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TR 365 Mouse Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Mason                                            PENTAERYTHRITOL TETRANITRATE                             DATE: 09/04/94       
EXPERIMENT: 05023 TEST: 02                                                                                     TIME: 02:15:15       
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: 02                                                                                     TIME: 02:15:15      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01CP9561901          ROUTE: DOSED FEED                                                                  NTP C#: 55743       
PATHOLOGIST: K. MURTHY                                                                                         CAS: 78-11-5        
 
 
 
 
 
                                                    MICE(B6C3F1)
                                              ----------------------------
             FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
             IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
 
 
                                                    ----------------
 
                                                    Adrenal Gland
                                                    Bone Marrow
                                                    Brain
                                                    Clitoral Gland
                                                    Epididymis
                                                    Gallbladder
                                                    Heart
                                                    Islets, Pancreatic
                                                    Kidney
                                                    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: 02                                                                                     TIME: 02:15:15       
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 MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Liver                         Hepatocellular Carcinoma or Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
                             Lung                          Alveolar/Bronchiolar Adenoma
                                                           Alveolar/Bronchiolar Carcinoma
                                                           Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
                             Skin: Subcutaneous Tissue     Fibroma
                                                           Fibrosarcoma
                                                           Neurofibrosarcoma, Fibrosarcoma, Sarcoma,
                                                            Neurofibroma, or Fibroma
                                                           Neurofibrosarcoma, Fibrosarcoma, or Sarcoma
                             All Organs                    Benign Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
 
                                                           FEMALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Liver                         Hepatocellular Carcinoma or Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
                             Lung                          Alveolar/Bronchiolar Adenoma
                                                           Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
                             Pituitary Gland: Pars Distalis or Unspecified Site
                                                           Adenoma
                             Uterus                        Polyp Stromal
                             All Organs                    Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,
                                                            NOS, or Undifferentiated Cell Type
                                                           Malignant Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
         DATE: 09/04/94                     EXPERIMENT: 05023 TEST: 02                                                 PAGE   1
                        STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PENTAERYTHRITOL TETRANITRATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2.5%            5.0%          |      CONTROL         2.5%            5.0%          |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/49 (2%)       2/50 (4%)       3/50 (6%)      |     2/50 (4%)       2/50 (4%)       5/50 (10%)     |
|ADJUSTED (b)           |      2.2%            5.3%            7.2%          |      5.3%            6.7%           12.7%          |
|TERMINAL (d)           |     0/26 (0%)       2/38 (5%)       1/38 (3%)      |     2/38 (5%)       2/30 (7%)       4/38 (11%)     |
|FIRST INCIDENCE (DAYS) |      456             729 (T)         682           |      730 (T)         730 (T)         663           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.314         P=0.597         P=0.403        |     P=0.154         P=0.607         P=0.217        |
|INCIDENTAL TUMOR       |     P=0.152         P=0.554         P=0.109        |     P=0.152         P=0.607         P=0.218        |
|LOGISTIC REGRESSION    |     P=0.219         P=0.467         P=0.290        |     P=0.144         P=0.607         P=0.212        |
|COCHRAN-ARMITAGE       |     P=0.228                                        |     P=0.146                                        |
|FISHER EXACT           |                     P=0.508         P=0.316        |                     P=0.691N        P=0.218        |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/49 (2%)       2/50 (4%)       3/50 (6%)      |     3/50 (6%)       2/50 (4%)       5/50 (10%)     |
|ADJUSTED (b)           |      2.2%            5.3%            7.2%          |      7.9%            6.7%           12.7%          |
|TERMINAL (d)           |     0/26 (0%)       2/38 (5%)       1/38 (3%)      |     3/38 (8%)       2/30 (7%)       4/38 (11%)     |
