National Toxicology Program

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TR 346 Mouse Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Northwest                                      ETHYL CHLORIDE                                    DATE: 09/10/94       
EXPERIMENT: 05078 TEST: 02                                                                                     TIME: 14:19:24       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01ES38061            ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                                             NTP C#: 06224        
PATHOLOGIST: R. BUSCH                                                                                          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: 02                                                                                     TIME: 14:19:24      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01ES38061            ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                                             NTP C#: 06224       
PATHOLOGIST: R. BUSCH                                                                                          CAS: 75-00-3        
 
 
 
 
 
                                                    MICE(B6C3F1)
                                              ----------------------------
             FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
             IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
 
 
                                                    ----------------
 
                                                    Adrenal Gland
                                                    Bone Marrow
                                                    Brain
                                                    Clitoral Gland
                                                    Epididymis
                                                    Gallbladder
                                                    Heart
                                                    Islets, Pancreatic
                                                    Kidney
                                                    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: 02                                                                                     TIME: 14:19:24       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01ES38061            ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                                             NTP C#: 06224        
PATHOLOGIST: R. BUSCH                                                                                          CAS: 75-00-3         
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                         IN THE ANALYSIS OF THE STUDY OF ETHYL CHLORIDE
 
              ====================================================================================================
 
                                                           MALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Harderian Gland               Adenoma
                             Lung                          Alveolar/Bronchiolar Adenoma
                                                           Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
                             All Organs                    Benign Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
 
                                                           FEMALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Liver                         Hepatocellular Carcinoma
                                                           Hepatocellular Carcinoma or Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
                             Lung                          Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
                             Pituitary Gland: Pars Distalis or Unspecified Site
                                                           Adenoma
                             Uterus                        Carcinoma
                             All Organs                    Malignant Lymphoma And Histiocytic Sarcoma
                                                           Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,
                                                            NOS, or Undifferentiated Cell Type
                                                           Benign Tumors
                                                           Malignant Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
         DATE: 09/10/94                     EXPERIMENT: 05078 TEST: 02                                                 PAGE   1
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ETHYL CHLORIDE
 
                                                 TERMINAL SACRIFICE AT 100 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          CONTROL             15000 PP              |          CONTROL             15000 PP              |
|                       |                              M                     |                              M                     |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma NOS                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         0/47 (0%)           0/47 (0%)              |         1/49 (2%)           2/47 (4%)              |
|ADJUSTED (b)           |          0.0%                0.0%                  |          3.1%                5.4%                  |
|TERMINAL (d)           |         0/27 (0%)           0/10 (0%)              |         1/32 (3%)           0/2 (0%)               |
|FIRST INCIDENCE (DAYS) |          ---                 ---                   |          700 (T)             581                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |           (e)                 (e)                  |                             P=0.231                |
|INCIDENTAL TUMOR       |           (e)                 (e)                  |                             P=0.823                |
|LOGISTIC REGRESSION    |           (e)                 (e)                  |                             P=0.499                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                               (e)                  |                             P=0.484                |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         2/50 (4%)           4/50 (8%)              |         2/49 (4%)           0/50 (0%)              |
|ADJUSTED (b)           |          7.1%               36.4%                  |          6.3%                0.0%                  |
|TERMINAL (d)           |         2/28 (7%)           4/11 (36%)             |         2/32 (6%)           0/2 (0%)               |
|FIRST INCIDENCE (DAYS) |          700 (T)             700 (T)               |          700 (T)             ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.039 *              |                             P=0.878N               |
|INCIDENTAL TUMOR       |                             P=0.039 *              |                             P=0.878N               |
|LOGISTIC REGRESSION    |                             P=0.039 *              |                             P=0.878N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.339                |                             P=0.242N               |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05078 TEST: 02                                                 PAGE   2
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ETHYL CHLORIDE
 
