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TR 381 Mouse Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: IRDC                                                       CARVONE                                        DATE: 09/04/94       
EXPERIMENT: 05032 TEST: 02                                                                                     TIME: 19:33:28       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT:                       ROUTE: GAVAGE                                                                      NTP C#: 55867A       
PATHOLOGIST: DR. A. BOOTHE                   S. EUSTIS                                                         CAS: 99490           
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08    
LAB: IRDC                                                       CARVONE                                        DATE: 09/04/94      
EXPERIMENT: 05032 TEST: 02                                                                                     TIME: 19:33:28      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT:                       ROUTE: GAVAGE                                                                      NTP C#: 55867A      
PATHOLOGIST: DR. A. BOOTHE                   S. EUSTIS                                                         CAS: 99490          
 
 
 
 
 
                                                    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
                                                    Epididymis
                                                    Gallbladder
                                                    Heart
                                                    Islets, Pancreatic
                                                    Kidney
                                                    Larynx
                                                    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: IRDC                                                       CARVONE                                        DATE: 09/04/94       
EXPERIMENT: 05032 TEST: 02                                                                                     TIME: 19:33:28       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT:                       ROUTE: GAVAGE                                                                      NTP C#: 55867A       
PATHOLOGIST: DR. A. BOOTHE                   S. EUSTIS                                                         CAS: 99490           
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                            IN THE ANALYSIS OF THE STUDY OF CARVONE
 
              ====================================================================================================
 
                                                           MALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Skin: Subcutaneous Tissue     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,
                                                            Neurofibroma, or Fibroma
                                                           Neurofibrosarcoma, Fibrosarcoma, or Sarcoma
                             All Organs                    Hemangiosarcoma or Hemangioma
                                                           Benign Tumors
                                                           Malignant Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
 
                                                           FEMALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Skeletal Muscle               Sarcoma
 
              ====================================================================================================
         DATE: 09/04/94                     EXPERIMENT: 05032 TEST: 02                                                 PAGE   1
                                   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CARVONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         375             750           |      VEHICLE         375             750           |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/48 (4%)       0/49 (0%)       0/48 (0%)      |     0/49 (0%)       0/48 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      5.6%            0.0%            0.0%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     2/36 (6%)       0/42 (0%)       0/36 (0%)      |     0/13 (0%)       0/29 (0%)       0/38 (0%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         ---             ---           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.090N        P=0.205N        P=0.238N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.090N        P=0.205N        P=0.238N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.090N        P=0.205N        P=0.238N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.095N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.242N        P=0.247N       |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       2/50 (4%)       1/50 (2%)      |     2/50 (4%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      2.7%            4.5%            2.8%          |      5.8%            0.0%            0.0%          |
|TERMINAL (d)           |     1/37 (3%)       1/42 (2%)       1/36 (3%)      |     0/14 (0%)       0/29 (0%)       0/38 (0%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         525             729 (T)       |      522             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.610         P=0.534         P=0.756        |     P=0.076N        P=0.219N        P=0.192N       |
