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TR 354 Mouse Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                                        DIMETHOXANE                                      DATE: 09/05/94       
EXPERIMENT: 05038 TEST: 02                                                                                     TIME: 09:14:02       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01CP9565302          ROUTE: GAVAGE                                                                      NTP C#: 56213        
PATHOLOGIST: J. TOFT                         S. EUSTIS                                                         CAS: 828-00-2        
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               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08    
LAB: Battelle Columbus                                        DIMETHOXANE                                      DATE: 09/05/94      
EXPERIMENT: 05038 TEST: 02                                                                                     TIME: 09:14:02      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01CP9565302          ROUTE: GAVAGE                                                                      NTP C#: 56213       
PATHOLOGIST: J. TOFT                         S. EUSTIS                                                         CAS: 828-00-2       
 
 
 
 
 
                                                    MICE(B6C3F1)
                                              ----------------------------
             FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
             IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
 
 
                                                    ----------------
 
                                                    Adrenal Gland
                                                    Bone Marrow
                                                    Brain
                                                    Epididymis
                                                    Gallbladder
                                                    Heart
                                                    Islets, Pancreatic
                                                    Kidney
                                                    Liver
                                                    Lung
                                                    Nose
                                                    Ovary
                                                    Pancreas
                                                    Parathyroid Gland
                                                    Pituitary Gland
                                                    Preputial Gland
                                                    Prostate
                                                    Salivary Glands
                                                    Spleen
                                                    Testes
                                                    Thymus
                                                    Thyroid Gland
                                                    Urinary Bladder
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                                        DIMETHOXANE                                      DATE: 09/05/94       
EXPERIMENT: 05038 TEST: 02                                                                                     TIME: 09:14:02       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01CP9565302          ROUTE: GAVAGE                                                                      NTP C#: 56213        
PATHOLOGIST: J. TOFT                         S. EUSTIS                                                         CAS: 828-00-2        
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                          IN THE ANALYSIS OF THE STUDY OF DIMETHOXANE
 
              ====================================================================================================
 
                                                           MALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Liver                         Hepatocellular Carcinoma or Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
                             Lung                          Alveolar/Bronchiolar Carcinoma
                             Stomach, Forestomach          Squamous Cell Carcinoma or Papilloma Squamous
                                                           Squamous Cell Papilloma
                             All Organs                    Malignant Lymphoma And Histiocytic Sarcoma
                                                           Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,
                                                            NOS, or Undifferentiated Cell Type
                                                           Benign Tumors
                                                           Malignant Tumors
 
              ====================================================================================================
 
                                                           FEMALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             All Organs                    Benign Tumors
 
              ====================================================================================================
         DATE: 09/05/94                     EXPERIMENT: 05038 TEST: 02                                                 PAGE   1
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- DIMETHOXANE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 MG/KG         250 MG/         500 MG/       |      0 MG/KG         250 MG/         500 MG/       |
|                       |                      KG              KG            |                      KG              KG            |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Cortex                                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     6/50 (12%)      0/21 (0%)       3/50 (6%)      |     0/50 (0%)       0/14 (0%)       1/50 (2%)      |
|ADJUSTED (b)           |     18.2%            0.0%           10.3%          |      0.0%            0.0%            2.9%          |
|TERMINAL (d)           |     6/33 (18%)      0/0             3/29 (10%)     |     0/36 (0%)       0/0             1/34 (3%)      |
|FIRST INCIDENCE (DAYS) |      731 (T)         ---             731 (T)       |      ---             ---             731 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.246N          (e)           P=0.306N       |     P=0.298           (e)           P=0.489        |
|INCIDENTAL TUMOR       |     P=0.246N          (e)           P=0.306N       |     P=0.298           (e)           P=0.489        |
