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TR 354 Rat Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                                        DIMETHOXANE                                      DATE: 09/05/94       
EXPERIMENT: 05038 TEST: 01                                                                                     TIME: 07:44:49       
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        
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               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: 01                                                                                     TIME: 07:44:49      
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       
 
 
 
 
 
                                                    RATS(FISCHER344)
                                              ----------------------------
             FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
             IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
 
 
                                                    ----------------
 
                                                    Adrenal Gland
                                                    Bone Marrow
                                                    Brain
                                                    Clitoral Gland
                                                    Epididymis
                                                    Heart
                                                    Islets, Pancreatic
                                                    Kidney
                                                    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: 01                                                                                     TIME: 07:44:49       
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 RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Thyroid Gland: Follicular Cell
                                                           Carcinoma or Adenoma
                             All Organs                    Leukemia: Lymphocytic, Monocytic, Mononuclear,
                                                            or Undifferentiated
 
              ====================================================================================================
 
                                                           FEMALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             All Organs                    Benign Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
         DATE: 09/05/94                     EXPERIMENT: 05038 TEST: 01                                                 PAGE   1
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIMETHOXANE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 MG/KG         62.5 MG/        125 MG/       |      0 MG/KG         125 MG/         250 MG/       |
|                       |                      KG              KG            |                      KG              KG            |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Cortex                                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       1/50 (2%)       0/49 (0%)      |     1/50 (2%)       1/50 (2%)       2/50 (4%)      |
|ADJUSTED (b)           |      0.0%            3.6%            0.0%          |      3.3%            3.2%            8.3%          |
|TERMINAL (d)           |     0/23 (0%)       1/28 (4%)       0/21 (0%)      |     1/30 (3%)       1/31 (3%)       2/24 (8%)      |
|FIRST INCIDENCE (DAYS) |      ---             730 (T)         ---           |      730 (T)         730 (T)         730 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.727         P=0.539           (e)          |     P=0.308         P=0.755N        P=0.422        |
|INCIDENTAL TUMOR       |     P=0.727         P=0.539           (e)          |     P=0.308         P=0.755N        P=0.422        |
|LOGISTIC REGRESSION    |     P=0.727         P=0.539           (e)          |     P=0.308         P=0.755N        P=0.422        |
|COCHRAN-ARMITAGE       |     P=0.728                                        |     P=0.378                                        |
|FISHER EXACT           |                     P=0.500           (e)          |                     P=0.753N        P=0.500        |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     5/50 (10%)     10/50 (20%)      4/50 (8%)      |     2/50 (4%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |     17.3%           30.8%           17.1%          |      6.5%            0.0%            0.0%          |
|TERMINAL (d)           |     3/23 (13%)      7/28 (25%)      3/21 (14%)     |     1/30 (3%)       0/31 (0%)       0/24 (0%)      |
|FIRST INCIDENCE (DAYS) |      571             563             634           |      723             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.539N        P=0.201         P=0.593N       |     P=0.113N        P=0.226N        P=0.294N       |
|INCIDENTAL TUMOR       |     P=0.336N        P=0.114         P=0.385N       |     P=0.089N        P=0.186N        P=0.243N       |
|LOGISTIC REGRESSION    |     P=0.533N        P=0.127         P=0.582N       |     P=0.106N        P=0.213N        P=0.286N       |
|COCHRAN-ARMITAGE       |     P=0.440N                                       |     P=0.095N                                       |
|FISHER EXACT           |                     P=0.131         P=0.500N       |                     P=0.247N        P=0.247N       |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05038 TEST: 01                                                 PAGE   2
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIMETHOXANE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 MG/KG         62.5 MG/        125 MG/       |      0 MG/KG         125 MG/         250 MG/       |
|                       |                      KG              KG            |                      KG              KG            |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/48 (0%)       2/47 (4%)       2/49 (4%)      |     1/47 (2%)       0/46 (0%)       0/48 (0%)      |
|ADJUSTED (b)           |      0.0%            6.2%            4.7%          |      2.6%            0.0%            0.0%          |
|TERMINAL (d)           |     0/21 (0%)       1/27 (4%)       0/21 (0%)      |     0/27 (0%)       0/29 (0%)       0/22 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             641             515           |      625             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.152         P=0.264         P=0.224        |     P=0.296N        P=0.500N        P=0.546N       |
|INCIDENTAL TUMOR       |     P=0.288         P=0.213         P=0.320        |     P=0.312N        P=0.718N        P=0.523N       |
