0.464        (e)      |
|INCIDENTAL TUMOR       |  P=0.023N*    P=0.541      P=0.112N     P=0.125N   |  P=0.576        (e)        P=0.464        (e)      |
|LOGISTIC REGRESSION    |  P=0.129N     P=0.690N     P=0.525N     P=0.238N   |  P=0.576        (e)        P=0.464        (e)      |
|COCHRAN-ARMITAGE       |  P=0.125N                                          |  P=0.694                                           |
|FISHER EXACT           |               P=0.691N     P=0.500N     P=0.247N   |                 (e)        P=0.500        (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 18/50 (36%)   8/50 (16%)  11/50 (22%)   1/50 (2%)  |  8/50 (16%)   6/50 (12%)   5/50 (10%)   3/50 (6%)  |
|ADJUSTED (b)           |  43.7%        21.8%        55.8%        14.3%      |  19.0%        14.8%        14.3%        14.5%      |
|TERMINAL (d)           | 15/38 (39%)   7/35 (20%)   0/4 (0%)     0/0        |  8/42 (19%)   5/39 (13%)   5/35 (14%)   1/12 (8%)  |
|FIRST INCIDENCE (DAYS) |   574          525          435          572       |   593 (T)      457          593 (T)      495       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.153      P=0.034N*    P=0.016 *    P=0.280    |  P=0.565N     P=0.441N     P=0.402N     P=0.591    |
|INCIDENTAL TUMOR       |  P=0.002N**   P=0.055N     P=0.219N     P=0.122N   |  P=0.314N     P=0.451N     P=0.402N     P=0.431N   |
|LOGISTIC REGRESSION    |  P=0.006N**   P=0.020N*    P=0.264N     P=0.188N   |  P=0.174N     P=0.416N     P=0.402N     P=0.299N   |
|COCHRAN-ARMITAGE       |  P<0.001N**                                        |  P=0.073N                                          |
|FISHER EXACT           |               P=0.020N*    P=0.093N     P<0.001N** |               P=0.387N     P=0.277N     P=0.100N   |
|=================================================================================================================================|
 
         DATE: 09/06/94                     EXPERIMENT: 05044 TEST: 02                                                 PAGE   4
                       STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4-VINYL-1-CYCLOHEXENE DIEPOXIDE
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 85 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/ML      25 MG/ML     50 MG/ML     100 MG/   |   0 MG/ML      25 MG/ML     50 MG/ML     100 MG/   |
|                       |                                          ML        |                                          ML        |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  6/50 (12%)   5/50 (10%)   4/50 (8%)    4/50 (8%)  |  2/50 (4%)    3/50 (6%)    3/50 (6%)    2/50 (4%)  |
|ADJUSTED (b)           |  14.7%        12.5%        12.4%        25.9%      |   4.7%         7.7%         8.6%        10.5%      |
|TERMINAL (d)           |  4/38 (11%)   2/35 (6%)    0/4 (0%)     0/0        |  1/42 (2%)    3/39 (8%)    3/35 (9%)    0/12 (0%)  |
|FIRST INCIDENCE (DAYS) |   587          590          543          452       |   569          593 (T)      593 (T)      562       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.002 **   P=0.525N     P=0.341      P=0.004 ** |  P=0.190      P=0.467      P=0.428      P=0.337    |
|INCIDENTAL TUMOR       |  P=0.110N     P=0.487N     P=0.531N     P=0.397N   |  P=0.587N     P=0.565      P=0.567      P=0.203N   |
|LOGISTIC REGRESSION    |  P=0.083N     P=0.504N     P=0.470N     P=0.671    |  P=0.387      P=0.479      P=0.467      P=0.561    |
|COCHRAN-ARMITAGE       |  P=0.298N                                          |  P=0.544N                                          |
|FISHER EXACT           |               P=0.500N     P=0.370N     P=0.370N   |               P=0.500      P=0.500      P=0.691N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 23/50 (46%)  12/50 (24%)  15/50 (30%)   4/50 (8%)  | 10/50 (20%)   9/50 (18%)   8/50 (16%)   5/50 (10%) |
|ADJUSTED (b)           |  53.3%        30.0%        61.5%        25.9%      |  23.3%        22.3%        22.9%        23.5%      |
|TERMINAL (d)           | 18/38 (47%)   8/35 (23%)   0/4 (0%)     0/0        |  9/42 (21%)   8/39 (21%)   8/35 (23%)   1/12 (8%)  |
|FIRST INCIDENCE (DAYS) |   574          525          435          452       |   569          457          593 (T)      495       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.008 **   P=0.039N*    P=0.010 *    P=0.008 ** |  P=0.307      P=0.567N     P=0.561N     P=0.361    |
|INCIDENTAL TUMOR       |  P<0.001N**   P=0.036N*    P=0.177N     P=0.024N*  |  P=0.329N     P=0.522N     P=0.482N     P=0.185N   |
|LOGISTIC REGRESSION    |  P<0.001N**   P=0.019N*    P=0.232N     P=0.085N   |  P=0.299N     P=0.539N     P=0.487N     P=0.403N   |
|COCHRAN-ARMITAGE       |  P<0.001N**                                        |  P=0.096N                                          |
|FISHER EXACT           |               P=0.018N*    P=0.074N     P<0.001N** |               P=0.500N     P=0.398N     P=0.131N   |
|=================================================================================================================================|
 