|LOGISTIC REGRESSION    |     P=0.246N          (e)           P=0.306N       |     P=0.298           (e)           P=0.489        |
|COCHRAN-ARMITAGE       |     P=0.170N                                       |     P=0.296                                        |
|FISHER EXACT           |                     P=0.111N        P=0.243N       |                       (e)           P=0.500        |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       0/21 (0%)       0/50 (0%)      |     1/49 (2%)       0/14 (0%)       1/50 (2%)      |
|ADJUSTED (b)           |      6.1%            0.0%            0.0%          |      2.9%            0.0%            2.9%          |
|TERMINAL (d)           |     2/33 (6%)       0/0             0/29 (0%)      |     1/35 (3%)       0/0             1/34 (3%)      |
|FIRST INCIDENCE (DAYS) |      731 (T)         ---             ---           |      731 (T)         ---             731 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.164N          (e)           P=0.267N       |     P=0.631           (e)           P=0.755        |
|INCIDENTAL TUMOR       |     P=0.164N          (e)           P=0.267N       |     P=0.631           (e)           P=0.755        |
|LOGISTIC REGRESSION    |     P=0.164N          (e)           P=0.267N       |     P=0.631           (e)           P=0.755        |
|COCHRAN-ARMITAGE       |     P=0.120N                                       |     P=0.643N                                       |
|FISHER EXACT           |                     P=0.493N        P=0.247N       |                     P=0.778N        P=0.747N       |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05038 TEST: 02                                                 PAGE   2
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- DIMETHOXANE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 MG/KG         250 MG/         500 MG/       |      0 MG/KG         250 MG/         500 MG/       |
|                       |                      KG              KG            |                      KG              KG            |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       2/48 (4%)       2/50 (4%)      |     2/50 (4%)       0/49 (0%)       1/50 (2%)      |
|ADJUSTED (b)           |      6.1%            7.4%            6.0%          |      5.6%            0.0%            2.6%          |
|TERMINAL (d)           |     2/33 (6%)       2/27 (7%)       1/29 (3%)      |     2/36 (6%)       0/35 (0%)       0/34 (0%)      |
|FIRST INCIDENCE (DAYS) |      731 (T)         731 (T)         668           |      731 (T)         ---             680           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.555         P=0.622         P=0.659        |     P=0.374N        P=0.244N        P=0.516N       |
|INCIDENTAL TUMOR       |     P=0.571         P=0.622         P=0.679        |     P=0.277N        P=0.244N        P=0.394N       |
|LOGISTIC REGRESSION    |     P=0.561         P=0.622         P=0.670        |     P=0.367N        P=0.244N        P=0.508N       |
|COCHRAN-ARMITAGE       |     P=0.600                                        |     P=0.361N                                       |
|FISHER EXACT           |                     P=0.676         P=0.691N       |                     P=0.253N        P=0.500N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       2/48 (4%)       2/50 (4%)      |     2/50 (4%)       0/49 (0%)       2/50 (4%)      |
|ADJUSTED (b)           |      6.1%            7.4%            6.0%          |      5.6%            0.0%            5.5%          |
|TERMINAL (d)           |     2/33 (6%)       2/27 (7%)       1/29 (3%)      |     2/36 (6%)       0/35 (0%)       1/34 (3%)      |
|FIRST INCIDENCE (DAYS) |      731 (T)         731 (T)         668           |      731 (T)         ---             680           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.555         P=0.622         P=0.659        |     P=0.606         P=0.244N        P=0.676        |
|INCIDENTAL TUMOR       |     P=0.571         P=0.622         P=0.679        |     P=0.551N        P=0.244N        P=0.620N       |
|LOGISTIC REGRESSION    |     P=0.561         P=0.622         P=0.670        |     P=0.614         P=0.244N        P=0.686        |
|COCHRAN-ARMITAGE       |     P=0.600                                        |     P=0.621                                        |
|FISHER EXACT           |                     P=0.676         P=0.691N       |                     P=0.253N        P=0.691N       |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05038 TEST: 02                                                 PAGE   3
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- DIMETHOXANE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 MG/KG         250 MG/         500 MG/       |      0 MG/KG         250 MG/         500 MG/       |
|                       |                      KG              KG            |                      KG              KG            |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/49 (6%)       1/28 (4%)       2/50 (4%)      |     1/50 (2%)       0/19 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      7.8%           14.3%            6.5%          |      2.8%            0.0%            0.0%          |
|TERMINAL (d)           |     1/33 (3%)       1/7 (14%)       1/29 (3%)      |     1/36 (3%)       0/5 (0%)        0/34 (0%)      |
|FIRST INCIDENCE (DAYS) |      664             731 (T)         697           |      731 (T)         ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.455N        P=0.617N        P=0.543N       |     P=0.312N        P=0.876N        P=0.511N       |
|INCIDENTAL TUMOR       |     P=0.395N        P=0.634N        P=0.462N       |     P=0.312N        P=0.876N        P=0.511N       |
|LOGISTIC REGRESSION    |     P=0.436N        P=0.691N        P=0.513N       |     P=0.312N        P=0.876N        P=0.511N       |
|COCHRAN-ARMITAGE       |     P=0.398N                                       |     P=0.292N                                       |
|FISHER EXACT           |                     P=0.538N        P=0.490N       |                     P=0.725N        P=0.500N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     7/49 (14%)      5/28 (18%)     13/50 (26%)     |     7/50 (14%)      3/19 (16%)      4/50 (8%)      |
|ADJUSTED (b)           |     19.9%           34.3%           37.8%          |     19.4%           41.5%           11.2%          |
|TERMINAL (d)           |     6/33 (18%)      2/7 (29%)       9/29 (31%)     |     7/36 (19%)      2/5 (40%)       3/34 (9%)      |