|FIRST INCIDENCE (DAYS) |      456             729 (T)         682           |      730 (T)         730 (T)         663           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.314         P=0.597         P=0.403        |     P=0.279         P=0.608N        P=0.355        |
|INCIDENTAL TUMOR       |     P=0.152         P=0.554         P=0.109        |     P=0.279         P=0.608N        P=0.357        |
|LOGISTIC REGRESSION    |     P=0.219         P=0.467         P=0.290        |     P=0.267         P=0.608N        P=0.348        |
|COCHRAN-ARMITAGE       |     P=0.228                                        |     P=0.274                                        |
|FISHER EXACT           |                     P=0.508         P=0.316        |                     P=0.500N        P=0.357        |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05023 TEST: 02                                                 PAGE   2
                        STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PENTAERYTHRITOL TETRANITRATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2.5%            5.0%          |      CONTROL         2.5%            5.0%          |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/48 (2%)       2/24 (8%)       0/49 (0%)      |     1/49 (2%)       2/50 (4%)       0/49 (0%)      |
|ADJUSTED (b)           |      3.3%           14.3%            0.0%          |      2.7%            6.7%            0.0%          |
|TERMINAL (d)           |     0/26 (0%)       2/14 (14%)      0/38 (0%)      |     1/37 (3%)       2/30 (7%)       0/38 (0%)      |
|FIRST INCIDENCE (DAYS) |      695             729 (T)         ---           |      730 (T)         730 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.274N        P=0.391         P=0.448N       |     P=0.358N        P=0.427         P=0.495N       |
|INCIDENTAL TUMOR       |     P=0.335N        P=0.272         P=0.581N       |     P=0.358N        P=0.427         P=0.495N       |
|LOGISTIC REGRESSION    |     P=0.307N        P=0.263         P=0.483N       |     P=0.358N        P=0.427         P=0.495N       |
|COCHRAN-ARMITAGE       |     P=0.366N                                       |     P=0.360N                                       |
|FISHER EXACT           |                     P=0.256         P=0.495N       |                     P=0.508         P=0.500N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     9/48 (19%)      7/24 (29%)      7/49 (14%)     |     5/49 (10%)      2/50 (4%)       1/49 (2%)      |
|ADJUSTED (b)           |     26.6%           38.7%           18.4%          |     13.5%            5.5%            2.6%          |
|TERMINAL (d)           |     4/26 (15%)      5/14 (36%)      7/38 (18%)     |     5/37 (14%)      0/30 (0%)       1/38 (3%)      |
|FIRST INCIDENCE (DAYS) |      414             600             729 (T)       |      730 (T)         662             730 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.124N        P=0.606N        P=0.169N       |     P=0.065N        P=0.301N        P=0.096N       |
|INCIDENTAL TUMOR       |     P=0.300N        P=0.226         P=0.402N       |     P=0.059N        P=0.236N        P=0.096N       |
|LOGISTIC REGRESSION    |     P=0.274N        P=0.246         P=0.343N       |     P=0.061N        P=0.247N        P=0.096N       |
|COCHRAN-ARMITAGE       |     P=0.331N                                       |     P=0.059N                                       |
|FISHER EXACT           |                     P=0.239         P=0.375N       |                     P=0.210N        P=0.102N       |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05023 TEST: 02                                                 PAGE   3
                        STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PENTAERYTHRITOL TETRANITRATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2.5%            5.0%          |      CONTROL         2.5%            5.0%          |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/48 (6%)       4/24 (17%)      5/49 (10%)     |     1/49 (2%)       0/50 (0%)       0/49 (0%)      |
|ADJUSTED (b)           |     10.2%           13.3%           13.2%          |      2.3%            0.0%            0.0%          |
|TERMINAL (d)           |     2/26 (8%)       1/14 (7%)       5/38 (13%)     |     0/37 (0%)       0/30 (0%)       0/38 (0%)      |
|FIRST INCIDENCE (DAYS) |      601             620             729 (T)       |      654             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.503         P=0.428         P=0.563        |     P=0.273N        P=0.519N        P=0.500N       |
|INCIDENTAL TUMOR       |     P=0.334         P=0.115         P=0.487        |     P=0.256N        P=0.429N        P=0.500N       |
|LOGISTIC REGRESSION    |     P=0.366         P=0.165         P=0.455        |     P=0.267N        P=0.482N        P=0.504N       |
|COCHRAN-ARMITAGE       |     P=0.317                                        |     P=0.269N                                       |
|FISHER EXACT           |                     P=0.162         P=0.369        |                     P=0.495N        P=0.500N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    11/48 (23%)     11/24 (46%)     11/49 (22%)     |     6/49 (12%)      2/50 (4%)       1/49 (2%)      |
|ADJUSTED (b)           |     33.2%           49.1%           28.9%          |     15.5%            5.5%            2.6%          |
|TERMINAL (d)           |     6/26 (23%)      6/14 (43%)     11/38 (29%)     |     5/37 (14%)      0/30 (0%)       1/38 (3%)      |
|FIRST INCIDENCE (DAYS) |      414             600             729 (T)       |      654             662             730 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.199N        P=0.357         P=0.258N       |     P=0.033N*       P=0.203N        P=0.056N       |
|INCIDENTAL TUMOR       |     P=0.461N        P=0.033 *       P=0.501N       |     P=0.028N*       P=0.131N        P=0.056N       |
