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TR 365 Rat Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Mason                                            PENTAERYTHRITOL TETRANITRATE                             DATE: 09/04/94       
EXPERIMENT: 05023 TEST: 01                                                                                     TIME: 00:50:33       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01CP9561901          ROUTE: DOSED FEED                                                                  NTP C#: 55743        
PATHOLOGIST: K. MURTHY                                                                                         CAS: 78-11-5         
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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: Mason                                            PENTAERYTHRITOL TETRANITRATE                             DATE: 09/04/94      
EXPERIMENT: 05023 TEST: 01                                                                                     TIME: 00:50:33      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01CP9561901          ROUTE: DOSED FEED                                                                  NTP C#: 55743       
PATHOLOGIST: K. MURTHY                                                                                         CAS: 78-11-5        
 
 
 
 
 
                                                    RATS(FISCHER344)
                                              ----------------------------
             FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
             IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
 
 
                                                    ----------------
 
                                                    Adrenal Gland
                                                    Bone Marrow
                                                    Brain
                                                    Clitoral Gland
                                                    Epididymis
                                                    Heart
                                                    Islets, Pancreatic
                                                    Kidney
                                                    Liver
                                                    Lung
                                                    Nose
                                                    Ovary
                                                    Pancreas
                                                    Parathyroid Gland
                                                    Pituitary Gland
                                                    Preputial Gland
                                                    Prostate
                                                    Salivary Glands
                                                    Spleen
                                                    Testes
                                                    Thymus
                                                    Thyroid Gland
                                                    Urinary Bladder
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Mason                                            PENTAERYTHRITOL TETRANITRATE                             DATE: 09/04/94       
EXPERIMENT: 05023 TEST: 01                                                                                     TIME: 00:50:33       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01CP9561901          ROUTE: DOSED FEED                                                                  NTP C#: 55743        
PATHOLOGIST: K. MURTHY                                                                                         CAS: 78-11-5         
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                  IN THE ANALYSIS OF THE STUDY OF PENTAERYTHRITOL TETRANITRATE
 
              ====================================================================================================
 
                                                           MALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Adrenal Medulla               Pheochromocytoma Malignant
                                                           Pheochromocytoma: Benign, Complex, Malignant, NOS
                             Clitoral/Preputial Gland      Adenoma
                                                           Carcinoma or Adenoma
                             Islets, Pancreatic            Adenoma
                                                           Carcinoma or Adenoma
                             Pituitary Gland: Pars Distalis or Unspecified Site
                                                           Adenoma
                                                           Carcinoma or Adenoma
                             Testes                        Adenoma
                             All Organs                    Leukemia: Lymphocytic, Monocytic, Mononuclear,
                                                            or Undifferentiated
 
              ====================================================================================================
 
                                                           FEMALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Clitoral/Preputial Gland      Adenoma
                                                           Carcinoma or Adenoma
                             Thyroid Gland: Follicular Cell
                                                           Carcinoma or Adenoma
                             All Organs                    Malignant and Benign Tumors
 
              ====================================================================================================
         DATE: 09/04/94                     EXPERIMENT: 05023 TEST: 01                                                 PAGE   1
                      STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PENTAERYTHRITOL TETRANITRATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2.5%            5.0%          |      CONTROL         0.62%           1.25%         |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    19/49 (39%)      8/18 (44%)     15/48 (31%)     |     2/49 (4%)       0/12 (0%)       4/49 (8%)      |
|ADJUSTED (b)           |     61.3%           69.9%           43.1%          |      5.7%            0.0%           12.3%          |
|TERMINAL (d)           |    11/22 (50%)      4/6 (67%)       9/27 (33%)     |     1/32 (3%)       0/1 (0%)        3/30 (10%)     |
|FIRST INCIDENCE (DAYS) |      479             641             589           |      710             ---             680           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.072N        P=0.286N        P=0.092N       |     P=0.229         P=0.488N        P=0.311        |
|INCIDENTAL TUMOR       |     P=0.138N        P=0.168         P=0.200N       |     P=0.286         P=0.842N        P=0.366        |
|LOGISTIC REGRESSION    |     P=0.153N        P=0.222         P=0.198N       |     P=0.250         P=0.876N        P=0.328        |
|COCHRAN-ARMITAGE       |     P=0.254N                                       |     P=0.252                                        |
|FISHER EXACT           |                     P=0.442         P=0.287N       |                     P=0.643N        P=0.339        |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Malignant                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/49 (0%)       2/18 (11%)      3/48 (6%)      |     0/49 (0%)       0/12 (0%)       0/49 (0%)      |
|ADJUSTED (b)           |      0.0%           33.3%            6.4%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/22 (0%)       2/6 (33%)       0/27 (0%)      |     0/32 (0%)       0/1 (0%)        0/30 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             735 (T)         560           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.132         P=0.030 *       P=0.154        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.075         P=0.030 *       P=0.044 *      |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.079         P=0.028 *       P=0.032 *      |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.103                                        |       (e)                                          |
|FISHER EXACT           |                     P=0.069         P=0.117        |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05023 TEST: 01                                                 PAGE   2
                      STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PENTAERYTHRITOL TETRANITRATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2.5%            5.0%          |      CONTROL         0.62%           1.25%         |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    19/49 (39%)     10/18 (56%)     18/48 (38%)     |     2/49 (4%)       0/12 (0%)       4/49 (8%)      |