                                                 TERMINAL SACRIFICE AT 100 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          CONTROL             15000 PP              |          CONTROL             15000 PP              |
|                       |                              M                     |                              M                     |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         2/50 (4%)           0/50 (0%)              |         0/49 (0%)           2/50 (4%)              |
|ADJUSTED (b)           |          5.5%                0.0%                  |          0.0%                5.6%                  |
|TERMINAL (d)           |         1/28 (4%)           0/11 (0%)              |         0/32 (0%)           0/2 (0%)               |
|FIRST INCIDENCE (DAYS) |          409                 ---                   |          ---                 581                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.391N               |                             P=0.191                |
|INCIDENTAL TUMOR       |                             P=0.269N               |                             P=0.848                |
|LOGISTIC REGRESSION    |                             P=0.207N               |                             P=0.256                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.247N               |                             P=0.253                |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         4/50 (8%)           4/50 (8%)              |         2/49 (4%)           2/50 (4%)              |
|ADJUSTED (b)           |         12.5%               36.4%                  |          6.3%                5.6%                  |
|TERMINAL (d)           |         3/28 (11%)          4/11 (36%)             |         2/32 (6%)           0/2 (0%)               |
|FIRST INCIDENCE (DAYS) |          409                 700 (T)               |          700 (T)             581                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.174                |                             P=0.261                |
|INCIDENTAL TUMOR       |                             P=0.226                |                             P=0.841                |
|LOGISTIC REGRESSION    |                             P=0.264                |                             P=0.689                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.643N               |                             P=0.684N               |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05078 TEST: 02                                                 PAGE   3
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ETHYL CHLORIDE
 
                                                 TERMINAL SACRIFICE AT 100 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          CONTROL             15000 PP              |          CONTROL             15000 PP              |
|                       |                              M                     |                              M                     |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         6/50 (12%)          2/47 (4%)              |         0/49 (0%)           1/48 (2%)              |
|ADJUSTED (b)           |         18.7%               12.9%                  |          0.0%                2.9%                  |
|TERMINAL (d)           |         4/28 (14%)          1/11 (9%)              |         0/32 (0%)           0/2 (0%)               |
|FIRST INCIDENCE (DAYS) |          409                 519                   |          ---                 590                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.511N               |                             P=0.449                |
|INCIDENTAL TUMOR       |                             P=0.360N               |                             P=0.948                |
|LOGISTIC REGRESSION    |                             P=0.315N               |                             P=0.510                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.155N               |                             P=0.495                |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         9/50 (18%)          9/47 (19%)             |         3/49 (6%)           7/48 (15%)             |
|ADJUSTED (b)           |         22.6%               52.6%                  |          9.4%               47.7%                  |
|TERMINAL (d)           |         2/28 (7%)           5/11 (45%)             |         3/32 (9%)           0/2 (0%)               |
|FIRST INCIDENCE (DAYS) |          479                 357                   |          700 (T)             622                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.092                |                             P<0.001 **             |
|INCIDENTAL TUMOR       |                             P=0.489                |                             P=0.130                |
|LOGISTIC REGRESSION    |                             P=0.480                |                             P=0.025 *              |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.545                |                             P=0.150                |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05078 TEST: 02                                                 PAGE   4
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ETHYL CHLORIDE
 
                                                 TERMINAL SACRIFICE AT 100 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          CONTROL             15000 PP              |          CONTROL             15000 PP              |
|                       |                              M                     |                              M                     |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |        15/50 (30%)         10/47 (21%)             |         3/49 (6%)           8/48 (17%)             |
|ADJUSTED (b)           |         37.9%               54.6%                  |          9.4%               49.2%                  |
|TERMINAL (d)           |         6/28 (21%)          5/11 (45%)             |         3/32 (9%)           0/2 (0%)               |
|FIRST INCIDENCE (DAYS) |          409                 357                   |          700 (T)             590                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.267                |                             P<0.001 **             |
|INCIDENTAL TUMOR       |                             P=0.377N               |                             P=0.121                |
|LOGISTIC REGRESSION    |                             P=0.352N               |                             P=0.025 *              |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.227N               |                             P=0.093                |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |        15/50 (30%)         10/47 (21%)             |         3/49 (6%)           8/48 (17%)             |
|ADJUSTED (b)           |         37.9%               54.6%                  |          9.4%               49.2%                  |
|TERMINAL (d)           |         6/28 (21%)          5/11 (45%)             |         3/32 (9%)           0/2 (0%)               |
|FIRST INCIDENCE (DAYS) |          409                 357                   |          700 (T)             590                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.267                |                             P<0.001 **             |
|INCIDENTAL TUMOR       |                             P=0.377N               |                             P=0.121                |
|LOGISTIC REGRESSION    |                             P=0.352N               |                             P=0.025 *              |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.227N               |                             P=0.093                |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05078 TEST: 02                                                 PAGE   5
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ETHYL CHLORIDE
 