         DATE: 09/06/94                     EXPERIMENT: 05044 TEST: 02                                                 PAGE   5
                       STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4-VINYL-1-CYCLOHEXENE DIEPOXIDE
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 85 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/ML      25 MG/ML     50 MG/ML     100 MG/   |   0 MG/ML      25 MG/ML     50 MG/ML     100 MG/   |
|                       |                                          ML        |                                          ML        |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 23/50 (46%)  12/50 (24%)  15/50 (30%)   4/50 (8%)  | 10/50 (20%)   9/50 (18%)   8/50 (16%)   5/50 (10%) |
|ADJUSTED (b)           |  53.3%        30.0%        61.5%        25.9%      |  23.3%        22.3%        22.9%        23.5%      |
|TERMINAL (d)           | 18/38 (47%)   8/35 (23%)   0/4 (0%)     0/0        |  9/42 (21%)   8/39 (21%)   8/35 (23%)   1/12 (8%)  |
|FIRST INCIDENCE (DAYS) |   574          525          435          452       |   569          457          593 (T)      495       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.008 **   P=0.039N*    P=0.010 *    P=0.008 ** |  P=0.307      P=0.567N     P=0.561N     P=0.361    |
|INCIDENTAL TUMOR       |  P<0.001N**   P=0.036N*    P=0.177N     P=0.024N*  |  P=0.329N     P=0.522N     P=0.482N     P=0.185N   |
|LOGISTIC REGRESSION    |  P<0.001N**   P=0.019N*    P=0.232N     P=0.085N   |  P=0.299N     P=0.539N     P=0.487N     P=0.403N   |
|COCHRAN-ARMITAGE       |  P<0.001N**                                        |  P=0.096N                                          |
|FISHER EXACT           |               P=0.018N*    P=0.074N     P<0.001N** |               P=0.500N     P=0.398N     P=0.131N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  8/50 (16%)   9/50 (18%)   8/50 (16%)   2/50 (4%)  |  3/50 (6%)    5/50 (10%)   8/50 (16%)   6/50 (12%) |
|ADJUSTED (b)           |  19.8%        24.3%        85.0%        42.9%      |   7.1%        12.8%        21.2%        36.6%      |
|TERMINAL (d)           |  6/38 (16%)   7/35 (20%)   3/4 (75%)    0/0        |  3/42 (7%)    5/39 (13%)   6/35 (17%)   4/12 (33%) |
|FIRST INCIDENCE (DAYS) |   587          698          572          572       |   593 (T)      593 (T)      495          444       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.442      P<0.001 **   P<0.001 ** |  P=0.002 **   P=0.316      P=0.061      P=0.008 ** |
|INCIDENTAL TUMOR       |  P=0.412      P=0.541      P=0.188      P=0.488N   |  P=0.025 *    P=0.316      P=0.091      P=0.023 *  |
|LOGISTIC REGRESSION    |  P=0.215      P=0.489      P=0.250      P=0.724N   |  P=0.077      P=0.316      P=0.083      P=0.135    |
|COCHRAN-ARMITAGE       |  P=0.032N*                                         |  P=0.200                                           |
|FISHER EXACT           |               P=0.500      P=0.607N     P=0.046N*  |               P=0.357      P=0.100      P=0.243    |
|=================================================================================================================================|
 
         DATE: 09/06/94                     EXPERIMENT: 05044 TEST: 02                                                 PAGE   6
                       STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4-VINYL-1-CYCLOHEXENE DIEPOXIDE
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 85 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/ML      25 MG/ML     50 MG/ML     100 MG/   |   0 MG/ML      25 MG/ML     50 MG/ML     100 MG/   |
|                       |                                          ML        |                                          ML        |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    2/50 (4%)    1/50 (2%)    1/50 (2%)  |  1/50 (2%)    4/50 (8%)    3/50 (6%)    1/50 (2%)  |
|ADJUSTED (b)           |   5.3%         5.7%         3.2%         4.3%      |   2.4%        10.3%         8.0%         6.3%      |
|TERMINAL (d)           |  2/38 (5%)    2/35 (6%)    0/4 (0%)     0/0        |  1/42 (2%)    4/39 (10%)   2/35 (6%)    0/12 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      729 (T)      613          510       |   593 (T)      593 (T)      497          579       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.103      P=0.665      P=0.575      P=0.366    |  P=0.343      P=0.158      P=0.254      P=0.499    |
|INCIDENTAL TUMOR       |  P=0.629      P=0.665      P=0.706      P=0.974    |  P=0.589N     P=0.158      P=0.260      P=0.764N   |
|LOGISTIC REGRESSION    |  P=0.625      P=0.665      P=0.638N     P=0.792    |  P=0.593N     P=0.158      P=0.294      P=0.616    |
|COCHRAN-ARMITAGE       |  P=0.337N                                          |  P=0.431N                                          |
|FISHER EXACT           |               P=0.691N     P=0.500N     P=0.500N   |               P=0.181      P=0.309      P=0.753N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 10/50 (20%)  11/50 (22%)   9/50 (18%)   3/50 (6%)  |  4/50 (8%)    9/50 (18%)  11/50 (22%)   7/50 (14%) |
|ADJUSTED (b)           |  24.8%        29.7%        85.5%        45.3%      |   9.5%        23.1%        28.4%        40.6%      |
|TERMINAL (d)           |  8/38 (21%)   9/35 (26%)   3/4 (75%)    0/0        |  4/42 (10%)   9/39 (23%)   8/35 (23%)   4/12 (33%) |
|FIRST INCIDENCE (DAYS) |   587          698          572          510       |   593 (T)      593 (T)      495          444       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.431      P<0.001 **   P<0.001 ** |  P=0.002 **   P=0.089      P=0.024 *    P=0.005 ** |
|INCIDENTAL TUMOR       |  P=0.399      P=0.520      P=0.172      P=0.513N   |  P=0.047 *    P=0.089      P=0.036 *    P=0.040 *  |
|LOGISTIC REGRESSION    |  P=0.237      P=0.487      P=0.312      P=0.747    |  P=0.111      P=0.089      P=0.036 *    P=0.118    |
|COCHRAN-ARMITAGE       |  P=0.021N*                                         |  P=0.310                                           |
|FISHER EXACT           |               P=0.500      P=0.500N     P=0.036N*  |               P=0.117      P=0.045 *    P=0.262    |
|=================================================================================================================================|
 