|ADJUSTED (b)           |     61.3%          100.0%           46.7%          |      5.7%            0.0%           12.3%          |
|TERMINAL (d)           |    11/22 (50%)      6/6 (100%)      9/27 (33%)     |     1/32 (3%)       0/1 (0%)        3/30 (10%)     |
|FIRST INCIDENCE (DAYS) |      479             641             560           |      710             ---             680           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.190N        P=0.580N        P=0.230N       |     P=0.229         P=0.488N        P=0.311        |
|INCIDENTAL TUMOR       |     P=0.356N        P=0.024 *       P=0.490N       |     P=0.286         P=0.842N        P=0.366        |
|LOGISTIC REGRESSION    |     P=0.384N        P=0.037 *       P=0.504N       |     P=0.250         P=0.876N        P=0.328        |
|COCHRAN-ARMITAGE       |     P=0.492N                                       |     P=0.252                                        |
|FISHER EXACT           |                     P=0.171         P=0.532N       |                     P=0.643N        P=0.339        |
|=================================================================================================================================|
|                                                                                                                                 |
|Brain                                                                                                                            |
|     Astrocytoma Malignant                                                                                                       |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/49 (0%)       0/48 (0%)       2/50 (4%)      |     0/50 (0%)       1/10 (10%)      0/50 (0%)      |
|ADJUSTED (b)           |      0.0%            0.0%            6.2%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/22 (0%)       0/27 (0%)       0/29 (0%)      |     0/33 (0%)       0/0             0/31 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             725           |      ---             200             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.127           (e)           P=0.315        |     P=0.729N        P=0.500           (e)          |
|INCIDENTAL TUMOR       |     P=0.124           (e)           P=0.283        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.123           (e)           P=0.300        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.099                                        |     P=0.700N                                       |
|FISHER EXACT           |                       (e)           P=0.253        |                     P=0.167           (e)          |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05023 TEST: 01                                                 PAGE   3
                      STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PENTAERYTHRITOL TETRANITRATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2.5%            5.0%          |      CONTROL         0.62%           1.25%         |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    11/46 (24%)     11/22 (50%)     13/50 (26%)     |     5/39 (13%)      6/12 (50%)      6/41 (15%)     |
|ADJUSTED (b)           |     32.0%           67.6%           36.7%          |     16.3%           72.0%           21.4%          |
|TERMINAL (d)           |     2/20 (10%)      5/8 (63%)       8/29 (28%)     |     3/26 (12%)      5/7 (71%)       6/28 (21%)     |
|FIRST INCIDENCE (DAYS) |      564             622             641           |      682             585             735 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.390N        P=0.408         P=0.461N       |     P=0.496         P=0.042 *       P=0.537        |
|INCIDENTAL TUMOR       |     P=0.458         P=0.037 *       P=0.506        |     P=0.496         P=0.001 **      P=0.563        |
|LOGISTIC REGRESSION    |     P=0.479         P=0.030 *       P=0.484        |     P=0.505         P=0.004 **      P=0.552        |
|COCHRAN-ARMITAGE       |     P=0.472                                        |     P=0.489                                        |
|FISHER EXACT           |                     P=0.032 *       P=0.501        |                     P=0.013 *       P=0.536        |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/46 (7%)       2/22 (9%)       1/50 (2%)      |     0/39 (0%)       1/12 (8%)       1/41 (2%)      |
|ADJUSTED (b)           |      7.6%           14.7%            2.4%          |      0.0%           14.3%            3.6%          |
|TERMINAL (d)           |     0/20 (0%)       1/8 (13%)       0/29 (0%)      |     0/26 (0%)       1/7 (14%)       1/28 (4%)      |
|FIRST INCIDENCE (DAYS) |      479             672             681           |      ---             735 (T)         735 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.157N        P=0.526N        P=0.239N       |     P=0.374         P=0.241         P=0.515        |
|INCIDENTAL TUMOR       |     P=0.298N        P=0.559         P=0.530N       |     P=0.374         P=0.241         P=0.515        |
|LOGISTIC REGRESSION    |     P=0.325N        P=0.591         P=0.510N       |     P=0.374         P=0.241         P=0.515        |
|COCHRAN-ARMITAGE       |     P=0.214N                                       |     P=0.366                                        |
|FISHER EXACT           |                     P=0.524         P=0.278N       |                     P=0.235         P=0.512        |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05023 TEST: 01                                                 PAGE   4
                      STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PENTAERYTHRITOL TETRANITRATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2.5%            5.0%          |      CONTROL         0.62%           1.25%         |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    14/46 (30%)     13/22 (59%)     14/50 (28%)     |     5/39 (13%)      7/12 (58%)      6/41 (15%)     |
|ADJUSTED (b)           |     37.2%           79.0%           38.2%          |     16.3%           86.0%           21.4%          |
|TERMINAL (d)           |     2/20 (10%)      6/8 (75%)       8/29 (28%)     |     3/26 (12%)      6/7 (86%)       6/28 (21%)     |
|FIRST INCIDENCE (DAYS) |      479             622             641           |      682             585             735 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.225N        P=0.487         P=0.285N       |     P=0.501         P=0.012 *       P=0.537        |
|INCIDENTAL TUMOR       |     P=0.492N        P=0.031 *       P=0.587        |     P=0.500         P<0.001 **      P=0.563        |
|LOGISTIC REGRESSION    |     P=0.490N        P=0.026 *       P=0.563        |     P=0.510         P<0.001 **      P=0.552        |
|COCHRAN-ARMITAGE       |     P=0.424N                                       |     P=0.492                                        |
|FISHER EXACT           |                     P=0.023 *       P=0.485N       |                     P=0.003 **      P=0.536        |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     6/49 (12%)      3/45 (7%)       1/47 (2%)      |     1/49 (2%)       1/17 (6%)       0/48 (0%)      |
|ADJUSTED (b)           |     25.0%           10.3%            3.4%          |      3.0%           14.3%            0.0%          |
|TERMINAL (d)           |     5/22 (23%)      2/26 (8%)       1/29 (3%)      |     1/33 (3%)       1/7 (14%)       0/31 (0%)      |
|FIRST INCIDENCE (DAYS) |      660             696             735 (T)       |      735 (T)         735 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.014N*       P=0.165N        P=0.024N*      |     P=0.369N        P=0.389         P=0.512N       |
|INCIDENTAL TUMOR       |     P=0.016N*       P=0.188N        P=0.026N*      |     P=0.369N        P=0.389         P=0.512N       |
|LOGISTIC REGRESSION    |     P=0.017N*       P=0.198N        P=0.028N*      |     P=0.369N        P=0.389         P=0.512N       |
|COCHRAN-ARMITAGE       |     P=0.042N*                                      |     P=0.354N                                       |
|FISHER EXACT           |                     P=0.288N        P=0.062N       |                     P=0.452         P=0.505N       |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05023 TEST: 01                                                 PAGE   5
                      STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PENTAERYTHRITOL TETRANITRATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2.5%            5.0%          |      CONTROL         0.62%           1.25%         |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     6/49 (12%)      3/45 (7%)       2/47 (4%)      |     1/49 (2%)       1/17 (6%)       0/48 (0%)      |
|ADJUSTED (b)           |     25.0%           10.3%            6.1%          |      3.0%           14.3%            0.0%          |