|INCIDENTAL TUMOR       |     P=0.595N        P=0.529         P=0.756        |     P=0.277N        P=0.485N        P=0.539N       |
|LOGISTIC REGRESSION    |     P=0.617         P=0.491         P=0.756        |     P=0.098N        P=0.232N        P=0.246N       |
|COCHRAN-ARMITAGE       |     P=0.622N                                       |     P=0.095N                                       |
|FISHER EXACT           |                     P=0.500         P=0.753N       |                     P=0.247N        P=0.247N       |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05032 TEST: 02                                                 PAGE   2
                                   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CARVONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         375             750           |      VEHICLE         375             750           |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       4/50 (8%)       4/49 (8%)      |     1/50 (2%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      5.4%            9.5%           10.5%          |      4.8%            0.0%            0.0%          |
|TERMINAL (d)           |     2/37 (5%)       4/42 (10%)      3/36 (8%)      |     0/14 (0%)       0/29 (0%)       0/38 (0%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         729 (T)         498           |      695             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.255         P=0.397         P=0.321        |     P=0.191N        P=0.429N        P=0.382N       |
|INCIDENTAL TUMOR       |     P=0.279         P=0.397         P=0.358        |     P=0.567N        P=0.731N        P=0.892N       |
|LOGISTIC REGRESSION    |     P=0.244         P=0.397         P=0.311        |     P=0.239N        P=0.471N        P=0.460N       |
|COCHRAN-ARMITAGE       |     P=0.265                                        |     P=0.269N                                       |
|FISHER EXACT           |                     P=0.339         P=0.329        |                     P=0.500N        P=0.500N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     5/50 (10%)      3/50 (6%)       3/49 (6%)      |     0/50 (0%)       2/50 (4%)       1/50 (2%)      |
|ADJUSTED (b)           |     13.5%            7.1%            8.3%          |      0.0%            5.7%            2.6%          |
|TERMINAL (d)           |     5/37 (14%)      3/42 (7%)       3/36 (8%)      |     0/14 (0%)       1/29 (3%)       1/38 (3%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         729 (T)         729 (T)       |      ---             565             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.289N        P=0.288N        P=0.370N       |     P=0.535         P=0.327         P=0.699        |
|INCIDENTAL TUMOR       |     P=0.289N        P=0.288N        P=0.370N       |     P=0.451         P=0.317         P=0.699        |
|LOGISTIC REGRESSION    |     P=0.289N        P=0.288N        P=0.370N       |     P=0.375         P=0.237         P=0.699        |
|COCHRAN-ARMITAGE       |     P=0.292N                                       |     P=0.360                                        |
|FISHER EXACT           |                     P=0.357N        P=0.369N       |                     P=0.247         P=0.500        |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05032 TEST: 02                                                 PAGE   3
                                   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CARVONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         375             750           |      VEHICLE         375             750           |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     7/50 (14%)      7/50 (14%)      7/49 (14%)     |     1/50 (2%)       2/50 (4%)       1/50 (2%)      |
|ADJUSTED (b)           |     18.9%           16.7%           18.7%          |      4.8%            5.7%            2.6%          |
|TERMINAL (d)           |     7/37 (19%)      7/42 (17%)      6/36 (17%)     |     0/14 (0%)       1/29 (3%)       1/38 (3%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         729 (T)         498           |      695             565             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.535         P=0.513N        P=0.589        |     P=0.421N        P=0.630         P=0.576N       |
|INCIDENTAL TUMOR       |     P=0.556         P=0.513N        P=0.612N       |     P=0.565         P=0.457         P=0.735        |
|LOGISTIC REGRESSION    |     P=0.511         P=0.513N        P=0.565        |     P=0.596N        P=0.509         P=0.686N       |
|COCHRAN-ARMITAGE       |     P=0.541                                        |     P=0.622N                                       |
|FISHER EXACT           |                     P=0.613N        P=0.597        |                     P=0.500         P=0.753N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     7/50 (14%)      7/50 (14%)      7/49 (14%)     |     1/50 (2%)       2/50 (4%)       1/50 (2%)      |
|ADJUSTED (b)           |     18.9%           16.7%           18.7%          |      4.8%            5.7%            2.6%          |