|LOGISTIC REGRESSION    |     P=0.203         P=0.231         P=0.308        |     P=0.260N        P=0.515N        P=0.492N       |
|COCHRAN-ARMITAGE       |     P=0.182                                        |     P=0.268N                                       |
|FISHER EXACT           |                     P=0.242         P=0.253        |                     P=0.505N        P=0.495N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/48 (0%)       2/47 (4%)       2/49 (4%)      |     1/47 (2%)       0/46 (0%)       0/48 (0%)      |
|ADJUSTED (b)           |      0.0%            6.2%            4.7%          |      2.6%            0.0%            0.0%          |
|TERMINAL (d)           |     0/21 (0%)       1/27 (4%)       0/21 (0%)      |     0/27 (0%)       0/29 (0%)       0/22 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             641             515           |      625             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.152         P=0.264         P=0.224        |     P=0.296N        P=0.500N        P=0.546N       |
|INCIDENTAL TUMOR       |     P=0.288         P=0.213         P=0.320        |     P=0.312N        P=0.718N        P=0.523N       |
|LOGISTIC REGRESSION    |     P=0.203         P=0.231         P=0.308        |     P=0.260N        P=0.515N        P=0.492N       |
|COCHRAN-ARMITAGE       |     P=0.182                                        |     P=0.268N                                       |
|FISHER EXACT           |                     P=0.242         P=0.253        |                     P=0.505N        P=0.495N       |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05038 TEST: 01                                                 PAGE   3
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIMETHOXANE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 MG/KG         62.5 MG/        125 MG/       |      0 MG/KG         125 MG/         250 MG/       |
|                       |                      KG              KG            |                      KG              KG            |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/49 (6%)       1/50 (2%)       0/50 (0%)      |     0/50 (0%)       0/50 (0%)       1/50 (2%)      |
|ADJUSTED (b)           |     11.9%            3.4%            0.0%          |      0.0%            0.0%            4.2%          |
|TERMINAL (d)           |     1/22 (5%)       0/28 (0%)       0/21 (0%)      |     0/30 (0%)       0/31 (0%)       1/24 (4%)      |
|FIRST INCIDENCE (DAYS) |      726             724             ---           |      ---             ---             730 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.072N        P=0.265N        P=0.152N       |     P=0.236           (e)           P=0.455        |
|INCIDENTAL TUMOR       |     P=0.138N        P=0.402N        P=0.232N       |     P=0.236           (e)           P=0.455        |
|LOGISTIC REGRESSION    |     P=0.070N        P=0.253N        P=0.156N       |     P=0.236           (e)           P=0.455        |
|COCHRAN-ARMITAGE       |     P=0.058N                                       |     P=0.269                                        |
|FISHER EXACT           |                     P=0.301N        P=0.117N       |                       (e)           P=0.500        |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/49 (6%)       1/50 (2%)       1/50 (2%)      |     0/50 (0%)       0/50 (0%)       1/50 (2%)      |
|ADJUSTED (b)           |     11.9%            3.4%            3.4%          |      0.0%            0.0%            4.2%          |
|TERMINAL (d)           |     1/22 (5%)       0/28 (0%)       0/21 (0%)      |     0/30 (0%)       0/31 (0%)       1/24 (4%)      |
|FIRST INCIDENCE (DAYS) |      726             724             635           |      ---             ---             730 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.248N        P=0.265N        P=0.378N       |     P=0.236           (e)           P=0.455        |
|INCIDENTAL TUMOR       |     P=0.292N        P=0.402N        P=0.386N       |     P=0.236           (e)           P=0.455        |
|LOGISTIC REGRESSION    |     P=0.235N        P=0.253N        P=0.360N       |     P=0.236           (e)           P=0.455        |
|COCHRAN-ARMITAGE       |     P=0.196N                                       |     P=0.269                                        |
|FISHER EXACT           |                     P=0.301N        P=0.301N       |                       (e)           P=0.500        |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05038 TEST: 01                                                 PAGE   4
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIMETHOXANE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 MG/KG         62.5 MG/        125 MG/       |      0 MG/KG         125 MG/         250 MG/       |
|                       |                      KG              KG            |                      KG              KG            |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       0/50 (0%)       0/50 (0%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      8.7%            0.0%            0.0%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     2/23 (9%)       0/28 (0%)       0/21 (0%)      |     0/30 (0%)       0/31 (0%)       0/24 (0%)      |
|FIRST INCIDENCE (DAYS) |      730 (T)         ---             ---           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.094N        P=0.195N        P=0.257N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.094N        P=0.195N        P=0.257N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.094N        P=0.195N        P=0.257N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.095N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.247N        P=0.247N       |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       0/50 (0%)       1/50 (2%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      8.7%            0.0%            4.8%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     2/23 (9%)       0/28 (0%)       1/21 (5%)      |     0/30 (0%)       0/31 (0%)       0/24 (0%)      |
|FIRST INCIDENCE (DAYS) |      730 (T)         ---             730 (T)       |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.377N        P=0.195N        P=0.532N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.377N        P=0.195N        P=0.532N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.377N        P=0.195N        P=0.532N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.360N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.247N        P=0.500N       |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05038 TEST: 01                                                 PAGE   5
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIMETHOXANE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 MG/KG         62.5 MG/        125 MG/       |      0 MG/KG         125 MG/         250 MG/       |