|TERMINAL (d)           |     5/22 (23%)      2/26 (8%)       1/29 (3%)      |     1/33 (3%)       1/7 (14%)       0/31 (0%)      |
|FIRST INCIDENCE (DAYS) |      660             696             711           |      735 (T)         735 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.041N*       P=0.165N        P=0.064N       |     P=0.369N        P=0.389         P=0.512N       |
|INCIDENTAL TUMOR       |     P=0.048N*       P=0.188N        P=0.073N       |     P=0.369N        P=0.389         P=0.512N       |
|LOGISTIC REGRESSION    |     P=0.051N        P=0.198N        P=0.075N       |     P=0.369N        P=0.389         P=0.512N       |
|COCHRAN-ARMITAGE       |     P=0.102N                                       |     P=0.354N                                       |
|FISHER EXACT           |                     P=0.288N        P=0.148N       |                     P=0.452         P=0.505N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney: Renal Tubule                                                                                                             |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/49 (0%)       0/50 (0%)       2/50 (4%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      0.0%            0.0%            6.9%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/22 (0%)       0/29 (0%)       2/29 (7%)      |     0/33 (0%)       0/33 (0%)       0/31 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             735 (T)       |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.117           (e)           P=0.300        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.117           (e)           P=0.300        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.117           (e)           P=0.300        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.097                                        |       (e)                                          |
|FISHER EXACT           |                       (e)           P=0.253        |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05023 TEST: 01                                                 PAGE   6
                      STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PENTAERYTHRITOL TETRANITRATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2.5%            5.0%          |      CONTROL         0.62%           1.25%         |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/49 (4%)       0/50 (0%)       1/50 (2%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      7.4%            0.0%            3.4%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/22 (0%)       0/29 (0%)       1/29 (3%)      |     0/33 (0%)       0/33 (0%)       0/31 (0%)      |
|FIRST INCIDENCE (DAYS) |      711             ---             735 (T)       |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.287N        P=0.189N        P=0.402N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.302N        P=0.253N        P=0.420N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.307N        P=0.214N        P=0.428N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.355N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.242N        P=0.492N       |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/49 (6%)       0/50 (0%)       1/50 (2%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |     11.6%            0.0%            3.4%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     1/22 (5%)       0/29 (0%)       1/29 (3%)      |     0/33 (0%)       0/33 (0%)       0/31 (0%)      |
|FIRST INCIDENCE (DAYS) |      711             ---             735 (T)       |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.120N        P=0.083N        P=0.213N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.130N        P=0.113N        P=0.225N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.126N        P=0.094N        P=0.220N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.171N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.117N        P=0.301N       |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05023 TEST: 01                                                 PAGE   7
                      STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PENTAERYTHRITOL TETRANITRATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2.5%            5.0%          |      CONTROL         0.62%           1.25%         |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/49 (6%)       0/50 (0%)       1/50 (2%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |     11.6%            0.0%            3.4%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     1/22 (5%)       0/29 (0%)       1/29 (3%)      |     0/33 (0%)       0/33 (0%)       0/31 (0%)      |
|FIRST INCIDENCE (DAYS) |      711             ---             735 (T)       |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.120N        P=0.083N        P=0.213N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.130N        P=0.113N        P=0.225N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.126N        P=0.094N        P=0.220N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.171N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.117N        P=0.301N       |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/49 (6%)       3/28 (11%)      4/50 (8%)      |     2/50 (4%)       1/50 (2%)       0/50 (0%)      |
|ADJUSTED (b)           |     11.1%           17.9%           10.4%          |      6.1%            3.0%            0.0%          |
|TERMINAL (d)           |     2/22 (9%)       2/13 (15%)      1/29 (3%)      |     2/33 (6%)       1/33 (3%)       0/31 (0%)      |
|FIRST INCIDENCE (DAYS) |      577             711             674           |      735 (T)         735 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.573         P=0.515         P=0.641        |     P=0.151N        P=0.500N        P=0.252N       |
|INCIDENTAL TUMOR       |     P=0.514         P=0.386         P=0.549        |     P=0.151N        P=0.500N        P=0.252N       |
|LOGISTIC REGRESSION    |     P=0.477         P=0.368         P=0.486        |     P=0.151N        P=0.500N        P=0.252N       |
|COCHRAN-ARMITAGE       |     P=0.438                                        |     P=0.143N                                       |
|FISHER EXACT           |                     P=0.378         P=0.511        |                     P=0.500N        P=0.247N       |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05023 TEST: 01                                                 PAGE   8
                      STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PENTAERYTHRITOL TETRANITRATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2.5%            5.0%          |      CONTROL         0.62%           1.25%         |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     4/49 (8%)       3/28 (11%)      4/50 (8%)      |     2/50 (4%)       1/50 (2%)       0/50 (0%)      |
|ADJUSTED (b)           |     15.5%           17.9%           10.4%          |      6.1%            3.0%            0.0%          |
|TERMINAL (d)           |     3/22 (14%)      2/13 (15%)      1/29 (3%)      |     2/33 (6%)       1/33 (3%)       0/31 (0%)      |
|FIRST INCIDENCE (DAYS) |      577             711             674           |      735 (T)         735 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.414N        P=0.631         P=0.490N       |     P=0.151N        P=0.500N        P=0.252N       |
|INCIDENTAL TUMOR       |     P=0.471N        P=0.514         P=0.581N       |     P=0.151N        P=0.500N        P=0.252N       |
|LOGISTIC REGRESSION    |     P=0.504N        P=0.490         P=0.638N       |     P=0.151N        P=0.500N        P=0.252N       |
|COCHRAN-ARMITAGE       |     P=0.559N                                       |     P=0.143N                                       |
|FISHER EXACT           |                     P=0.502         P=0.631N       |                     P=0.500N        P=0.247N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       0/50 (0%)       1/50 (2%)      |     0/50 (0%)       1/50 (2%)       2/50 (4%)      |
|ADJUSTED (b)           |      4.5%            0.0%            2.1%          |      0.0%            2.9%            6.3%          |
|TERMINAL (d)           |     1/22 (5%)       0/29 (0%)       0/29 (0%)      |     0/33 (0%)       0/33 (0%)       1/31 (3%)      |
|FIRST INCIDENCE (DAYS) |      735 (T)         ---             589           |      ---             715             724           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.634N        P=0.445N        P=0.722N       |     P=0.133         P=0.494         P=0.230        |
|INCIDENTAL TUMOR       |     P=0.604         P=0.445N        P=0.705        |     P=0.184         P=0.473         P=0.267        |
|LOGISTIC REGRESSION    |     P=0.632         P=0.445N        P=0.717        |     P=0.139         P=0.498         P=0.229        |