         DATE: 09/06/94                     EXPERIMENT: 05044 TEST: 02                                                 PAGE   7
                       STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4-VINYL-1-CYCLOHEXENE DIEPOXIDE
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 85 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/ML      25 MG/ML     50 MG/ML     100 MG/   |   0 MG/ML      25 MG/ML     50 MG/ML     100 MG/   |
|                       |                                          ML        |                                          ML        |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |  1/50 (2%)    1/50 (2%)    3/50 (6%)    4/50 (8%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   2.4%         2.6%         8.2%        23.6%      |
|TERMINAL (d)           |  0/38 (0%)    0/35 (0%)    0/4 (0%)     0/0        |  1/42 (2%)    1/39 (3%)    2/35 (6%)    1/12 (8%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   593 (T)      593 (T)      579          578       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.002 **   P=0.745      P=0.251      P=0.013 *  |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.108      P=0.745      P=0.381      P=0.345    |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.010 *    P=0.745      P=0.276      P=0.035 *  |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.075                                           |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.753N     P=0.309      P=0.181    |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Granulosa Cell Tumor Benign                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  0/50 (0%)    0/49 (0%)    5/49 (10%)  10/50 (20%) |
|ADJUSTED (b)           |                                                    |   0.0%         0.0%        14.7%        35.3%      |
|TERMINAL (d)           |                                                    |  0/42 (0%)    0/38 (0%)    5/34 (15%)   2/12 (17%) |
|FIRST INCIDENCE (DAYS) |                                                    |   ---          ---          593 (T)      388       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P<0.001 **     (e)        P=0.018 *    P<0.001 ** |
|INCIDENTAL TUMOR       |                                                    |  P<0.001 **     (e)        P=0.018 *    P=0.012 *  |
|LOGISTIC REGRESSION    |                                                    |  P<0.001 **     (e)        P=0.018 *    P=0.002 ** |
|COCHRAN-ARMITAGE       |                                                    |  P<0.001 **                                        |
|FISHER EXACT           |                                                    |                 (e)        P=0.027 *    P<0.001 ** |
|=================================================================================================================================|
 
         DATE: 09/06/94                     EXPERIMENT: 05044 TEST: 02                                                 PAGE   8
                       STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4-VINYL-1-CYCLOHEXENE DIEPOXIDE
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 85 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/ML      25 MG/ML     50 MG/ML     100 MG/   |   0 MG/ML      25 MG/ML     50 MG/ML     100 MG/   |
|                       |                                          ML        |                                          ML        |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Granulosa Cell Tumor Malignant                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  0/50 (0%)    0/49 (0%)    2/49 (4%)    2/50 (4%)  |
|ADJUSTED (b)           |                                                    |   0.0%         0.0%         5.5%        16.7%      |
|TERMINAL (d)           |                                                    |  0/42 (0%)    0/38 (0%)    1/34 (3%)    2/12 (17%) |
|FIRST INCIDENCE (DAYS) |                                                    |   ---          ---          579          593 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.006 **     (e)        P=0.206      P=0.035 *  |
|INCIDENTAL TUMOR       |                                                    |  P=0.033 *      (e)        P=0.374      P=0.035 *  |
|LOGISTIC REGRESSION    |                                                    |  P=0.015 *      (e)        P=0.218      P=0.035 *  |
|COCHRAN-ARMITAGE       |                                                    |  P=0.087                                           |
|FISHER EXACT           |                                                    |                 (e)        P=0.242      P=0.247    |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Granulosa Cell Tumor, Benign, Malignant, NOS                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  0/50 (0%)    0/49 (0%)    7/49 (14%)  12/50 (24%) |
|ADJUSTED (b)           |                                                    |   0.0%         0.0%        19.8%        48.2%      |
|TERMINAL (d)           |                                                    |  0/42 (0%)    0/38 (0%)    6/34 (18%)   4/12 (33%) |
|FIRST INCIDENCE (DAYS) |                                                    |   ---          ---          579          388       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P<0.001 **     (e)        P=0.004 **   P<0.001 ** |
|INCIDENTAL TUMOR       |                                                    |  P<0.001 **     (e)        P=0.008 **   P<0.001 ** |
|LOGISTIC REGRESSION    |                                                    |  P<0.001 **     (e)        P=0.006 **   P<0.001 ** |
|COCHRAN-ARMITAGE       |                                                    |  P<0.001 **                                        |
|FISHER EXACT           |                                                    |                 (e)        P=0.006 **   P<0.001 ** |
|=================================================================================================================================|
 
