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TR 386 Rat Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Midwest Research Inst                                 TETRANITROMETHANE                                   DATE: 09/09/94       
EXPERIMENT: 05072 TEST: 01                                                                                     TIME: 01:29:20       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01ES38042            ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                                             NTP C#: 55947        
PATHOLOGIST: M. STEDHAM                                                                                        CAS: 509-14-8        
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               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08    
LAB: Midwest Research Inst                                 TETRANITROMETHANE                                   DATE: 09/09/94      
EXPERIMENT: 05072 TEST: 01                                                                                     TIME: 01:29:20      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01ES38042            ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                                             NTP C#: 55947       
PATHOLOGIST: M. STEDHAM                                                                                        CAS: 509-14-8       
 
 
 
 
 
                                                    RATS(FISCHER344)
                                              ----------------------------
             FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
             IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
 
 
                                                    ----------------
 
                                                    Adrenal Gland
                                                    Bone Marrow
                                                    Brain
                                                    Clitoral Gland
                                                    Epididymis
                                                    Heart
                                                    Islets, Pancreatic
                                                    Kidney
                                                    Larynx
                                                    Liver
                                                    Lung
                                                    Nose
                                                    Ovary
                                                    Pancreas
                                                    Parathyroid Gland
                                                    Pituitary Gland
                                                    Preputial Gland
                                                    Prostate
                                                    Salivary Glands
                                                    Spleen
                                                    Testes
                                                    Thymus
                                                    Thyroid Gland
                                                    Urinary Bladder
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Midwest Research Inst                                 TETRANITROMETHANE                                   DATE: 09/09/94       
EXPERIMENT: 05072 TEST: 01                                                                                     TIME: 01:29:20       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01ES38042            ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                                             NTP C#: 55947        
PATHOLOGIST: M. STEDHAM                                                                                        CAS: 509-14-8        
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                       IN THE ANALYSIS OF THE STUDY OF TETRANITROMETHANE
 
              ====================================================================================================
 
                                                           MALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Adrenal Medulla               Pheochromocytoma Benign
                                                           Pheochromocytoma: Benign, Complex, Malignant, NOS
                             Islets, Pancreatic            Adenoma
                                                           Carcinoma or Adenoma
                             Lung                          Alveolar/Bronchiolar Adenoma
                                                           Alveolar/Bronchiolar Carcinoma
                                                           Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
                                                           Squamous Cell Carcinoma
                             Pancreas                      Adenoma
                             Pituitary Gland: Pars Distalis or Unspecified Site
                                                           Adenoma
                                                           Carcinoma or Adenoma
                             Skin                          Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma,
                                                            Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma
                             Testes                        Adenoma
                             All Organs                    Leukemia: Lymphocytic, Monocytic, Mononuclear,
                                                            or Undifferentiated
                                                           Benign Tumors
                                                           Malignant Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
 
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Midwest Research Inst                                 TETRANITROMETHANE                                   DATE: 09/09/94       
EXPERIMENT: 05072 TEST: 01                                                                                     TIME: 01:29:20       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01ES38042            ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                                             NTP C#: 55947        
PATHOLOGIST: M. STEDHAM                                                                                        CAS: 509-14-8        
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                       IN THE ANALYSIS OF THE STUDY OF TETRANITROMETHANE
 
              ====================================================================================================
 
                                                           FEMALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Adrenal Cortex                Adenoma
                             Lung                          Alveolar/Bronchiolar Adenoma
                                                           Alveolar/Bronchiolar Carcinoma
                                                           Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
                                                           Squamous Cell Carcinoma
                             All Organs                    Leukemia: Lymphocytic, Monocytic, Mononuclear,
                                                            or Undifferentiated
                                                           Benign Tumors
                                                           Malignant Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
         DATE: 09/09/94                     EXPERIMENT: 05072 TEST: 01                                                 PAGE   1
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TETRANITROMETHANE
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2 PPM           5 PPM         |      CONTROL         2 PPM           5 PPM         |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Cortex                                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       1/49 (2%)       0/48 (0%)      |     0/50 (0%)       0/49 (0%)       3/50 (6%)      |
|ADJUSTED (b)           |      2.5%            5.9%            0.0%          |      0.0%            0.0%           13.5%          |
|TERMINAL (d)           |     0/18 (0%)       1/17 (6%)       0/4 (0%)       |     0/25 (0%)       0/34 (0%)       1/15 (7%)      |
|FIRST INCIDENCE (DAYS) |      618             727 (T)         ---           |      ---             ---             616           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.531N        P=0.748         P=0.602N       |     P=0.016 *         (e)           P=0.085        |
|INCIDENTAL TUMOR       |     P=0.343N        P=0.742N        P=0.318N       |     P=0.047 *         (e)           P=0.139        |
|LOGISTIC REGRESSION    |     P=0.390N        P=0.761         P=0.494N       |     P=0.032 *         (e)           P=0.123        |
|COCHRAN-ARMITAGE       |     P=0.352N                                       |     P=0.033 *                                      |
|FISHER EXACT           |                     P=0.747         P=0.510N       |                       (e)           P=0.121        |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    12/46 (26%)     16/48 (33%)     10/48 (21%)     |     2/43 (5%)       4/48 (8%)       3/47 (6%)      |
|ADJUSTED (b)           |     45.5%           58.3%           83.2%          |      9.1%           10.8%           18.4%          |
|TERMINAL (d)           |     6/18 (33%)      7/17 (41%)      2/3 (67%)      |     2/22 (9%)       3/34 (9%)       2/15 (13%)     |
|FIRST INCIDENCE (DAYS) |      483             541             548           |      727 (T)         563             722           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.022 *       P=0.252         P=0.031 *      |     P=0.280         P=0.524         P=0.324        |
|INCIDENTAL TUMOR       |     P=0.431         P=0.297         P=0.396        |     P=0.390         P=0.512         P=0.440        |
|LOGISTIC REGRESSION    |     P=0.412         P=0.290         P=0.433        |     P=0.484         P=0.447         P=0.399        |
|COCHRAN-ARMITAGE       |     P=0.277N                                       |     P=0.506                                        |
|FISHER EXACT           |                     P=0.294         P=0.360N       |                     P=0.392         P=0.543        |
|=================================================================================================================================|
 
         DATE: 09/09/94                     EXPERIMENT: 05072 TEST: 01                                                 PAGE   2
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TETRANITROMETHANE
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2 PPM           5 PPM         |      CONTROL         2 PPM           5 PPM         |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Malignant                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/46 (2%)       2/48 (4%)       1/48 (2%)      |     0/43 (0%)       0/48 (0%)       0/47 (0%)      |
|ADJUSTED (b)           |      5.6%           10.2%            2.6%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     1/18 (6%)       1/17 (6%)       0/3 (0%)       |     0/22 (0%)       0/34 (0%)       0/15 (0%)      |
|FIRST INCIDENCE (DAYS) |      727 (T)         699             548           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.369         P=0.477         P=0.577        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.582         P=0.501         P=0.760        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.612         P=0.490         P=0.763N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.601N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.516         P=0.742N       |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    13/46 (28%)     17/48 (35%)     10/48 (21%)     |     2/43 (5%)       4/48 (8%)       4/47 (9%)      |
|ADJUSTED (b)           |     50.1%           60.2%           83.2%          |      9.1%           10.8%           24.7%          |
|TERMINAL (d)           |     7/18 (39%)      7/17 (41%)      2/3 (67%)      |     2/22 (9%)       3/34 (9%)       3/15 (20%)     |
|FIRST INCIDENCE (DAYS) |      483             541             548           |      727 (T)         563             722           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.029 *       P=0.253         P=0.037 *      |     P=0.135         P=0.524         P=0.173        |
|INCIDENTAL TUMOR       |     P=0.499         P=0.302         P=0.428        |     P=0.212         P=0.512         P=0.252        |
|LOGISTIC REGRESSION    |     P=0.475         P=0.294         P=0.493        |     P=0.311         P=0.447         P=0.223        |
|COCHRAN-ARMITAGE       |     P=0.203N                                       |     P=0.343                                        |
|FISHER EXACT           |                     P=0.301         P=0.275N       |                     P=0.392         P=0.382        |
|=================================================================================================================================|
 