|FIRST INCIDENCE (DAYS) |      530             446             550           |      731 (T)         680             680           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.056         P=0.183         P=0.069        |     P=0.256N        P=0.186         P=0.292N       |
|INCIDENTAL TUMOR       |     P=0.068         P=0.241         P=0.087        |     P=0.188N        P=0.219         P=0.236N       |
|LOGISTIC REGRESSION    |     P=0.075         P=0.327         P=0.094        |     P=0.243N        P=0.215         P=0.282N       |
|COCHRAN-ARMITAGE       |     P=0.090                                        |     P=0.219N                                       |
|FISHER EXACT           |                     P=0.456         P=0.115        |                     P=0.560         P=0.262N       |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05038 TEST: 02                                                 PAGE   4
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- DIMETHOXANE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 MG/KG         250 MG/         500 MG/       |      0 MG/KG         250 MG/         500 MG/       |
|                       |                      KG              KG            |                      KG              KG            |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     9/49 (18%)     10/28 (36%)      6/50 (12%)     |     2/50 (4%)       2/19 (11%)      1/50 (2%)      |
|ADJUSTED (b)           |     21.7%           63.8%           16.9%          |      4.8%           21.8%            2.9%          |
|TERMINAL (d)           |     4/33 (12%)      4/7 (57%)       3/29 (10%)     |     1/36 (3%)       1/5 (20%)       1/34 (3%)      |
|FIRST INCIDENCE (DAYS) |      509             448             423           |      462             617             731 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.353N        P=0.053         P=0.359N       |     P=0.416N        P=0.381         P=0.516N       |
|INCIDENTAL TUMOR       |     P=0.284N        P=0.089         P=0.290N       |     P=0.487N        P=0.251         P=0.513N       |
|LOGISTIC REGRESSION    |     P=0.226N        P=0.083         P=0.188N       |     P=0.381N        P=0.421         P=0.466N       |
|COCHRAN-ARMITAGE       |     P=0.248N                                       |     P=0.402N                                       |
|FISHER EXACT           |                     P=0.079         P=0.274N       |                     P=0.303         P=0.500N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    14/49 (29%)     12/28 (43%)     19/50 (38%)     |     8/50 (16%)      5/19 (26%)      4/50 (8%)      |
|ADJUSTED (b)           |     35.2%           76.4%           51.0%          |     21.1%           61.9%           11.2%          |
|TERMINAL (d)           |     9/33 (27%)      5/7 (71%)      12/29 (41%)     |     7/36 (19%)      3/5 (60%)       3/34 (9%)      |
|FIRST INCIDENCE (DAYS) |      509             446             423           |      462             617             680           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.116         P=0.042 *       P=0.137        |     P=0.190N        P=0.078         P=0.205N       |
|INCIDENTAL TUMOR       |     P=0.130         P=0.067         P=0.178        |     P=0.161N        P=0.057         P=0.160N       |
|LOGISTIC REGRESSION    |     P=0.180         P=0.113         P=0.231        |     P=0.170N        P=0.176         P=0.186N       |
|COCHRAN-ARMITAGE       |     P=0.192                                        |     P=0.159N                                       |
|FISHER EXACT           |                     P=0.153         P=0.217        |                     P=0.257         P=0.178N       |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05038 TEST: 02                                                 PAGE   5
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- DIMETHOXANE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 MG/KG         250 MG/         500 MG/       |      0 MG/KG         250 MG/         500 MG/       |
|                       |                      KG              KG            |                      KG              KG            |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    14/49 (29%)     12/28 (43%)     19/50 (38%)     |     8/50 (16%)      5/19 (26%)      4/50 (8%)      |
|ADJUSTED (b)           |     35.2%           76.4%           51.0%          |     21.1%           61.9%           11.2%          |
|TERMINAL (d)           |     9/33 (27%)      5/7 (71%)      12/29 (41%)     |     7/36 (19%)      3/5 (60%)       3/34 (9%)      |
|FIRST INCIDENCE (DAYS) |      509             446             423           |      462             617             680           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.116         P=0.042 *       P=0.137        |     P=0.190N        P=0.078         P=0.205N       |
|INCIDENTAL TUMOR       |     P=0.130         P=0.067         P=0.178        |     P=0.161N        P=0.057         P=0.160N       |
|LOGISTIC REGRESSION    |     P=0.180         P=0.113         P=0.231        |     P=0.170N        P=0.176         P=0.186N       |
|COCHRAN-ARMITAGE       |     P=0.192                                        |     P=0.159N                                       |
|FISHER EXACT           |                     P=0.153         P=0.217        |                     P=0.257         P=0.178N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     8/49 (16%)      2/25 (8%)       9/50 (18%)     |     3/50 (6%)       1/14 (7%)       4/50 (8%)      |
|ADJUSTED (b)           |     23.0%           27.3%           28.4%          |      8.3%            0.0%           11.8%          |
|TERMINAL (d)           |     7/33 (21%)      1/4 (25%)       7/29 (24%)     |     3/36 (8%)       0/0             4/34 (12%)     |
|FIRST INCIDENCE (DAYS) |      549             662             551           |      731 (T)         623             731 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.343         P=0.603         P=0.395        |     P=0.398         P=0.505         P=0.468        |
|INCIDENTAL TUMOR       |     P=0.394         P=0.646         P=0.458        |     P=0.344         P=0.473         P=0.468        |
|LOGISTIC REGRESSION    |     P=0.386         P=0.640N        P=0.450        |     P=0.408         P=0.580         P=0.468        |
|COCHRAN-ARMITAGE       |     P=0.461                                        |     P=0.422                                        |
|FISHER EXACT           |                     P=0.271N        P=0.518        |                     P=0.638         P=0.500        |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05038 TEST: 02                                                 PAGE   6
