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TR 346 Rat Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Northwest                                      ETHYL CHLORIDE                                    DATE: 09/10/94       
EXPERIMENT: 05078 TEST: 01                                                                                     TIME: 13:13:45       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01ES38061            ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                                             NTP C#: 06224        
PATHOLOGIST: R. MILLER                                                                                         CAS: 75-00-3         
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08    
LAB: Battelle Northwest                                      ETHYL CHLORIDE                                    DATE: 09/10/94      
EXPERIMENT: 05078 TEST: 01                                                                                     TIME: 13:13:45      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01ES38061            ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                                             NTP C#: 06224       
PATHOLOGIST: R. MILLER                                                                                         CAS: 75-00-3        
 
 
 
 
 
                                                    RATS(FISCHER344)
                                              ----------------------------
             FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
             IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
 
 
                                                    ----------------
 
                                                    Adrenal Gland
                                                    Bone Marrow
                                                    Brain
                                                    Clitoral Gland
                                                    Epididymis
                                                    Heart
                                                    Islets, Pancreatic
                                                    Kidney
                                                    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: Battelle Northwest                                      ETHYL CHLORIDE                                    DATE: 09/10/94       
EXPERIMENT: 05078 TEST: 01                                                                                     TIME: 13:13:45       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01ES38061            ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                                             NTP C#: 06224        
PATHOLOGIST: R. MILLER                                                                                         CAS: 75-00-3         
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                         IN THE ANALYSIS OF THE STUDY OF ETHYL CHLORIDE
 
              ====================================================================================================
 
                                                           MALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Skin                          Trichoepithelioma, Basal Cell Carcinoma, or Basal Cell Adenoma
                             Thyroid Gland: C-Cell         Adenoma
                                                           Carcinoma or Adenoma
                             All Organs                    Leukemia: Lymphocytic, Monocytic, Mononuclear,
                                                            or Undifferentiated
 
              ====================================================================================================
 
                                                           FEMALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Pituitary Gland: Pars Distalis or Unspecified Site
                                                           Adenoma
                             Uterus                        Polyp Stromal
                             All Organs                    Leukemia: Lymphocytic, Monocytic, Mononuclear,
                                                            or Undifferentiated
                                                           Benign Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
         DATE: 09/10/94                     EXPERIMENT: 05078 TEST: 01                                                 PAGE   1
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYL CHLORIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          CONTROL             15000 PP              |          CONTROL             15000 PP              |
|                       |                              M                     |                              M                     |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Cortex                                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         1/50 (2%)           0/50 (0%)              |         2/50 (4%)           1/50 (2%)              |
|ADJUSTED (b)           |          6.3%                0.0%                  |          5.9%                4.5%                  |
|TERMINAL (d)           |         1/16 (6%)           0/8 (0%)               |         1/31 (3%)           1/22 (5%)              |
|FIRST INCIDENCE (DAYS) |          729 (T)             ---                   |          661                 729 (T)               |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.638N               |                             P=0.600N               |
|INCIDENTAL TUMOR       |                             P=0.638N               |                             P=0.579N               |
|LOGISTIC REGRESSION    |                             P=0.638N               |                             P=0.555N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.500N               |                             P=0.500N               |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         8/36 (22%)          9/48 (19%)             |         1/35 (3%)           2/40 (5%)              |
|ADJUSTED (b)           |         48.9%               56.2%                  |          5.6%               12.5%                  |
|TERMINAL (d)           |         6/13 (46%)          3/7 (43%)              |         1/18 (6%)           2/16 (13%)             |
|FIRST INCIDENCE (DAYS) |          500                 562                   |          729 (T)             729 (T)               |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.175                |                             P=0.458                |
|INCIDENTAL TUMOR       |                             P=0.418                |                             P=0.458                |
|LOGISTIC REGRESSION    |                             P=0.589N               |                             P=0.458                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.450N               |                             P=0.551                |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05078 TEST: 01                                                 PAGE   2
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYL CHLORIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          CONTROL             15000 PP              |          CONTROL             15000 PP              |