|COCHRAN-ARMITAGE       |     P=0.669N                                       |     P=0.143                                        |
|FISHER EXACT           |                     P=0.500N        P=0.753N       |                     P=0.500         P=0.247        |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05023 TEST: 01                                                 PAGE   9
                      STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PENTAERYTHRITOL TETRANITRATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2.5%            5.0%          |      CONTROL         0.62%           1.25%         |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       0/50 (0%)       1/50 (2%)      |     1/50 (2%)       1/50 (2%)       2/50 (4%)      |
|ADJUSTED (b)           |      4.5%            0.0%            2.1%          |      2.9%            2.9%            6.3%          |
|TERMINAL (d)           |     1/22 (5%)       0/29 (0%)       0/29 (0%)      |     0/33 (0%)       0/33 (0%)       1/31 (3%)      |
|FIRST INCIDENCE (DAYS) |      735 (T)         ---             589           |      723             715             724           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.634N        P=0.445N        P=0.722N       |     P=0.359         P=0.754         P=0.482        |
|INCIDENTAL TUMOR       |     P=0.604         P=0.445N        P=0.705        |     P=0.458         P=0.738         P=0.567        |
|LOGISTIC REGRESSION    |     P=0.632         P=0.445N        P=0.717        |     P=0.109         P=0.761         P=0.490        |
|COCHRAN-ARMITAGE       |     P=0.669N                                       |     P=0.378                                        |
|FISHER EXACT           |                     P=0.500N        P=0.753N       |                     P=0.753N        P=0.500        |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroadenoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     4/50 (8%)       1/50 (2%)       1/50 (2%)      |    27/50 (54%)     23/50 (46%)     29/50 (58%)     |
|ADJUSTED (b)           |     14.9%            3.4%            2.9%          |     68.9%           56.6%           68.5%          |
|TERMINAL (d)           |     2/22 (9%)       1/29 (3%)       0/29 (0%)      |    21/33 (64%)     16/33 (48%)     18/31 (58%)     |
|FIRST INCIDENCE (DAYS) |      534             735 (T)         718           |      441             443             441           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.063N        P=0.125N        P=0.120N       |     P=0.307         P=0.295N        P=0.336        |
|INCIDENTAL TUMOR       |     P=0.121N        P=0.191N        P=0.225N       |     P=0.419         P=0.341N        P=0.461        |
|LOGISTIC REGRESSION    |     P=0.094N        P=0.172N        P=0.181N       |     P=0.363         P=0.289N        P=0.399        |
|COCHRAN-ARMITAGE       |     P=0.101N                                       |     P=0.380                                        |
|FISHER EXACT           |                     P=0.181N        P=0.181N       |                     P=0.274N        P=0.420        |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05023 TEST: 01                                                 PAGE  10
                      STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PENTAERYTHRITOL TETRANITRATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2.5%            5.0%          |      CONTROL         0.62%           1.25%         |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma or Adenoma                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     4/50 (8%)       1/50 (2%)       1/50 (2%)      |    27/50 (54%)     23/50 (46%)     29/50 (58%)     |
|ADJUSTED (b)           |     14.9%            3.4%            2.9%          |     68.9%           56.6%           68.5%          |
|TERMINAL (d)           |     2/22 (9%)       1/29 (3%)       0/29 (0%)      |    21/33 (64%)     16/33 (48%)     18/31 (58%)     |
|FIRST INCIDENCE (DAYS) |      534             735 (T)         718           |      441             443             441           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.063N        P=0.125N        P=0.120N       |     P=0.307         P=0.295N        P=0.336        |
|INCIDENTAL TUMOR       |     P=0.121N        P=0.191N        P=0.225N       |     P=0.419         P=0.341N        P=0.461        |
|LOGISTIC REGRESSION    |     P=0.094N        P=0.172N        P=0.181N       |     P=0.363         P=0.289N        P=0.399        |
|COCHRAN-ARMITAGE       |     P=0.101N                                       |     P=0.380                                        |
|FISHER EXACT           |                     P=0.181N        P=0.181N       |                     P=0.274N        P=0.420        |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     5/50 (10%)      1/50 (2%)       2/50 (4%)      |    27/50 (54%)     24/50 (48%)     29/50 (58%)     |
|ADJUSTED (b)           |     19.1%            3.4%            5.0%          |     68.9%           57.9%           68.5%          |
|TERMINAL (d)           |     3/22 (14%)      1/29 (3%)       0/29 (0%)      |    21/33 (64%)     16/33 (48%)     18/31 (58%)     |
|FIRST INCIDENCE (DAYS) |      534             735 (T)         589           |      441             443             441           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.085N        P=0.062N        P=0.144N       |     P=0.306         P=0.364N        P=0.336        |
|INCIDENTAL TUMOR       |     P=0.181N        P=0.098N        P=0.304N       |     P=0.429         P=0.424N        P=0.461        |
|LOGISTIC REGRESSION    |     P=0.139N        P=0.091N        P=0.248N       |     P=0.363         P=0.363N        P=0.399        |
|COCHRAN-ARMITAGE       |     P=0.133N                                       |     P=0.381                                        |
|FISHER EXACT           |                     P=0.102N        P=0.218N       |                     P=0.345N        P=0.420        |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05023 TEST: 01                                                 PAGE  11
                      STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PENTAERYTHRITOL TETRANITRATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2.5%            5.0%          |      CONTROL         0.62%           1.25%         |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip)                                                                           |
|     Papilloma Squamous or Papilloma                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       1/50 (2%)       0/50 (0%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      6.8%            3.4%            0.0%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     1/22 (5%)       1/29 (3%)       0/29 (0%)      |     0/33 (0%)       0/33 (0%)       0/31 (0%)      |
|FIRST INCIDENCE (DAYS) |      629             735 (T)         ---           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.108N        P=0.428N        P=0.200N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.156N        P=0.497N        P=0.295N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.133N        P=0.485N        P=0.251N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.142N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.500N        P=0.247N       |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip)                                                                           |
|     Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       1/50 (2%)       0/50 (0%)      |     1/50 (2%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      6.8%            3.4%            0.0%          |      3.0%            0.0%            0.0%          |
|TERMINAL (d)           |     1/22 (5%)       1/29 (3%)       0/29 (0%)      |     1/33 (3%)       0/33 (0%)       0/31 (0%)      |
|FIRST INCIDENCE (DAYS) |      629             735 (T)         ---           |      735 (T)         ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.108N        P=0.428N        P=0.200N       |     P=0.280N        P=0.500N        P=0.512N       |
|INCIDENTAL TUMOR       |     P=0.156N        P=0.497N        P=0.295N       |     P=0.280N        P=0.500N        P=0.512N       |
|LOGISTIC REGRESSION    |     P=0.133N        P=0.485N        P=0.251N       |     P=0.280N        P=0.500N        P=0.512N       |
|COCHRAN-ARMITAGE       |     P=0.142N                                       |     P=0.272N                                       |
|FISHER EXACT           |                     P=0.500N        P=0.247N       |                     P=0.500N        P=0.500N       |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05023 TEST: 01                                                 PAGE  12