|TERMINAL (d)           |     7/37 (19%)      7/42 (17%)      6/36 (17%)     |     0/14 (0%)       1/29 (3%)       1/38 (3%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         729 (T)         498           |      695             565             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.535         P=0.513N        P=0.589        |     P=0.421N        P=0.630         P=0.576N       |
|INCIDENTAL TUMOR       |     P=0.556         P=0.513N        P=0.612N       |     P=0.565         P=0.457         P=0.735        |
|LOGISTIC REGRESSION    |     P=0.511         P=0.513N        P=0.565        |     P=0.596N        P=0.509         P=0.686N       |
|COCHRAN-ARMITAGE       |     P=0.541                                        |     P=0.622N                                       |
|FISHER EXACT           |                     P=0.613N        P=0.597        |                     P=0.500         P=0.753N       |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05032 TEST: 02                                                 PAGE   4
                                   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CARVONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         375             750           |      VEHICLE         375             750           |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     7/50 (14%)      4/50 (8%)       5/50 (10%)     |     1/50 (2%)       6/50 (12%)      3/50 (6%)      |
|ADJUSTED (b)           |     17.0%            9.5%           13.9%          |      3.1%           19.7%            7.6%          |
|TERMINAL (d)           |     4/37 (11%)      4/42 (10%)      5/36 (14%)     |     0/14 (0%)       5/29 (17%)      2/38 (5%)      |
|FIRST INCIDENCE (DAYS) |      337             729 (T)         729 (T)       |      638             645             690           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.331N        P=0.208N        P=0.405N       |     P=0.515N        P=0.190         P=0.561        |
|INCIDENTAL TUMOR       |     P=0.340N        P=0.309N        P=0.411N       |     P=0.343         P=0.122         P=0.220        |
|LOGISTIC REGRESSION    |     P=0.342N        P=0.264N        P=0.410N       |     P=0.417         P=0.089         P=0.375        |
|COCHRAN-ARMITAGE       |     P=0.314N                                       |     P=0.274                                        |
|FISHER EXACT           |                     P=0.262N        P=0.380N       |                     P=0.056         P=0.309        |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     7/50 (14%)      5/50 (10%)      6/50 (12%)     |     1/50 (2%)       6/50 (12%)      3/50 (6%)      |
|ADJUSTED (b)           |     17.0%           11.9%           16.2%          |      3.1%           19.7%            7.6%          |
|TERMINAL (d)           |     4/37 (11%)      5/42 (12%)      5/36 (14%)     |     0/14 (0%)       5/29 (17%)      2/38 (5%)      |
|FIRST INCIDENCE (DAYS) |      337             729 (T)         707           |      638             645             690           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.459N        P=0.308N        P=0.522N       |     P=0.515N        P=0.190         P=0.561        |
|INCIDENTAL TUMOR       |     P=0.480N        P=0.424N        P=0.548N       |     P=0.343         P=0.122         P=0.220        |
|LOGISTIC REGRESSION    |     P=0.476N        P=0.379N        P=0.536N       |     P=0.417         P=0.089         P=0.375        |
|COCHRAN-ARMITAGE       |     P=0.439N                                       |     P=0.274                                        |
|FISHER EXACT           |                     P=0.380N        P=0.500N       |                     P=0.056         P=0.309        |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05032 TEST: 02                                                 PAGE   5
                                   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CARVONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         375             750           |      VEHICLE         375             750           |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/40 (0%)       0/48 (0%)       0/48 (0%)      |     1/46 (2%)       0/49 (0%)       2/48 (4%)      |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |      6.3%            0.0%            5.6%          |
|TERMINAL (d)           |     0/28 (0%)       0/40 (0%)       0/35 (0%)      |     0/12 (0%)       0/29 (0%)       2/36 (6%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      709             ---             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.620         P=0.381N        P=0.652N       |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.350         P=0.718N        P=0.568        |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.525         P=0.430N        P=0.729        |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.371                                        |
|FISHER EXACT           |                       (e)             (e)          |                     P=0.484N        P=0.516        |
|=================================================================================================================================|
|                                                                                                                                 |
|Skeletal Muscle                                                                                                                  |