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- DIMETHOXANE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 MG/KG         250 MG/         500 MG/       |      0 MG/KG         250 MG/         500 MG/       |
|                       |                      KG              KG            |                      KG              KG            |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/49 (0%)       2/25 (8%)       4/50 (8%)      |     1/50 (2%)       0/14 (0%)       1/50 (2%)      |
|ADJUSTED (b)           |      0.0%           50.0%           10.6%          |      2.8%            0.0%            2.3%          |
|TERMINAL (d)           |     0/33 (0%)       2/4 (50%)       1/29 (3%)      |     1/36 (3%)       0/0             0/34 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             731 (T)         550           |      731 (T)         ---             634           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.046 *       P=0.002 **      P=0.060        |     P=0.648N          (e)           P=0.753N       |
|INCIDENTAL TUMOR       |     P=0.059         P=0.002 **      P=0.092        |     P=0.539           (e)           P=0.614        |
|LOGISTIC REGRESSION    |     P=0.051         P=0.002 **      P=0.076        |     P=0.647           (e)           P=0.761N       |
|COCHRAN-ARMITAGE       |     P=0.053                                        |     P=0.648N                                       |
|FISHER EXACT           |                     P=0.111         P=0.061        |                     P=0.781N        P=0.753N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     8/49 (16%)      4/25 (16%)     13/50 (26%)     |     4/50 (8%)       1/14 (7%)       5/50 (10%)     |
|ADJUSTED (b)           |     23.0%           75.8%           36.7%          |     11.1%            0.0%           13.8%          |
|TERMINAL (d)           |     7/33 (21%)      3/4 (75%)       8/29 (28%)     |     4/36 (11%)      0/0             4/34 (12%)     |
|FIRST INCIDENCE (DAYS) |      549             662             550           |      731 (T)         623             634           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.085         P=0.086         P=0.111        |     P=0.409         P=0.505         P=0.477        |
|INCIDENTAL TUMOR       |     P=0.116         P=0.103         P=0.161        |     P=0.307         P=0.473         P=0.384        |
|LOGISTIC REGRESSION    |     P=0.105         P=0.169         P=0.146        |     P=0.416         P=0.620         P=0.483        |
|COCHRAN-ARMITAGE       |     P=0.141                                        |     P=0.430                                        |
|FISHER EXACT           |                     P=0.625N        P=0.176        |                     P=0.701N        P=0.500        |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05038 TEST: 02                                                 PAGE   7
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- DIMETHOXANE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 MG/KG         250 MG/         500 MG/       |      0 MG/KG         250 MG/         500 MG/       |
|                       |                      KG              KG            |                      KG              KG            |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       0/48 (0%)       0/50 (0%)      |     1/50 (2%)       0/49 (0%)       2/50 (4%)      |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |      2.8%            0.0%            5.3%          |
|TERMINAL (d)           |     0/33 (0%)       0/27 (0%)       0/29 (0%)      |     1/36 (3%)       0/35 (0%)       1/34 (3%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      731 (T)         ---             653           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.358         P=0.506N        P=0.495        |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.447         P=0.506N        P=0.606        |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.356         P=0.506N        P=0.493        |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.361                                        |
|FISHER EXACT           |                       (e)             (e)          |                     P=0.505N        P=0.500        |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       0/48 (0%)       0/50 (0%)      |     1/50 (2%)       0/49 (0%)       3/50 (6%)      |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |      2.8%            0.0%            8.1%          |
|TERMINAL (d)           |     0/33 (0%)       0/27 (0%)       0/29 (0%)      |     1/36 (3%)       0/35 (0%)       2/34 (6%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      731 (T)         ---             653           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.172         P=0.506N        P=0.298        |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.225         P=0.506N        P=0.380        |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.171         P=0.506N        P=0.297        |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.177                                        |
|FISHER EXACT           |                       (e)             (e)          |                     P=0.505N        P=0.309        |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05038 TEST: 02                                                 PAGE   8
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- DIMETHOXANE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 MG/KG         250 MG/         500 MG/       |      0 MG/KG         250 MG/         500 MG/       |
|                       |                      KG              KG            |                      KG              KG            |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       0/48 (0%)       0/50 (0%)      |     1/50 (2%)       0/49 (0%)       3/50 (6%)      |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |      2.8%            0.0%            8.1%          |
|TERMINAL (d)           |     0/33 (0%)       0/27 (0%)       0/29 (0%)      |     1/36 (3%)       0/35 (0%)       2/34 (6%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      731 (T)         ---             653           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.172         P=0.506N        P=0.298        |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.225         P=0.506N        P=0.380        |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.171         P=0.506N        P=0.297        |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.177                                        |