         DATE: 09/06/94                     EXPERIMENT: 05044 TEST: 02                                                 PAGE   9
                       STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4-VINYL-1-CYCLOHEXENE DIEPOXIDE
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 85 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/ML      25 MG/ML     50 MG/ML     100 MG/   |   0 MG/ML      25 MG/ML     50 MG/ML     100 MG/   |
|                       |                                          ML        |                                          ML        |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Mixed Tumor Benign                                                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  0/50 (0%)    0/49 (0%)   11/49 (22%)   6/50 (12%) |
|ADJUSTED (b)           |                                                    |   0.0%         0.0%        30.0%        28.2%      |
|TERMINAL (d)           |                                                    |  0/42 (0%)    0/38 (0%)    9/34 (26%)   2/12 (17%) |
|FIRST INCIDENCE (DAYS) |                                                    |   ---          ---          497          474       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P<0.001 **     (e)        P<0.001 **   P=0.001 ** |
|INCIDENTAL TUMOR       |                                                    |  P=0.002 **     (e)        P<0.001 **   P=0.034 *  |
|LOGISTIC REGRESSION    |                                                    |  P=0.001 **     (e)        P<0.001 **   P=0.012 *  |
|COCHRAN-ARMITAGE       |                                                    |  P=0.005 **                                        |
|FISHER EXACT           |                                                    |                 (e)        P<0.001 **   P=0.013 *  |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/43 (2%)    0/47 (0%)    0/42 (0%)    0/38 (0%)  | 17/49 (35%)  16/48 (33%)   5/47 (11%)   0/45 (0%)  |
|ADJUSTED (b)           |   2.9%         0.0%         0.0%         0.0%      |  41.5%        41.0%        14.3%         0.0%      |
|TERMINAL (d)           |  1/34 (3%)    0/33 (0%)    0/3 (0%)     0/0        | 17/41 (41%)  16/39 (41%)   4/33 (12%)   0/11 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      ---          ---          ---       |   593 (T)      593 (T)      566          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.779N     P=0.506N     P=0.938N       (e)      |  P<0.001N**   P=0.574N     P=0.015N*    P=0.013N*  |
|INCIDENTAL TUMOR       |  P=0.779N     P=0.506N     P=0.938N       (e)      |  P<0.001N**   P=0.574N     P=0.009N**   P=0.013N*  |
|LOGISTIC REGRESSION    |  P=0.779N     P=0.506N     P=0.938N       (e)      |  P<0.001N**   P=0.574N     P=0.009N**   P=0.013N*  |
|COCHRAN-ARMITAGE       |  P=0.322N                                          |  P<0.001N**                                        |
|FISHER EXACT           |               P=0.478N     P=0.506N     P=0.531N   |               P=0.529N     P=0.005N**   P<0.001N** |
|=================================================================================================================================|
 
         DATE: 09/06/94                     EXPERIMENT: 05044 TEST: 02                                                 PAGE  10
                       STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4-VINYL-1-CYCLOHEXENE DIEPOXIDE
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 85 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/ML      25 MG/ML     50 MG/ML     100 MG/   |   0 MG/ML      25 MG/ML     50 MG/ML     100 MG/   |
|                       |                                          ML        |                                          ML        |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/43 (2%)    0/47 (0%)    0/42 (0%)    0/38 (0%)  | 17/49 (35%)  16/48 (33%)   6/47 (13%)   0/45 (0%)  |
|ADJUSTED (b)           |   2.9%         0.0%         0.0%         0.0%      |  41.5%        41.0%        17.2%         0.0%      |
|TERMINAL (d)           |  1/34 (3%)    0/33 (0%)    0/3 (0%)     0/0        | 17/41 (41%)  16/39 (41%)   5/33 (15%)   0/11 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      ---          ---          ---       |   593 (T)      593 (T)      566          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.779N     P=0.506N     P=0.938N       (e)      |  P=0.002N**   P=0.574N     P=0.031N*    P=0.013N*  |
|INCIDENTAL TUMOR       |  P=0.779N     P=0.506N     P=0.938N       (e)      |  P<0.001N**   P=0.574N     P=0.019N*    P=0.013N*  |
|LOGISTIC REGRESSION    |  P=0.779N     P=0.506N     P=0.938N       (e)      |  P<0.001N**   P=0.574N     P=0.019N*    P=0.013N*  |
|COCHRAN-ARMITAGE       |  P=0.322N                                          |  P<0.001N**                                        |
|FISHER EXACT           |               P=0.478N     P=0.506N     P=0.531N   |               P=0.529N     P=0.011N*    P<0.001N** |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Intermedia                                                                                                 |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/43 (2%)    0/47 (0%)    0/42 (0%)    0/38 (0%)  |  2/49 (4%)    0/48 (0%)    0/47 (0%)    1/45 (2%)  |
|ADJUSTED (b)           |   2.9%         0.0%         0.0%         0.0%      |   4.9%         0.0%         0.0%         9.1%      |
|TERMINAL (d)           |  1/34 (3%)    0/33 (0%)    0/3 (0%)     0/0        |  2/41 (5%)    0/39 (0%)    0/33 (0%)    1/11 (9%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      ---          ---          ---       |   593 (T)      ---          ---          593 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.779N     P=0.506N     P=0.938N       (e)      |  P=0.619      P=0.249N     P=0.287N     P=0.577    |
|INCIDENTAL TUMOR       |  P=0.779N     P=0.506N     P=0.938N       (e)      |  P=0.619      P=0.249N     P=0.287N     P=0.577    |
|LOGISTIC REGRESSION    |  P=0.779N     P=0.506N     P=0.938N       (e)      |  P=0.619      P=0.249N     P=0.287N     P=0.577    |
|COCHRAN-ARMITAGE       |  P=0.322N                                          |  P=0.482N                                          |
|FISHER EXACT           |               P=0.478N     P=0.506N     P=0.531N   |               P=0.253N     P=0.258N     P=0.532N   |
|=================================================================================================================================|
 