|                       |                      KG              KG            |                      KG              KG            |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |     2/50 (4%)       0/50 (0%)       1/50 (2%)      |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |      6.7%            0.0%            3.0%          |
|TERMINAL (d)           |     0/23 (0%)       0/28 (0%)       0/21 (0%)      |     2/30 (7%)       0/31 (0%)       0/24 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      730 (T)         ---             604           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.412N        P=0.231N        P=0.571N       |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.415N        P=0.231N        P=0.565N       |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.383N        P=0.231N        P=0.539N       |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.360N                                       |
|FISHER EXACT           |                       (e)             (e)          |                     P=0.247N        P=0.500N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroadenoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       1/50 (2%)       2/50 (4%)      |    14/50 (28%)     11/50 (22%)     13/50 (26%)     |
|ADJUSTED (b)           |      4.3%            3.2%            4.7%          |     38.9%           29.5%           45.6%          |
|TERMINAL (d)           |     1/23 (4%)       0/28 (0%)       0/21 (0%)      |     9/30 (30%)      6/31 (19%)      9/24 (38%)     |
|FIRST INCIDENCE (DAYS) |      730 (T)         722             493           |      449             533             607           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.342         P=0.718N        P=0.470        |     P=0.406         P=0.286N        P=0.422        |
|INCIDENTAL TUMOR       |     P=0.391         P=0.736         P=0.599        |     P=0.524         P=0.283N        P=0.537        |
|LOGISTIC REGRESSION    |     P=0.406         P=0.741N        P=0.569        |     P=0.507         P=0.291N        P=0.520        |
|COCHRAN-ARMITAGE       |     P=0.378                                        |     P=0.454N                                       |
|FISHER EXACT           |                     P=0.753N        P=0.500        |                     P=0.322N        P=0.500N       |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05038 TEST: 01                                                 PAGE   6
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIMETHOXANE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 MG/KG         62.5 MG/        125 MG/       |      0 MG/KG         125 MG/         250 MG/       |
|                       |                      KG              KG            |                      KG              KG            |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma or Adenoma                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       1/50 (2%)       2/50 (4%)      |    16/50 (32%)     11/50 (22%)     14/50 (28%)     |
|ADJUSTED (b)           |      4.3%            3.2%            4.7%          |     44.7%           29.5%           47.3%          |
|TERMINAL (d)           |     1/23 (4%)       0/28 (0%)       0/21 (0%)      |    11/30 (37%)      6/31 (19%)      9/24 (38%)     |
|FIRST INCIDENCE (DAYS) |      730 (T)         722             493           |      449             533             604           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.342         P=0.718N        P=0.470        |     P=0.478         P=0.163N        P=0.483        |
|INCIDENTAL TUMOR       |     P=0.391         P=0.736         P=0.599        |     P=0.494N        P=0.153N        P=0.578N       |
|LOGISTIC REGRESSION    |     P=0.406         P=0.741N        P=0.569        |     P=0.502N        P=0.155N        P=0.586N       |
|COCHRAN-ARMITAGE       |     P=0.378                                        |     P=0.368N                                       |
|FISHER EXACT           |                     P=0.753N        P=0.500        |                     P=0.184N        P=0.414N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       1/50 (2%)       2/50 (4%)      |    16/50 (32%)     11/50 (22%)     14/50 (28%)     |
|ADJUSTED (b)           |      4.3%            3.2%            4.7%          |     44.7%           29.5%           47.3%          |
|TERMINAL (d)           |     1/23 (4%)       0/28 (0%)       0/21 (0%)      |    11/30 (37%)      6/31 (19%)      9/24 (38%)     |
|FIRST INCIDENCE (DAYS) |      730 (T)         722             493           |      449             533             604           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.342         P=0.718N        P=0.470        |     P=0.478         P=0.163N        P=0.483        |
|INCIDENTAL TUMOR       |     P=0.391         P=0.736         P=0.599        |     P=0.494N        P=0.153N        P=0.578N       |
|LOGISTIC REGRESSION    |     P=0.406         P=0.741N        P=0.569        |     P=0.502N        P=0.155N        P=0.586N       |
|COCHRAN-ARMITAGE       |     P=0.378                                        |     P=0.368N                                       |
|FISHER EXACT           |                     P=0.753N        P=0.500        |                     P=0.184N        P=0.414N       |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05038 TEST: 01                                                 PAGE   7
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIMETHOXANE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 MG/KG         62.5 MG/        125 MG/       |      0 MG/KG         125 MG/         250 MG/       |
|                       |                      KG              KG            |                      KG              KG            |
|=================================================================================================================================|
|                                                                                                                                 |
|Parathyroid Gland                                                                                                                |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/49 (4%)       0/46 (0%)       0/47 (0%)      |     0/46 (0%)       0/43 (0%)       0/42 (0%)      |
|ADJUSTED (b)           |      8.1%            0.0%            0.0%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     1/22 (5%)       0/26 (0%)       0/18 (0%)      |     0/27 (0%)       0/26 (0%)       0/20 (0%)      |