|     Sarcoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |     0/50 (0%)       0/50 (0%)       2/50 (4%)      |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |      0.0%            0.0%            4.5%          |
|TERMINAL (d)           |     0/37 (0%)       0/42 (0%)       0/36 (0%)      |     0/14 (0%)       0/29 (0%)       0/38 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      ---             ---             535           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.116           (e)           P=0.282        |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.035 *         (e)           P=0.089        |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.089           (e)           P=0.229        |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.095                                        |
|FISHER EXACT           |                       (e)             (e)          |                       (e)           P=0.247        |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05032 TEST: 02                                                 PAGE   6
                                   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CARVONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         375             750           |      VEHICLE         375             750           |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       0/50 (0%)       1/50 (2%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      5.4%            0.0%            2.8%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     2/37 (5%)       0/42 (0%)       1/36 (3%)      |     0/14 (0%)       0/29 (0%)       0/38 (0%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         ---             729 (T)       |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.364N        P=0.211N        P=0.510N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.364N        P=0.211N        P=0.510N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.364N        P=0.211N        P=0.510N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.360N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.247N        P=0.500N       |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma                                                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       1/50 (2%)       0/50 (0%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      5.3%            2.4%            0.0%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     1/37 (3%)       1/42 (2%)       0/36 (0%)      |     0/14 (0%)       0/29 (0%)       0/38 (0%)      |
|FIRST INCIDENCE (DAYS) |      699             729 (T)         ---           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.141N        P=0.456N        P=0.243N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.161N        P=0.504N        P=0.274N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.147N        P=0.480N        P=0.250N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.142N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.500N        P=0.247N       |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05032 TEST: 02                                                 PAGE   7
                                   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CARVONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         375             750           |      VEHICLE         375             750           |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,                                                                                   |
|     Neurofibroma, or Fibroma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     9/50 (18%)      1/50 (2%)       3/50 (6%)      |     0/50 (0%)       1/50 (2%)       0/50 (0%)      |
|ADJUSTED (b)           |     21.2%            2.4%            7.9%          |      0.0%            3.4%            0.0%          |
|TERMINAL (d)           |     4/37 (11%)      1/42 (2%)       2/36 (6%)      |     0/14 (0%)       1/29 (3%)       0/38 (0%)      |
|FIRST INCIDENCE (DAYS) |      592             729 (T)         592           |      ---             729 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.030N*       P=0.008N**      P=0.080N       |     P=0.608N        P=0.645           (e)          |
|INCIDENTAL TUMOR       |     P=0.057N        P=0.020N*       P=0.124N       |     P=0.608N        P=0.645           (e)          |
|LOGISTIC REGRESSION    |     P=0.083N        P=0.023N*       P=0.072N       |     P=0.608N        P=0.645           (e)          |
|COCHRAN-ARMITAGE       |     P=0.025N*                                      |     P=0.731                                        |
|FISHER EXACT           |                     P=0.008N**      P=0.061N       |                     P=0.500           (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, or Sarcoma                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     7/50 (14%)      1/50 (2%)       2/50 (4%)      |     0/50 (0%)       1/50 (2%)       0/50 (0%)      |
|ADJUSTED (b)           |     16.4%            2.4%            5.1%          |      0.0%            3.4%            0.0%          |
|TERMINAL (d)           |     2/37 (5%)       1/42 (2%)       1/36 (3%)      |     0/14 (0%)       1/29 (3%)       0/38 (0%)      |