         DATE: 09/06/94                     EXPERIMENT: 05044 TEST: 02                                                 PAGE  11
                       STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4-VINYL-1-CYCLOHEXENE DIEPOXIDE
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 85 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/ML      25 MG/ML     50 MG/ML     100 MG/   |   0 MG/ML      25 MG/ML     50 MG/ML     100 MG/   |
|                       |                                          ML        |                                          ML        |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Basosquamous Tumor Malignant                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    2/50 (4%)    0/50 (0%)    3/50 (6%)  |  0/50 (0%)    0/50 (0%)    1/50 (2%)    1/50 (2%)  |
|ADJUSTED (b)           |   0.0%         5.7%         0.0%        16.3%      |   0.0%         0.0%         2.9%         3.7%      |
|TERMINAL (d)           |  0/38 (0%)    2/35 (6%)    0/4 (0%)     0/0        |  0/42 (0%)    0/39 (0%)    1/35 (3%)    0/12 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          729 (T)      ---          486       |   ---          ---          593 (T)      541       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.220        (e)        P=0.024 *  |  P=0.106        (e)        P=0.464      P=0.407    |
|INCIDENTAL TUMOR       |  P=0.101      P=0.220        (e)        P=0.514    |  P=0.298        (e)        P=0.464      P=0.765    |
|LOGISTIC REGRESSION    |  P=0.060      P=0.220        (e)        P=0.154    |  P=0.202        (e)        P=0.464      P=0.496    |
|COCHRAN-ARMITAGE       |  P=0.097                                           |  P=0.236                                           |
|FISHER EXACT           |               P=0.247        (e)        P=0.121    |                 (e)        P=0.500      P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Carcinoma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)   14/50 (28%)  40/50 (80%)  43/50 (86%) |  0/50 (0%)    6/50 (12%)  37/50 (74%)  43/50 (86%) |
|ADJUSTED (b)           |   0.0%        35.7%       100.0%       100.0%      |   0.0%        15.4%        94.8%       100.0%      |
|TERMINAL (d)           |  0/38 (0%)   10/35 (29%)   4/4 (100%)   0/0        |  0/42 (0%)    6/39 (15%)  33/35 (94%)  12/12 (100%)|
|FIRST INCIDENCE (DAYS) |   ---          525          411          376       |   ---          593 (T)      402          376       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.014 *    P<0.001 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.014 *    P<0.001 **   P<0.001 ** |
|LOGISTIC REGRESSION    |  P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.014 *    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=0.013 *    P<0.001 **   P<0.001 ** |
|=================================================================================================================================|
 
         DATE: 09/06/94                     EXPERIMENT: 05044 TEST: 02                                                 PAGE  12
                       STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4-VINYL-1-CYCLOHEXENE DIEPOXIDE
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 85 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/ML      25 MG/ML     50 MG/ML     100 MG/   |   0 MG/ML      25 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)            |  0/50 (0%)   14/50 (28%)  40/50 (80%)  43/50 (86%) |  0/50 (0%)    6/50 (12%)  37/50 (74%)  43/50 (86%) |
|ADJUSTED (b)           |   0.0%        35.7%       100.0%       100.0%      |   0.0%        15.4%        94.8%       100.0%      |
|TERMINAL (d)           |  0/38 (0%)   10/35 (29%)   4/4 (100%)   0/0        |  0/42 (0%)    6/39 (15%)  33/35 (94%)  12/12 (100%)|
|FIRST INCIDENCE (DAYS) |   ---          525          411          376       |   ---          593 (T)      402          376       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.014 *    P<0.001 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.014 *    P<0.001 **   P<0.001 ** |
|LOGISTIC REGRESSION    |  P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.014 *    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=0.013 *    P<0.001 **   P<0.001 ** |
|=================================================================================================================================|
|                                                                                                                                 |
|Spleen                                                                                                                           |
|     Hemangioma                                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/49 (0%)    1/50 (2%)    1/50 (2%)    0/50 (0%)  |  2/50 (4%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   0.0%         2.9%         3.2%         0.0%      |   4.8%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/37 (0%)    1/35 (3%)    0/4 (0%)     0/0        |  2/42 (5%)    0/39 (0%)    0/35 (0%)    0/12 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          729 (T)      613          ---       |   593 (T)      ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.299      P=0.489      P=0.444        (e)      |  P=0.191N     P=0.255N     P=0.279N     P=0.538N   |
|INCIDENTAL TUMOR       |  P=0.691      P=0.489      P=0.623        (e)      |  P=0.191N     P=0.255N     P=0.279N     P=0.538N   |
|LOGISTIC REGRESSION    |  P=0.675      P=0.489      P=0.499        (e)      |  P=0.191N     P=0.255N     P=0.279N     P=0.538N   |
|COCHRAN-ARMITAGE       |  P=0.592N                                          |  P=0.115N                                          |
|FISHER EXACT           |               P=0.505      P=0.505        (e)      |               P=0.247N     P=0.247N     P=0.247N   |
|=================================================================================================================================|
 