                      STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PENTAERYTHRITOL TETRANITRATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2.5%            5.0%          |      CONTROL         0.62%           1.25%         |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Pancreas                                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/49 (2%)       5/49 (10%)      3/48 (6%)      |     0/50 (0%)       1/17 (6%)       1/49 (2%)      |
|ADJUSTED (b)           |      4.5%           17.2%            9.0%          |      0.0%           14.3%            3.2%          |
|TERMINAL (d)           |     1/22 (5%)       5/29 (17%)      2/29 (7%)      |     0/33 (0%)       1/7 (14%)       1/31 (3%)      |
|FIRST INCIDENCE (DAYS) |      735 (T)         735 (T)         669           |      ---             735 (T)         735 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.382         P=0.172         P=0.416        |     P=0.341         P=0.196         P=0.488        |
|INCIDENTAL TUMOR       |     P=0.372         P=0.172         P=0.396        |     P=0.341         P=0.196         P=0.488        |
|LOGISTIC REGRESSION    |     P=0.376         P=0.172         P=0.366        |     P=0.341         P=0.196         P=0.488        |
|COCHRAN-ARMITAGE       |     P=0.255                                        |     P=0.348                                        |
|FISHER EXACT           |                     P=0.102         P=0.301        |                     P=0.254         P=0.495        |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    13/49 (27%)     12/20 (60%)     12/50 (24%)     |    19/50 (38%)     14/30 (47%)     23/49 (47%)     |
|ADJUSTED (b)           |     43.5%          100.0%           31.1%          |     47.3%           58.2%           61.2%          |
|TERMINAL (d)           |     8/22 (36%)      7/7 (100%)      5/29 (17%)     |    13/33 (39%)      7/14 (50%)     16/30 (53%)     |
|FIRST INCIDENCE (DAYS) |      534             501             622           |      504             547             442           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.196N        P=0.091         P=0.257N       |     P=0.175         P=0.328         P=0.201        |
|INCIDENTAL TUMOR       |     P=0.477N        P=0.003 **      P=0.562N       |     P=0.204         P=0.250         P=0.227        |
|LOGISTIC REGRESSION    |     P=0.398N        P=0.004 **      P=0.517N       |     P=0.203         P=0.260         P=0.236        |
|COCHRAN-ARMITAGE       |     P=0.430N                                       |     P=0.213                                        |
|FISHER EXACT           |                     P=0.010 **      P=0.477N       |                     P=0.298         P=0.243        |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05023 TEST: 01                                                 PAGE  13
                      STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PENTAERYTHRITOL TETRANITRATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2.5%            5.0%          |      CONTROL         0.62%           1.25%         |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    13/49 (27%)     12/20 (60%)     12/50 (24%)     |    19/50 (38%)     14/30 (47%)     24/49 (49%)     |
|ADJUSTED (b)           |     43.5%          100.0%           31.1%          |     47.3%           58.2%           62.1%          |
|TERMINAL (d)           |     8/22 (36%)      7/7 (100%)      5/29 (17%)     |    13/33 (39%)      7/14 (50%)     16/30 (53%)     |
|FIRST INCIDENCE (DAYS) |      534             501             622           |      504             547             442           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.196N        P=0.091         P=0.257N       |     P=0.134         P=0.328         P=0.157        |
|INCIDENTAL TUMOR       |     P=0.477N        P=0.003 **      P=0.562N       |     P=0.145         P=0.250         P=0.158        |
|LOGISTIC REGRESSION    |     P=0.398N        P=0.004 **      P=0.517N       |     P=0.152         P=0.260         P=0.181        |
|COCHRAN-ARMITAGE       |     P=0.430N                                       |     P=0.159                                        |
|FISHER EXACT           |                     P=0.010 **      P=0.477N       |                     P=0.298         P=0.184        |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Keratoacanthoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/50 (6%)       0/50 (0%)       2/50 (4%)      |     1/50 (2%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |     10.5%            0.0%            5.4%          |      3.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/22 (0%)       0/29 (0%)       1/29 (3%)      |     1/33 (3%)       0/33 (0%)       0/31 (0%)      |
|FIRST INCIDENCE (DAYS) |      672             ---             562           |      735 (T)         ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.305N        P=0.084N        P=0.386N       |     P=0.280N        P=0.500N        P=0.512N       |
|INCIDENTAL TUMOR       |     P=0.388N        P=0.128N        P=0.493N       |     P=0.280N        P=0.500N        P=0.512N       |
|LOGISTIC REGRESSION    |     P=0.430N        P=0.115N        P=0.568N       |     P=0.280N        P=0.500N        P=0.512N       |
|COCHRAN-ARMITAGE       |     P=0.390N                                       |     P=0.272N                                       |
|FISHER EXACT           |                     P=0.121N        P=0.500N       |                     P=0.500N        P=0.500N       |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05023 TEST: 01                                                 PAGE  14
                      STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PENTAERYTHRITOL TETRANITRATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2.5%            5.0%          |      CONTROL         0.62%           1.25%         |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       2/50 (4%)       1/50 (2%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      4.5%            5.8%            3.4%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     1/22 (5%)       1/29 (3%)       1/29 (3%)      |     0/33 (0%)       0/33 (0%)       0/31 (0%)      |
|FIRST INCIDENCE (DAYS) |      735 (T)         645             735 (T)       |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.539N        P=0.582         P=0.700N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.541N        P=0.555         P=0.700N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.580N        P=0.523         P=0.700N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.622N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.500         P=0.753N       |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma,                                                                |
|     Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     4/50 (8%)       2/50 (4%)       3/50 (6%)      |     1/50 (2%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |     14.5%            5.8%            8.8%          |      3.0%            0.0%            0.0%          |
|TERMINAL (d)           |     1/22 (5%)       1/29 (3%)       2/29 (7%)      |     1/33 (3%)       0/33 (0%)       0/31 (0%)      |
|FIRST INCIDENCE (DAYS) |      672             645             562           |      735 (T)         ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.298N        P=0.239N        P=0.362N       |     P=0.280N        P=0.500N        P=0.512N       |
|INCIDENTAL TUMOR       |     P=0.360N        P=0.316N        P=0.451N       |     P=0.280N        P=0.500N        P=0.512N       |
|LOGISTIC REGRESSION    |     P=0.424N        P=0.316N        P=0.508N       |     P=0.280N        P=0.500N        P=0.512N       |
|COCHRAN-ARMITAGE       |     P=0.417N                                       |     P=0.272N                                       |
|FISHER EXACT           |                     P=0.339N        P=0.500N       |                     P=0.500N        P=0.500N       |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05023 TEST: 01                                                 PAGE  15
                      STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PENTAERYTHRITOL TETRANITRATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2.5%            5.0%          |      CONTROL         0.62%           1.25%         |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     4/50 (8%)       2/50 (4%)       2/50 (4%)      |     4/50 (8%)       0/50 (0%)       1/50 (2%)      |
|ADJUSTED (b)           |     12.8%            5.7%            5.8%          |     10.5%            0.0%            3.2%          |
|TERMINAL (d)           |     0/22 (0%)       1/29 (3%)       1/29 (3%)      |     2/33 (6%)       0/33 (0%)       1/31 (3%)      |
|FIRST INCIDENCE (DAYS) |      660             641             681           |      639             ---             735 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.164N        P=0.260N        P=0.220N       |     P=0.090N        P=0.067N        P=0.193N       |