|FIRST INCIDENCE (DAYS) |      592             729 (T)         592           |      ---             729 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.041N*       P=0.028N*       P=0.100N       |     P=0.608N        P=0.645           (e)          |
|INCIDENTAL TUMOR       |     P=0.082N        P=0.070N        P=0.160N       |     P=0.608N        P=0.645           (e)          |
|LOGISTIC REGRESSION    |     P=0.126N        P=0.085N        P=0.263N       |     P=0.608N        P=0.645           (e)          |
|COCHRAN-ARMITAGE       |     P=0.036N*                                      |     P=0.731                                        |
|FISHER EXACT           |                     P=0.030N*       P=0.080N       |                     P=0.500           (e)          |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05032 TEST: 02                                                 PAGE   8
                                   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CARVONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         375             750           |      VEHICLE         375             750           |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Sarcoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     4/50 (8%)       0/50 (0%)       2/50 (4%)      |     0/50 (0%)       1/50 (2%)       0/50 (0%)      |
|ADJUSTED (b)           |      9.7%            0.0%            5.1%          |      0.0%            3.4%            0.0%          |
|TERMINAL (d)           |     1/37 (3%)       0/42 (0%)       1/36 (3%)      |     0/14 (0%)       1/29 (3%)       0/38 (0%)      |
|FIRST INCIDENCE (DAYS) |      637             ---             592           |      ---             729 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.236N        P=0.057N        P=0.362N       |     P=0.608N        P=0.645           (e)          |
|INCIDENTAL TUMOR       |     P=0.357N        P=0.114N        P=0.496N       |     P=0.608N        P=0.645           (e)          |
|LOGISTIC REGRESSION    |     P=0.513N        P=0.063N        P=0.683        |     P=0.608N        P=0.645           (e)          |
|COCHRAN-ARMITAGE       |     P=0.222N                                       |     P=0.731                                        |
|FISHER EXACT           |                     P=0.059N        P=0.339N       |                     P=0.500           (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Squamous Cell Carcinoma or Papilloma Squamous                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       1/50 (2%)       0/50 (0%)      |     0/50 (0%)       3/50 (6%)       0/50 (0%)      |
|ADJUSTED (b)           |      2.7%            2.4%            0.0%          |      0.0%           10.3%            0.0%          |
|TERMINAL (d)           |     1/37 (3%)       1/42 (2%)       0/36 (0%)      |     0/14 (0%)       3/29 (10%)      0/38 (0%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         729 (T)         ---           |      ---             729 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.334N        P=0.733N        P=0.505N       |     P=0.380N        P=0.274           (e)          |
|INCIDENTAL TUMOR       |     P=0.334N        P=0.733N        P=0.505N       |     P=0.380N        P=0.274           (e)          |
|LOGISTIC REGRESSION    |     P=0.334N        P=0.733N        P=0.505N       |     P=0.380N        P=0.274           (e)          |
|COCHRAN-ARMITAGE       |     P=0.331N                                       |     P=0.640                                        |
|FISHER EXACT           |                     P=0.753N        P=0.500N       |                     P=0.121           (e)          |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05032 TEST: 02                                                 PAGE   9
                                   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CARVONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         375             750           |      VEHICLE         375             750           |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       1/50 (2%)       0/50 (0%)      |     0/50 (0%)       3/50 (6%)       0/50 (0%)      |
|ADJUSTED (b)           |      2.7%            2.4%            0.0%          |      0.0%           10.3%            0.0%          |
|TERMINAL (d)           |     1/37 (3%)       1/42 (2%)       0/36 (0%)      |     0/14 (0%)       3/29 (10%)      0/38 (0%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         729 (T)         ---           |      ---             729 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.334N        P=0.733N        P=0.505N       |     P=0.380N        P=0.274           (e)          |
|INCIDENTAL TUMOR       |     P=0.334N        P=0.733N        P=0.505N       |     P=0.380N        P=0.274           (e)          |
|LOGISTIC REGRESSION    |     P=0.334N        P=0.733N        P=0.505N       |     P=0.380N        P=0.274           (e)          |
|COCHRAN-ARMITAGE       |     P=0.331N                                       |     P=0.640                                        |
|FISHER EXACT           |                     P=0.753N        P=0.500N       |                     P=0.121           (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |     0/50 (0%)       0/50 (0%)       2/50 (4%)      |
|ADJUSTED (b)           |                                                    |      0.0%            0.0%            5.3%          |