|FIRST INCIDENCE (DAYS) |      718             ---             ---           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.107N        P=0.207N        P=0.291N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.150N        P=0.279N        P=0.356N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.119N        P=0.225N        P=0.317N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.101N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.263N        P=0.258N       |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    13/49 (27%)      7/50 (14%)     11/49 (22%)     |    13/48 (27%)     13/49 (27%)      7/50 (14%)     |
|ADJUSTED (b)           |     35.7%           21.5%           36.0%          |     36.2%           38.6%           23.6%          |
|TERMINAL (d)           |     3/23 (13%)      4/28 (14%)      5/21 (24%)     |     8/30 (27%)     10/30 (33%)      3/24 (13%)     |
|FIRST INCIDENCE (DAYS) |      349             674             371           |      580             599             567           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.494N        P=0.080N        P=0.561N       |     P=0.221N        P=0.560N        P=0.249N       |
|INCIDENTAL TUMOR       |     P=0.453N        P=0.174N        P=0.461N       |     P=0.161N        P=0.493         P=0.163N       |
|LOGISTIC REGRESSION    |     P=0.356N        P=0.097N        P=0.363N       |     P=0.144N        P=0.549N        P=0.151N       |
|COCHRAN-ARMITAGE       |     P=0.355N                                       |     P=0.075N                                       |
|FISHER EXACT           |                     P=0.096N        P=0.407N       |                     P=0.566N        P=0.087N       |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05038 TEST: 01                                                 PAGE   8
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIMETHOXANE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 MG/KG         62.5 MG/        125 MG/       |      0 MG/KG         125 MG/         250 MG/       |
|                       |                      KG              KG            |                      KG              KG            |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Keratoacanthoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       3/50 (6%)       2/50 (4%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      2.8%           10.3%            7.3%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/23 (0%)       2/28 (7%)       0/21 (0%)      |     0/30 (0%)       0/31 (0%)       0/24 (0%)      |
|FIRST INCIDENCE (DAYS) |      656             724             598           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.326         P=0.355         P=0.409        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.286         P=0.261         P=0.390        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.359         P=0.311         P=0.508        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.399                                        |       (e)                                          |
|FISHER EXACT           |                     P=0.309         P=0.500        |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       2/50 (4%)       0/50 (0%)      |     0/50 (0%)       1/50 (2%)       0/50 (0%)      |
|ADJUSTED (b)           |      4.3%            5.7%            0.0%          |      0.0%            2.3%            0.0%          |
|TERMINAL (d)           |     1/23 (4%)       0/28 (0%)       0/21 (0%)      |     0/30 (0%)       0/31 (0%)       0/24 (0%)      |
|FIRST INCIDENCE (DAYS) |      730 (T)         674             ---           |      ---             541             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.408N        P=0.554         P=0.518N       |     P=0.716         P=0.500           (e)          |
|INCIDENTAL TUMOR       |     P=0.524N        P=0.420         P=0.518N       |     P=0.669N        P=0.612           (e)          |
|LOGISTIC REGRESSION    |     P=0.396N        P=0.500         P=0.518N       |     P=0.697N        P=0.473           (e)          |
|COCHRAN-ARMITAGE       |     P=0.360N                                       |     P=0.731                                        |
|FISHER EXACT           |                     P=0.500         P=0.500N       |                     P=0.500           (e)          |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05038 TEST: 01                                                 PAGE   9
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIMETHOXANE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 MG/KG         62.5 MG/        125 MG/       |      0 MG/KG         125 MG/         250 MG/       |
|                       |                      KG              KG            |                      KG              KG            |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma,                                                                |
|     Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       5/50 (10%)      2/50 (4%)      |     0/50 (0%)       1/50 (2%)       1/50 (2%)      |
|ADJUSTED (b)           |      7.0%           15.4%            7.3%          |      0.0%            2.3%            3.4%          |
|TERMINAL (d)           |     1/23 (4%)       2/28 (7%)       0/21 (0%)      |     0/30 (0%)       0/31 (0%)       0/24 (0%)      |
|FIRST INCIDENCE (DAYS) |      656             674             598           |      ---             541             668           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.491         P=0.283         P=0.611        |     P=0.301         P=0.500         P=0.468        |
|INCIDENTAL TUMOR       |     P=0.385         P=0.149         P=0.609        |     P=0.397         P=0.612         P=0.536        |
|LOGISTIC REGRESSION    |     P=0.529         P=0.218         P=0.681        |     P=0.354         P=0.473         P=0.487        |
|COCHRAN-ARMITAGE       |     P=0.583                                        |     P=0.331                                        |
|FISHER EXACT           |                     P=0.218         P=0.691N       |                     P=0.500         P=0.500        |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       1/50 (2%)       1/50 (2%)      |     1/50 (2%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      5.5%            3.6%            4.8%          |      3.3%            0.0%            0.0%          |
|TERMINAL (d)           |     0/23 (0%)       1/28 (4%)       1/21 (5%)      |     1/30 (3%)       0/31 (0%)       0/24 (0%)      |
|FIRST INCIDENCE (DAYS) |      641             730 (T)         730 (T)       |      730 (T)         ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.435N        P=0.467N        P=0.580N       |     P=0.294N        P=0.493N        P=0.545N       |
|INCIDENTAL TUMOR       |     P=0.385N        P=0.582N        P=0.521N       |     P=0.294N        P=0.493N        P=0.545N       |