|LOGISTIC REGRESSION    |     P=0.428N        P=0.044 *       P=0.496N       |     P=0.029N*       P=0.145N        P=0.056N       |
|COCHRAN-ARMITAGE       |     P=0.521N                                       |     P=0.029N*                                      |
|FISHER EXACT           |                     P=0.044 *       P=0.574N       |                     P=0.128N        P=0.056N       |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05023 TEST: 02                                                 PAGE   4
                        STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PENTAERYTHRITOL TETRANITRATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2.5%            5.0%          |      CONTROL         2.5%            5.0%          |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    11/48 (23%)     11/24 (46%)     11/49 (22%)     |     6/49 (12%)      2/50 (4%)       1/49 (2%)      |
|ADJUSTED (b)           |     33.2%           49.1%           28.9%          |     15.5%            5.5%            2.6%          |
|TERMINAL (d)           |     6/26 (23%)      6/14 (43%)     11/38 (29%)     |     5/37 (14%)      0/30 (0%)       1/38 (3%)      |
|FIRST INCIDENCE (DAYS) |      414             600             729 (T)       |      654             662             730 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.199N        P=0.357         P=0.258N       |     P=0.033N*       P=0.203N        P=0.056N       |
|INCIDENTAL TUMOR       |     P=0.461N        P=0.033 *       P=0.501N       |     P=0.028N*       P=0.131N        P=0.056N       |
|LOGISTIC REGRESSION    |     P=0.428N        P=0.044 *       P=0.496N       |     P=0.029N*       P=0.145N        P=0.056N       |
|COCHRAN-ARMITAGE       |     P=0.521N                                       |     P=0.029N*                                      |
|FISHER EXACT           |                     P=0.044 *       P=0.574N       |                     P=0.128N        P=0.056N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    11/47 (23%)      5/17 (29%)      3/50 (6%)      |     2/50 (4%)       2/16 (13%)      5/49 (10%)     |
|ADJUSTED (b)           |     40.7%           40.3%            7.9%          |      5.3%          100.0%           12.7%          |
|TERMINAL (d)           |    10/26 (38%)      3/8 (38%)       3/38 (8%)      |     2/38 (5%)       1/1 (100%)      4/38 (11%)     |
|FIRST INCIDENCE (DAYS) |      727             600             729 (T)       |      730 (T)         714             663           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.002N**      P=0.563         P=0.002N**     |     P=0.182         P=0.044 *       P=0.217        |
|INCIDENTAL TUMOR       |     P=0.004N**      P=0.306         P=0.003N**     |     P=0.185         P=0.036 *       P=0.218        |
|LOGISTIC REGRESSION    |     P=0.004N**      P=0.268         P=0.002N**     |     P=0.175         P=0.007 **      P=0.210        |
|COCHRAN-ARMITAGE       |     P=0.015N*                                      |     P=0.167                                        |
|FISHER EXACT           |                     P=0.425         P=0.015N*      |                     P=0.245         P=0.210        |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05023 TEST: 02                                                 PAGE   5
                        STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PENTAERYTHRITOL TETRANITRATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2.5%            5.0%          |      CONTROL         2.5%            5.0%          |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/47 (2%)       4/17 (24%)      5/50 (10%)     |     1/50 (2%)       1/16 (6%)       0/49 (0%)      |
|ADJUSTED (b)           |      3.8%           38.9%           11.6%          |      2.6%            3.2%            0.0%          |
|TERMINAL (d)           |     1/26 (4%)       3/8 (38%)       2/38 (5%)      |     1/38 (3%)       0/1 (0%)        0/38 (0%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         655             652           |      730 (T)         728             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.211         P=0.017 *       P=0.196        |     P=0.353N        P=0.476         P=0.500N       |
|INCIDENTAL TUMOR       |     P=0.144         P=0.006 **      P=0.112        |     P=0.352N        P=0.456         P=0.500N       |
|LOGISTIC REGRESSION    |     P=0.153         P=0.004 **      P=0.128        |     P=0.367N        P=0.111         P=0.500N       |
|COCHRAN-ARMITAGE       |     P=0.123                                        |     P=0.355N                                       |
|FISHER EXACT           |                     P=0.015 *       P=0.117        |                     P=0.429         P=0.505N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    11/47 (23%)      9/17 (53%)      7/50 (14%)     |     3/50 (6%)       3/16 (19%)      5/49 (10%)     |
|ADJUSTED (b)           |     40.7%           76.7%           16.5%          |      7.9%          100.0%           12.7%          |
|TERMINAL (d)           |    10/26 (38%)      6/8 (75%)       4/38 (11%)     |     3/38 (8%)       1/1 (100%)      4/38 (11%)     |
|FIRST INCIDENCE (DAYS) |      727             600             652           |      730 (T)         714             663           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.037N*       P=0.059         P=0.053N       |     P=0.307         P=0.026 *       P=0.355        |
|INCIDENTAL TUMOR       |     P=0.077N        P=0.006 **      P=0.084N       |     P=0.310         P=0.016 *       P=0.357        |
|LOGISTIC REGRESSION    |     P=0.077N        P=0.003 **      P=0.086N       |     P=0.297         P<0.001 **      P=0.347        |
|COCHRAN-ARMITAGE       |     P=0.157N                                       |     P=0.293                                        |