|INCIDENTAL TUMOR       |     P=0.218N        P=0.379N        P=0.235N       |     P=0.092N        P=0.066N        P=0.207N       |
|LOGISTIC REGRESSION    |     P=0.235N        P=0.373N        P=0.241N       |     P=0.084N        P=0.062N        P=0.180N       |
|COCHRAN-ARMITAGE       |     P=0.252N                                       |     P=0.083N                                       |
|FISHER EXACT           |                     P=0.339N        P=0.339N       |                     P=0.059N        P=0.181N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibrosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       0/50 (0%)       2/50 (4%)      |     1/50 (2%)       1/50 (2%)       0/50 (0%)      |
|ADJUSTED (b)           |      0.0%            0.0%            4.4%          |      2.0%            3.0%            0.0%          |
|TERMINAL (d)           |     0/22 (0%)       0/29 (0%)       0/29 (0%)      |     0/33 (0%)       1/33 (3%)       0/31 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             622           |      504             735 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.118           (e)           P=0.289        |     P=0.341N        P=0.758         P=0.504N       |
|INCIDENTAL TUMOR       |     P=0.068           (e)           P=0.166        |     P=0.262N        P=0.686         P=0.362N       |
|LOGISTIC REGRESSION    |     P=0.064           (e)           P=0.143        |     P=0.317N        P=0.733N        P=0.419N       |
|COCHRAN-ARMITAGE       |     P=0.095                                        |     P=0.332N                                       |
|FISHER EXACT           |                       (e)           P=0.247        |                     P=0.753N        P=0.500N       |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05023 TEST: 01                                                 PAGE  16
                      STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PENTAERYTHRITOL TETRANITRATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2.5%            5.0%          |      CONTROL         0.62%           1.25%         |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,                                                                                   |
|     Neurofibroma, or Fibroma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     5/50 (10%)      2/50 (4%)       4/50 (8%)      |     5/50 (10%)      1/50 (2%)       2/50 (4%)      |
|ADJUSTED (b)           |     15.4%            5.7%            9.9%          |     12.3%            3.0%            5.8%          |
|TERMINAL (d)           |     0/22 (0%)       1/29 (3%)       1/29 (3%)      |     2/33 (6%)       1/33 (3%)       1/31 (3%)      |
|FIRST INCIDENCE (DAYS) |      660             641             622           |      504             735 (T)         689           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.293N        P=0.158N        P=0.341N       |     P=0.147N        P=0.110N        P=0.234N       |
|INCIDENTAL TUMOR       |     P=0.407N        P=0.248N        P=0.434N       |     P=0.114N        P=0.134N        P=0.186N       |
|LOGISTIC REGRESSION    |     P=0.553N        P=0.250N        P=0.642N       |     P=0.131N        P=0.091N        P=0.205N       |
|COCHRAN-ARMITAGE       |     P=0.424N                                       |     P=0.135N                                       |
|FISHER EXACT           |                     P=0.218N        P=0.500N       |                     P=0.102N        P=0.218N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, or Sarcoma                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       0/50 (0%)       2/50 (4%)      |     1/50 (2%)       1/50 (2%)       1/50 (2%)      |
|ADJUSTED (b)           |      2.9%            0.0%            4.4%          |      2.0%            3.0%            2.7%          |
|TERMINAL (d)           |     0/22 (0%)       0/29 (0%)       0/29 (0%)      |     0/33 (0%)       1/33 (3%)       0/31 (0%)      |
|FIRST INCIDENCE (DAYS) |      660             ---             622           |      504             735 (T)         689           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.423         P=0.473N        P=0.580        |     P=0.632         P=0.758         P=0.758        |
|INCIDENTAL TUMOR       |     P=0.324         P=0.516N        P=0.451        |     P=0.533N        P=0.686         P=0.645N       |
|LOGISTIC REGRESSION    |     P=0.290         P=0.509N        P=0.376        |     P=0.635N        P=0.733N        P=0.738N       |
|COCHRAN-ARMITAGE       |     P=0.360                                        |     P=0.641                                        |
|FISHER EXACT           |                     P=0.500N        P=0.500        |                     P=0.753N        P=0.753N       |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05023 TEST: 01                                                 PAGE  17
                      STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PENTAERYTHRITOL TETRANITRATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2.5%            5.0%          |      CONTROL         0.62%           1.25%         |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    47/49 (96%)     44/50 (88%)     49/50 (98%)     |                                                    |
|ADJUSTED (b)           |    100.0%           95.6%          100.0%          |                                                    |
|TERMINAL (d)           |    22/22 (100%)    27/29 (93%)     29/29 (100%)    |                                                    |
|FIRST INCIDENCE (DAYS) |      479             562             560           |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.076N        P=0.034N*       P=0.082N       |                                                    |
|INCIDENTAL TUMOR       |     P=0.484N        P=0.125N        P=0.674        |                                                    |
|LOGISTIC REGRESSION    |     P=0.507N        P=0.101N        P=0.734        |                                                    |
|COCHRAN-ARMITAGE       |     P=0.407                                        |                                                    |
|FISHER EXACT           |                     P=0.141N        P=0.492        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     5/49 (10%)      2/15 (13%)      7/50 (14%)     |     7/50 (14%)      3/48 (6%)       4/50 (8%)      |
|ADJUSTED (b)           |     18.5%            4.9%           22.1%          |     20.1%            9.4%           11.1%          |
|TERMINAL (d)           |     3/22 (14%)      0/2 (0%)        5/29 (17%)     |     6/33 (18%)      3/32 (9%)       2/31 (6%)      |
|FIRST INCIDENCE (DAYS) |      589             645             709           |      644             735 (T)         662           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.505         P=0.543N        P=0.571        |     P=0.217N        P=0.170N        P=0.286N       |
|INCIDENTAL TUMOR       |     P=0.466         P=0.427         P=0.500        |     P=0.213N        P=0.168N        P=0.284N       |
|LOGISTIC REGRESSION    |     P=0.429         P=0.468         P=0.512        |     P=0.203N        P=0.172N        P=0.268N       |
|COCHRAN-ARMITAGE       |     P=0.337                                        |     P=0.198N                                       |
|FISHER EXACT           |                     P=0.524         P=0.394        |                     P=0.176N        P=0.262N       |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05023 TEST: 01                                                 PAGE  18
                      STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PENTAERYTHRITOL TETRANITRATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2.5%            5.0%          |      CONTROL         0.62%           1.25%         |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/49 (0%)       0/15 (0%)       2/50 (4%)      |     1/50 (2%)       1/48 (2%)       3/50 (6%)      |
|ADJUSTED (b)           |      0.0%            0.0%            5.5%          |      2.5%            3.1%            9.3%          |
|TERMINAL (d)           |     0/22 (0%)       0/2 (0%)        1/29 (3%)      |     0/33 (0%)       1/32 (3%)       2/31 (6%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             641           |      647             735 (T)         709           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.152           (e)           P=0.292        |     P=0.191         P=0.757         P=0.291        |
|INCIDENTAL TUMOR       |     P=0.093           (e)           P=0.172        |     P=0.233         P=0.742         P=0.351        |
|LOGISTIC REGRESSION    |     P=0.125           (e)           P=0.218        |     P=0.200         P=0.755         P=0.302        |