         DATE: 09/09/94                     EXPERIMENT: 05072 TEST: 01                                                 PAGE   3
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TETRANITROMETHANE
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2 PPM           5 PPM         |      CONTROL         2 PPM           5 PPM         |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Brain                                                                                                                            |
|     Astrocytoma Malignant                                                                                                       |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |     0/50 (0%)       0/50 (0%)       2/50 (4%)      |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |      0.0%            0.0%            5.0%          |
|TERMINAL (d)           |     0/18 (0%)       0/17 (0%)       0/4 (0%)       |     0/25 (0%)       0/34 (0%)       0/15 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      ---             ---             567           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.092           (e)           P=0.245        |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.098           (e)           P=0.259        |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.070           (e)           P=0.201        |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.092                                        |
|FISHER EXACT           |                       (e)             (e)          |                       (e)           P=0.247        |
|=================================================================================================================================|
|                                                                                                                                 |
|Brain                                                                                                                            |
|     Oligodendroglioma, Glioma, or Astrocytoma                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |     1/50 (2%)       0/50 (0%)       2/50 (4%)      |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |      4.0%            0.0%            5.0%          |
|TERMINAL (d)           |     0/18 (0%)       0/17 (0%)       0/4 (0%)       |     1/25 (4%)       0/34 (0%)       0/15 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      727 (T)         ---             567           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.289         P=0.439N        P=0.447        |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.303         P=0.439N        P=0.469        |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.320         P=0.439N        P=0.490        |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.335                                        |
|FISHER EXACT           |                       (e)             (e)          |                     P=0.500N        P=0.500        |
|=================================================================================================================================|
 
         DATE: 09/09/94                     EXPERIMENT: 05072 TEST: 01                                                 PAGE   4
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TETRANITROMETHANE
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2 PPM           5 PPM         |      CONTROL         2 PPM           5 PPM         |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/49 (0%)       0/48 (0%)       0/49 (0%)      |     1/47 (2%)       4/48 (8%)       0/44 (0%)      |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |      4.0%           11.0%            0.0%          |
|TERMINAL (d)           |     0/17 (0%)       0/17 (0%)       0/4 (0%)       |     1/25 (4%)       3/33 (9%)       0/14 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      727 (T)         559             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.457N        P=0.264         P=0.616N       |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.453N        P=0.271         P=0.616N       |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.341N        P=0.204         P=0.616N       |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.338N                                       |
|FISHER EXACT           |                       (e)             (e)          |                     P=0.187         P=0.516N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/49 (6%)       2/48 (4%)       1/49 (2%)      |     2/47 (4%)       1/48 (2%)       0/44 (0%)      |
|ADJUSTED (b)           |     14.6%            8.1%            3.7%          |      8.0%            3.0%            0.0%          |
|TERMINAL (d)           |     2/17 (12%)      1/17 (6%)       0/4 (0%)       |     2/25 (8%)       1/33 (3%)       0/14 (0%)      |
|FIRST INCIDENCE (DAYS) |      658             556             605           |      727 (T)         727 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.523N        P=0.492N        P=0.667N       |     P=0.236N        P=0.403N        P=0.372N       |
|INCIDENTAL TUMOR       |     P=0.289N        P=0.485N        P=0.469N       |     P=0.236N        P=0.403N        P=0.372N       |
|LOGISTIC REGRESSION    |     P=0.287N        P=0.504N        P=0.444N       |     P=0.236N        P=0.403N        P=0.372N       |
|COCHRAN-ARMITAGE       |     P=0.239N                                       |     P=0.170N                                       |
|FISHER EXACT           |                     P=0.510N        P=0.309N       |                     P=0.492N        P=0.264N       |
|=================================================================================================================================|
 
         DATE: 09/09/94                     EXPERIMENT: 05072 TEST: 01                                                 PAGE   5
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TETRANITROMETHANE
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2 PPM           5 PPM         |      CONTROL         2 PPM           5 PPM         |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/49 (6%)       2/48 (4%)       1/49 (2%)      |     3/47 (6%)       5/48 (10%)      0/44 (0%)      |
|ADJUSTED (b)           |     14.6%            8.1%            3.7%          |     12.0%           14.0%            0.0%          |
|TERMINAL (d)           |     2/17 (12%)      1/17 (6%)       0/4 (0%)       |     3/25 (12%)      4/33 (12%)      0/14 (0%)      |
|FIRST INCIDENCE (DAYS) |      658             556             605           |      727 (T)         559             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.523N        P=0.492N        P=0.667N       |     P=0.202N        P=0.507         P=0.238N       |
|INCIDENTAL TUMOR       |     P=0.289N        P=0.485N        P=0.469N       |     P=0.199N        P=0.514         P=0.238N       |
|LOGISTIC REGRESSION    |     P=0.287N        P=0.504N        P=0.444N       |     P=0.119N        P=0.434         P=0.238N       |
|COCHRAN-ARMITAGE       |     P=0.239N                                       |     P=0.115N                                       |
|FISHER EXACT           |                     P=0.510N        P=0.309N       |                     P=0.369         P=0.133N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/49 (6%)       5/48 (10%)      6/50 (12%)     |     0/50 (0%)       0/50 (0%)       0/49 (0%)      |
|ADJUSTED (b)           |     13.2%           21.2%           42.2%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     2/18 (11%)      2/17 (12%)      1/4 (25%)      |     0/25 (0%)       0/34 (0%)       0/15 (0%)      |
|FIRST INCIDENCE (DAYS) |      569             633             521           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.014 *       P=0.347         P=0.031 *      |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.193         P=0.363         P=0.225        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.168         P=0.340         P=0.244        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.225                                        |       (e)                                          |
|FISHER EXACT           |                     P=0.346         P=0.254        |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/09/94                     EXPERIMENT: 05072 TEST: 01                                                 PAGE   6
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TETRANITROMETHANE
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2 PPM           5 PPM         |      CONTROL         2 PPM           5 PPM         |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     5/49 (10%)      3/48 (6%)       4/50 (8%)      |     0/50 (0%)       0/50 (0%)       1/49 (2%)      |
|ADJUSTED (b)           |     18.3%            9.3%           21.7%          |      0.0%            0.0%            2.5%          |
|TERMINAL (d)           |     1/18 (6%)       0/17 (0%)       0/4 (0%)       |     0/25 (0%)       0/34 (0%)       0/15 (0%)      |
|FIRST INCIDENCE (DAYS) |      546             535             500           |      ---             ---             584           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.373         P=0.345N        P=0.387        |     P=0.276           (e)           P=0.495        |
|INCIDENTAL TUMOR       |     P=0.502N        P=0.406N        P=0.589N       |     P=0.299           (e)           P=0.523        |
|LOGISTIC REGRESSION    |     P=0.437N        P=0.371N        P=0.529N       |     P=0.243           (e)           P=0.461        |
|COCHRAN-ARMITAGE       |     P=0.457N                                       |     P=0.281                                        |
|FISHER EXACT           |                     P=0.369N        P=0.487N       |                       (e)           P=0.495        |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     8/49 (16%)      8/48 (17%)     10/50 (20%)     |     0/50 (0%)       0/50 (0%)       1/49 (2%)      |
|ADJUSTED (b)           |     29.7%           28.5%           54.8%          |      0.0%            0.0%            2.5%          |
|TERMINAL (d)           |     3/18 (17%)      2/17 (12%)      1/4 (25%)      |     0/25 (0%)       0/34 (0%)       0/15 (0%)      |
|FIRST INCIDENCE (DAYS) |      546             535             500           |      ---             ---             584           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.024 *       P=0.597N        P=0.038 *      |     P=0.276           (e)           P=0.495        |
|INCIDENTAL TUMOR       |     P=0.314         P=0.573         P=0.337        |     P=0.299           (e)           P=0.523        |
|LOGISTIC REGRESSION    |     P=0.327         P=0.591         P=0.383        |     P=0.243           (e)           P=0.461        |
|COCHRAN-ARMITAGE       |     P=0.365                                        |     P=0.281                                        |
|FISHER EXACT           |                     P=0.590         P=0.416        |                       (e)           P=0.495        |
|=================================================================================================================================|
 