|FISHER EXACT           |                       (e)             (e)          |                     P=0.505N        P=0.309        |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/46 (0%)       0/20 (0%)       0/41 (0%)      |     6/47 (13%)      4/19 (21%)      6/45 (13%)     |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |     16.8%           66.7%           17.0%          |
|TERMINAL (d)           |     0/33 (0%)       0/0             0/27 (0%)      |     5/34 (15%)      4/6 (67%)       5/34 (15%)     |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      629             731 (T)         688           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.557N        P=0.064         P=0.619N       |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.558         P=0.059         P=0.604        |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.539N        P=0.102         P=0.612N       |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.525                                        |
|FISHER EXACT           |                       (e)             (e)          |                     P=0.309         P=0.589        |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05038 TEST: 02                                                 PAGE   9
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- DIMETHOXANE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 MG/KG         250 MG/         500 MG/       |      0 MG/KG         250 MG/         500 MG/       |
|                       |                      KG              KG            |                      KG              KG            |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/46 (0%)       1/20 (5%)       0/41 (0%)      |     6/47 (13%)      4/19 (21%)      6/45 (13%)     |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |     16.8%           66.7%           17.0%          |
|TERMINAL (d)           |     0/33 (0%)       0/0             0/27 (0%)      |     5/34 (15%)      4/6 (67%)       5/34 (15%)     |
|FIRST INCIDENCE (DAYS) |      ---             509             ---           |      629             731 (T)         688           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.714         P=0.464           (e)          |     P=0.557N        P=0.064         P=0.619N       |
|INCIDENTAL TUMOR       |     P=0.708         P=0.545           (e)          |     P=0.558         P=0.059         P=0.604        |
|LOGISTIC REGRESSION    |     P=0.721N        P=0.507           (e)          |     P=0.539N        P=0.102         P=0.612N       |
|COCHRAN-ARMITAGE       |     P=0.693                                        |     P=0.525                                        |
|FISHER EXACT           |                     P=0.303           (e)          |                     P=0.309         P=0.589        |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       0/48 (0%)       4/50 (8%)      |     0/50 (0%)       0/49 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      6.1%            0.0%           13.1%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     2/33 (6%)       0/27 (0%)       3/29 (10%)     |     0/36 (0%)       0/35 (0%)       0/34 (0%)      |
|FIRST INCIDENCE (DAYS) |      731 (T)         ---             697           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.189         P=0.283N        P=0.281        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.208         P=0.283N        P=0.305        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.192         P=0.282N        P=0.284        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.223                                        |       (e)                                          |
|FISHER EXACT           |                     P=0.258N        P=0.339        |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05038 TEST: 02                                                 PAGE  10
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- DIMETHOXANE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 MG/KG         250 MG/         500 MG/       |      0 MG/KG         250 MG/         500 MG/       |
|                       |                      KG              KG            |                      KG              KG            |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibrosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    10/50 (20%)     10/48 (21%)      5/50 (10%)     |     1/50 (2%)       3/49 (6%)       2/50 (4%)      |
|ADJUSTED (b)           |     24.1%           29.2%           13.6%          |      2.2%            7.2%            5.5%          |
|TERMINAL (d)           |     3/33 (9%)       4/27 (15%)      1/29 (3%)      |     0/36 (0%)       1/35 (3%)       1/34 (3%)      |
|FIRST INCIDENCE (DAYS) |      519             551             549           |      596             601             680           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.185N        P=0.402         P=0.197N       |     P=0.398         P=0.322         P=0.488        |
|INCIDENTAL TUMOR       |     P=0.056N        P=0.469         P=0.071N       |     P=0.241         P=0.260         P=0.467        |
|LOGISTIC REGRESSION    |     P=0.063N        P=0.574         P=0.084N       |     P=0.424         P=0.295         P=0.512        |
|COCHRAN-ARMITAGE       |     P=0.115N                                       |     P=0.400                                        |
|FISHER EXACT           |                     P=0.558         P=0.131N       |                     P=0.301         P=0.500        |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,                                                                                   |
|     Neurofibroma, or Fibroma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    12/50 (24%)     10/48 (21%)      9/50 (18%)     |     1/50 (2%)       3/49 (6%)       2/50 (4%)      |
|ADJUSTED (b)           |     29.2%           29.2%           25.1%          |      2.2%            7.2%            5.5%          |
|TERMINAL (d)           |     5/33 (15%)      4/27 (15%)      4/29 (14%)     |     0/36 (0%)       1/35 (3%)       1/34 (3%)      |
|FIRST INCIDENCE (DAYS) |      519             551             549           |      596             601             680           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.374N        P=0.563         P=0.419N       |     P=0.398         P=0.322         P=0.488        |
|INCIDENTAL TUMOR       |     P=0.188N        P=0.550N        P=0.246N       |     P=0.241         P=0.260         P=0.467        |
|LOGISTIC REGRESSION    |     P=0.200N        P=0.459N        P=0.265N       |     P=0.424         P=0.295         P=0.512        |
|COCHRAN-ARMITAGE       |     P=0.269N                                       |     P=0.400                                        |