         DATE: 09/06/94                     EXPERIMENT: 05044 TEST: 02                                                 PAGE  13
                       STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4-VINYL-1-CYCLOHEXENE DIEPOXIDE
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 85 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/ML      25 MG/ML     50 MG/ML     100 MG/   |   0 MG/ML      25 MG/ML     50 MG/ML     100 MG/   |
|                       |                                          ML        |                                          ML        |
|=================================================================================================================================|
|                                                                                                                                 |
|Spleen                                                                                                                           |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/49 (6%)    0/50 (0%)    1/50 (2%)    0/50 (0%)  |  0/50 (0%)    1/50 (2%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   7.2%         0.0%         4.8%         0.0%      |   0.0%         2.5%         0.0%         0.0%      |
|TERMINAL (d)           |  1/37 (3%)    0/35 (0%)    0/4 (0%)     0/0        |  0/42 (0%)    0/39 (0%)    0/35 (0%)    0/12 (0%)  |
|FIRST INCIDENCE (DAYS) |   600          ---          672          ---       |   ---          576          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.446N     P=0.130N     P=0.586N       (e)      |  P=0.692N     P=0.490        (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.043N*    P=0.281N     P=0.106N     P=0.125N   |  P=0.257N     P=0.718        (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.101N     P=0.117N     P=0.350N     P=0.169N   |  P=0.612N     P=0.495        (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.084N                                          |  P=0.567N                                          |
|FISHER EXACT           |               P=0.117N     P=0.301N     P=0.117N   |               P=0.500        (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    1/50 (2%)    1/50 (2%)    0/50 (0%)  |  3/50 (6%)    0/50 (0%)    1/50 (2%)    3/50 (6%)  |
|ADJUSTED (b)           |   2.6%         2.9%        25.0%         0.0%      |   7.1%         0.0%         2.9%        21.9%      |
|TERMINAL (d)           |  1/38 (3%)    1/35 (3%)    1/4 (25%)    0/0        |  3/42 (7%)    0/39 (0%)    1/35 (3%)    2/12 (17%) |
|FIRST INCIDENCE (DAYS) |   729 (T)      729 (T)      729 (T)      ---       |   593 (T)      ---          593 (T)      579       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.374      P=0.743      P=0.225        (e)      |  P=0.082      P=0.135N     P=0.372N     P=0.133    |
|INCIDENTAL TUMOR       |  P=0.374      P=0.743      P=0.225        (e)      |  P=0.187      P=0.135N     P=0.372N     P=0.309    |
|LOGISTIC REGRESSION    |  P=0.374      P=0.743      P=0.225        (e)      |  P=0.133      P=0.135N     P=0.372N     P=0.211    |
|COCHRAN-ARMITAGE       |  P=0.311N                                          |  P=0.423                                           |
|FISHER EXACT           |               P=0.753N     P=0.753N     P=0.500N   |               P=0.121N     P=0.309N     P=0.661N   |
|=================================================================================================================================|
 
         DATE: 09/06/94                     EXPERIMENT: 05044 TEST: 02                                                 PAGE  14
                       STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4-VINYL-1-CYCLOHEXENE DIEPOXIDE
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 85 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/ML      25 MG/ML     50 MG/ML     100 MG/   |   0 MG/ML      25 MG/ML     50 MG/ML     100 MG/   |
|                       |                                          ML        |                                          ML        |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/49 (0%)    0/50 (0%)    1/49 (2%)    0/48 (0%)  |  2/49 (4%)    1/49 (2%)    2/50 (4%)    0/50 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         7.7%         0.0%      |   4.9%         2.6%         5.7%         0.0%      |
|TERMINAL (d)           |  0/37 (0%)    0/35 (0%)    0/4 (0%)     0/0        |  2/41 (5%)    1/39 (3%)    2/35 (6%)    0/12 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          695          ---       |   593 (T)      593 (T)      593 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.344        (e)        P=0.287        (e)      |  P=0.472N     P=0.517N     P=0.637      P=0.532N   |
|INCIDENTAL TUMOR       |  P=0.958        (e)          (e)          (e)      |  P=0.472N     P=0.517N     P=0.637      P=0.532N   |
|LOGISTIC REGRESSION    |  P=0.541        (e)        P=0.413        (e)      |  P=0.472N     P=0.517N     P=0.637      P=0.532N   |
|COCHRAN-ARMITAGE       |  P=0.692                                           |  P=0.195N                                          |
|FISHER EXACT           |                 (e)        P=0.500        (e)      |               P=0.500N     P=0.684N     P=0.242N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangioma                                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    6/50 (12%)   1/50 (2%)    0/50 (0%)  |  4/50 (8%)    0/50 (0%)    1/50 (2%)    1/50 (2%)  |
|ADJUSTED (b)           |   5.3%        16.6%         3.2%         0.0%      |   9.1%         0.0%         2.8%         2.5%      |
|TERMINAL (d)           |  2/38 (5%)    5/35 (14%)   0/4 (0%)     0/0        |  3/42 (7%)    0/39 (0%)    0/35 (0%)    0/12 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      698          613          ---       |   451          ---          584          474       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.208      P=0.113      P=0.575        (e)      |  P=0.341N     P=0.074N     P=0.231N     P=0.459N   |
|INCIDENTAL TUMOR       |  P=0.660      P=0.183      P=0.706        (e)      |  P=0.064N     P=0.079N     P=0.122N     P=0.202N   |
|LOGISTIC REGRESSION    |  P=0.660      P=0.126      P=0.638N       (e)      |  P=0.165N     P=0.062N     P=0.184N     P=0.175N   |
|COCHRAN-ARMITAGE       |  P=0.060N                                          |  P=0.163N                                          |
|FISHER EXACT           |               P=0.134      P=0.500N     P=0.247N   |               P=0.059N     P=0.181N     P=0.181N   |
|=================================================================================================================================|
 