|TERMINAL (d)           |                                                    |     0/14 (0%)       0/29 (0%)       2/38 (5%)      |
|FIRST INCIDENCE (DAYS) |                                                    |      ---             ---             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.193           (e)           P=0.475        |
|INCIDENTAL TUMOR       |                                                    |     P=0.193           (e)           P=0.475        |
|LOGISTIC REGRESSION    |                                                    |     P=0.193           (e)           P=0.475        |
|COCHRAN-ARMITAGE       |                                                    |     P=0.095                                        |
|FISHER EXACT           |                                                    |                       (e)           P=0.247        |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05032 TEST: 02                                                 PAGE  10
                                   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CARVONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         375             750           |      VEHICLE         375             750           |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangioma                                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       0/50 (0%)       0/50 (0%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      5.4%            0.0%            0.0%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     2/37 (5%)       0/42 (0%)       0/36 (0%)      |     0/14 (0%)       0/29 (0%)       0/38 (0%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         ---             ---           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.093N        P=0.211N        P=0.244N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.093N        P=0.211N        P=0.244N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.093N        P=0.211N        P=0.244N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.095N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.247N        P=0.247N       |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma or Hemangioma                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/50 (6%)       0/50 (0%)       0/50 (0%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      8.1%            0.0%            0.0%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     3/37 (8%)       0/42 (0%)       0/36 (0%)      |     0/14 (0%)       0/29 (0%)       0/38 (0%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         ---             ---           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.035N*       P=0.100N        P=0.126N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.035N*       P=0.100N        P=0.126N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.035N*       P=0.100N        P=0.126N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.037N*                                      |       (e)                                          |
|FISHER EXACT           |                     P=0.121N        P=0.121N       |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05032 TEST: 02                                                 PAGE  11
                                   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CARVONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         375             750           |      VEHICLE         375             750           |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma And Histiocytic Sarcoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     5/50 (10%)      2/50 (4%)       1/50 (2%)      |     2/50 (4%)       4/50 (8%)       4/50 (8%)      |
|ADJUSTED (b)           |     12.5%            4.4%            2.6%          |     10.7%           11.5%           10.5%          |
|TERMINAL (d)           |     3/37 (8%)       0/42 (0%)       0/36 (0%)      |     1/14 (7%)       2/29 (7%)       4/38 (11%)     |
|FIRST INCIDENCE (DAYS) |      504             552             695           |      676             580             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.065N        P=0.186N        P=0.115N       |     P=0.529N        P=0.546         P=0.589N       |
|INCIDENTAL TUMOR       |     P=0.087N        P=0.300N        P=0.110N       |     P=0.405         P=0.417         P=0.604        |
|LOGISTIC REGRESSION    |     P=0.059N        P=0.225N        P=0.111N       |     P=0.365         P=0.364         P=0.593        |
|COCHRAN-ARMITAGE       |     P=0.060N                                       |     P=0.274                                        |
|FISHER EXACT           |                     P=0.218N        P=0.102N       |                     P=0.339         P=0.339        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,                                                                        |
|     NOS, or Undifferentiated Cell Type                                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     5/50 (10%)      2/50 (4%)       1/50 (2%)      |     2/50 (4%)       4/50 (8%)       4/50 (8%)      |
|ADJUSTED (b)           |     12.5%            4.4%            2.6%          |     10.7%           11.5%           10.5%          |
|TERMINAL (d)           |     3/37 (8%)       0/42 (0%)       0/36 (0%)      |     1/14 (7%)       2/29 (7%)       4/38 (11%)     |