|                       |                              M                     |                              M                     |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         8/36 (22%)         10/48 (21%)             |         1/35 (3%)           3/40 (8%)              |
|ADJUSTED (b)           |         48.9%               57.5%                  |          5.6%               18.8%                  |
|TERMINAL (d)           |         6/13 (46%)          3/7 (43%)              |         1/18 (6%)           3/16 (19%)             |
|FIRST INCIDENCE (DAYS) |          500                 562                   |          729 (T)             729 (T)               |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.119                |                             P=0.258                |
|INCIDENTAL TUMOR       |                             P=0.367                |                             P=0.258                |
|LOGISTIC REGRESSION    |                             P=0.549                |                             P=0.258                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.543N               |                             P=0.360                |
|=================================================================================================================================|
|                                                                                                                                 |
|Brain                                                                                                                            |
|     Astrocytoma Malignant                                                                                                       |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         0/50 (0%)           1/50 (2%)              |         0/50 (0%)           3/50 (6%)              |
|ADJUSTED (b)           |          0.0%               12.5%                  |          0.0%                9.1%                  |
|TERMINAL (d)           |         0/16 (0%)           1/8 (13%)              |         0/31 (0%)           0/22 (0%)              |
|FIRST INCIDENCE (DAYS) |          ---                 729 (T)               |          ---                 364                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.362                |                             P=0.095                |
|INCIDENTAL TUMOR       |                             P=0.362                |                             P=0.119                |
|LOGISTIC REGRESSION    |                             P=0.362                |                             P=0.128                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.500                |                             P=0.121                |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05078 TEST: 01                                                 PAGE   3
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYL CHLORIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          CONTROL             15000 PP              |          CONTROL             15000 PP              |
|                       |                              M                     |                              M                     |
|=================================================================================================================================|
|                                                                                                                                 |
|Brain                                                                                                                            |
|     Oligodendroglioma, Glioma, or Astrocytoma                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         1/50 (2%)           2/50 (4%)              |         0/50 (0%)           3/50 (6%)              |
|ADJUSTED (b)           |          2.4%               15.6%                  |          0.0%                9.1%                  |
|TERMINAL (d)           |         0/16 (0%)           1/8 (13%)              |         0/31 (0%)           0/22 (0%)              |
|FIRST INCIDENCE (DAYS) |          567                 633                   |          ---                 364                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.388                |                             P=0.095                |
|INCIDENTAL TUMOR       |                             P=0.657                |                             P=0.119                |
|LOGISTIC REGRESSION    |                             P=0.507                |                             P=0.128                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.500                |                             P=0.121                |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         1/47 (2%)           1/45 (2%)              |         1/46 (2%)           4/43 (9%)              |
|ADJUSTED (b)           |          6.3%                6.7%                  |          3.3%               16.3%                  |
|TERMINAL (d)           |         1/16 (6%)           0/6 (0%)               |         1/30 (3%)           2/21 (10%)             |
|FIRST INCIDENCE (DAYS) |          729 (T)             709                   |          729 (T)             672                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.633                |                             P=0.105                |
|INCIDENTAL TUMOR       |                             P=0.666                |                             P=0.106                |
|LOGISTIC REGRESSION    |                             P=0.679                |                             P=0.106                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.742                |                             P=0.160                |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05078 TEST: 01                                                 PAGE   4
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYL CHLORIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          CONTROL             15000 PP              |          CONTROL             15000 PP              |
|                       |                              M                     |                              M                     |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         1/47 (2%)           2/45 (4%)              |         2/46 (4%)           1/43 (2%)              |
|ADJUSTED (b)           |          4.3%               19.6%                  |          5.4%                4.8%                  |
|TERMINAL (d)           |         0/16 (0%)           1/6 (17%)              |         1/30 (3%)           1/21 (5%)              |
|FIRST INCIDENCE (DAYS) |          692                 633                   |          568                 729 (T)               |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.345                |                             P=0.592N               |
|INCIDENTAL TUMOR       |                             P=0.501                |                             P=0.531N               |
|LOGISTIC REGRESSION    |                             P=0.440                |                             P=0.516N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.484                |                             P=0.526N               |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         2/47 (4%)           3/45 (7%)              |         3/46 (7%)           5/43 (12%)             |