|FISHER EXACT           |                     P=0.447N        P=0.312N       |                     P=0.301         P=0.500        |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05038 TEST: 02                                                 PAGE  11
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- DIMETHOXANE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 MG/KG         250 MG/         500 MG/       |      0 MG/KG         250 MG/         500 MG/       |
|                       |                      KG              KG            |                      KG              KG            |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, or Sarcoma                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    10/50 (20%)     10/48 (21%)      6/50 (12%)     |     1/50 (2%)       3/49 (6%)       2/50 (4%)      |
|ADJUSTED (b)           |     24.1%           29.2%           16.1%          |      2.2%            7.2%            5.5%          |
|TERMINAL (d)           |     3/33 (9%)       4/27 (15%)      1/29 (3%)      |     0/36 (0%)       1/35 (3%)       1/34 (3%)      |
|FIRST INCIDENCE (DAYS) |      519             551             549           |      596             601             680           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.263N        P=0.402         P=0.287N       |     P=0.398         P=0.322         P=0.488        |
|INCIDENTAL TUMOR       |     P=0.093N        P=0.469         P=0.116N       |     P=0.241         P=0.260         P=0.467        |
|LOGISTIC REGRESSION    |     P=0.101N        P=0.574         P=0.132N       |     P=0.424         P=0.295         P=0.512        |
|COCHRAN-ARMITAGE       |     P=0.179N                                       |     P=0.400                                        |
|FISHER EXACT           |                     P=0.558         P=0.207N       |                     P=0.301         P=0.500        |
|=================================================================================================================================|
|                                                                                                                                 |
|Spleen                                                                                                                           |
|     Hemangioma                                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/49 (0%)       0/26 (0%)       2/50 (4%)      |     0/50 (0%)       0/23 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      0.0%            0.0%            6.9%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/33 (0%)       0/5 (0%)        2/29 (7%)      |     0/36 (0%)       0/9 (0%)        0/34 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             731 (T)       |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.115           (e)           P=0.210        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.115           (e)           P=0.210        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.115           (e)           P=0.210        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.117                                        |       (e)                                          |
|FISHER EXACT           |                       (e)           P=0.253        |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05038 TEST: 02                                                 PAGE  12
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- DIMETHOXANE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 MG/KG         250 MG/         500 MG/       |      0 MG/KG         250 MG/         500 MG/       |
|                       |                      KG              KG            |                      KG              KG            |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Squamous Cell Carcinoma or Papilloma Squamous                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       3/48 (6%)       8/50 (16%)     |     3/50 (6%)       3/49 (6%)       1/50 (2%)      |
|ADJUSTED (b)           |      5.1%           11.1%           20.5%          |      8.0%            8.6%            2.9%          |
|TERMINAL (d)           |     1/33 (3%)       3/27 (11%)      2/29 (7%)      |     2/36 (6%)       3/35 (9%)       1/34 (3%)      |
|FIRST INCIDENCE (DAYS) |      542             731 (T)         469           |      697             731 (T)         731 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.024 *       P=0.412         P=0.044 *      |     P=0.262N        P=0.647         P=0.332N       |
|INCIDENTAL TUMOR       |     P=0.028 *       P=0.447         P=0.055        |     P=0.203N        P=0.635N        P=0.230N       |
|LOGISTIC REGRESSION    |     P=0.026 *       P=0.438         P=0.054        |     P=0.251N        P=0.658         P=0.315N       |
|COCHRAN-ARMITAGE       |     P=0.026 *                                      |     P=0.239N                                       |
|FISHER EXACT           |                     P=0.480         P=0.046 *      |                     P=0.651         P=0.309N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       3/48 (6%)       7/50 (14%)     |     3/50 (6%)       3/49 (6%)       1/50 (2%)      |
|ADJUSTED (b)           |      5.1%           11.1%           18.7%          |      8.0%            8.6%            2.9%          |
|TERMINAL (d)           |     1/33 (3%)       3/27 (11%)      2/29 (7%)      |     2/36 (6%)       3/35 (9%)       1/34 (3%)      |
|FIRST INCIDENCE (DAYS) |      542             731 (T)         550           |      697             731 (T)         731 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.044 *       P=0.412         P=0.073        |     P=0.262N        P=0.647         P=0.332N       |
|INCIDENTAL TUMOR       |     P=0.058         P=0.447         P=0.104        |     P=0.203N        P=0.635N        P=0.230N       |
|LOGISTIC REGRESSION    |     P=0.048 *       P=0.438         P=0.086        |     P=0.251N        P=0.658         P=0.315N       |
|COCHRAN-ARMITAGE       |     P=0.050 *                                      |     P=0.239N                                       |
|FISHER EXACT           |                     P=0.480         P=0.080        |                     P=0.651         P=0.309N       |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05038 TEST: 02                                                 PAGE  13
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- DIMETHOXANE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 MG/KG         250 MG/         500 MG/       |      0 MG/KG         250 MG/         500 MG/       |