                                                 TERMINAL SACRIFICE AT 100 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          CONTROL             15000 PP              |          CONTROL             15000 PP              |
|                       |                              M                     |                              M                     |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         3/50 (6%)           8/48 (17%)             |         2/49 (4%)           2/50 (4%)              |
|ADJUSTED (b)           |         10.7%               43.5%                  |          6.3%               18.3%                  |
|TERMINAL (d)           |         3/28 (11%)          3/11 (27%)             |         2/32 (6%)           0/2 (0%)               |
|FIRST INCIDENCE (DAYS) |          700 (T)             409                   |          700 (T)             652                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.003 **             |                             P=0.078                |
|INCIDENTAL TUMOR       |                             P=0.020 *              |                             P=0.382                |
|LOGISTIC REGRESSION    |                             P=0.016 *              |                             P=0.354                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.087                |                             P=0.684N               |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         2/50 (4%)           2/48 (4%)              |         3/49 (6%)           2/50 (4%)              |
|ADJUSTED (b)           |          7.1%               16.1%                  |          8.9%               51.9%                  |
|TERMINAL (d)           |         2/28 (7%)           1/11 (9%)              |         2/32 (6%)           1/2 (50%)              |
|FIRST INCIDENCE (DAYS) |          700 (T)             671                   |          688                 622                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.349                |                             P=0.112                |
|INCIDENTAL TUMOR       |                             P=0.338                |                             P=0.607                |
|LOGISTIC REGRESSION    |                             P=0.358                |                             P=0.479                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.676                |                             P=0.490N               |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05078 TEST: 02                                                 PAGE   6
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ETHYL CHLORIDE
 
                                                 TERMINAL SACRIFICE AT 100 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          CONTROL             15000 PP              |          CONTROL             15000 PP              |
|                       |                              M                     |                              M                     |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         5/50 (10%)         10/48 (21%)             |         5/49 (10%)          4/50 (8%)              |
|ADJUSTED (b)           |         17.9%               54.4%                  |         15.0%               60.7%                  |
|TERMINAL (d)           |         5/28 (18%)          4/11 (36%)             |         4/32 (13%)          1/2 (50%)              |
|FIRST INCIDENCE (DAYS) |          700 (T)             409                   |          688                 622                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.002 **             |                             P=0.008 **             |
|INCIDENTAL TUMOR       |                             P=0.010 **             |                             P=0.291                |
|LOGISTIC REGRESSION    |                             P=0.008 **             |                             P=0.216                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.113                |                             P=0.487N               |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         0/50 (0%)           0/50 (0%)              |         2/49 (4%)           0/50 (0%)              |
|ADJUSTED (b)           |          0.0%                0.0%                  |          6.3%                0.0%                  |
|TERMINAL (d)           |         0/28 (0%)           0/11 (0%)              |         2/32 (6%)           0/2 (0%)               |
|FIRST INCIDENCE (DAYS) |          ---                 ---                   |          700 (T)             ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |           (e)                 (e)                  |                             P=0.878N               |
|INCIDENTAL TUMOR       |           (e)                 (e)                  |                             P=0.878N               |
|LOGISTIC REGRESSION    |           (e)                 (e)                  |                             P=0.878N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                               (e)                  |                             P=0.242N               |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05078 TEST: 02                                                 PAGE   7
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ETHYL CHLORIDE
 
                                                 TERMINAL SACRIFICE AT 100 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          CONTROL             15000 PP              |          CONTROL             15000 PP              |
|                       |                              M                     |                              M                     |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         0/47 (0%)           0/44 (0%)              |        11/49 (22%)          1/45 (2%)              |
|ADJUSTED (b)           |          0.0%                0.0%                  |         32.9%                7.1%                  |
|TERMINAL (d)           |         0/28 (0%)           0/10 (0%)              |        10/32 (31%)          0/2 (0%)               |
|FIRST INCIDENCE (DAYS) |          ---                 ---                   |          657                 653                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |           (e)                 (e)                  |                             P=0.707N               |
|INCIDENTAL TUMOR       |           (e)                 (e)                  |                             P=0.398N               |
|LOGISTIC REGRESSION    |           (e)                 (e)                  |                             P=0.250N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                               (e)                  |                             P=0.003N**             |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         0/50 (0%)           0/50 (0%)              |         0/49 (0%)           2/50 (4%)              |
|ADJUSTED (b)           |          0.0%                0.0%                  |          0.0%                7.2%                  |
|TERMINAL (d)           |         0/28 (0%)           0/11 (0%)              |         0/32 (0%)           0/2 (0%)               |
|FIRST INCIDENCE (DAYS) |          ---                 ---                   |          ---                 594                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |           (e)                 (e)                  |                             P=0.146                |
|INCIDENTAL TUMOR       |           (e)                 (e)                  |                             P=0.848                |
|LOGISTIC REGRESSION    |           (e)                 (e)                  |                             P=0.254                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                               (e)                  |                             P=0.253                |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05078 TEST: 02                                                 PAGE   8
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ETHYL CHLORIDE
 