|ADJUSTED (b)           |         10.3%               25.0%                  |          8.7%               20.7%                  |
|TERMINAL (d)           |         1/16 (6%)           1/6 (17%)              |         2/30 (7%)           3/21 (14%)             |
|FIRST INCIDENCE (DAYS) |          692                 633                   |          568                 672                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.284                |                             P=0.216                |
|INCIDENTAL TUMOR       |                             P=0.419                |                             P=0.250                |
|LOGISTIC REGRESSION    |                             P=0.394                |                             P=0.254                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.479                |                             P=0.319                |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05078 TEST: 01                                                 PAGE   5
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYL CHLORIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          CONTROL             15000 PP              |          CONTROL             15000 PP              |
|                       |                              M                     |                              M                     |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         6/48 (13%)          3/48 (6%)              |         0/49 (0%)           0/50 (0%)              |
|ADJUSTED (b)           |         26.2%               21.7%                  |          0.0%                0.0%                  |
|TERMINAL (d)           |         2/15 (13%)          1/8 (13%)              |         0/30 (0%)           0/22 (0%)              |
|FIRST INCIDENCE (DAYS) |          570                 701                   |          ---                 ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.411N               |           (e)                 (e)                  |
|INCIDENTAL TUMOR       |                             P=0.313N               |           (e)                 (e)                  |
|LOGISTIC REGRESSION    |                             P=0.310N               |           (e)                 (e)                  |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.243N               |                               (e)                  |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         6/48 (13%)          3/48 (6%)              |         1/49 (2%)           0/50 (0%)              |
|ADJUSTED (b)           |         26.2%               21.7%                  |          3.3%                0.0%                  |
|TERMINAL (d)           |         2/15 (13%)          1/8 (13%)              |         1/30 (3%)           0/22 (0%)              |
|FIRST INCIDENCE (DAYS) |          570                 701                   |          729 (T)             ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.411N               |                             P=0.562N               |
|INCIDENTAL TUMOR       |                             P=0.313N               |                             P=0.562N               |
|LOGISTIC REGRESSION    |                             P=0.310N               |                             P=0.562N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.243N               |                             P=0.495N               |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05078 TEST: 01                                                 PAGE   6
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYL CHLORIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          CONTROL             15000 PP              |          CONTROL             15000 PP              |
|                       |                              M                     |                              M                     |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         0/50 (0%)           0/50 (0%)              |         2/50 (4%)           1/50 (2%)              |
|ADJUSTED (b)           |          0.0%                0.0%                  |          6.5%                4.5%                  |
|TERMINAL (d)           |         0/16 (0%)           0/8 (0%)               |         2/31 (6%)           1/22 (5%)              |
|FIRST INCIDENCE (DAYS) |          ---                 ---                   |          729 (T)             729 (T)               |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |           (e)                 (e)                  |                             P=0.620N               |
|INCIDENTAL TUMOR       |           (e)                 (e)                  |                             P=0.620N               |
|LOGISTIC REGRESSION    |           (e)                 (e)                  |                             P=0.620N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                               (e)                  |                             P=0.500N               |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         0/50 (0%)           0/50 (0%)              |         2/50 (4%)           2/50 (4%)              |
|ADJUSTED (b)           |          0.0%                0.0%                  |          6.5%                9.1%                  |
|TERMINAL (d)           |         0/16 (0%)           0/8 (0%)               |         2/31 (6%)           2/22 (9%)              |
|FIRST INCIDENCE (DAYS) |          ---                 ---                   |          729 (T)             729 (T)               |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |           (e)                 (e)                  |                             P=0.567                |
|INCIDENTAL TUMOR       |           (e)                 (e)                  |                             P=0.567                |
|LOGISTIC REGRESSION    |           (e)                 (e)                  |                             P=0.567                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                               (e)                  |                             P=0.691N               |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05078 TEST: 01                                                 PAGE   7
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYL CHLORIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          CONTROL             15000 PP              |          CONTROL             15000 PP              |
|                       |                              M                     |                              M                     |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroadenoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         1/50 (2%)           0/50 (0%)              |        11/50 (22%)          8/50 (16%)             |
|ADJUSTED (b)           |          2.0%                0.0%                  |         28.1%               27.1%                  |
|TERMINAL (d)           |         0/16 (0%)           0/8 (0%)               |         6/31 (19%)          3/22 (14%)             |
|FIRST INCIDENCE (DAYS) |          485                 ---                   |          545                 574                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.517N               |                             P=0.540N               |