|FISHER EXACT           |                     P=0.028 *       P=0.176N       |                     P=0.148         P=0.346        |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05023 TEST: 02                                                 PAGE   6
                        STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PENTAERYTHRITOL TETRANITRATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2.5%            5.0%          |      CONTROL         2.5%            5.0%          |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/49 (0%)       0/50 (0%)       0/50 (0%)      |     1/50 (2%)       2/50 (4%)       1/50 (2%)      |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |      2.6%            5.4%            2.6%          |
|TERMINAL (d)           |     0/26 (0%)       0/38 (0%)       0/38 (0%)      |     0/38 (0%)       0/30 (0%)       1/38 (3%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      729             586             730 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.616         P=0.439         P=0.757        |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.607N        P=0.703         P=0.760        |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.622         P=0.506         P=0.756        |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.622N                                       |
|FISHER EXACT           |                       (e)             (e)          |                     P=0.500         P=0.753N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Cystadenoma                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |     1/50 (2%)       0/19 (0%)       2/48 (4%)      |
|ADJUSTED (b)           |                                                    |      2.3%            0.0%            5.4%          |
|TERMINAL (d)           |                                                    |     0/38 (0%)       0/5 (0%)        2/37 (5%)      |
|FIRST INCIDENCE (DAYS) |                                                    |      689             ---             730 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.365         P=0.541N        P=0.485        |
|INCIDENTAL TUMOR       |                                                    |     P=0.373         P=0.612N        P=0.494        |
|LOGISTIC REGRESSION    |                                                    |     P=0.366         P=0.735N        P=0.488        |
|COCHRAN-ARMITAGE       |                                                    |     P=0.362                                        |
|FISHER EXACT           |                                                    |                     P=0.725N        P=0.485        |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05023 TEST: 02                                                 PAGE   7
                        STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PENTAERYTHRITOL TETRANITRATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2.5%            5.0%          |      CONTROL         2.5%            5.0%          |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Granulosa Cell Tumor Benign                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |     2/50 (4%)       1/19 (5%)       0/48 (0%)      |
|ADJUSTED (b)           |                                                    |      5.3%           20.0%            0.0%          |
|TERMINAL (d)           |                                                    |     2/38 (5%)       1/5 (20%)       0/37 (0%)      |
|FIRST INCIDENCE (DAYS) |                                                    |      730 (T)         730 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.189N        P=0.390         P=0.244N       |
|INCIDENTAL TUMOR       |                                                    |     P=0.189N        P=0.390         P=0.244N       |
|LOGISTIC REGRESSION    |                                                    |     P=0.189N        P=0.390         P=0.244N       |
|COCHRAN-ARMITAGE       |                                                    |     P=0.177N                                       |
|FISHER EXACT           |                                                    |                     P=0.626         P=0.258N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/45 (0%)       0/8 (0%)        1/48 (2%)      |     8/45 (18%)      3/15 (20%)      5/42 (12%)     |
|ADJUSTED (b)           |      0.0%            0.0%            2.8%          |     22.9%          100.0%           13.9%          |
|TERMINAL (d)           |     0/25 (0%)       0/0             1/36 (3%)      |     8/35 (23%)      3/3 (100%)      5/36 (14%)     |
|FIRST INCIDENCE (DAYS) |      ---             ---             729 (T)       |      730 (T)         730 (T)         730 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.373           (e)           P=0.573        |     P=0.218N        P=0.016 *       P=0.253N       |
|INCIDENTAL TUMOR       |     P=0.373           (e)           P=0.573        |     P=0.218N        P=0.016 *       P=0.253N       |
|LOGISTIC REGRESSION    |     P=0.373           (e)           P=0.573        |     P=0.218N        P=0.016 *       P=0.253N       |
|COCHRAN-ARMITAGE       |     P=0.311                                        |     P=0.275N                                       |
|FISHER EXACT           |                       (e)           P=0.516        |                     P=0.559         P=0.322N       |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05023 TEST: 02                                                 PAGE   8
                        STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PENTAERYTHRITOL TETRANITRATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2.5%            5.0%          |      CONTROL         2.5%            5.0%          |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/45 (0%)       0/8 (0%)        1/48 (2%)      |     9/45 (20%)      3/15 (20%)      5/42 (12%)     |