|FIRST INCIDENCE (DAYS) |      504             552             695           |      676             580             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.065N        P=0.186N        P=0.115N       |     P=0.529N        P=0.546         P=0.589N       |
|INCIDENTAL TUMOR       |     P=0.087N        P=0.300N        P=0.110N       |     P=0.405         P=0.417         P=0.604        |
|LOGISTIC REGRESSION    |     P=0.059N        P=0.225N        P=0.111N       |     P=0.365         P=0.364         P=0.593        |
|COCHRAN-ARMITAGE       |     P=0.060N                                       |     P=0.274                                        |
|FISHER EXACT           |                     P=0.218N        P=0.102N       |                     P=0.339         P=0.339        |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05032 TEST: 02                                                 PAGE  12
                                   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CARVONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         375             750           |      VEHICLE         375             750           |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    17/50 (34%)     10/50 (20%)     10/50 (20%)     |     6/50 (12%)      8/50 (16%)      7/50 (14%)     |
|ADJUSTED (b)           |     42.1%           23.1%           26.8%          |     24.4%           26.4%           17.9%          |
|TERMINAL (d)           |    14/37 (38%)      9/42 (21%)      9/36 (25%)     |     1/14 (7%)       7/29 (24%)      6/38 (16%)     |
|FIRST INCIDENCE (DAYS) |      337             525             498           |      522             645             690           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.075N        P=0.047N*       P=0.107N       |     P=0.140N        P=0.447N        P=0.219N       |
|INCIDENTAL TUMOR       |     P=0.067N        P=0.073N        P=0.098N       |     P=0.512         P=0.409         P=0.409        |
|LOGISTIC REGRESSION    |     P=0.085N        P=0.077N        P=0.118N       |     P=0.471N        P=0.486         P=0.607N       |
|COCHRAN-ARMITAGE       |     P=0.066N                                       |     P=0.443                                        |
|FISHER EXACT           |                     P=0.088N        P=0.088N       |                     P=0.387         P=0.500        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    17/50 (34%)      7/50 (14%)      7/50 (14%)     |     3/50 (6%)       9/50 (18%)      8/50 (16%)     |
|ADJUSTED (b)           |     39.3%           15.8%           17.7%          |     17.6%           24.8%           19.5%          |
|TERMINAL (d)           |    11/37 (30%)      5/42 (12%)      4/36 (11%)     |     2/14 (14%)      5/29 (17%)      6/38 (16%)     |
|FIRST INCIDENCE (DAYS) |      504             552             592           |      676             435             535           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.014N*       P=0.012N*       P=0.030N*      |     P=0.470         P=0.236         P=0.512        |
|INCIDENTAL TUMOR       |     P=0.022N*       P=0.031N*       P=0.036N*      |     P=0.186         P=0.127         P=0.250        |
|LOGISTIC REGRESSION    |     P=0.029N*       P=0.016N*       P=0.052N       |     P=0.111         P=0.067         P=0.161        |
|COCHRAN-ARMITAGE       |     P=0.009N**                                     |     P=0.093                                        |
|FISHER EXACT           |                     P=0.017N*       P=0.017N*      |                     P=0.061         P=0.100        |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05032 TEST: 02                                                 PAGE  13
                                   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CARVONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         375             750           |      VEHICLE         375             750           |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    27/50 (54%)     15/50 (30%)     16/50 (32%)     |     9/50 (18%)     15/50 (30%)     14/50 (28%)     |
|ADJUSTED (b)           |     61.1%           33.2%           39.8%          |     38.5%           42.2%           33.8%          |
|TERMINAL (d)           |    20/37 (54%)     12/42 (29%)     12/36 (33%)     |     3/14 (21%)     10/29 (34%)     11/38 (29%)     |
|FIRST INCIDENCE (DAYS) |      337             525             498           |      522             435             535           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.027N*       P=0.007N**      P=0.043N*      |     P=0.246N        P=0.542         P=0.301N       |
|INCIDENTAL TUMOR       |     P=0.029N*       P=0.017N*       P=0.039N*      |     P=0.217         P=0.162         P=0.205        |
|LOGISTIC REGRESSION    |     P=0.023N*       P=0.011N*       P=0.035N*      |     P=0.236         P=0.151         P=0.300        |
|COCHRAN-ARMITAGE       |     P=0.016N*                                      |     P=0.150                                        |
|FISHER EXACT           |                     P=0.013N*       P=0.021N*      |                     P=0.121         P=0.171        |
|=================================================================================================================================|
 
 (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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