|INCIDENTAL TUMOR       |                             P=0.557N               |                             P=0.263N               |
|LOGISTIC REGRESSION    |                             P=0.304N               |                             P=0.304N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.500N               |                             P=0.306N               |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma or Adenoma                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         1/50 (2%)           0/50 (0%)              |        13/50 (26%)          8/50 (16%)             |
|ADJUSTED (b)           |          2.0%                0.0%                  |         33.9%               27.1%                  |
|TERMINAL (d)           |         0/16 (0%)           0/8 (0%)               |         8/31 (26%)          3/22 (14%)             |
|FIRST INCIDENCE (DAYS) |          485                 ---                   |          545                 574                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.517N               |                             P=0.386N               |
|INCIDENTAL TUMOR       |                             P=0.557N               |                             P=0.154N               |
|LOGISTIC REGRESSION    |                             P=0.304N               |                             P=0.173N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.500N               |                             P=0.163N               |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05078 TEST: 01                                                 PAGE   8
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYL CHLORIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          CONTROL             15000 PP              |          CONTROL             15000 PP              |
|                       |                              M                     |                              M                     |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         1/50 (2%)           0/50 (0%)              |        13/50 (26%)          9/50 (18%)             |
|ADJUSTED (b)           |          2.0%                0.0%                  |         33.9%               31.0%                  |
|TERMINAL (d)           |         0/16 (0%)           0/8 (0%)               |         8/31 (26%)          4/22 (18%)             |
|FIRST INCIDENCE (DAYS) |          485                 ---                   |          545                 574                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.517N               |                             P=0.493N               |
|INCIDENTAL TUMOR       |                             P=0.557N               |                             P=0.236N               |
|LOGISTIC REGRESSION    |                             P=0.304N               |                             P=0.255N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.500N               |                             P=0.235N               |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip)                                                                           |
|     Papilloma Squamous or Papilloma                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         0/50 (0%)           0/50 (0%)              |         1/50 (2%)           2/50 (4%)              |
|ADJUSTED (b)           |          0.0%                0.0%                  |          2.9%                6.9%                  |
|TERMINAL (d)           |         0/16 (0%)           0/8 (0%)               |         0/31 (0%)           1/22 (5%)              |
|FIRST INCIDENCE (DAYS) |          ---                 ---                   |          688                 574                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |           (e)                 (e)                  |                             P=0.425                |
|INCIDENTAL TUMOR       |           (e)                 (e)                  |                             P=0.539                |
|LOGISTIC REGRESSION    |           (e)                 (e)                  |                             P=0.510                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                               (e)                  |                             P=0.500                |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05078 TEST: 01                                                 PAGE   9
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYL CHLORIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          CONTROL             15000 PP              |          CONTROL             15000 PP              |
|                       |                              M                     |                              M                     |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip)                                                                           |
|     Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         0/50 (0%)           0/50 (0%)              |         1/50 (2%)           2/50 (4%)              |
|ADJUSTED (b)           |          0.0%                0.0%                  |          2.9%                6.9%                  |
|TERMINAL (d)           |         0/16 (0%)           0/8 (0%)               |         0/31 (0%)           1/22 (5%)              |
|FIRST INCIDENCE (DAYS) |          ---                 ---                   |          688                 574                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |           (e)                 (e)                  |                             P=0.425                |
|INCIDENTAL TUMOR       |           (e)                 (e)                  |                             P=0.539                |
|LOGISTIC REGRESSION    |           (e)                 (e)                  |                             P=0.510                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                               (e)                  |                             P=0.500                |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |        31/49 (63%)         25/50 (50%)             |        26/49 (53%)         30/50 (60%)             |
|ADJUSTED (b)           |         83.3%               84.6%                  |         65.7%               77.2%                  |
|TERMINAL (d)           |        10/15 (67%)          5/8 (63%)              |        18/31 (58%)         14/22 (64%)             |
|FIRST INCIDENCE (DAYS) |          485                 519                   |          540                 490                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.457                |                             P=0.044 *              |
|INCIDENTAL TUMOR       |                             P=0.137N               |                             P=0.240                |
|LOGISTIC REGRESSION    |                             P=0.158N               |                             P=0.250                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.129N               |                             P=0.311                |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05078 TEST: 01                                                 PAGE  10
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYL CHLORIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          CONTROL             15000 PP              |          CONTROL             15000 PP              |