|LOGISTIC REGRESSION    |     P=0.412N        P=0.503N        P=0.530N       |     P=0.294N        P=0.493N        P=0.545N       |
|COCHRAN-ARMITAGE       |     P=0.378N                                       |     P=0.269N                                       |
|FISHER EXACT           |                     P=0.500N        P=0.500N       |                     P=0.500N        P=0.500N       |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05038 TEST: 01                                                 PAGE  10
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIMETHOXANE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 MG/KG         62.5 MG/        125 MG/       |      0 MG/KG         125 MG/         250 MG/       |
|                       |                      KG              KG            |                      KG              KG            |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibrosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       2/50 (4%)       2/50 (4%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      0.0%            7.1%            7.7%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/23 (0%)       2/28 (7%)       1/21 (5%)      |     0/30 (0%)       0/31 (0%)       0/24 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             730 (T)         619           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.145         P=0.282         P=0.209        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.210         P=0.282         P=0.308        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.140         P=0.282         P=0.221        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.176                                        |       (e)                                          |
|FISHER EXACT           |                     P=0.247         P=0.247        |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,                                                                                   |
|     Neurofibroma, or Fibroma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       3/50 (6%)       3/50 (6%)      |     1/50 (2%)       1/50 (2%)       0/50 (0%)      |
|ADJUSTED (b)           |      5.5%           10.7%           12.4%          |      3.3%            2.1%            0.0%          |
|TERMINAL (d)           |     0/23 (0%)       3/28 (11%)      2/21 (10%)     |     1/30 (3%)       0/31 (0%)       0/24 (0%)      |
|FIRST INCIDENCE (DAYS) |      641             730 (T)         619           |      730 (T)         515             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.341         P=0.561         P=0.412        |     P=0.355N        P=0.750N        P=0.545N       |
|INCIDENTAL TUMOR       |     P=0.444         P=0.472         P=0.543        |     P=0.294N        P=0.696N        P=0.545N       |
|LOGISTIC REGRESSION    |     P=0.350         P=0.500         P=0.465        |     P=0.317N        P=0.752         P=0.545N       |
|COCHRAN-ARMITAGE       |     P=0.412                                        |     P=0.331N                                       |
|FISHER EXACT           |                     P=0.500         P=0.500        |                     P=0.753N        P=0.500N       |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05038 TEST: 01                                                 PAGE  11
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIMETHOXANE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 MG/KG         62.5 MG/        125 MG/       |      0 MG/KG         125 MG/         250 MG/       |
|                       |                      KG              KG            |                      KG              KG            |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, or Sarcoma                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       2/50 (4%)       2/50 (4%)      |     0/50 (0%)       1/50 (2%)       0/50 (0%)      |
|ADJUSTED (b)           |      0.0%            7.1%            7.7%          |      0.0%            2.1%            0.0%          |
|TERMINAL (d)           |     0/23 (0%)       2/28 (7%)       1/21 (5%)      |     0/30 (0%)       0/31 (0%)       0/24 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             730 (T)         619           |      ---             515             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.145         P=0.282         P=0.209        |     P=0.730         P=0.513           (e)          |
|INCIDENTAL TUMOR       |     P=0.210         P=0.282         P=0.308        |     P=0.669N        P=0.612           (e)          |
|LOGISTIC REGRESSION    |     P=0.140         P=0.282         P=0.221        |     P=0.689N        P=0.468           (e)          |
|COCHRAN-ARMITAGE       |     P=0.176                                        |     P=0.731                                        |
|FISHER EXACT           |                     P=0.247         P=0.247        |                     P=0.500           (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    45/50 (90%)     43/50 (86%)     44/50 (88%)     |                                                    |
|ADJUSTED (b)           |     97.8%           97.7%          100.0%          |                                                    |
|TERMINAL (d)           |    22/23 (96%)     27/28 (96%)     21/21 (100%)    |                                                    |
|FIRST INCIDENCE (DAYS) |      450             514             493           |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.254         P=0.152N        P=0.256        |                                                    |
|INCIDENTAL TUMOR       |     P=0.533         P=0.415N        P=0.563        |                                                    |
|LOGISTIC REGRESSION    |     P=0.402         P=0.578N        P=0.501        |                                                    |
|COCHRAN-ARMITAGE       |     P=0.439N                                       |                                                    |
|FISHER EXACT           |                     P=0.380N        P=0.500N       |                                                    |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05038 TEST: 01                                                 PAGE  12
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIMETHOXANE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 MG/KG         62.5 MG/        125 MG/       |      0 MG/KG         125 MG/         250 MG/       |
|                       |                      KG              KG            |                      KG              KG            |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    13/50 (26%)     12/50 (24%)     10/50 (20%)     |    13/50 (26%)     12/50 (24%)      7/50 (14%)     |
|ADJUSTED (b)           |     41.9%           34.4%           36.1%          |     39.0%           38.7%           25.2%          |