|COCHRAN-ARMITAGE       |     P=0.128                                        |     P=0.203                                        |
|FISHER EXACT           |                       (e)           P=0.253        |                     P=0.742         P=0.309        |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     5/49 (10%)      2/15 (13%)      9/50 (18%)     |     8/50 (16%)      4/48 (8%)       7/50 (14%)     |
|ADJUSTED (b)           |     18.5%            4.9%           26.9%          |     22.1%           12.5%           19.8%          |
|TERMINAL (d)           |     3/22 (14%)      0/2 (0%)        6/29 (21%)     |     6/33 (18%)      4/32 (13%)      4/31 (13%)     |
|FIRST INCIDENCE (DAYS) |      589             645             641           |      644             735 (T)         662           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.303         P=0.543N        P=0.368        |     P=0.477N        P=0.193N        P=0.532N       |
|INCIDENTAL TUMOR       |     P=0.242         P=0.427         P=0.253        |     P=0.443N        P=0.196N        P=0.495N       |
|LOGISTIC REGRESSION    |     P=0.226         P=0.468         P=0.279        |     P=0.453N        P=0.197N        P=0.509N       |
|COCHRAN-ARMITAGE       |     P=0.165                                        |     P=0.443N                                       |
|FISHER EXACT           |                     P=0.524         P=0.205        |                     P=0.199N        P=0.500N       |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05023 TEST: 01                                                 PAGE  19
                      STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PENTAERYTHRITOL TETRANITRATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2.5%            5.0%          |      CONTROL         0.62%           1.25%         |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/49 (2%)       1/15 (7%)       0/50 (0%)      |     0/50 (0%)       0/48 (0%)       2/50 (4%)      |
|ADJUSTED (b)           |      2.6%            2.9%            0.0%          |      0.0%            0.0%            6.5%          |
|TERMINAL (d)           |     0/22 (0%)       0/2 (0%)        0/29 (0%)      |     0/33 (0%)       0/32 (0%)       2/31 (6%)      |
|FIRST INCIDENCE (DAYS) |      641             696             ---           |      ---             ---             735 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.279N        P=0.724N        P=0.462N       |     P=0.089           (e)           P=0.224        |
|INCIDENTAL TUMOR       |     P=0.403N        P=0.564         P=0.674N       |     P=0.089           (e)           P=0.224        |
|LOGISTIC REGRESSION    |     P=0.363N        P=0.480         P=0.586N       |     P=0.089           (e)           P=0.224        |
|COCHRAN-ARMITAGE       |     P=0.346N                                       |     P=0.097                                        |
|FISHER EXACT           |                     P=0.417         P=0.495N       |                       (e)           P=0.247        |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/49 (2%)       2/15 (13%)      0/50 (0%)      |     0/50 (0%)       0/48 (0%)       3/50 (6%)      |
|ADJUSTED (b)           |      2.6%           51.4%            0.0%          |      0.0%            0.0%            9.7%          |
|TERMINAL (d)           |     0/22 (0%)       1/2 (50%)       0/29 (0%)      |     0/33 (0%)       0/32 (0%)       3/31 (10%)     |
|FIRST INCIDENCE (DAYS) |      641             696             ---           |      ---             ---             735 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.296N        P=0.328         P=0.462N       |     P=0.033 *         (e)           P=0.110        |
|INCIDENTAL TUMOR       |     P=0.391N        P=0.123         P=0.674N       |     P=0.033 *         (e)           P=0.110        |
|LOGISTIC REGRESSION    |     P=0.363N        P=0.069         P=0.586N       |     P=0.033 *         (e)           P=0.110        |
|COCHRAN-ARMITAGE       |     P=0.371N                                       |     P=0.038 *                                      |
|FISHER EXACT           |                     P=0.134         P=0.495N       |                       (e)           P=0.121        |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05023 TEST: 01                                                 PAGE  20
                      STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PENTAERYTHRITOL TETRANITRATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2.5%            5.0%          |      CONTROL         0.62%           1.25%         |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Tongue                                                                                                                           |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       1/50 (2%)       0/50 (0%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      6.8%            3.4%            0.0%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     1/22 (5%)       1/29 (3%)       0/29 (0%)      |     0/33 (0%)       0/33 (0%)       0/31 (0%)      |
|FIRST INCIDENCE (DAYS) |      629             735 (T)         ---           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.108N        P=0.428N        P=0.200N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.156N        P=0.497N        P=0.295N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.133N        P=0.485N        P=0.251N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.142N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.500N        P=0.247N       |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |     8/50 (16%)     10/50 (20%)     12/50 (24%)     |
|ADJUSTED (b)           |                                                    |     19.7%           26.0%           31.4%          |
|TERMINAL (d)           |                                                    |     4/33 (12%)      6/33 (18%)      7/31 (23%)     |
|FIRST INCIDENCE (DAYS) |                                                    |      504             585             508           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.182         P=0.400         P=0.217        |
|INCIDENTAL TUMOR       |                                                    |     P=0.181         P=0.373         P=0.204        |
|LOGISTIC REGRESSION    |                                                    |     P=0.195         P=0.410         P=0.237        |
|COCHRAN-ARMITAGE       |                                                    |     P=0.191                                        |
|FISHER EXACT           |                                                    |                     P=0.398         P=0.227        |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05023 TEST: 01                                                 PAGE  21
                      STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PENTAERYTHRITOL TETRANITRATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2.5%            5.0%          |      CONTROL         0.62%           1.25%         |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Zymbal's Gland                                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       1/50 (2%)       0/50 (0%)      |     0/50 (0%)       0/50 (0%)       2/50 (4%)      |
|ADJUSTED (b)           |      0.0%            3.4%            0.0%          |      0.0%            0.0%            5.8%          |
|TERMINAL (d)           |     0/22 (0%)       1/29 (3%)       0/29 (0%)      |     0/33 (0%)       0/33 (0%)       1/31 (3%)      |
|FIRST INCIDENCE (DAYS) |      ---             735 (T)         ---           |      ---             ---             689           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.698N        P=0.555           (e)          |     P=0.093           (e)           P=0.233        |
|INCIDENTAL TUMOR       |     P=0.698N        P=0.555           (e)          |     P=0.115           (e)           P=0.267        |
|LOGISTIC REGRESSION    |     P=0.698N        P=0.555           (e)          |     P=0.094           (e)           P=0.235        |
|COCHRAN-ARMITAGE       |     P=0.731                                        |     P=0.095                                        |
|FISHER EXACT           |                     P=0.500           (e)          |                       (e)           P=0.247        |
|=================================================================================================================================|
|                                                                                                                                 |
|Zymbal's Gland                                                                                                                   |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       2/50 (4%)       2/50 (4%)      |     0/50 (0%)       1/50 (2%)       1/50 (2%)      |