|                       |                              M                     |                              M                     |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         1/49 (2%)           0/50 (0%)              |         6/49 (12%)          3/50 (6%)              |
|ADJUSTED (b)           |          6.7%                0.0%                  |         14.8%               10.7%                  |
|TERMINAL (d)           |         1/15 (7%)           0/8 (0%)               |         1/31 (3%)           1/22 (5%)              |
|FIRST INCIDENCE (DAYS) |          729 (T)             ---                   |          545                 629                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.625N               |                             P=0.380N               |
|INCIDENTAL TUMOR       |                             P=0.625N               |                             P=0.143N               |
|LOGISTIC REGRESSION    |                             P=0.625N               |                             P=0.180N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.495N               |                             P=0.233N               |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |        32/49 (65%)         25/50 (50%)             |        32/49 (65%)         33/50 (66%)             |
|ADJUSTED (b)           |         86.7%               84.6%                  |         72.2%               81.4%                  |
|TERMINAL (d)           |        11/15 (73%)          5/8 (63%)              |        19/31 (61%)         15/22 (68%)             |
|FIRST INCIDENCE (DAYS) |          485                 519                   |          540                 490                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.498                |                             P=0.099                |
|INCIDENTAL TUMOR       |                             P=0.106N               |                             P=0.548                |
|LOGISTIC REGRESSION    |                             P=0.116N               |                             P=0.526                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.090N               |                             P=0.555                |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05078 TEST: 01                                                 PAGE  11
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYL CHLORIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          CONTROL             15000 PP              |          CONTROL             15000 PP              |
|                       |                              M                     |                              M                     |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Basal Cell Carcinoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         0/50 (0%)           3/50 (6%)              |         0/50 (0%)           1/50 (2%)              |
|ADJUSTED (b)           |          0.0%               25.6%                  |          0.0%                4.5%                  |
|TERMINAL (d)           |         0/16 (0%)           1/8 (13%)              |         0/31 (0%)           1/22 (5%)              |
|FIRST INCIDENCE (DAYS) |          ---                 678                   |          ---                 729 (T)               |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.055                |                             P=0.432                |
|INCIDENTAL TUMOR       |                             P=0.078                |                             P=0.432                |
|LOGISTIC REGRESSION    |                             P=0.083                |                             P=0.432                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.121                |                             P=0.500                |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Keratoacanthoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         4/50 (8%)           2/50 (4%)              |         0/50 (0%)           0/50 (0%)              |
|ADJUSTED (b)           |         19.5%               15.0%                  |          0.0%                0.0%                  |
|TERMINAL (d)           |         2/16 (13%)          0/8 (0%)               |         0/31 (0%)           0/22 (0%)              |
|FIRST INCIDENCE (DAYS) |          682                 678                   |          ---                 ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.531N               |           (e)                 (e)                  |
|INCIDENTAL TUMOR       |                             P=0.460N               |           (e)                 (e)                  |
|LOGISTIC REGRESSION    |                             P=0.423N               |           (e)                 (e)                  |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.339N               |                               (e)                  |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05078 TEST: 01                                                 PAGE  12
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYL CHLORIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          CONTROL             15000 PP              |          CONTROL             15000 PP              |
|                       |                              M                     |                              M                     |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Carcinoma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         0/50 (0%)           2/50 (4%)              |         0/50 (0%)           0/50 (0%)              |
|ADJUSTED (b)           |          0.0%                7.6%                  |          0.0%                0.0%                  |
|TERMINAL (d)           |         0/16 (0%)           0/8 (0%)               |         0/31 (0%)           0/22 (0%)              |
|FIRST INCIDENCE (DAYS) |          ---                 577                   |          ---                 ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.251                |           (e)                 (e)                  |
|INCIDENTAL TUMOR       |                             P=0.340                |           (e)                 (e)                  |
|LOGISTIC REGRESSION    |                             P=0.243                |           (e)                 (e)                  |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.247                |                               (e)                  |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Trichoepithelioma, Basal Cell Carcinoma, or Basal Cell Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         0/50 (0%)           4/50 (8%)              |         0/50 (0%)           1/50 (2%)              |
|ADJUSTED (b)           |          0.0%               31.8%                  |          0.0%                4.5%                  |
|TERMINAL (d)           |         0/16 (0%)           1/8 (13%)              |         0/31 (0%)           1/22 (5%)              |
|FIRST INCIDENCE (DAYS) |          ---                 678                   |          ---                 729 (T)               |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.023 *              |                             P=0.432                |
|INCIDENTAL TUMOR       |                             P=0.039 *              |                             P=0.432                |