|TERMINAL (d)           |     7/23 (30%)      6/28 (21%)      6/21 (29%)     |    10/30 (33%)     12/31 (39%)      4/24 (17%)     |
|FIRST INCIDENCE (DAYS) |      593             619             423           |      634             730 (T)         607           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.426N        P=0.360N        P=0.472N       |     P=0.199N        P=0.451N        P=0.240N       |
|INCIDENTAL TUMOR       |     P=0.371N        P=0.559         P=0.337N       |     P=0.165N        P=0.469N        P=0.171N       |
|LOGISTIC REGRESSION    |     P=0.376N        P=0.500N        P=0.406N       |     P=0.168N        P=0.393N        P=0.192N       |
|COCHRAN-ARMITAGE       |     P=0.277N                                       |     P=0.090N                                       |
|FISHER EXACT           |                     P=0.500N        P=0.318N       |                     P=0.500N        P=0.105N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       2/50 (4%)       0/50 (0%)      |     2/50 (4%)       1/50 (2%)       1/50 (2%)      |
|ADJUSTED (b)           |      8.7%            6.7%            0.0%          |      6.7%            2.3%            3.0%          |
|TERMINAL (d)           |     2/23 (9%)       1/28 (4%)       0/21 (0%)      |     2/30 (7%)       0/31 (0%)       0/24 (0%)      |
|FIRST INCIDENCE (DAYS) |      730 (T)         722             ---           |      730 (T)         541             604           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.190N        P=0.624N        P=0.257N       |     P=0.434N        P=0.492N        P=0.571N       |
|INCIDENTAL TUMOR       |     P=0.230N        P=0.682N        P=0.257N       |     P=0.386N        P=0.429N        P=0.565N       |
|LOGISTIC REGRESSION    |     P=0.214N        P=0.654N        P=0.257N       |     P=0.377N        P=0.501N        P=0.539N       |
|COCHRAN-ARMITAGE       |     P=0.176N                                       |     P=0.378N                                       |
|FISHER EXACT           |                     P=0.691N        P=0.247N       |                     P=0.500N        P=0.500N       |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05038 TEST: 01                                                 PAGE  13
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIMETHOXANE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 MG/KG         62.5 MG/        125 MG/       |      0 MG/KG         125 MG/         250 MG/       |
|                       |                      KG              KG            |                      KG              KG            |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    14/50 (28%)     14/50 (28%)     10/50 (20%)     |    15/50 (30%)     13/50 (26%)      8/50 (16%)     |
|ADJUSTED (b)           |     45.5%           39.4%           36.1%          |     45.1%           40.1%           27.4%          |
|TERMINAL (d)           |     8/23 (35%)      7/28 (25%)      6/21 (29%)     |    12/30 (40%)     12/31 (39%)      4/24 (17%)     |
|FIRST INCIDENCE (DAYS) |      593             619             423           |      634             541             604           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.352N        P=0.422N        P=0.387N       |     P=0.162N        P=0.361N        P=0.203N       |
|INCIDENTAL TUMOR       |     P=0.315N        P=0.464         P=0.259N       |     P=0.123N        P=0.351N        P=0.140N       |
|LOGISTIC REGRESSION    |     P=0.312N        P=0.587N        P=0.329N       |     P=0.121N        P=0.320N        P=0.149N       |
|COCHRAN-ARMITAGE       |     P=0.210N                                       |     P=0.064N                                       |
|FISHER EXACT           |                     P=0.588N        P=0.241N       |                     P=0.412N        P=0.077N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       3/50 (6%)       0/50 (0%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      0.0%            9.2%            0.0%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/23 (0%)       1/28 (4%)       0/21 (0%)      |     0/30 (0%)       0/31 (0%)       0/24 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             694             ---           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.591         P=0.150           (e)          |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.476         P=0.082           (e)          |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.597         P=0.122           (e)          |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.640                                        |       (e)                                          |
|FISHER EXACT           |                     P=0.121           (e)          |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05038 TEST: 01                                                 PAGE  14
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIMETHOXANE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 MG/KG         62.5 MG/        125 MG/       |      0 MG/KG         125 MG/         250 MG/       |
|                       |                      KG              KG            |                      KG              KG            |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       4/50 (8%)       1/50 (2%)      |     1/50 (2%)       0/50 (0%)       1/50 (2%)      |
|ADJUSTED (b)           |      0.0%           12.6%            4.8%          |      3.3%            0.0%            3.1%          |
|TERMINAL (d)           |     0/23 (0%)       2/28 (7%)       1/21 (5%)      |     1/30 (3%)       0/31 (0%)       0/24 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             694             730 (T)       |      730 (T)         ---             607           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.333         P=0.087         P=0.482        |     P=0.628         P=0.493N        P=0.713        |
|INCIDENTAL TUMOR       |     P=0.255         P=0.047 *       P=0.482        |     P=0.623         P=0.493N        P=0.722        |
|LOGISTIC REGRESSION    |     P=0.314         P=0.065         P=0.482        |     P=0.662         P=0.493N        P=0.750        |
|COCHRAN-ARMITAGE       |     P=0.390                                        |     P=0.669N                                       |
|FISHER EXACT           |                     P=0.059         P=0.500        |                     P=0.500N        P=0.753N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |     6/50 (12%)      3/50 (6%)       2/50 (4%)      |
|ADJUSTED (b)           |                                                    |     17.4%            8.6%            4.6%          |
|TERMINAL (d)           |                                                    |     4/30 (13%)      2/31 (6%)       0/24 (0%)      |