|ADJUSTED (b)           |      0.0%            4.3%            5.9%          |      0.0%            3.0%            2.3%          |
|TERMINAL (d)           |     0/22 (0%)       0/29 (0%)       1/29 (3%)      |     0/33 (0%)       1/33 (3%)       0/31 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             562             687           |      ---             735 (T)         634           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.221         P=0.255         P=0.308        |     P=0.330         P=0.500         P=0.505        |
|INCIDENTAL TUMOR       |     P=0.113         P=0.125         P=0.294        |     P=0.271         P=0.500         P=0.388        |
|LOGISTIC REGRESSION    |     P=0.124         P=0.225         P=0.263        |     P=0.335         P=0.500         P=0.515        |
|COCHRAN-ARMITAGE       |     P=0.176                                        |     P=0.334                                        |
|FISHER EXACT           |                     P=0.247         P=0.247        |                     P=0.500         P=0.500        |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05023 TEST: 01                                                 PAGE  22
                      STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PENTAERYTHRITOL TETRANITRATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2.5%            5.0%          |      CONTROL         0.62%           1.25%         |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Zymbal's Gland                                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       3/50 (6%)       2/50 (4%)      |     0/50 (0%)       1/50 (2%)       3/50 (6%)      |
|ADJUSTED (b)           |      0.0%            7.6%            5.9%          |      0.0%            3.0%            8.0%          |
|TERMINAL (d)           |     0/22 (0%)       1/29 (3%)       1/29 (3%)      |     0/33 (0%)       1/33 (3%)       1/31 (3%)      |
|FIRST INCIDENCE (DAYS) |      ---             562             687           |      ---             735 (T)         634           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.260         P=0.150         P=0.308        |     P=0.059         P=0.500         P=0.122        |
|INCIDENTAL TUMOR       |     P=0.150         P=0.074         P=0.294        |     P=0.054         P=0.500         P=0.104        |
|LOGISTIC REGRESSION    |     P=0.161         P=0.110         P=0.263        |     P=0.060         P=0.500         P=0.122        |
|COCHRAN-ARMITAGE       |     P=0.202                                        |     P=0.060                                        |
|FISHER EXACT           |                     P=0.121         P=0.247        |                     P=0.500         P=0.121        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Leukemia: Lymphocytic, Monocytic, Mononuclear,                                                                              |
|     or Undifferentiated                                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    29/50 (58%)     27/50 (54%)     20/50 (40%)     |    14/50 (28%)     14/50 (28%)      9/50 (18%)     |
|ADJUSTED (b)           |     70.9%           62.0%           54.4%          |     34.3%           31.7%           23.5%          |
|TERMINAL (d)           |    11/22 (50%)     13/29 (45%)     13/29 (45%)     |     7/33 (21%)      4/33 (12%)      4/31 (13%)     |
|FIRST INCIDENCE (DAYS) |      577             501             589           |      610             547             506           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.009N**      P=0.157N        P=0.011N*      |     P=0.202N        P=0.566         P=0.225N       |
|INCIDENTAL TUMOR       |     P=0.038N*       P=0.529N        P=0.037N*      |     P=0.124N        P=0.577         P=0.142N       |
|LOGISTIC REGRESSION    |     P=0.035N*       P=0.528N        P=0.036N*      |     P=0.152N        P=0.583         P=0.171N       |
|COCHRAN-ARMITAGE       |     P=0.045N*                                      |     P=0.148N                                       |
|FISHER EXACT           |                     P=0.420N        P=0.055N       |                     P=0.588N        P=0.171N       |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05023 TEST: 01                                                 PAGE  23
                      STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PENTAERYTHRITOL TETRANITRATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2.5%            5.0%          |      CONTROL         0.62%           1.25%         |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    49/50 (98%)     48/50 (96%)     50/50 (100%)    |    43/50 (86%)     40/50 (80%)     47/50 (94%)     |
|ADJUSTED (b)           |    100.0%          100.0%          100.0%          |     89.5%           88.7%           95.9%          |
|TERMINAL (d)           |    22/22 (100%)    29/29 (100%)    29/29 (100%)    |    28/33 (85%)     28/33 (85%)     29/31 (94%)     |
|FIRST INCIDENCE (DAYS) |      479             501             560           |      441             443             441           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.054N        P=0.061N        P=0.064N       |     P=0.183         P=0.378N        P=0.214        |
|INCIDENTAL TUMOR       |     P=0.695N        P=0.572N          (e)          |     P=0.153         P=0.394N        P=0.160        |
|LOGISTIC REGRESSION    |     P=0.603N        P=0.449N          (e)          |     P=0.139         P=0.325N        P=0.157        |
|COCHRAN-ARMITAGE       |     P=0.360                                        |     P=0.150                                        |
|FISHER EXACT           |                     P=0.500N        P=0.500        |                     P=0.298N        P=0.159        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    33/50 (66%)     32/50 (64%)     31/50 (62%)     |    17/50 (34%)     20/50 (40%)     18/50 (36%)     |
|ADJUSTED (b)           |     75.3%           69.0%           66.5%          |     39.7%           44.6%           42.6%          |
|TERMINAL (d)           |    12/22 (55%)     15/29 (52%)     14/29 (48%)     |     8/33 (24%)      9/33 (27%)      8/31 (26%)     |
|FIRST INCIDENCE (DAYS) |      479             501             560           |      504             200             506           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.099N        P=0.185N        P=0.112N       |     P=0.418         P=0.353         P=0.454        |
|INCIDENTAL TUMOR       |     P=0.539         P=0.453         P=0.576N       |     P=0.496         P=0.363         P=0.561        |
|LOGISTIC REGRESSION    |     P=0.485         P=0.465         P=0.542        |     P=0.474         P=0.363         P=0.477        |
|COCHRAN-ARMITAGE       |     P=0.377N                                       |     P=0.460                                        |
|FISHER EXACT           |                     P=0.500N        P=0.418N       |                     P=0.339         P=0.500        |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05023 TEST: 01                                                 PAGE  24
                      STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PENTAERYTHRITOL TETRANITRATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2.5%            5.0%          |      CONTROL         0.62%           1.25%         |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    49/50 (98%)     49/50 (98%)     50/50 (100%)    |    46/50 (92%)     47/50 (94%)     50/50 (100%)    |
|ADJUSTED (b)           |    100.0%          100.0%          100.0%          |     92.0%           94.0%          100.0%          |
|TERMINAL (d)           |    22/22 (100%)    29/29 (100%)    29/29 (100%)    |    29/33 (88%)     30/33 (91%)     31/31 (100%)    |
|FIRST INCIDENCE (DAYS) |      479             501             560           |      441             200             441           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.056N        P=0.084N        P=0.064N       |     P=0.188         P=0.490         P=0.212        |
|INCIDENTAL TUMOR       |     P=0.718         P=0.718           (e)          |     P=0.053         P=0.500         P=0.070        |
|LOGISTIC REGRESSION    |     P=0.718         P=0.718           (e)          |     P=0.053         P=0.500         P=0.070        |
|COCHRAN-ARMITAGE       |     P=0.331                                        |     P=0.048 *                                      |
|FISHER EXACT           |                     P=0.753N        P=0.500        |                     P=0.500         P=0.059        |
|=================================================================================================================================|
 
 (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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