|LOGISTIC REGRESSION    |                             P=0.036 *              |                             P=0.432                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.059                |                             P=0.500                |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05078 TEST: 01                                                 PAGE  13
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYL CHLORIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          CONTROL             15000 PP              |          CONTROL             15000 PP              |
|                       |                              M                     |                              M                     |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma,                                                                |
|     Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         4/50 (8%)           7/50 (14%)             |         0/50 (0%)           1/50 (2%)              |
|ADJUSTED (b)           |         19.5%               39.8%                  |          0.0%                4.5%                  |
|TERMINAL (d)           |         2/16 (13%)          1/8 (13%)              |         0/31 (0%)           1/22 (5%)              |
|FIRST INCIDENCE (DAYS) |          682                 577                   |          ---                 729 (T)               |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.122                |                             P=0.432                |
|INCIDENTAL TUMOR       |                             P=0.185                |                             P=0.432                |
|LOGISTIC REGRESSION    |                             P=0.183                |                             P=0.432                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.262                |                             P=0.500                |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         1/50 (2%)           2/50 (4%)              |         1/50 (2%)           1/50 (2%)              |
|ADJUSTED (b)           |          2.2%                5.2%                  |          3.2%                4.5%                  |
|TERMINAL (d)           |         0/16 (0%)           0/8 (0%)               |         1/31 (3%)           1/22 (5%)              |
|FIRST INCIDENCE (DAYS) |          526                 552                   |          729 (T)             729 (T)               |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.487                |                             P=0.684                |
|INCIDENTAL TUMOR       |                             P=0.698                |                             P=0.684                |
|LOGISTIC REGRESSION    |                             P=0.601                |                             P=0.684                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.500                |                             P=0.753N               |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05078 TEST: 01                                                 PAGE  14
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYL CHLORIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          CONTROL             15000 PP              |          CONTROL             15000 PP              |
|                       |                              M                     |                              M                     |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,                                                                                   |
|     Neurofibroma, or Fibroma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         1/50 (2%)           3/50 (6%)              |         1/50 (2%)           1/50 (2%)              |
|ADJUSTED (b)           |          2.2%                9.3%                  |          3.2%                4.5%                  |
|TERMINAL (d)           |         0/16 (0%)           0/8 (0%)               |         1/31 (3%)           1/22 (5%)              |
|FIRST INCIDENCE (DAYS) |          526                 552                   |          729 (T)             729 (T)               |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.288                |                             P=0.684                |
|INCIDENTAL TUMOR       |                             P=0.455                |                             P=0.684                |
|LOGISTIC REGRESSION    |                             P=0.366                |                             P=0.684                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.309                |                             P=0.753N               |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |        29/50 (58%)         25/50 (50%)             |                                                    |
|ADJUSTED (b)           |         89.5%               90.3%                  |                                                    |
|TERMINAL (d)           |        13/16 (81%)          6/8 (75%)              |                                                    |
|FIRST INCIDENCE (DAYS) |          500                 479                   |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.240                |                                                    |
|INCIDENTAL TUMOR       |                             P=0.449N               |                                                    |
|LOGISTIC REGRESSION    |                             P=0.417N               |                                                    |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.274N               |                                                    |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05078 TEST: 01                                                 PAGE  15
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYL CHLORIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          CONTROL             15000 PP              |          CONTROL             15000 PP              |
|                       |                              M                     |                              M                     |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         7/49 (14%)          1/47 (2%)              |         5/49 (10%)          2/48 (4%)              |
|ADJUSTED (b)           |         33.4%                6.7%                  |         16.1%                9.1%                  |
|TERMINAL (d)           |         4/16 (25%)          0/8 (0%)               |         5/31 (16%)          2/22 (9%)              |
|FIRST INCIDENCE (DAYS) |          587                 709                   |          729 (T)             729 (T)               |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.095N               |                             P=0.370N               |
|INCIDENTAL TUMOR       |                             P=0.060N               |                             P=0.370N               |
|LOGISTIC REGRESSION    |                             P=0.052N               |                             P=0.370N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.034N*              |                             P=0.226N               |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         2/49 (4%)           0/47 (0%)              |         3/49 (6%)           1/48 (2%)              |
|ADJUSTED (b)           |          9.0%                0.0%                  |          8.9%                3.1%                  |