         DATE: 09/09/94                     EXPERIMENT: 05072 TEST: 01                                                 PAGE   7
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TETRANITROMETHANE
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2 PPM           5 PPM         |      CONTROL         2 PPM           5 PPM         |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       2/50 (4%)       0/50 (0%)      |     1/50 (2%)       1/50 (2%)       0/50 (0%)      |
|ADJUSTED (b)           |      0.0%            7.0%            0.0%          |      4.0%            2.9%            0.0%          |
|TERMINAL (d)           |     0/18 (0%)       0/17 (0%)       0/4 (0%)       |     1/25 (4%)       1/34 (3%)       0/15 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             605             ---           |      727 (T)         727 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.659         P=0.227           (e)          |     P=0.442N        P=0.692N        P=0.602N       |
|INCIDENTAL TUMOR       |     P=0.504N        P=0.264           (e)          |     P=0.442N        P=0.692N        P=0.602N       |
|LOGISTIC REGRESSION    |     P=0.630N        P=0.237           (e)          |     P=0.442N        P=0.692N        P=0.602N       |
|COCHRAN-ARMITAGE       |     P=0.614N                                       |     P=0.343N                                       |
|FISHER EXACT           |                     P=0.247           (e)          |                     P=0.753N        P=0.500N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       2/50 (4%)       0/50 (0%)      |     1/50 (2%)       1/50 (2%)       1/50 (2%)      |
|ADJUSTED (b)           |      4.3%            7.0%            0.0%          |      4.0%            2.9%            3.8%          |
|TERMINAL (d)           |     0/18 (0%)       0/17 (0%)       0/4 (0%)       |     1/25 (4%)       1/34 (3%)       0/15 (0%)      |
|FIRST INCIDENCE (DAYS) |      708             605             ---           |      727 (T)         727 (T)         696           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.556N        P=0.471         P=0.736N       |     P=0.582         P=0.692N        P=0.705        |
|INCIDENTAL TUMOR       |     P=0.265N        P=0.526         P=0.525N       |     P=0.663N        P=0.692N        P=0.742N       |
|LOGISTIC REGRESSION    |     P=0.384N        P=0.501         P=0.663N       |     P=0.651         P=0.692N        P=0.755        |
|COCHRAN-ARMITAGE       |     P=0.335N                                       |     P=0.665                                        |
|FISHER EXACT           |                     P=0.500         P=0.500N       |                     P=0.753N        P=0.753N       |
|=================================================================================================================================|
 
         DATE: 09/09/94                     EXPERIMENT: 05072 TEST: 01                                                 PAGE   8
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TETRANITROMETHANE
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2 PPM           5 PPM         |      CONTROL         2 PPM           5 PPM         |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       2/50 (4%)       0/50 (0%)      |     1/50 (2%)       1/50 (2%)       1/50 (2%)      |
|ADJUSTED (b)           |      4.3%            7.0%            0.0%          |      4.0%            2.9%            3.8%          |
|TERMINAL (d)           |     0/18 (0%)       0/17 (0%)       0/4 (0%)       |     1/25 (4%)       1/34 (3%)       0/15 (0%)      |
|FIRST INCIDENCE (DAYS) |      708             605             ---           |      727 (T)         727 (T)         696           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.556N        P=0.471         P=0.736N       |     P=0.582         P=0.692N        P=0.705        |
|INCIDENTAL TUMOR       |     P=0.265N        P=0.526         P=0.525N       |     P=0.663N        P=0.692N        P=0.742N       |
|LOGISTIC REGRESSION    |     P=0.384N        P=0.501         P=0.663N       |     P=0.651         P=0.692N        P=0.755        |
|COCHRAN-ARMITAGE       |     P=0.335N                                       |     P=0.665                                        |
|FISHER EXACT           |                     P=0.500         P=0.500N       |                     P=0.753N        P=0.753N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)      13/50 (26%)     11/50 (22%)     |     0/50 (0%)       6/50 (12%)      3/50 (6%)      |
|ADJUSTED (b)           |      5.6%           51.8%           30.4%          |      0.0%           17.6%            9.9%          |
|TERMINAL (d)           |     1/18 (6%)       7/17 (41%)      0/4 (0%)       |     0/25 (0%)       6/34 (18%)      0/15 (0%)      |
|FIRST INCIDENCE (DAYS) |      727 (T)         535             497           |      ---             727 (T)         567           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P<0.001 **      P<0.001 **      P<0.001 **     |     P=0.094         P=0.039 *       P=0.110        |
|INCIDENTAL TUMOR       |     P=0.013 *       P<0.001 **      P=0.024 *      |     P=0.146         P=0.039 *       P=0.181        |
|LOGISTIC REGRESSION    |     P=0.015 *       P<0.001 **      P=0.005 **     |     P=0.218         P=0.039 *       P=0.111        |
|COCHRAN-ARMITAGE       |     P=0.012 *                                      |     P=0.226                                        |
|FISHER EXACT           |                     P<0.001 **      P=0.002 **     |                     P=0.013 *       P=0.121        |
|=================================================================================================================================|
 