                                                 TERMINAL SACRIFICE AT 100 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          CONTROL             15000 PP              |          CONTROL             15000 PP              |
|                       |                              M                     |                              M                     |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         0/49 (0%)           1/48 (2%)              |         0/48 (0%)           2/48 (4%)              |
|ADJUSTED (b)           |          0.0%                9.1%                  |          0.0%               19.8%                  |
|TERMINAL (d)           |         0/27 (0%)           1/11 (9%)              |         0/32 (0%)           0/2 (0%)               |
|FIRST INCIDENCE (DAYS) |          ---                 700 (T)               |          ---                 618                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.321                |                             P=0.051                |
|INCIDENTAL TUMOR       |                             P=0.321                |                             P=0.492                |
|LOGISTIC REGRESSION    |                             P=0.321                |                             P=0.204                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.495                |                             P=0.247                |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |         1/49 (2%)          43/50 (86%)             |
|ADJUSTED (b)           |                                                    |          2.2%              100.0%                  |
|TERMINAL (d)           |                                                    |         0/32 (0%)           2/2 (100%)             |
|FIRST INCIDENCE (DAYS) |                                                    |          500                 469                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |                             P<0.001 **             |
|INCIDENTAL TUMOR       |                                                    |                             P<0.001 **             |
|LOGISTIC REGRESSION    |                                                    |                             P<0.001 **             |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                                                    |                             P<0.001 **             |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05078 TEST: 02                                                 PAGE   9
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ETHYL CHLORIDE
 
                                                 TERMINAL SACRIFICE AT 100 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          CONTROL             15000 PP              |          CONTROL             15000 PP              |
|                       |                              M                     |                              M                     |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |         2/49 (4%)           1/50 (2%)              |
|ADJUSTED (b)           |                                                    |          5.4%                5.9%                  |
|TERMINAL (d)           |                                                    |         0/32 (0%)           0/2 (0%)               |
|FIRST INCIDENCE (DAYS) |                                                    |          668                 645                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |                             P=0.536                |
|INCIDENTAL TUMOR       |                                                    |                             P=0.389N               |
|LOGISTIC REGRESSION    |                                                    |                             P=0.667N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                                                    |                             P=0.492N               |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal or Polyp Stromal                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |         2/49 (4%)           1/50 (2%)              |
|ADJUSTED (b)           |                                                    |          5.4%                5.9%                  |
|TERMINAL (d)           |                                                    |         0/32 (0%)           0/2 (0%)               |
|FIRST INCIDENCE (DAYS) |                                                    |          668                 645                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |                             P=0.536                |
|INCIDENTAL TUMOR       |                                                    |                             P=0.389N               |
|LOGISTIC REGRESSION    |                                                    |                             P=0.667N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                                                    |                             P=0.492N               |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05078 TEST: 02                                                 PAGE  10
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ETHYL CHLORIDE
 
                                                 TERMINAL SACRIFICE AT 100 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          CONTROL             15000 PP              |          CONTROL             15000 PP              |
|                       |                              M                     |                              M                     |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         0/50 (0%)           2/50 (4%)              |         1/49 (2%)           0/50 (0%)              |
|ADJUSTED (b)           |          0.0%               15.2%                  |          3.1%                0.0%                  |
|TERMINAL (d)           |         0/28 (0%)           1/11 (9%)              |         1/32 (3%)           0/2 (0%)               |
|FIRST INCIDENCE (DAYS) |          ---                 610                   |          700 (T)             ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.076                |                             P=0.970N               |
|INCIDENTAL TUMOR       |                             P=0.130                |                             P=0.970N               |
|LOGISTIC REGRESSION    |                             P=0.108                |                             P=0.970N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.247                |                             P=0.495N               |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma or Hemangioma                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         0/50 (0%)           2/50 (4%)              |         1/49 (2%)           0/50 (0%)              |
|ADJUSTED (b)           |          0.0%               15.2%                  |          3.1%                0.0%                  |
|TERMINAL (d)           |         0/28 (0%)           1/11 (9%)              |         1/32 (3%)           0/2 (0%)               |
|FIRST INCIDENCE (DAYS) |          ---                 610                   |          700 (T)             ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.076                |                             P=0.970N               |
|INCIDENTAL TUMOR       |                             P=0.130                |                             P=0.970N               |
|LOGISTIC REGRESSION    |                             P=0.108                |                             P=0.970N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.247                |                             P=0.495N               |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05078 TEST: 02                                                 PAGE  11
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ETHYL CHLORIDE
 