|FIRST INCIDENCE (DAYS) |                                                    |      562             544             515           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.135N        P=0.238N        P=0.202N       |
|INCIDENTAL TUMOR       |                                                    |     P=0.090N        P=0.312N        P=0.134N       |
|LOGISTIC REGRESSION    |                                                    |     P=0.086N        P=0.239N        P=0.132N       |
|COCHRAN-ARMITAGE       |                                                    |     P=0.090N                                       |
|FISHER EXACT           |                                                    |                     P=0.243N        P=0.134N       |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05038 TEST: 01                                                 PAGE  15
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIMETHOXANE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 MG/KG         62.5 MG/        125 MG/       |      0 MG/KG         125 MG/         250 MG/       |
|                       |                      KG              KG            |                      KG              KG            |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |     0/50 (0%)       2/50 (4%)       0/50 (0%)      |
|ADJUSTED (b)           |                                                    |      0.0%            4.7%            0.0%          |
|TERMINAL (d)           |                                                    |     0/30 (0%)       0/31 (0%)       0/24 (0%)      |
|FIRST INCIDENCE (DAYS) |                                                    |      ---             526             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.641         P=0.259           (e)          |
|INCIDENTAL TUMOR       |                                                    |     P=0.603N        P=0.358           (e)          |
|LOGISTIC REGRESSION    |                                                    |     P=0.645N        P=0.220           (e)          |
|COCHRAN-ARMITAGE       |                                                    |     P=0.669                                        |
|FISHER EXACT           |                                                    |                     P=0.247           (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal or Polyp Stromal                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |     6/50 (12%)      5/50 (10%)      2/50 (4%)      |
|ADJUSTED (b)           |                                                    |     17.4%           12.9%            4.6%          |
|TERMINAL (d)           |                                                    |     4/30 (13%)      2/31 (6%)       0/24 (0%)      |
|FIRST INCIDENCE (DAYS) |                                                    |      562             526             515           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.163N        P=0.480N        P=0.202N       |
|INCIDENTAL TUMOR       |                                                    |     P=0.091N        P=0.516N        P=0.134N       |
|LOGISTIC REGRESSION    |                                                    |     P=0.098N        P=0.507N        P=0.132N       |
|COCHRAN-ARMITAGE       |                                                    |     P=0.107N                                       |
|FISHER EXACT           |                                                    |                     P=0.500N        P=0.134N       |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05038 TEST: 01                                                 PAGE  16
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIMETHOXANE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 MG/KG         62.5 MG/        125 MG/       |      0 MG/KG         125 MG/         250 MG/       |
|                       |                      KG              KG            |                      KG              KG            |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Leukemia: Lymphocytic, Monocytic, Mononuclear,                                                                              |
|     or Undifferentiated                                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    19/50 (38%)     14/50 (28%)      9/50 (18%)     |    12/50 (24%)     14/50 (28%)     12/50 (24%)     |
|ADJUSTED (b)           |     47.4%           39.7%           33.4%          |     31.4%           36.5%           38.5%          |
|TERMINAL (d)           |     4/23 (17%)      8/28 (29%)      5/21 (24%)     |     6/30 (20%)      7/31 (23%)      6/24 (25%)     |
|FIRST INCIDENCE (DAYS) |      507             563             423           |      485             544             523           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.070N        P=0.155N        P=0.107N       |     P=0.342         P=0.480         P=0.394        |
|INCIDENTAL TUMOR       |     P=0.032N*       P=0.410N        P=0.058N       |     P=0.530         P=0.584         P=0.582        |
|LOGISTIC REGRESSION    |     P=0.024N*       P=0.390N        P=0.028N*      |     P=0.452         P=0.434         P=0.519        |
|COCHRAN-ARMITAGE       |     P=0.017N*                                      |     P=0.546N                                       |
|FISHER EXACT           |                     P=0.198N        P=0.022N*      |                     P=0.410         P=0.592N       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma And Histiocytic Sarcoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |     0/50 (0%)       1/50 (2%)       2/50 (4%)      |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |      0.0%            3.2%            6.4%          |
|TERMINAL (d)           |     0/23 (0%)       0/28 (0%)       0/21 (0%)      |     0/30 (0%)       1/31 (3%)       0/24 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      ---             730 (T)         604           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.111         P=0.507         P=0.205        |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.137         P=0.507         P=0.246        |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.133         P=0.507         P=0.236        |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.142                                        |
|FISHER EXACT           |                       (e)             (e)          |                     P=0.500         P=0.247        |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05038 TEST: 01                                                 PAGE  17
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIMETHOXANE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 MG/KG         62.5 MG/        125 MG/       |      0 MG/KG         125 MG/         250 MG/       |