         DATE: 09/09/94                     EXPERIMENT: 05072 TEST: 01                                                 PAGE   9
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TETRANITROMETHANE
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2 PPM           5 PPM         |      CONTROL         2 PPM           5 PPM         |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)      26/50 (52%)     46/50 (92%)     |     0/50 (0%)      19/50 (38%)     50/50 (100%)    |
|ADJUSTED (b)           |      0.0%           76.0%          100.0%          |      0.0%           52.7%          100.0%          |
|TERMINAL (d)           |     0/18 (0%)      10/17 (59%)      4/4 (100%)     |     0/25 (0%)      17/34 (50%)     15/15 (100%)    |
|FIRST INCIDENCE (DAYS) |      ---             533             497           |      ---             703             475           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P<0.001 **      P<0.001 **      P<0.001 **     |     P<0.001 **      P<0.001 **      P<0.001 **     |
|INCIDENTAL TUMOR       |     P<0.001 **      P<0.001 **      P<0.001 **     |     P<0.001 **      P<0.001 **      P<0.001 **     |
|LOGISTIC REGRESSION    |     P<0.001 **      P<0.001 **      P<0.001 **     |     P<0.001 **      P<0.001 **      P<0.001 **     |
|COCHRAN-ARMITAGE       |     P<0.001 **                                     |     P<0.001 **                                     |
|FISHER EXACT           |                     P<0.001 **      P<0.001 **     |                     P<0.001 **      P<0.001 **     |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)      33/50 (66%)     46/50 (92%)     |     0/50 (0%)      22/50 (44%)     50/50 (100%)    |
|ADJUSTED (b)           |      5.6%           83.2%          100.0%          |      0.0%           61.0%          100.0%          |
|TERMINAL (d)           |     1/18 (6%)      11/17 (65%)      4/4 (100%)     |     0/25 (0%)      20/34 (59%)     15/15 (100%)    |
|FIRST INCIDENCE (DAYS) |      727 (T)         533             497           |      ---             703             475           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P<0.001 **      P<0.001 **      P<0.001 **     |     P<0.001 **      P<0.001 **      P<0.001 **     |
|INCIDENTAL TUMOR       |     P<0.001 **      P<0.001 **      P<0.001 **     |     P<0.001 **      P<0.001 **      P<0.001 **     |
|LOGISTIC REGRESSION    |     P<0.001 **      P<0.001 **      P<0.001 **     |     P<0.001 **      P<0.001 **      P<0.001 **     |
|COCHRAN-ARMITAGE       |     P<0.001 **                                     |     P<0.001 **                                     |
|FISHER EXACT           |                     P<0.001 **      P<0.001 **     |                     P<0.001 **      P<0.001 **     |
|=================================================================================================================================|
 
         DATE: 09/09/94                     EXPERIMENT: 05072 TEST: 01                                                 PAGE  10
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TETRANITROMETHANE
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2 PPM           5 PPM         |      CONTROL         2 PPM           5 PPM         |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Squamous Cell Carcinoma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       1/50 (2%)      19/50 (38%)     |     0/50 (0%)       1/50 (2%)      12/50 (24%)     |
|ADJUSTED (b)           |      0.0%            5.9%           77.1%          |      0.0%            2.5%           45.8%          |
|TERMINAL (d)           |     0/18 (0%)       1/17 (6%)       1/4 (25%)      |     0/25 (0%)       0/34 (0%)       4/15 (27%)     |
|FIRST INCIDENCE (DAYS) |      ---             727 (T)         518           |      ---             639             512           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P<0.001 **      P=0.489         P<0.001 **     |     P<0.001 **      P=0.527         P<0.001 **     |
|INCIDENTAL TUMOR       |     P<0.001 **      P=0.489         P<0.001 **     |     P<0.001 **      P=0.523         P<0.001 **     |
|LOGISTIC REGRESSION    |     P<0.001 **      P=0.489         P<0.001 **     |     P<0.001 **      P=0.478         P<0.001 **     |
|COCHRAN-ARMITAGE       |     P<0.001 **                                     |     P<0.001 **                                     |
|FISHER EXACT           |                     P=0.500         P<0.001 **     |                     P=0.500         P<0.001 **     |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroadenoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       0/50 (0%)       1/50 (2%)      |     8/50 (16%)     12/50 (24%)      6/50 (12%)     |
|ADJUSTED (b)           |      4.0%            0.0%            2.6%          |     28.1%           30.7%           22.5%          |
|TERMINAL (d)           |     0/18 (0%)       0/17 (0%)       0/4 (0%)       |     6/25 (24%)      8/34 (24%)      1/15 (7%)      |
|FIRST INCIDENCE (DAYS) |      694             ---             548           |      590             428             534           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.566         P=0.525N        P=0.661        |     P=0.562N        P=0.467         P=0.603N       |
|INCIDENTAL TUMOR       |     P=0.639N        P=0.500N        P=0.672N       |     P=0.292N        P=0.297         P=0.397N       |
|LOGISTIC REGRESSION    |     P=0.676         P=0.501N        P=0.752N       |     P=0.285N        P=0.303         P=0.373N       |
|COCHRAN-ARMITAGE       |     P=0.657                                        |     P=0.294N                                       |
|FISHER EXACT           |                     P=0.500N        P=0.753N       |                     P=0.227         P=0.387N       |
|=================================================================================================================================|
 
         DATE: 09/09/94                     EXPERIMENT: 05072 TEST: 01                                                 PAGE  11
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TETRANITROMETHANE
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2 PPM           5 PPM         |      CONTROL         2 PPM           5 PPM         |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma or Adenoma                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       0/50 (0%)       2/50 (4%)      |     8/50 (16%)     12/50 (24%)      7/50 (14%)     |
|ADJUSTED (b)           |      4.0%            0.0%           18.8%          |     28.1%           30.7%           28.0%          |
|TERMINAL (d)           |     0/18 (0%)       0/17 (0%)       0/4 (0%)       |     6/25 (24%)      8/34 (24%)      2/15 (13%)     |
|FIRST INCIDENCE (DAYS) |      694             ---             548           |      590             428             534           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.166         P=0.525N        P=0.262        |     P=0.436         P=0.467         P=0.481        |
|INCIDENTAL TUMOR       |     P=0.409         P=0.500N        P=0.582        |     P=0.417N        P=0.297         P=0.542N       |
|LOGISTIC REGRESSION    |     P=0.318         P=0.501N        P=0.465        |     P=0.390N        P=0.303         P=0.488N       |
|COCHRAN-ARMITAGE       |     P=0.335                                        |     P=0.398N                                       |
|FISHER EXACT           |                     P=0.500N        P=0.500        |                     P=0.227         P=0.500N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       0/50 (0%)       2/50 (4%)      |     8/50 (16%)     13/50 (26%)      7/50 (14%)     |
|ADJUSTED (b)           |      4.0%            0.0%           18.8%          |     28.1%           33.4%           28.0%          |
|TERMINAL (d)           |     0/18 (0%)       0/17 (0%)       0/4 (0%)       |     6/25 (24%)      9/34 (26%)      2/15 (13%)     |
|FIRST INCIDENCE (DAYS) |      694             ---             548           |      590             428             534           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.166         P=0.525N        P=0.262        |     P=0.434         P=0.387         P=0.481        |
|INCIDENTAL TUMOR       |     P=0.409         P=0.500N        P=0.582        |     P=0.420N        P=0.231         P=0.542N       |
|LOGISTIC REGRESSION    |     P=0.318         P=0.501N        P=0.465        |     P=0.379N        P=0.234         P=0.488N       |
|COCHRAN-ARMITAGE       |     P=0.335                                        |     P=0.386N                                       |
|FISHER EXACT           |                     P=0.500N        P=0.500        |                     P=0.163         P=0.500N       |
|=================================================================================================================================|
 