         DATE: 09/06/94                     EXPERIMENT: 05044 TEST: 02                                                 PAGE  15
                       STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4-VINYL-1-CYCLOHEXENE DIEPOXIDE
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 85 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/ML      25 MG/ML     50 MG/ML     100 MG/   |   0 MG/ML      25 MG/ML     50 MG/ML     100 MG/   |
|                       |                                          ML        |                                          ML        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/50 (8%)    3/50 (6%)    1/50 (2%)    0/50 (0%)  |  1/50 (2%)    1/50 (2%)    1/50 (2%)    0/50 (0%)  |
|ADJUSTED (b)           |   9.7%         7.8%         4.8%         0.0%      |   2.4%         2.5%         2.9%         0.0%      |
|TERMINAL (d)           |  2/38 (5%)    2/35 (6%)    0/4 (0%)     0/0        |  1/42 (2%)    0/39 (0%)    1/35 (3%)    0/12 (0%)  |
|FIRST INCIDENCE (DAYS) |   600          470          672          ---       |   593 (T)      576          593 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.423N     P=0.529N     P=0.543N       (e)      |  P=0.535N     P=0.747      P=0.721      P=0.748N   |
|INCIDENTAL TUMOR       |  P=0.018N*    P=0.651N     P=0.100N     P=0.125N   |  P=0.268N     P=0.658N     P=0.721      P=0.748N   |
|LOGISTIC REGRESSION    |  P=0.039N*    P=0.500N     P=0.243N     P=0.145N   |  P=0.432N     P=0.754      P=0.721      P=0.748N   |
|COCHRAN-ARMITAGE       |  P=0.025N*                                         |  P=0.311N                                          |
|FISHER EXACT           |               P=0.500N     P=0.181N     P=0.059N   |               P=0.753N     P=0.753N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma or Hemangioma                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/50 (10%)   9/50 (18%)   2/50 (4%)    0/50 (0%)  |  5/50 (10%)   1/50 (2%)    2/50 (4%)    1/50 (2%)  |
|ADJUSTED (b)           |  12.2%        23.9%         7.8%         0.0%      |  11.4%         2.5%         5.6%         2.5%      |
|TERMINAL (d)           |  3/38 (8%)    7/35 (20%)   0/4 (0%)     0/0        |  4/42 (10%)   0/39 (0%)    1/35 (3%)    0/12 (0%)  |
|FIRST INCIDENCE (DAYS) |   600          470          613          ---       |   451          576          584          474       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.415      P=0.167      P=0.650        (e)      |  P=0.288N     P=0.123N     P=0.288N     P=0.381N   |
|INCIDENTAL TUMOR       |  P=0.066N     P=0.166      P=0.213N     P=0.125N   |  P=0.029N*    P=0.084N     P=0.182N     P=0.161N   |
|LOGISTIC REGRESSION    |  P=0.072N     P=0.189      P=0.309N     P=0.136N   |  P=0.105N     P=0.106N     P=0.230N     P=0.110N   |
|COCHRAN-ARMITAGE       |  P=0.007N**                                        |  P=0.092N                                          |
|FISHER EXACT           |               P=0.194      P=0.218N     P=0.028N*  |               P=0.102N     P=0.218N     P=0.102N   |
|=================================================================================================================================|
 
         DATE: 09/06/94                     EXPERIMENT: 05044 TEST: 02                                                 PAGE  16
                       STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4-VINYL-1-CYCLOHEXENE DIEPOXIDE
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 85 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/ML      25 MG/ML     50 MG/ML     100 MG/   |   0 MG/ML      25 MG/ML     50 MG/ML     100 MG/   |
|                       |                                          ML        |                                          ML        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Histiocytic Sarcoma                                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |  0/50 (0%)    2/50 (4%)    1/50 (2%)    0/50 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   0.0%         4.6%         2.2%         0.0%      |
|TERMINAL (d)           |  0/38 (0%)    0/35 (0%)    0/4 (0%)     0/0        |  0/42 (0%)    1/39 (3%)    0/35 (0%)    0/12 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   ---          415          436          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.562N     P=0.229      P=0.492        (e)      |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.251N     P=0.212      P=0.500        (e)      |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.416N     P=0.253      P=0.551        (e)      |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.461N                                          |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.247      P=0.500        (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma And Histiocytic Sarcoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/50 (6%)    6/50 (12%)   2/50 (4%)    1/50 (2%)  | 17/50 (34%)   7/50 (14%)   6/50 (12%)   1/50 (2%)  |
|ADJUSTED (b)           |   7.9%        15.8%        11.5%         2.1%      |  39.5%        16.7%        15.5%         2.8%      |
|TERMINAL (d)           |  3/38 (8%)    4/35 (11%)   0/4 (0%)     0/0        | 16/42 (38%)   5/39 (13%)   4/35 (11%)   0/12 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      609          635          315       |   534          415          436          499       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.054      P=0.215      P=0.240      P=0.500    |  P=0.006N**   P=0.029N*    P=0.028N*    P=0.033N*  |
|INCIDENTAL TUMOR       |  P=0.610      P=0.245      P=0.737      P=0.557    |  P<0.001N**   P=0.023N*    P=0.016N*    P=0.008N** |
|LOGISTIC REGRESSION    |  P=0.411N     P=0.235      P=0.643      P=0.492N   |  P<0.001N**   P=0.021N*    P=0.012N*    P=0.001N** |
|COCHRAN-ARMITAGE       |  P=0.114N                                          |  P<0.001N**                                        |
|FISHER EXACT           |               P=0.243      P=0.500N     P=0.309N   |               P=0.017N*    P=0.008N**   P<0.001N** |
|=================================================================================================================================|
 