|ADJUSTED (b)           |      0.0%            0.0%            2.8%          |     24.5%          100.0%           13.9%          |
|TERMINAL (d)           |     0/25 (0%)       0/0             1/36 (3%)      |     8/35 (23%)      3/3 (100%)      5/36 (14%)     |
|FIRST INCIDENCE (DAYS) |      ---             ---             729 (T)       |      549             730 (T)         730 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.373           (e)           P=0.573        |     P=0.150N        P=0.107         P=0.176N       |
|INCIDENTAL TUMOR       |     P=0.373           (e)           P=0.573        |     P=0.148N        P=0.158         P=0.177N       |
|LOGISTIC REGRESSION    |     P=0.373           (e)           P=0.573        |     P=0.182N        P=0.208         P=0.217N       |
|COCHRAN-ARMITAGE       |     P=0.311                                        |     P=0.194N                                       |
|FISHER EXACT           |                       (e)           P=0.516        |                     P=0.657N        P=0.232N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     5/49 (10%)      2/50 (4%)       1/50 (2%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |     18.0%            5.3%            2.6%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     4/26 (15%)      2/38 (5%)       1/38 (3%)      |     0/38 (0%)       0/30 (0%)       0/38 (0%)      |
|FIRST INCIDENCE (DAYS) |      682             729 (T)         729 (T)       |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.021N*       P=0.098N        P=0.041N*      |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.026N*       P=0.122N        P=0.052N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.027N*       P=0.125N        P=0.053N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.057N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.210N        P=0.098N       |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05023 TEST: 02                                                 PAGE   9
                        STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PENTAERYTHRITOL TETRANITRATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2.5%            5.0%          |      CONTROL         2.5%            5.0%          |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibrosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    14/49 (29%)      2/50 (4%)       8/50 (16%)     |     0/50 (0%)       2/50 (4%)       1/50 (2%)      |
|ADJUSTED (b)           |     35.8%            4.9%           17.8%          |      0.0%            5.6%            2.1%          |
|TERMINAL (d)           |     4/26 (15%)      0/38 (0%)       3/38 (8%)      |     0/38 (0%)       1/30 (3%)       0/38 (0%)      |
|FIRST INCIDENCE (DAYS) |      456             656             564           |      ---             630             586           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.026N*       P<0.001N**      P=0.042N*      |     P=0.366         P=0.204         P=0.508        |
|INCIDENTAL TUMOR       |     P=0.257N        P=0.007N**      P=0.413N       |     P=0.398         P=0.320         P=0.581        |
|LOGISTIC REGRESSION    |     P=0.193N        P=0.003N**      P=0.347N       |     P=0.359         P=0.240         P=0.510        |
|COCHRAN-ARMITAGE       |     P=0.061N                                       |     P=0.360                                        |
|FISHER EXACT           |                     P<0.001N**      P=0.103N       |                     P=0.247         P=0.500        |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,                                                                                   |
|     Neurofibroma, or Fibroma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    20/49 (41%)      7/50 (14%)      9/50 (18%)     |     0/50 (0%)       2/50 (4%)       1/50 (2%)      |
|ADJUSTED (b)           |     50.5%           17.0%           20.1%          |      0.0%            5.6%            2.1%          |
|TERMINAL (d)           |     8/26 (31%)      4/38 (11%)      4/38 (11%)     |     0/38 (0%)       1/30 (3%)       0/38 (0%)      |
|FIRST INCIDENCE (DAYS) |      456             656             564           |      ---             630             586           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.001N**      P<0.001N**      P=0.003N**     |     P=0.366         P=0.204         P=0.508        |
|INCIDENTAL TUMOR       |     P=0.024N*       P=0.010N**      P=0.057N       |     P=0.398         P=0.320         P=0.581        |
|LOGISTIC REGRESSION    |     P=0.015N*       P=0.005N**      P=0.040N*      |     P=0.359         P=0.240         P=0.510        |
|COCHRAN-ARMITAGE       |     P=0.006N**                                     |     P=0.360                                        |
|FISHER EXACT           |                     P=0.003N**      P=0.011N*      |                     P=0.247         P=0.500        |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05023 TEST: 02                                                 PAGE  10
                        STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PENTAERYTHRITOL TETRANITRATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2.5%            5.0%          |      CONTROL         2.5%            5.0%          |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, or Sarcoma                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    15/49 (31%)      5/50 (10%)      8/50 (16%)     |     0/50 (0%)       2/50 (4%)       1/50 (2%)      |
|ADJUSTED (b)           |     37.5%           12.1%           17.8%          |      0.0%            5.6%            2.1%          |
|TERMINAL (d)           |     4/26 (15%)      2/38 (5%)       3/38 (8%)      |     0/38 (0%)       1/30 (3%)       0/38 (0%)      |
|FIRST INCIDENCE (DAYS) |      456             656             564           |      ---             630             586           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.016N*       P=0.004N**      P=0.027N*      |     P=0.366         P=0.204         P=0.508        |