         DATE: 09/09/94                     EXPERIMENT: 05072 TEST: 01                                                 PAGE  12
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TETRANITROMETHANE
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2 PPM           5 PPM         |      CONTROL         2 PPM           5 PPM         |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Pancreas                                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/49 (0%)       0/48 (0%)       2/50 (4%)      |     0/50 (0%)       0/50 (0%)       0/49 (0%)      |
|ADJUSTED (b)           |      0.0%            0.0%           18.4%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/18 (0%)       0/17 (0%)       0/4 (0%)       |     0/25 (0%)       0/34 (0%)       0/15 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             506           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.038 *         (e)           P=0.117        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.118           (e)           P=0.269        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.125           (e)           P=0.278        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.096                                        |       (e)                                          |
|FISHER EXACT           |                       (e)           P=0.253        |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    29/49 (59%)     24/49 (49%)     18/48 (38%)     |    28/50 (56%)     29/48 (60%)     25/50 (50%)     |
|ADJUSTED (b)           |     76.2%           74.9%           70.7%          |     79.4%           66.8%           87.0%          |
|TERMINAL (d)           |    10/18 (56%)     10/17 (59%)      1/4 (25%)      |    18/25 (72%)     19/33 (58%)     12/15 (80%)     |
|FIRST INCIDENCE (DAYS) |      422             591             521           |      525             559             512           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.165         P=0.299N        P=0.223        |     P=0.206         P=0.189N        P=0.246        |
|INCIDENTAL TUMOR       |     P=0.029N*       P=0.169N        P=0.022N*      |     P=0.387N        P=0.497N        P=0.542N       |
|LOGISTIC REGRESSION    |     P=0.062N        P=0.185N        P=0.051N       |     P=0.252N        P=0.522N        P=0.290N       |
|COCHRAN-ARMITAGE       |     P=0.022N*                                      |     P=0.282N                                       |
|FISHER EXACT           |                     P=0.209N        P=0.026N*      |                     P=0.406         P=0.344N       |
|=================================================================================================================================|
 
         DATE: 09/09/94                     EXPERIMENT: 05072 TEST: 01                                                 PAGE  13
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TETRANITROMETHANE
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2 PPM           5 PPM         |      CONTROL         2 PPM           5 PPM         |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/49 (0%)       1/49 (2%)       0/48 (0%)      |     1/50 (2%)       2/48 (4%)       0/50 (0%)      |
|ADJUSTED (b)           |      0.0%            5.9%            0.0%          |      2.9%            6.1%            0.0%          |
|TERMINAL (d)           |     0/18 (0%)       1/17 (6%)       0/4 (0%)       |     0/25 (0%)       2/33 (6%)       0/15 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             727 (T)         ---           |      646             727 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.716         P=0.489           (e)          |     P=0.413N        P=0.580         P=0.494N       |
|INCIDENTAL TUMOR       |     P=0.716         P=0.489           (e)          |     P=0.316N        P=0.498         P=0.341N       |
|LOGISTIC REGRESSION    |     P=0.716         P=0.489           (e)          |     P=0.334N        P=0.533         P=0.503N       |
|COCHRAN-ARMITAGE       |     P=0.719N                                       |     P=0.335N                                       |
|FISHER EXACT           |                     P=0.500           (e)          |                     P=0.485         P=0.500N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    29/49 (59%)     25/49 (51%)     18/48 (38%)     |    29/50 (58%)     31/48 (65%)     25/50 (50%)     |
|ADJUSTED (b)           |     76.2%           78.5%           70.7%          |     80.0%           71.5%           87.0%          |
|TERMINAL (d)           |    10/18 (56%)     11/17 (65%)      1/4 (25%)      |    18/25 (72%)     21/33 (64%)     12/15 (80%)     |
|FIRST INCIDENCE (DAYS) |      422             591             521           |      525             559             512           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.154         P=0.356N        P=0.223        |     P=0.257         P=0.223N        P=0.310        |
|INCIDENTAL TUMOR       |     P=0.033N*       P=0.227N        P=0.022N*      |     P=0.288N        P=0.586N        P=0.421N       |
|LOGISTIC REGRESSION    |     P=0.064N        P=0.243N        P=0.051N       |     P=0.176N        P=0.575         P=0.220N       |
|COCHRAN-ARMITAGE       |     P=0.021N*                                      |     P=0.206N                                       |
|FISHER EXACT           |                     P=0.271N        P=0.026N*      |                     P=0.323         P=0.274N       |
|=================================================================================================================================|
 
         DATE: 09/09/94                     EXPERIMENT: 05072 TEST: 01                                                 PAGE  14
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TETRANITROMETHANE
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2 PPM           5 PPM         |      CONTROL         2 PPM           5 PPM         |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Keratoacanthoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       2/50 (4%)       0/50 (0%)      |     1/50 (2%)       0/50 (0%)       1/50 (2%)      |
|ADJUSTED (b)           |      5.1%            9.4%            0.0%          |      4.0%            0.0%            6.7%          |
|TERMINAL (d)           |     0/18 (0%)       0/17 (0%)       0/4 (0%)       |     1/25 (4%)       0/34 (0%)       1/15 (7%)      |
|FIRST INCIDENCE (DAYS) |      618             692             ---           |      727 (T)         ---             727 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.357N        P=0.670         P=0.379N       |     P=0.558         P=0.439N        P=0.644        |
|INCIDENTAL TUMOR       |     P=0.088N        P=0.655N        P=0.058N       |     P=0.558         P=0.439N        P=0.644        |
|LOGISTIC REGRESSION    |     P=0.202N        P=0.694N        P=0.228N       |     P=0.558         P=0.439N        P=0.644        |
|COCHRAN-ARMITAGE       |     P=0.172N                                       |     P=0.657                                        |
|FISHER EXACT           |                     P=0.691N        P=0.247N       |                     P=0.500N        P=0.753N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       1/50 (2%)       0/50 (0%)      |     1/50 (2%)       2/50 (4%)       1/50 (2%)      |
|ADJUSTED (b)           |      0.0%            5.9%            0.0%          |      4.0%            5.0%            2.4%          |
|TERMINAL (d)           |     0/18 (0%)       1/17 (6%)       0/4 (0%)       |     1/25 (4%)       1/34 (3%)       0/15 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             727 (T)         ---           |      727 (T)         563             570           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.716         P=0.489           (e)          |     P=0.610         P=0.587         P=0.708        |
|INCIDENTAL TUMOR       |     P=0.716         P=0.489           (e)          |     P=0.626         P=0.584         P=0.720        |
|LOGISTIC REGRESSION    |     P=0.716         P=0.489           (e)          |     P=0.626N        P=0.505         P=0.761        |
|COCHRAN-ARMITAGE       |     P=0.716N                                       |     P=0.613N                                       |
|FISHER EXACT           |                     P=0.500           (e)          |                     P=0.500         P=0.753N       |
|=================================================================================================================================|
 