|TERMINAL (d)           |         1/16 (6%)           0/8 (0%)               |         2/31 (6%)           0/22 (0%)              |
|FIRST INCIDENCE (DAYS) |          654                 ---                   |          659                 643                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.353N               |                             P=0.416N               |
|INCIDENTAL TUMOR       |                             P=0.321N               |                             P=0.305N               |
|LOGISTIC REGRESSION    |                             P=0.270N               |                             P=0.330N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.258N               |                             P=0.316N               |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05078 TEST: 01                                                 PAGE  16
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYL CHLORIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          CONTROL             15000 PP              |          CONTROL             15000 PP              |
|                       |                              M                     |                              M                     |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         9/49 (18%)          1/47 (2%)              |         8/49 (16%)          3/48 (6%)              |
|ADJUSTED (b)           |         40.8%                6.7%                  |         24.6%               11.9%                  |
|TERMINAL (d)           |         5/16 (31%)          0/8 (0%)               |         7/31 (23%)          2/22 (9%)              |
|FIRST INCIDENCE (DAYS) |          587                 709                   |          659                 643                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.044N*              |                             P=0.233N               |
|INCIDENTAL TUMOR       |                             P=0.023N*              |                             P=0.179N               |
|LOGISTIC REGRESSION    |                             P=0.017N*              |                             P=0.171N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.009N**             |                             P=0.106N               |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         2/49 (4%)           0/47 (0%)              |         2/49 (4%)           3/48 (6%)              |
|ADJUSTED (b)           |         12.5%                0.0%                  |          6.5%               12.7%                  |
|TERMINAL (d)           |         2/16 (13%)          0/8 (0%)               |         2/31 (6%)           2/22 (9%)              |
|FIRST INCIDENCE (DAYS) |          729 (T)             ---                   |          729 (T)             707                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.399N               |                             P=0.355                |
|INCIDENTAL TUMOR       |                             P=0.399N               |                             P=0.377                |
|LOGISTIC REGRESSION    |                             P=0.399N               |                             P=0.380                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.258N               |                             P=0.490                |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05078 TEST: 01                                                 PAGE  17
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYL CHLORIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          CONTROL             15000 PP              |          CONTROL             15000 PP              |
|                       |                              M                     |                              M                     |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         2/49 (4%)           0/47 (0%)              |         3/49 (6%)           3/48 (6%)              |
|ADJUSTED (b)           |         12.5%                0.0%                  |          8.7%               12.7%                  |
|TERMINAL (d)           |         2/16 (13%)          0/8 (0%)               |         2/31 (6%)           2/22 (9%)              |
|FIRST INCIDENCE (DAYS) |          729 (T)             ---                   |          643                 707                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.399N               |                             P=0.513                |
|INCIDENTAL TUMOR       |                             P=0.399N               |                             P=0.609                |
|LOGISTIC REGRESSION    |                             P=0.399N               |                             P=0.578                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.258N               |                             P=0.651                |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |         2/50 (4%)           7/50 (14%)             |
|ADJUSTED (b)           |                                                    |          5.2%               23.1%                  |
|TERMINAL (d)           |                                                    |         1/31 (3%)           3/22 (14%)             |
|FIRST INCIDENCE (DAYS) |                                                    |          540                 573                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |                             P=0.045 *              |
|INCIDENTAL TUMOR       |                                                    |                             P=0.118                |
|LOGISTIC REGRESSION    |                                                    |                             P=0.088                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                                                    |                             P=0.080                |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05078 TEST: 01                                                 PAGE  18
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYL CHLORIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          CONTROL             15000 PP              |          CONTROL             15000 PP              |
|                       |                              M                     |                              M                     |
|=================================================================================================================================|
|                                                                                                                                 |
|Zymbal's Gland                                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         1/50 (2%)           0/50 (0%)              |         0/50 (0%)           2/50 (4%)              |
|ADJUSTED (b)           |          2.1%                0.0%                  |          0.0%                6.3%                  |
|TERMINAL (d)           |         0/16 (0%)           0/8 (0%)               |         0/31 (0%)           0/22 (0%)              |
|FIRST INCIDENCE (DAYS) |          512                 ---                   |          ---                 622                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.508N               |                             P=0.197                |