|INCIDENTAL TUMOR       |     P=0.195N        P=0.055N        P=0.344N       |     P=0.398         P=0.320         P=0.581        |
|LOGISTIC REGRESSION    |     P=0.136N        P=0.026N*       P=0.278N       |     P=0.359         P=0.240         P=0.510        |
|COCHRAN-ARMITAGE       |     P=0.043N*                                      |     P=0.360                                        |
|FISHER EXACT           |                     P=0.010N**      P=0.069N       |                     P=0.247         P=0.500        |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Sarcoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/49 (4%)       2/50 (4%)       0/50 (0%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      5.7%            5.1%            0.0%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/26 (0%)       1/38 (3%)       0/38 (0%)      |     0/38 (0%)       0/30 (0%)       0/38 (0%)      |
|FIRST INCIDENCE (DAYS) |      600             698             ---           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.120N        P=0.587N        P=0.188N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.251N        P=0.550         P=0.363N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.169N        P=0.685N        P=0.243N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.171N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.684N        P=0.242N       |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05023 TEST: 02                                                 PAGE  11
                        STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PENTAERYTHRITOL TETRANITRATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2.5%            5.0%          |      CONTROL         2.5%            5.0%          |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Spleen                                                                                                                           |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/47 (0%)       2/26 (8%)       0/47 (0%)      |     0/50 (0%)       0/50 (0%)       1/50 (2%)      |
|ADJUSTED (b)           |      0.0%           12.5%            0.0%          |      0.0%            0.0%            2.2%          |
|TERMINAL (d)           |     0/26 (0%)       2/16 (13%)      0/38 (0%)      |     0/38 (0%)       0/30 (0%)       0/38 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             729 (T)         ---           |      ---             ---             646           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.564N        P=0.138           (e)          |     P=0.274           (e)           P=0.500        |
|INCIDENTAL TUMOR       |     P=0.564N        P=0.138           (e)          |     P=0.256           (e)           P=0.500        |
|LOGISTIC REGRESSION    |     P=0.564N        P=0.138           (e)          |     P=0.266           (e)           P=0.503        |
|COCHRAN-ARMITAGE       |     P=0.656                                        |     P=0.269                                        |
|FISHER EXACT           |                     P=0.124           (e)          |                       (e)           P=0.500        |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Squamous Cell Carcinoma or Papilloma Squamous                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/49 (0%)       2/50 (4%)       0/50 (0%)      |     1/50 (2%)       0/50 (0%)       1/50 (2%)      |
|ADJUSTED (b)           |      0.0%            5.3%            0.0%          |      2.6%            0.0%            2.6%          |
|TERMINAL (d)           |     0/26 (0%)       2/38 (5%)       0/38 (0%)      |     1/38 (3%)       0/30 (0%)       1/38 (3%)      |
|FIRST INCIDENCE (DAYS) |      ---             729 (T)         ---           |      730 (T)         ---             730 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.595N        P=0.325           (e)          |     P=0.663         P=0.547N        P=0.762        |
|INCIDENTAL TUMOR       |     P=0.595N        P=0.325           (e)          |     P=0.663         P=0.547N        P=0.762        |
|LOGISTIC REGRESSION    |     P=0.595N        P=0.325           (e)          |     P=0.663         P=0.547N        P=0.762        |
|COCHRAN-ARMITAGE       |     P=0.665N                                       |     P=0.669N                                       |
|FISHER EXACT           |                     P=0.253           (e)          |                     P=0.500N        P=0.753N       |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05023 TEST: 02                                                 PAGE  12
                        STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PENTAERYTHRITOL TETRANITRATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2.5%            5.0%          |      CONTROL         2.5%            5.0%          |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/46 (4%)       0/8 (0%)        2/46 (4%)      |     1/47 (2%)       0/12 (0%)       0/47 (0%)      |
|ADJUSTED (b)           |      7.7%            0.0%            5.3%          |      2.8%            0.0%            0.0%          |
|TERMINAL (d)           |     2/26 (8%)       0/0             2/38 (5%)      |     1/36 (3%)       0/0             0/38 (0%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         ---             729 (T)       |      730 (T)         ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.448N          (e)           P=0.552N       |     P=0.299N          (e)           P=0.489N       |
|INCIDENTAL TUMOR       |     P=0.448N          (e)           P=0.552N       |     P=0.299N          (e)           P=0.489N       |
|LOGISTIC REGRESSION    |     P=0.448N          (e)           P=0.552N       |     P=0.299N          (e)           P=0.489N       |