         DATE: 09/09/94                     EXPERIMENT: 05072 TEST: 01                                                 PAGE  15
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TETRANITROMETHANE
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2 PPM           5 PPM         |      CONTROL         2 PPM           5 PPM         |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       1/50 (2%)       0/50 (0%)      |     0/50 (0%)       2/50 (4%)       1/50 (2%)      |
|ADJUSTED (b)           |      0.0%            5.9%            0.0%          |      0.0%            5.0%            2.4%          |
|TERMINAL (d)           |     0/18 (0%)       1/17 (6%)       0/4 (0%)       |     0/25 (0%)       1/34 (3%)       0/15 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             727 (T)         ---           |      ---             563             570           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.716         P=0.489           (e)          |     P=0.398         P=0.289         P=0.505        |
|INCIDENTAL TUMOR       |     P=0.716         P=0.489           (e)          |     P=0.415         P=0.287         P=0.523        |
|LOGISTIC REGRESSION    |     P=0.716         P=0.489           (e)          |     P=0.409         P=0.211         P=0.456        |
|COCHRAN-ARMITAGE       |     P=0.716N                                       |     P=0.444                                        |
|FISHER EXACT           |                     P=0.500           (e)          |                     P=0.247         P=0.500        |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Trichoepithelioma, Basal Cell Carcinoma, or Basal Cell Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       2/50 (4%)       0/50 (0%)      |     0/50 (0%)       1/50 (2%)       0/50 (0%)      |
|ADJUSTED (b)           |      6.3%           11.8%            0.0%          |      0.0%            2.9%            0.0%          |
|TERMINAL (d)           |     0/18 (0%)       2/17 (12%)      0/4 (0%)       |     0/25 (0%)       1/34 (3%)       0/15 (0%)      |
|FIRST INCIDENCE (DAYS) |      653             727 (T)         ---           |      ---             727 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.382N        P=0.689N        P=0.377N       |     P=0.789         P=0.561           (e)          |
|INCIDENTAL TUMOR       |     P=0.315N        P=0.684         P=0.264N       |     P=0.789         P=0.561           (e)          |
|LOGISTIC REGRESSION    |     P=0.257N        P=0.694         P=0.257N       |     P=0.789         P=0.561           (e)          |
|COCHRAN-ARMITAGE       |     P=0.172N                                       |     P=0.716N                                       |
|FISHER EXACT           |                     P=0.691N        P=0.247N       |                     P=0.500           (e)          |
|=================================================================================================================================|
 
         DATE: 09/09/94                     EXPERIMENT: 05072 TEST: 01                                                 PAGE  16
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TETRANITROMETHANE
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2 PPM           5 PPM         |      CONTROL         2 PPM           5 PPM         |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma,                                                                |
|     Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     4/50 (8%)       5/50 (10%)      0/50 (0%)      |     2/50 (4%)       3/50 (6%)       2/50 (4%)      |
|ADJUSTED (b)           |     11.0%           25.4%            0.0%          |      8.0%            7.9%            8.9%          |
|TERMINAL (d)           |     0/18 (0%)       3/17 (18%)      0/4 (0%)       |     2/25 (8%)       2/34 (6%)       1/15 (7%)      |
|FIRST INCIDENCE (DAYS) |      618             692             ---           |      727 (T)         563             570           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.266N        P=0.482         P=0.168N       |     P=0.489         P=0.623         P=0.554        |
|INCIDENTAL TUMOR       |     P=0.072N        P=0.519         P=0.020N*      |     P=0.501         P=0.621         P=0.564        |
|LOGISTIC REGRESSION    |     P=0.106N        P=0.500         P=0.062N       |     P=0.584N        P=0.548         P=0.691N       |
|COCHRAN-ARMITAGE       |     P=0.056N                                       |     P=0.587N                                       |
|FISHER EXACT           |                     P=0.500         P=0.059N       |                     P=0.500         P=0.691N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     4/50 (8%)       2/50 (4%)       3/50 (6%)      |     0/50 (0%)       1/50 (2%)       1/50 (2%)      |
|ADJUSTED (b)           |     16.6%            7.8%           28.3%          |      0.0%            2.9%            6.7%          |
|TERMINAL (d)           |     2/18 (11%)      0/17 (0%)       1/4 (25%)      |     0/25 (0%)       1/34 (3%)       1/15 (7%)      |
|FIRST INCIDENCE (DAYS) |      401             659             506           |      ---             727 (T)         727 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.390         P=0.361N        P=0.425        |     P=0.257         P=0.561         P=0.398        |
|INCIDENTAL TUMOR       |     P=0.601N        P=0.361N        P=0.610        |     P=0.257         P=0.561         P=0.398        |
|LOGISTIC REGRESSION    |     P=0.442N        P=0.338N        P=0.463N       |     P=0.257         P=0.561         P=0.398        |
|COCHRAN-ARMITAGE       |     P=0.467N                                       |     P=0.386                                        |
|FISHER EXACT           |                     P=0.339N        P=0.500N       |                     P=0.500         P=0.500        |
|=================================================================================================================================|
 
         DATE: 09/09/94                     EXPERIMENT: 05072 TEST: 01                                                 PAGE  17
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TETRANITROMETHANE
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2 PPM           5 PPM         |      CONTROL         2 PPM           5 PPM         |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,                                                                                   |
|     Neurofibroma, or Fibroma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     4/50 (8%)       3/50 (6%)       3/50 (6%)      |     2/50 (4%)       1/50 (2%)       1/50 (2%)      |
|ADJUSTED (b)           |     16.6%            9.8%           28.3%          |      5.2%            2.9%            6.7%          |
|TERMINAL (d)           |     2/18 (11%)      0/17 (0%)       1/4 (25%)      |     0/25 (0%)       1/34 (3%)       1/15 (7%)      |
|FIRST INCIDENCE (DAYS) |      401             535             506           |      520             727 (T)         727 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.417         P=0.517N        P=0.425        |     P=0.491N        P=0.433N        P=0.547N       |
|INCIDENTAL TUMOR       |     P=0.546N        P=0.537N        P=0.610        |     P=0.400N        P=0.651N        P=0.469N       |
|LOGISTIC REGRESSION    |     P=0.401N        P=0.509N        P=0.463N       |     P=0.424N        P=0.545N        P=0.514N       |
|COCHRAN-ARMITAGE       |     P=0.447N                                       |     P=0.419N                                       |
|FISHER EXACT           |                     P=0.500N        P=0.500N       |                     P=0.500N        P=0.500N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, or Sarcoma                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       1/50 (2%)       0/50 (0%)      |     2/50 (4%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      0.0%            2.1%            0.0%          |      5.2%            0.0%            0.0%          |
|TERMINAL (d)           |     0/18 (0%)       0/17 (0%)       0/4 (0%)       |     0/25 (0%)       0/34 (0%)       0/15 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             535             ---           |      520             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.725N        P=0.509           (e)          |     P=0.130N        P=0.210N        P=0.229N       |
|INCIDENTAL TUMOR       |     P=0.635N        P=0.464           (e)          |     P=0.096N        P=0.434N        P=0.156N       |
|LOGISTIC REGRESSION    |     P=0.725N        P=0.454           (e)          |     P=0.162N        P=0.290N        P=0.265N       |
|COCHRAN-ARMITAGE       |     P=0.716N                                       |     P=0.136N                                       |
|FISHER EXACT           |                     P=0.500           (e)          |                     P=0.247N        P=0.247N       |
|=================================================================================================================================|
 