         DATE: 09/06/94                     EXPERIMENT: 05044 TEST: 02                                                 PAGE  17
                       STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4-VINYL-1-CYCLOHEXENE DIEPOXIDE
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 85 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/ML      25 MG/ML     50 MG/ML     100 MG/   |   0 MG/ML      25 MG/ML     50 MG/ML     100 MG/   |
|                       |                                          ML        |                                          ML        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,                                                                        |
|     NOS, or Undifferentiated Cell Type                                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/50 (6%)    6/50 (12%)   2/50 (4%)    1/50 (2%)  | 17/50 (34%)   5/50 (10%)   5/50 (10%)   1/50 (2%)  |
|ADJUSTED (b)           |   7.9%        15.8%        11.5%         2.1%      |  39.5%        12.4%        13.6%         2.8%      |
|TERMINAL (d)           |  3/38 (8%)    4/35 (11%)   0/4 (0%)     0/0        | 16/42 (38%)   4/39 (10%)   4/35 (11%)   0/12 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      609          635          315       |   534          553          569          499       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.054      P=0.215      P=0.240      P=0.500    |  P=0.005N**   P=0.007N**   P=0.013N*    P=0.033N*  |
|INCIDENTAL TUMOR       |  P=0.610      P=0.245      P=0.737      P=0.557    |  P<0.001N**   P=0.005N**   P=0.007N**   P=0.008N** |
|LOGISTIC REGRESSION    |  P=0.411N     P=0.235      P=0.643      P=0.492N   |  P<0.001N**   P=0.005N**   P=0.006N**   P=0.001N** |
|COCHRAN-ARMITAGE       |  P=0.114N                                          |  P<0.001N**                                        |
|FISHER EXACT           |               P=0.243      P=0.500N     P=0.309N   |               P=0.004N**   P=0.004N**   P<0.001N** |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 31/50 (62%)  26/50 (52%)  23/50 (46%)   7/50 (14%) | 31/50 (62%)  25/50 (50%)  34/50 (68%)  29/50 (58%) |
|ADJUSTED (b)           |  68.8%        66.5%        94.5%        77.9%      |  72.0%        62.4%        79.0%        88.7%      |
|TERMINAL (d)           | 24/38 (63%)  22/35 (63%)   3/4 (75%)    0/0        | 30/42 (71%)  24/39 (62%)  26/35 (74%)   9/12 (75%) |
|FIRST INCIDENCE (DAYS) |   495          525          435          486       |   451          457          464          388       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.352N     P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.254N     P=0.066      P<0.001 ** |
|INCIDENTAL TUMOR       |  P=0.015N*    P=0.293N     P=0.341N     P=0.013N*  |  P=0.037 *    P=0.264N     P=0.210      P=0.122    |
|LOGISTIC REGRESSION    |  P=0.059N     P=0.216N     P=0.408N     P=0.021N*  |  P=0.093      P=0.203N     P=0.193      P=0.298    |
|COCHRAN-ARMITAGE       |  P<0.001N**                                        |  P=0.510                                           |
|FISHER EXACT           |               P=0.210N     P=0.080N     P<0.001N** |               P=0.157N     P=0.338      P=0.419N   |
|=================================================================================================================================|
 
         DATE: 09/06/94                     EXPERIMENT: 05044 TEST: 02                                                 PAGE  18
                       STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4-VINYL-1-CYCLOHEXENE DIEPOXIDE
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 85 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/ML      25 MG/ML     50 MG/ML     100 MG/   |   0 MG/ML      25 MG/ML     50 MG/ML     100 MG/   |
|                       |                                          ML        |                                          ML        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 16/50 (32%)  26/50 (52%)  40/50 (80%)  47/50 (94%) | 23/50 (46%)  23/50 (46%)  44/50 (88%)  45/50 (90%) |
|ADJUSTED (b)           |  37.8%        59.0%       100.0%       100.0%      |  52.3%        54.6%       100.0%       100.0%      |
|TERMINAL (d)           | 12/38 (32%)  17/35 (49%)   4/4 (100%)   0/0        | 21/42 (50%)  20/39 (51%)  35/35 (100%) 12/12 (100%)|
|FIRST INCIDENCE (DAYS) |   587          470          411          315       |   534          415          402          376       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.032 *    P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.451      P<0.001 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P<0.001 **   P=0.042 *    P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.566      P<0.001 **   P<0.001 ** |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.021 *    P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.505      P<0.001 **   P<0.001 ** |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P<0.001 **                                        |
|FISHER EXACT           |               P=0.034 *    P<0.001 **   P<0.001 ** |               P=0.579N     P<0.001 **   P<0.001 ** |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 35/50 (70%)  40/50 (80%)  42/50 (84%)  47/50 (94%) | 41/50 (82%)  36/50 (72%)  47/50 (94%)  46/50 (92%) |
|ADJUSTED (b)           |  77.7%        90.9%       100.0%       100.0%      |  91.1%        83.7%       100.0%       100.0%      |
|TERMINAL (d)           | 28/38 (74%)  31/35 (89%)   4/4 (100%)   0/0        | 38/42 (90%)  32/39 (82%)  35/35 (100%) 12/12 (100%)|
|FIRST INCIDENCE (DAYS) |   495          470          411          315       |   451          415          402          376       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.108      P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.377N     P=0.003 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P<0.001 **   P=0.095      P=0.035 *    P=0.019 *  |  P<0.001 **   P=0.241N     P=0.005 **   P=0.002 ** |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.124      P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.242N     P=0.003 **   P<0.001 ** |
|COCHRAN-ARMITAGE       |  P=0.001 **                                        |  P=0.019 *                                         |
|FISHER EXACT           |               P=0.178      P=0.077      P=0.002 ** |               P=0.171N     P=0.061      P=0.117    |
|=================================================================================================================================|
 
         DATE: 09/06/94                     EXPERIMENT: 05044 TEST: 02                                                 PAGE  19
                       STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4-VINYL-1-CYCLOHEXENE DIEPOXIDE
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 85 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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