|COCHRAN-ARMITAGE       |     P=0.605                                        |     P=0.297N                                       |
|FISHER EXACT           |                     P=0.723N        P=0.692N       |                     P=0.797N        P=0.500N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |     3/50 (6%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |                                                    |      7.9%            0.0%            0.0%          |
|TERMINAL (d)           |                                                    |     3/38 (8%)       0/30 (0%)       0/38 (0%)      |
|FIRST INCIDENCE (DAYS) |                                                    |      730 (T)         ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.043N*       P=0.165N        P=0.121N       |
|INCIDENTAL TUMOR       |                                                    |     P=0.043N*       P=0.165N        P=0.121N       |
|LOGISTIC REGRESSION    |                                                    |     P=0.043N*       P=0.165N        P=0.121N       |
|COCHRAN-ARMITAGE       |                                                    |     P=0.037N*                                      |
|FISHER EXACT           |                                                    |                     P=0.121N        P=0.121N       |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05023 TEST: 02                                                 PAGE  13
                        STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PENTAERYTHRITOL TETRANITRATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2.5%            5.0%          |      CONTROL         2.5%            5.0%          |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/49 (2%)       5/50 (10%)      1/50 (2%)      |     1/50 (2%)       2/50 (4%)       1/50 (2%)      |
|ADJUSTED (b)           |      3.3%           13.2%            2.5%          |      2.6%            6.7%            2.2%          |
|TERMINAL (d)           |     0/26 (0%)       5/38 (13%)      0/38 (0%)      |     1/38 (3%)       2/30 (7%)       0/38 (0%)      |
|FIRST INCIDENCE (DAYS) |      695             729 (T)         694           |      730 (T)         730 (T)         646           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.449N        P=0.206         P=0.698N       |     P=0.617N        P=0.417         P=0.760        |
|INCIDENTAL TUMOR       |     P=0.518N        P=0.167         P=0.710        |     P=0.620         P=0.417         P=0.760        |
|LOGISTIC REGRESSION    |     P=0.498N        P=0.169         P=0.744N       |     P=0.620         P=0.417         P=0.762N       |
|COCHRAN-ARMITAGE       |     P=0.585N                                       |     P=0.622N                                       |
|FISHER EXACT           |                     P=0.107         P=0.747N       |                     P=0.500         P=0.753N       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma or Hemangioma                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/49 (2%)       6/50 (12%)      2/50 (4%)      |     1/50 (2%)       2/50 (4%)       1/50 (2%)      |
|ADJUSTED (b)           |      3.3%           15.8%            5.1%          |      2.6%            6.7%            2.2%          |
|TERMINAL (d)           |     0/26 (0%)       6/38 (16%)      1/38 (3%)      |     1/38 (3%)       2/30 (7%)       0/38 (0%)      |
|FIRST INCIDENCE (DAYS) |      695             729 (T)         694           |      730 (T)         730 (T)         646           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.586         P=0.138         P=0.606        |     P=0.617N        P=0.417         P=0.760        |
|INCIDENTAL TUMOR       |     P=0.524         P=0.110         P=0.485        |     P=0.620         P=0.417         P=0.760        |
|LOGISTIC REGRESSION    |     P=0.537         P=0.109         P=0.521        |     P=0.620         P=0.417         P=0.762N       |
|COCHRAN-ARMITAGE       |     P=0.426                                        |     P=0.622N                                       |
|FISHER EXACT           |                     P=0.059         P=0.508        |                     P=0.500         P=0.753N       |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05023 TEST: 02                                                 PAGE  14
                        STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PENTAERYTHRITOL TETRANITRATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2.5%            5.0%          |      CONTROL         2.5%            5.0%          |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma And Histiocytic Sarcoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     4/49 (8%)       5/50 (10%)      4/50 (8%)      |    20/50 (40%)     17/50 (34%)     13/50 (26%)     |
|ADJUSTED (b)           |     13.0%           12.6%           10.5%          |     44.1%           41.3%           30.4%          |
|TERMINAL (d)           |     2/26 (8%)       4/38 (11%)      4/38 (11%)     |    13/38 (34%)      8/30 (27%)      9/38 (24%)     |
|FIRST INCIDENCE (DAYS) |      578             655             729 (T)       |      522             521             463           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.373N        P=0.576N        P=0.451N       |     P=0.119N        P=0.551         P=0.130N       |
|INCIDENTAL TUMOR       |     P=0.477N        P=0.524         P=0.559N       |     P=0.078N        P=0.195N        P=0.110N       |
|LOGISTIC REGRESSION    |     P=0.479N        P=0.580         P=0.561N       |     P=0.056N        P=0.165N        P=0.101N       |
|COCHRAN-ARMITAGE       |     P=0.558N                                       |     P=0.084N                                       |
|FISHER EXACT           |                     P=0.513         P=0.631N       |                     P=0.339N        P=0.101N       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,                                                                        |