         DATE: 09/09/94                     EXPERIMENT: 05072 TEST: 01                                                 PAGE  18
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TETRANITROMETHANE
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2 PPM           5 PPM         |      CONTROL         2 PPM           5 PPM         |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    33/50 (66%)     38/50 (76%)     39/50 (78%)     |                                                    |
|ADJUSTED (b)           |     96.8%           97.3%          100.0%          |                                                    |
|TERMINAL (d)           |    17/18 (94%)     16/17 (94%)      4/4 (100%)     |                                                    |
|FIRST INCIDENCE (DAYS) |      483             535             500           |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P<0.001 **      P=0.216         P<0.001 **     |                                                    |
|INCIDENTAL TUMOR       |     P=0.009 **      P=0.143         P=0.018 *      |                                                    |
|LOGISTIC REGRESSION    |     P=0.010 **      P=0.180         P=0.020 *      |                                                    |
|COCHRAN-ARMITAGE       |     P=0.124                                        |                                                    |
|FISHER EXACT           |                     P=0.189         P=0.133        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/49 (6%)       1/49 (2%)       3/50 (6%)      |     3/49 (6%)       6/50 (12%)      4/50 (8%)      |
|ADJUSTED (b)           |     10.7%            5.9%           15.6%          |     11.3%           15.9%           23.1%          |
|TERMINAL (d)           |     1/17 (6%)       1/17 (6%)       0/4 (0%)       |     2/25 (8%)       4/34 (12%)      3/15 (20%)     |
|FIRST INCIDENCE (DAYS) |      618             727 (T)         629           |      674             563             696           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.240         P=0.322N        P=0.321        |     P=0.280         P=0.408         P=0.313        |
|INCIDENTAL TUMOR       |     P=0.535N        P=0.265N        P=0.465N       |     P=0.441         P=0.287         P=0.420        |
|LOGISTIC REGRESSION    |     P=0.504         P=0.297N        P=0.616        |     P=0.475         P=0.301         P=0.470        |
|COCHRAN-ARMITAGE       |     P=0.572                                        |     P=0.502                                        |
|FISHER EXACT           |                     P=0.309N        P=0.651N       |                     P=0.254         P=0.511        |
|=================================================================================================================================|
 
         DATE: 09/09/94                     EXPERIMENT: 05072 TEST: 01                                                 PAGE  19
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TETRANITROMETHANE
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2 PPM           5 PPM         |      CONTROL         2 PPM           5 PPM         |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/49 (0%)       1/49 (2%)       0/50 (0%)      |     3/49 (6%)       2/50 (4%)       1/50 (2%)      |
|ADJUSTED (b)           |      0.0%            5.9%            0.0%          |     12.0%            5.9%            3.4%          |
|TERMINAL (d)           |     0/17 (0%)       1/17 (6%)       0/4 (0%)       |     3/25 (12%)      2/34 (6%)       0/15 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             727 (T)         ---           |      727 (T)         727 (T)         689           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.724         P=0.500           (e)          |     P=0.364N        P=0.360N        P=0.441N       |
|INCIDENTAL TUMOR       |     P=0.724         P=0.500           (e)          |     P=0.295N        P=0.360N        P=0.369N       |
|LOGISTIC REGRESSION    |     P=0.724         P=0.500           (e)          |     P=0.262N        P=0.360N        P=0.329N       |
|COCHRAN-ARMITAGE       |     P=0.712N                                       |     P=0.233N                                       |
|FISHER EXACT           |                     P=0.500           (e)          |                     P=0.490N        P=0.301N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/49 (6%)       2/49 (4%)       3/50 (6%)      |     6/49 (12%)      8/50 (16%)      5/50 (10%)     |
|ADJUSTED (b)           |     10.7%           11.8%           15.6%          |     22.9%           21.5%           25.7%          |
|TERMINAL (d)           |     1/17 (6%)       2/17 (12%)      0/4 (0%)       |     5/25 (20%)      6/34 (18%)      3/15 (20%)     |
|FIRST INCIDENCE (DAYS) |      618             727 (T)         629           |      674             563             689           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.215         P=0.515N        P=0.321        |     P=0.462         P=0.604N        P=0.509        |
|INCIDENTAL TUMOR       |     P=0.578N        P=0.459N        P=0.465N       |     P=0.504N        P=0.519         P=0.616N       |
|LOGISTIC REGRESSION    |     P=0.483         P=0.490N        P=0.616        |     P=0.441N        P=0.522         P=0.542N       |
|COCHRAN-ARMITAGE       |     P=0.591                                        |     P=0.399N                                       |
|FISHER EXACT           |                     P=0.500N        P=0.651N       |                     P=0.403         P=0.486N       |
|=================================================================================================================================|
 
         DATE: 09/09/94                     EXPERIMENT: 05072 TEST: 01                                                 PAGE  20
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TETRANITROMETHANE
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2 PPM           5 PPM         |      CONTROL         2 PPM           5 PPM         |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/49 (2%)       0/49 (0%)       1/50 (2%)      |     0/49 (0%)       0/50 (0%)       2/50 (4%)      |
|ADJUSTED (b)           |      2.6%            0.0%            2.6%          |      0.0%            0.0%            9.2%          |
|TERMINAL (d)           |     0/17 (0%)       0/17 (0%)       0/4 (0%)       |     0/25 (0%)       0/34 (0%)       1/15 (7%)      |
|FIRST INCIDENCE (DAYS) |      644             ---             548           |      ---             ---             626           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.577         P=0.522N        P=0.674        |     P=0.058           (e)           P=0.185        |
|INCIDENTAL TUMOR       |     P=0.500N        P=0.455N        P=0.522N       |     P=0.063           (e)           P=0.196        |
|LOGISTIC REGRESSION    |     P=0.683         P=0.507N        P=0.736N       |     P=0.093           (e)           P=0.242        |
|COCHRAN-ARMITAGE       |     P=0.661                                        |     P=0.094                                        |
|FISHER EXACT           |                     P=0.500N        P=0.747N       |                       (e)           P=0.253        |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |    11/50 (22%)     12/50 (24%)      5/50 (10%)     |
|ADJUSTED (b)           |                                                    |     31.0%           32.7%           25.2%          |
|TERMINAL (d)           |                                                    |     5/25 (20%)     10/34 (29%)      3/15 (20%)     |
|FIRST INCIDENCE (DAYS) |                                                    |      454             428             512           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.206N        P=0.428N        P=0.206N       |
|INCIDENTAL TUMOR       |                                                    |     P=0.112N        P=0.427         P=0.135N       |
|LOGISTIC REGRESSION    |                                                    |     P=0.064N        P=0.488         P=0.091N       |
|COCHRAN-ARMITAGE       |                                                    |     P=0.065N                                       |
|FISHER EXACT           |                                                    |                     P=0.500         P=0.086N       |
|=================================================================================================================================|
 
         DATE: 09/09/94                     EXPERIMENT: 05072 TEST: 01                                                 PAGE  21
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TETRANITROMETHANE
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2 PPM           5 PPM         |      CONTROL         2 PPM           5 PPM         |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |     0/50 (0%)       0/50 (0%)       2/50 (4%)      |
|ADJUSTED (b)           |                                                    |      0.0%            0.0%            4.8%          |
|TERMINAL (d)           |                                                    |     0/25 (0%)       0/34 (0%)       0/15 (0%)      |
|FIRST INCIDENCE (DAYS) |                                                    |      ---             ---             495           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.094           (e)           P=0.250        |
|INCIDENTAL TUMOR       |                                                    |     P=0.187           (e)           P=0.324        |
|LOGISTIC REGRESSION    |                                                    |     P=0.060           (e)           P=0.181        |
|COCHRAN-ARMITAGE       |                                                    |     P=0.092                                        |
|FISHER EXACT           |                                                    |                       (e)           P=0.247        |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal or Polyp Stromal                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |    11/50 (22%)     13/50 (26%)      5/50 (10%)     |
|ADJUSTED (b)           |                                                    |     31.0%           34.2%           25.2%          |
|TERMINAL (d)           |                                                    |     5/25 (20%)     10/34 (29%)      3/15 (20%)     |
|FIRST INCIDENCE (DAYS) |                                                    |      454             428             512           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.202N        P=0.515N        P=0.206N       |
|INCIDENTAL TUMOR       |                                                    |     P=0.108N        P=0.340         P=0.135N       |
|LOGISTIC REGRESSION    |                                                    |     P=0.064N        P=0.379         P=0.091N       |
|COCHRAN-ARMITAGE       |                                                    |     P=0.063N                                       |
|FISHER EXACT           |                                                    |                     P=0.408         P=0.086N       |
|=================================================================================================================================|
 