|                       |                      KG              KG            |                      KG              KG            |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |     3/50 (6%)       1/49 (2%)       0/50 (0%)      |
|ADJUSTED (b)           |                                                    |      7.9%            2.9%            0.0%          |
|TERMINAL (d)           |                                                    |     2/36 (6%)       1/35 (3%)       0/34 (0%)      |
|FIRST INCIDENCE (DAYS) |                                                    |      633             731 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.063N        P=0.310N        P=0.124N       |
|INCIDENTAL TUMOR       |                                                    |     P=0.090N        P=0.326N        P=0.203N       |
|LOGISTIC REGRESSION    |                                                    |     P=0.062N        P=0.310N        P=0.123N       |
|COCHRAN-ARMITAGE       |                                                    |     P=0.061N                                       |
|FISHER EXACT           |                                                    |                     P=0.316N        P=0.121N       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangioma                                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       0/48 (0%)       2/50 (4%)      |     0/50 (0%)       1/49 (2%)       0/50 (0%)      |
|ADJUSTED (b)           |      0.0%            0.0%            6.9%          |      0.0%            2.9%            0.0%          |
|TERMINAL (d)           |     0/33 (0%)       0/27 (0%)       2/29 (7%)      |     0/36 (0%)       1/35 (3%)       0/34 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             731 (T)       |      ---             731 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.087           (e)           P=0.210        |     P=0.722         P=0.494           (e)          |
|INCIDENTAL TUMOR       |     P=0.087           (e)           P=0.210        |     P=0.722         P=0.494           (e)          |
|LOGISTIC REGRESSION    |     P=0.087           (e)           P=0.210        |     P=0.722         P=0.494           (e)          |
|COCHRAN-ARMITAGE       |     P=0.097                                        |     P=0.730                                        |
|FISHER EXACT           |                       (e)           P=0.247        |                     P=0.495           (e)          |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05038 TEST: 02                                                 PAGE  14
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- DIMETHOXANE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 MG/KG         250 MG/         500 MG/       |      0 MG/KG         250 MG/         500 MG/       |
|                       |                      KG              KG            |                      KG              KG            |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     4/50 (8%)       3/48 (6%)       3/50 (6%)      |     3/50 (6%)       1/49 (2%)       0/50 (0%)      |
|ADJUSTED (b)           |     10.7%            9.8%            8.7%          |      7.7%            2.9%            0.0%          |
|TERMINAL (d)           |     2/33 (6%)       2/27 (7%)       1/29 (3%)      |     2/36 (6%)       1/35 (3%)       0/34 (0%)      |
|FIRST INCIDENCE (DAYS) |      664             549             623           |      596             731 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.470N        P=0.605N        P=0.546N       |     P=0.066N        P=0.310N        P=0.131N       |
|INCIDENTAL TUMOR       |     P=0.380N        P=0.575N        P=0.447N       |     P=0.090N        P=0.326N        P=0.203N       |
|LOGISTIC REGRESSION    |     P=0.435N        P=0.563N        P=0.513N       |     P=0.062N        P=0.312N        P=0.119N       |
|COCHRAN-ARMITAGE       |     P=0.421N                                       |     P=0.061N                                       |
|FISHER EXACT           |                     P=0.523N        P=0.500N       |                     P=0.316N        P=0.121N       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma or Hemangioma                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     4/50 (8%)       3/48 (6%)       5/50 (10%)     |     3/50 (6%)       2/49 (4%)       0/50 (0%)      |
|ADJUSTED (b)           |     10.7%            9.8%           15.3%          |      7.7%            5.7%            0.0%          |
|TERMINAL (d)           |     2/33 (6%)       2/27 (7%)       3/29 (10%)     |     2/36 (6%)       2/35 (6%)       0/34 (0%)      |
|FIRST INCIDENCE (DAYS) |      664             549             623           |      596             731 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.377         P=0.605N        P=0.442        |     P=0.090N        P=0.506N        P=0.131N       |
|INCIDENTAL TUMOR       |     P=0.455         P=0.575N        P=0.529        |     P=0.118N        P=0.522N        P=0.203N       |
|LOGISTIC REGRESSION    |     P=0.407         P=0.563N        P=0.475        |     P=0.084N        P=0.507N        P=0.119N       |
|COCHRAN-ARMITAGE       |     P=0.427                                        |     P=0.083N                                       |
|FISHER EXACT           |                     P=0.523N        P=0.500        |                     P=0.510N        P=0.121N       |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05038 TEST: 02                                                 PAGE  15
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- DIMETHOXANE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 MG/KG         250 MG/         500 MG/       |      0 MG/KG         250 MG/         500 MG/       |
|                       |                      KG              KG            |                      KG              KG            |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma And Histiocytic Sarcoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     9/50 (18%)      2/48 (4%)       3/50 (6%)      |    15/50 (30%)     12/49 (24%)     18/50 (36%)     |
|ADJUSTED (b)           |     24.2%            6.1%           10.3%          |     33.9%           29.0%           42.1%          |
|TERMINAL (d)           |     6/33 (18%)      1/27 (4%)       3/29 (10%)     |     8/36 (22%)      6/35 (17%)     10/34 (29%)     |
|FIRST INCIDENCE (DAYS) |      600             537             731 (T)       |      409             617             474           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.050N        P=0.063N        P=0.096N       |     P=0.277         P=0.358N        P=0.318        |
|INCIDENTAL TUMOR       |     P=0.036N*       P=0.036N*       P=0.064N       |     P=0.273         P=0.312N        P=0.198        |