                                                 TERMINAL SACRIFICE AT 100 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          CONTROL             15000 PP              |          CONTROL             15000 PP              |
|                       |                              M                     |                              M                     |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma And Histiocytic Sarcoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         1/50 (2%)           2/50 (4%)              |         4/49 (8%)          10/50 (20%)             |
|ADJUSTED (b)           |          2.7%               14.4%                  |         10.7%               65.8%                  |
|TERMINAL (d)           |         0/28 (0%)           1/11 (9%)              |         1/32 (3%)           1/2 (50%)              |
|FIRST INCIDENCE (DAYS) |          578                 587                   |          663                 486                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.233                |                             P<0.001 **             |
|INCIDENTAL TUMOR       |                             P=0.358                |                             P=0.344                |
|LOGISTIC REGRESSION    |                             P=0.362                |                             P=0.086                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.500                |                             P=0.080                |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,                                                                        |
|     NOS, or Undifferentiated Cell Type                                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         1/50 (2%)           2/50 (4%)              |         4/49 (8%)          10/50 (20%)             |
|ADJUSTED (b)           |          2.7%               14.4%                  |         10.7%               65.8%                  |
|TERMINAL (d)           |         0/28 (0%)           1/11 (9%)              |         1/32 (3%)           1/2 (50%)              |
|FIRST INCIDENCE (DAYS) |          578                 587                   |          663                 486                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.233                |                             P<0.001 **             |
|INCIDENTAL TUMOR       |                             P=0.358                |                             P=0.344                |
|LOGISTIC REGRESSION    |                             P=0.362                |                             P=0.086                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.500                |                             P=0.080                |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05078 TEST: 02                                                 PAGE  12
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ETHYL CHLORIDE
 
                                                 TERMINAL SACRIFICE AT 100 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          CONTROL             15000 PP              |          CONTROL             15000 PP              |
|                       |                              M                     |                              M                     |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |        12/50 (24%)         11/50 (22%)             |        15/49 (31%)          9/50 (18%)             |
|ADJUSTED (b)           |         39.1%               59.4%                  |         42.3%               48.4%                  |
|TERMINAL (d)           |        10/28 (36%)          5/11 (45%)             |        12/32 (38%)          0/2 (0%)               |
|FIRST INCIDENCE (DAYS) |          409                 409                   |          657                 590                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.035 *              |                             P=0.002 **             |
|INCIDENTAL TUMOR       |                             P=0.152                |                             P=0.624N               |
|LOGISTIC REGRESSION    |                             P=0.161                |                             P=0.620                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.500N               |                             P=0.109N               |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |        17/50 (34%)         13/50 (26%)             |        18/49 (37%)         47/50 (94%)             |
|ADJUSTED (b)           |         43.3%               67.3%                  |         42.1%              100.0%                  |
|TERMINAL (d)           |         8/28 (29%)          6/11 (55%)             |         8/32 (25%)          2/2 (100%)             |
|FIRST INCIDENCE (DAYS) |          409                 357                   |          132                 469                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.109                |                             P<0.001 **             |
|INCIDENTAL TUMOR       |                             P=0.578                |                             P<0.001 **             |
|LOGISTIC REGRESSION    |                             P=0.583N               |                             P<0.001 **             |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.257N               |                             P<0.001 **             |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05078 TEST: 02                                                 PAGE  13
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ETHYL CHLORIDE
 
                                                 TERMINAL SACRIFICE AT 100 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          CONTROL             15000 PP              |          CONTROL             15000 PP              |
|                       |                              M                     |                              M                     |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |        27/50 (54%)         20/50 (40%)             |        28/49 (57%)         47/50 (94%)             |
|ADJUSTED (b)           |         67.8%               84.5%                  |         63.3%              100.0%                  |
|TERMINAL (d)           |        16/28 (57%)          8/11 (73%)             |        16/32 (50%)          2/2 (100%)             |
|FIRST INCIDENCE (DAYS) |          409                 357                   |          132                 469                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.042 *              |                             P<0.001 **             |
|INCIDENTAL TUMOR       |                             P=0.519                |                             P=0.016 *              |
|LOGISTIC REGRESSION    |                             P=0.574                |                             P<0.001 **             |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.115N               |                             P<0.001 **             |
|=================================================================================================================================|
 
 (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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