|     NOS, or Undifferentiated Cell Type                                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     4/49 (8%)       5/50 (10%)      4/50 (8%)      |    20/50 (40%)     17/50 (34%)     12/50 (24%)     |
|ADJUSTED (b)           |     13.0%           12.6%           10.5%          |     44.1%           41.3%           28.0%          |
|TERMINAL (d)           |     2/26 (8%)       4/38 (11%)      4/38 (11%)     |    13/38 (34%)      8/30 (27%)      8/38 (21%)     |
|FIRST INCIDENCE (DAYS) |      578             655             729 (T)       |      522             521             463           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.373N        P=0.576N        P=0.451N       |     P=0.085N        P=0.551         P=0.092N       |
|INCIDENTAL TUMOR       |     P=0.477N        P=0.524         P=0.559N       |     P=0.050N        P=0.195N        P=0.073N       |
|LOGISTIC REGRESSION    |     P=0.479N        P=0.580         P=0.561N       |     P=0.034N*       P=0.165N        P=0.067N       |
|COCHRAN-ARMITAGE       |     P=0.558N                                       |     P=0.055N                                       |
|FISHER EXACT           |                     P=0.513         P=0.631N       |                     P=0.339N        P=0.066N       |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05023 TEST: 02                                                 PAGE  15
                        STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PENTAERYTHRITOL TETRANITRATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2.5%            5.0%          |      CONTROL         2.5%            5.0%          |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    25/49 (51%)     16/50 (32%)     19/50 (38%)     |    18/50 (36%)     12/50 (24%)     18/50 (36%)     |
|ADJUSTED (b)           |     74.9%           38.7%           47.3%          |     46.0%           34.5%           44.6%          |
|TERMINAL (d)           |    18/26 (69%)     13/38 (34%)     17/38 (45%)     |    17/38 (45%)      8/30 (27%)     16/38 (42%)     |
|FIRST INCIDENCE (DAYS) |      414             600             682           |      689             662             258           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.006N**      P=0.002N**      P=0.005N**     |     P=0.535         P=0.356N        P=0.581        |
|INCIDENTAL TUMOR       |     P=0.036N*       P=0.011N*       P=0.037N*      |     P=0.543N        P=0.252N        P=0.585        |
|LOGISTIC REGRESSION    |     P=0.039N*       P=0.013N*       P=0.043N*      |     P=0.521         P=0.239N        P=0.581N       |
|COCHRAN-ARMITAGE       |     P=0.113N                                       |     P=0.543                                        |
|FISHER EXACT           |                     P=0.043N*       P=0.135N       |                     P=0.138N        P=0.582N       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    21/49 (43%)     21/50 (42%)     20/50 (40%)     |    28/50 (56%)     22/50 (44%)     17/50 (34%)     |
|ADJUSTED (b)           |     50.5%           47.6%           43.1%          |     57.1%           50.9%           38.0%          |
|TERMINAL (d)           |     7/26 (27%)     15/38 (39%)     12/38 (32%)     |    17/38 (45%)     10/30 (33%)     11/38 (29%)     |
|FIRST INCIDENCE (DAYS) |      456             620             564           |      338               5             463           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.123N        P=0.188N        P=0.155N       |     P=0.045N*       P=0.461N        P=0.048N*      |
|INCIDENTAL TUMOR       |     P=0.438         P=0.360         P=0.341        |     P=0.013N*       P=0.055N        P=0.019N*      |
|LOGISTIC REGRESSION    |     P=0.506         P=0.478         P=0.387        |     P=0.016N*       P=0.115N        P=0.016N*      |
|COCHRAN-ARMITAGE       |     P=0.426N                                       |     P=0.017N*                                      |
|FISHER EXACT           |                     P=0.547N        P=0.466N       |                     P=0.159N        P=0.022N*      |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05023 TEST: 02                                                 PAGE  16
                        STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PENTAERYTHRITOL TETRANITRATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         2.5%            5.0%          |      CONTROL         2.5%            5.0%          |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    36/49 (73%)     28/50 (56%)     32/50 (64%)     |    37/50 (74%)     29/50 (58%)     29/50 (58%)     |
|ADJUSTED (b)           |     83.4%           62.1%           68.0%          |     75.5%           65.3%           64.0%          |
|TERMINAL (d)           |    19/26 (73%)     21/38 (55%)     23/38 (61%)     |    26/38 (68%)     15/30 (50%)     22/38 (58%)     |
|FIRST INCIDENCE (DAYS) |      414             600             564           |      338               5             258           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.013N*       P=0.003N**      P=0.014N*      |     P=0.124N        P=0.449N        P=0.127N       |
|INCIDENTAL TUMOR       |     P=0.200N        P=0.064N        P=0.291N       |     P=0.054N        P=0.036N*       P=0.068N       |
|LOGISTIC REGRESSION    |     P=0.175N        P=0.019N*       P=0.120N       |     P=0.059N        P=0.062N        P=0.068N       |
|COCHRAN-ARMITAGE       |     P=0.192N                                       |     P=0.060N                                       |
|FISHER EXACT           |                     P=0.054N        P=0.212N       |                     P=0.069N        P=0.069N       |
|=================================================================================================================================|
 
 (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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