|LOGISTIC REGRESSION    |     P=0.037N*       P=0.042N*       P=0.074N       |     P=0.246         P=0.355N        P=0.353        |
|COCHRAN-ARMITAGE       |     P=0.030N*                                      |     P=0.293                                        |
|FISHER EXACT           |                     P=0.030N*       P=0.061N       |                     P=0.349N        P=0.335        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,                                                                        |
|     NOS, or Undifferentiated Cell Type                                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     9/50 (18%)      2/48 (4%)       3/50 (6%)      |    14/50 (28%)     12/49 (24%)     18/50 (36%)     |
|ADJUSTED (b)           |     24.2%            6.1%           10.3%          |     32.5%           29.0%           42.1%          |
|TERMINAL (d)           |     6/33 (18%)      1/27 (4%)       3/29 (10%)     |     8/36 (22%)      6/35 (17%)     10/34 (29%)     |
|FIRST INCIDENCE (DAYS) |      600             537             731 (T)       |      574             617             474           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.050N        P=0.063N        P=0.096N       |     P=0.213         P=0.433N        P=0.252        |
|INCIDENTAL TUMOR       |     P=0.036N*       P=0.036N*       P=0.064N       |     P=0.197         P=0.352N        P=0.137        |
|LOGISTIC REGRESSION    |     P=0.037N*       P=0.042N*       P=0.074N       |     P=0.187         P=0.435N        P=0.221        |
|COCHRAN-ARMITAGE       |     P=0.030N*                                      |     P=0.221                                        |
|FISHER EXACT           |                     P=0.030N*       P=0.061N       |                     P=0.433N        P=0.260        |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05038 TEST: 02                                                 PAGE  16
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- DIMETHOXANE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 MG/KG         250 MG/         500 MG/       |      0 MG/KG         250 MG/         500 MG/       |
|                       |                      KG              KG            |                      KG              KG            |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    18/50 (36%)     13/48 (27%)     26/50 (52%)     |    20/50 (40%)     13/49 (27%)     17/50 (34%)     |
|ADJUSTED (b)           |     48.9%           40.5%           69.6%          |     51.1%           33.7%           47.1%          |
|TERMINAL (d)           |    15/33 (45%)      9/27 (33%)     18/29 (62%)     |    17/36 (47%)     10/35 (29%)     15/34 (44%)     |
|FIRST INCIDENCE (DAYS) |      530             446             550           |      629             623             680           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.030 *       P=0.413N        P=0.035 *      |     P=0.359N        P=0.119N        P=0.411N       |
|INCIDENTAL TUMOR       |     P=0.040 *       P=0.324N        P=0.049 *      |     P=0.297N        P=0.092N        P=0.380N       |
|LOGISTIC REGRESSION    |     P=0.041 *       P=0.336N        P=0.051        |     P=0.320N        P=0.047N*       P=0.366N       |
|COCHRAN-ARMITAGE       |     P=0.062                                        |     P=0.298N                                       |
|FISHER EXACT           |                     P=0.232N        P=0.079        |                     P=0.113N        P=0.339N       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    29/50 (58%)     26/48 (54%)     18/50 (36%)     |    18/50 (36%)     18/49 (37%)     22/50 (44%)     |
|ADJUSTED (b)           |     59.2%           64.5%           43.0%          |     39.0%           40.5%           49.1%          |
|TERMINAL (d)           |    13/33 (39%)     13/27 (48%)      7/29 (24%)     |     9/36 (25%)      9/35 (26%)     12/34 (35%)     |
|FIRST INCIDENCE (DAYS) |      509             448             423           |      409             454             282           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.106N        P=0.412         P=0.109N       |     P=0.234         P=0.556         P=0.264        |
|INCIDENTAL TUMOR       |     P=0.007N**      P=0.529N        P=0.008N**     |     P=0.181         P=0.485         P=0.163        |
|LOGISTIC REGRESSION    |     P=0.009N**      P=0.471N        P=0.008N**     |     P=0.188         P=0.501         P=0.234        |
|COCHRAN-ARMITAGE       |     P=0.018N*                                      |     P=0.236                                        |
|FISHER EXACT           |                     P=0.429N        P=0.022N*      |                     P=0.553         P=0.270        |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05038 TEST: 02                                                 PAGE  17
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- DIMETHOXANE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 MG/KG         250 MG/         500 MG/       |      0 MG/KG         250 MG/         500 MG/       |
|                       |                      KG              KG            |                      KG              KG            |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    38/50 (76%)     31/48 (65%)     37/50 (74%)     |    32/50 (64%)     26/49 (53%)     33/50 (66%)     |
|ADJUSTED (b)           |     77.6%           75.2%           83.8%          |     67.8%           57.6%           73.0%          |
|TERMINAL (d)           |    22/33 (67%)     17/27 (63%)     22/29 (76%)     |    21/36 (58%)     16/35 (46%)     22/34 (65%)     |
|FIRST INCIDENCE (DAYS) |      509             446             423           |      409             454             282           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.372         P=0.550N        P=0.394        |     P=0.389         P=0.234N        P=0.415        |
|INCIDENTAL TUMOR       |     P=0.483N        P=0.266N        P=0.512N       |     P=0.420         P=0.201N        P=0.362        |
|LOGISTIC REGRESSION    |     P=0.474N        P=0.207N        P=0.541N       |     P=0.471         P=0.189N        P=0.511        |
|COCHRAN-ARMITAGE       |     P=0.456N                                       |     P=0.459                                        |
|FISHER EXACT           |                     P=0.155N        P=0.500N       |                     P=0.184N        P=0.500        |
|=================================================================================================================================|
 
 (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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