         DATE: 09/09/94                     EXPERIMENT: 05072 TEST: 01                                                 PAGE  22
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TETRANITROMETHANE
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2 PPM           5 PPM         |      CONTROL         2 PPM           5 PPM         |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Zymbal's Gland                                                                                                                   |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       2/50 (4%)       0/50 (0%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      0.0%            9.0%            0.0%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/18 (0%)       1/17 (6%)       0/4 (0%)       |     0/25 (0%)       0/34 (0%)       0/15 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             675             ---           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.610         P=0.249           (e)          |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.668         P=0.233           (e)          |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.685         P=0.234           (e)          |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.614N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.247           (e)          |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Leukemia: Lymphocytic, Monocytic, Mononuclear,                                                                              |
|     or Undifferentiated                                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    27/50 (54%)     26/50 (52%)     22/50 (44%)     |    18/50 (36%)     10/50 (20%)      7/50 (14%)     |
|ADJUSTED (b)           |     75.5%           78.7%           79.8%          |     45.2%           26.3%           27.8%          |
|TERMINAL (d)           |    11/18 (61%)     11/17 (65%)      2/4 (50%)      |     5/25 (20%)      7/34 (21%)      2/15 (13%)     |
|FIRST INCIDENCE (DAYS) |      422             486             497           |      491             545             475           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.032 *       P=0.534N        P=0.063        |     P=0.040N*       P=0.021N*       P=0.044N*      |
|INCIDENTAL TUMOR       |     P=0.199N        P=0.489N        P=0.204N       |     P=0.002N**      P=0.154N        P=0.002N**     |
|LOGISTIC REGRESSION    |     P=0.216N        P=0.492N        P=0.195N       |     P=0.010N**      P=0.067N        P=0.012N*      |
|COCHRAN-ARMITAGE       |     P=0.180N                                       |     P=0.009N**                                     |
|FISHER EXACT           |                     P=0.500N        P=0.212N       |                     P=0.059N        P=0.010N**     |
|=================================================================================================================================|
 
         DATE: 09/09/94                     EXPERIMENT: 05072 TEST: 01                                                 PAGE  23
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TETRANITROMETHANE
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2 PPM           5 PPM         |      CONTROL         2 PPM           5 PPM         |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Mesothelioma Benign, Malignant, NOS                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/50 (6%)       2/50 (4%)       5/50 (10%)     |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |     10.9%            6.1%           18.2%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     1/18 (6%)       0/17 (0%)       0/4 (0%)       |     0/25 (0%)       0/34 (0%)       0/15 (0%)      |
|FIRST INCIDENCE (DAYS) |      618             560             548           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.085         P=0.500N        P=0.131        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.436         P=0.465N        P=0.507        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.288         P=0.502N        P=0.375        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.253                                        |       (e)                                          |
|FISHER EXACT           |                     P=0.500N        P=0.357        |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    47/50 (94%)     46/50 (92%)     49/50 (98%)     |    37/50 (74%)     42/50 (84%)     37/50 (74%)     |
|ADJUSTED (b)           |    100.0%          100.0%          100.0%          |     92.2%           91.2%           97.0%          |
|TERMINAL (d)           |    18/18 (100%)    17/17 (100%)     4/4 (100%)     |    22/25 (88%)     30/34 (88%)     14/15 (93%)     |
|FIRST INCIDENCE (DAYS) |      401             535             497           |      454             428             512           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P<0.001 **      P=0.551         P<0.001 **     |     P=0.043 *       P=0.232N        P=0.087        |
|INCIDENTAL TUMOR       |     P=0.209         P=0.469N        P=0.420        |     P=0.497         P=0.425         P=0.491        |
|LOGISTIC REGRESSION    |     P=0.242         P=0.325N        P=0.322        |     P=0.411N        P=0.365         P=0.489N       |
|COCHRAN-ARMITAGE       |     P=0.231                                        |     P=0.494N                                       |
|FISHER EXACT           |                     P=0.500N        P=0.309        |                     P=0.163         P=0.590N       |
|=================================================================================================================================|
 
         DATE: 09/09/94                     EXPERIMENT: 05072 TEST: 01                                                 PAGE  24
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TETRANITROMETHANE
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2 PPM           5 PPM         |      CONTROL         2 PPM           5 PPM         |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    38/50 (76%)     43/50 (86%)     50/50 (100%)    |    24/50 (48%)     31/50 (62%)     50/50 (100%)    |
|ADJUSTED (b)           |     89.6%           95.3%          100.0%          |     58.3%           73.6%          100.0%          |
|TERMINAL (d)           |    14/18 (78%)     15/17 (88%)      4/4 (100%)     |     9/25 (36%)     23/34 (68%)     15/15 (100%)    |
|FIRST INCIDENCE (DAYS) |      422             486             497           |      251             545             475           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P<0.001 **      P=0.269         P<0.001 **     |     P<0.001 **      P=0.557         P<0.001 **     |
|INCIDENTAL TUMOR       |     P<0.001 **      P=0.142         P=0.002 **     |     P<0.001 **      P=0.060         P<0.001 **     |
|LOGISTIC REGRESSION    |     P=0.002 **      P=0.164         P<0.001 **     |     P<0.001 **      P=0.139         P<0.001 **     |
|COCHRAN-ARMITAGE       |     P<0.001 **                                     |     P<0.001 **                                     |
|FISHER EXACT           |                     P=0.154         P<0.001 **     |                     P=0.114         P<0.001 **     |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    48/50 (96%)     49/50 (98%)     50/50 (100%)    |    47/50 (94%)     49/50 (98%)     50/50 (100%)    |
|ADJUSTED (b)           |    100.0%          100.0%          100.0%          |     97.9%           98.0%          100.0%          |
|TERMINAL (d)           |    18/18 (100%)    17/17 (100%)     4/4 (100%)     |    24/25 (96%)     33/34 (97%)     15/15 (100%)    |
|FIRST INCIDENCE (DAYS) |      401             486             497           |      251             428             475           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P<0.001 **      P=0.450         P<0.001 **     |     P=0.016 *       P=0.084N        P=0.054        |
|INCIDENTAL TUMOR       |     P=0.360         P=0.500         P=0.525        |     P=0.194         P=0.416         P=0.280        |
|LOGISTIC REGRESSION    |     P=0.265         P=0.685         P=0.274        |     P=0.132         P=0.498         P=0.211        |
|COCHRAN-ARMITAGE       |     P=0.160                                        |     P=0.075                                        |
|FISHER EXACT           |                     P=0.500         P=0.247        |                     P=0.309         P=0.121        |
|=================================================================================================================================|
 
         DATE: 09/09/94                     EXPERIMENT: 05072 TEST: 01                                                 PAGE  25
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TETRANITROMETHANE
 
                                                 TERMINAL SACRIFICE AT 104 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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