|                       |                      KG              KG            |                      KG              KG            |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Mesothelioma Benign, Malignant, NOS                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       1/50 (2%)       1/50 (2%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      5.7%            3.2%            3.3%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/23 (0%)       0/28 (0%)       0/21 (0%)      |     0/30 (0%)       0/31 (0%)       0/24 (0%)      |
|FIRST INCIDENCE (DAYS) |      652             722             634           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.460N        P=0.467N        P=0.602N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.507N        P=0.657N        P=0.610N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.387N        P=0.503N        P=0.494N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.378N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.500N        P=0.500N       |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    50/50 (100%)    45/50 (90%)     48/50 (96%)     |    35/50 (70%)     28/50 (56%)     26/50 (52%)     |
|ADJUSTED (b)           |    100.0%          100.0%          100.0%          |     81.3%           71.2%           71.4%          |
|TERMINAL (d)           |    23/23 (100%)    28/28 (100%)    21/21 (100%)    |    22/30 (73%)     20/31 (65%)     14/24 (58%)     |
|FIRST INCIDENCE (DAYS) |      349             514             371           |      449             533             388           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.290         P=0.069N        P=0.291        |     P=0.319N        P=0.105N        P=0.385N       |
|INCIDENTAL TUMOR       |     P=0.298N        P=0.062N        P=0.320N       |     P=0.109N        P=0.129N        P=0.114N       |
|LOGISTIC REGRESSION    |     P=0.389N        P=0.059N        P=0.384N       |     P=0.103N        P=0.062N        P=0.122N       |
|COCHRAN-ARMITAGE       |     P=0.238N                                       |     P=0.042N*                                      |
|FISHER EXACT           |                     P=0.028N*       P=0.247N       |                     P=0.107N        P=0.050N       |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05038 TEST: 01                                                 PAGE  18
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIMETHOXANE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 MG/KG         62.5 MG/        125 MG/       |      0 MG/KG         125 MG/         250 MG/       |
|                       |                      KG              KG            |                      KG              KG            |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    24/50 (48%)     24/50 (48%)     16/50 (32%)     |    14/50 (28%)     20/50 (40%)     16/50 (32%)     |
|ADJUSTED (b)           |     58.2%           58.9%           54.9%          |     37.1%           46.9%           46.4%          |
|TERMINAL (d)           |     7/23 (30%)     12/28 (43%)      9/21 (43%)     |     8/30 (27%)      9/31 (29%)      6/24 (25%)     |
|FIRST INCIDENCE (DAYS) |      507             380             423           |      485             515             523           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.231N        P=0.405N        P=0.283N       |     P=0.195         P=0.227         P=0.228        |
|INCIDENTAL TUMOR       |     P=0.127N        P=0.368         P=0.163N       |     P=0.371         P=0.324         P=0.382        |
|LOGISTIC REGRESSION    |     P=0.090N        P=0.418         P=0.117N       |     P=0.301         P=0.153         P=0.330        |
|COCHRAN-ARMITAGE       |     P=0.065N                                       |     P=0.375                                        |
|FISHER EXACT           |                     P=0.579N        P=0.076N       |                     P=0.146         P=0.414        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    50/50 (100%)    47/50 (94%)     48/50 (96%)     |    41/50 (82%)     37/50 (74%)     32/50 (64%)     |
|ADJUSTED (b)           |    100.0%          100.0%          100.0%          |     89.0%           80.3%           81.7%          |
|TERMINAL (d)           |    23/23 (100%)    28/28 (100%)    21/21 (100%)    |    25/30 (83%)     22/31 (71%)     17/24 (71%)     |
|FIRST INCIDENCE (DAYS) |      349             380             371           |      449             515             388           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.292         P=0.126N        P=0.291        |     P=0.401N        P=0.229N        P=0.452N       |
|INCIDENTAL TUMOR       |     P=0.246N        P=0.187N        P=0.320N       |     P=0.059N        P=0.150N        P=0.080N       |
|LOGISTIC REGRESSION    |     P=0.314N        P=0.301N        P=0.384N       |     P=0.073N        P=0.174N        P=0.092N       |
|COCHRAN-ARMITAGE       |     P=0.202N                                       |     P=0.027N*                                      |
|FISHER EXACT           |                     P=0.121N        P=0.247N       |                     P=0.235N        P=0.035N*      |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05038 TEST: 01                                                 PAGE  19
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIMETHOXANE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
 
 (a)  Number of tumor-bearing animals / number of animals examined at site.
 (b)  Kaplan-Meier estimated lifetime tumor incidence after adjustment for 
      intercurrent mortality.
 (d)  Observed incidence at terminal kill.
 (f)  Beneath the control incidence are the P-values associated with the trend 
      test.  Beneath the dosed group incidence are the P-values corresponding to 
      pairwise comparisons between the controls and that dosed group.  The life
      table analysis regards tumors in animals dying  prior to terminal kill as
      being (directly or indirectly) the cause of death.  The incidental tumor 
      test regards these lesions as non-fatal.  Logistic regression is an alternative
      method for analyzing the incidence of non-fatal tumors.  The Cochran-Armitage
      and Fisher's exact tests compare directly the overall incidence rates.  
      For all tests, a negative trend is indicated by "N".
 (e)  Value of Statistic cannot be computed. 
 (I)  Interim sacrifice
 (T)  Terminal sacrifice
  #   Tumor rates based on number of animals necropsied.
 
  *   To the right of any statistical result, indicates significance at (P<=0.05).
  **  To the right of any statistical result, indicates significance at (P<=0.01).

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