|INCIDENTAL TUMOR       |                             P=0.557N               |                             P=0.314                |
|LOGISTIC REGRESSION    |                             P=0.373N               |                             P=0.247                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.500N               |                             P=0.247                |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Leukemia: Lymphocytic, Monocytic, Mononuclear,                                                                              |
|     or Undifferentiated                                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |        33/50 (66%)         36/50 (72%)             |        20/50 (40%)         26/50 (52%)             |
|ADJUSTED (b)           |         87.6%               96.9%                  |         48.1%               77.5%                  |
|TERMINAL (d)           |        12/16 (75%)          7/8 (88%)              |        10/31 (32%)         15/22 (68%)             |
|FIRST INCIDENCE (DAYS) |          517                 437                   |          574                 535                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.046 *              |                             P=0.025 *              |
|INCIDENTAL TUMOR       |                             P=0.310                |                             P=0.110                |
|LOGISTIC REGRESSION    |                             P=0.214                |                             P=0.090                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.333                |                             P=0.158                |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05078 TEST: 01                                                 PAGE  19
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYL CHLORIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          CONTROL             15000 PP              |          CONTROL             15000 PP              |
|                       |                              M                     |                              M                     |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Mesothelioma Benign, Malignant, NOS                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         3/50 (6%)           3/50 (6%)              |         0/50 (0%)           0/50 (0%)              |
|ADJUSTED (b)           |         15.3%               11.9%                  |          0.0%                0.0%                  |
|TERMINAL (d)           |         2/16 (13%)          0/8 (0%)               |         0/31 (0%)           0/22 (0%)              |
|FIRST INCIDENCE (DAYS) |          665                 577                   |          ---                 ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.509                |           (e)                 (e)                  |
|INCIDENTAL TUMOR       |                             P=0.632N               |           (e)                 (e)                  |
|LOGISTIC REGRESSION    |                             P=0.633                |           (e)                 (e)                  |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.661N               |                               (e)                  |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |        46/50 (92%)         44/50 (88%)             |        37/50 (74%)         38/50 (76%)             |
|ADJUSTED (b)           |         97.8%              100.0%                  |         85.6%               94.7%                  |
|TERMINAL (d)           |        15/16 (94%)          8/8 (100%)             |        25/31 (81%)         20/22 (91%)             |
|FIRST INCIDENCE (DAYS) |          485                 479                   |          540                 490                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.117                |                             P=0.048 *              |
|INCIDENTAL TUMOR       |                             P=0.317N               |                             P=0.344                |
|LOGISTIC REGRESSION    |                             P=0.558N               |                             P=0.348                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.370N               |                             P=0.500                |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05078 TEST: 01                                                 PAGE  20
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYL CHLORIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          CONTROL             15000 PP              |          CONTROL             15000 PP              |
|                       |                              M                     |                              M                     |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |        39/50 (78%)         40/50 (80%)             |        33/50 (66%)         36/50 (72%)             |
|ADJUSTED (b)           |         92.0%               97.3%                  |         68.7%               85.1%                  |
|TERMINAL (d)           |        13/16 (81%)          7/8 (88%)              |        16/31 (52%)         16/22 (73%)             |
|FIRST INCIDENCE (DAYS) |          512                 437                   |          251                 364                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.082                |                             P=0.063                |
|INCIDENTAL TUMOR       |                             P=0.547                |                             P=0.402                |
|LOGISTIC REGRESSION    |                             P=0.408                |                             P=0.388                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.500                |                             P=0.333                |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |        49/50 (98%)         48/50 (96%)             |        45/50 (90%)         49/50 (98%)             |
|ADJUSTED (b)           |        100.0%              100.0%                  |         90.0%              100.0%                  |
|TERMINAL (d)           |        16/16 (100%)         8/8 (100%)             |        26/31 (84%)         22/22 (100%)            |
|FIRST INCIDENCE (DAYS) |          485                 437                   |          251                 364                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.094                |                             P=0.017 *              |
|INCIDENTAL TUMOR       |                             P=0.574N               |                             P=0.142                |
|LOGISTIC REGRESSION    |                             P=0.616N               |                             P=0.127                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.500N               |                             P=0.102                |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05078 TEST: 01                                                 PAGE  21
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYL CHLORIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
 
 (a)  Number of tumor-bearing animals / number of animals examined at site.
 (b)  Kaplan-Meier estimated lifetime tumor incidence after adjustment for 
      intercurrent mortality.
 (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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