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TDMS Study 05217-04 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                               T-BUTYLHYDROQUINONE                                  DATE: 04/04/96       
EXPERIMENT: 05217 TEST: 04                                                                                     TIME: 08:26:28       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1ES85219                                ROUTE: DOSED FEED                                              NTP C#: C62157       
PATHOLOGIST: J. E. HEATH                                                                                       CAS: 1948330         
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    

               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                               T-BUTYLHYDROQUINONE                                  DATE: 04/04/96       
EXPERIMENT: 05217 TEST: 04                                                                                     TIME: 08:26:28       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1ES85219                                ROUTE: DOSED FEED                                              NTP C#: C62157       
PATHOLOGIST: J. E. HEATH                                                                                       CAS: 1948330         




                                                    RATS(FISCHER344)
                                              ----------------------------
             FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
             IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
                                                                    

                                                    ----------------

                                                    Adrenal Cortex
                                                    Adrenal Medulla
                                                    Bone Marrow
                                                    Brain
                                                    Clitoral Gland
                                                    Clitoral/Preputial Gland
                                                    Epididymis
                                                    Heart
                                                    Islets, Pancreatic
                                                    Kidney
                                                    Liver
                                                    Lung
                                                    Nose
                                                    Ovary
                                                    Pancreas
                                                    Parathyroid Gland
                                                    Pituitary Gland
                                                    Preputial Gland
                                                    Prostate
                                                    Salivary Glands
                                                    Spleen
                                                    Testes
                                                    Thymus
                                                    Thyroid Gland
                                                    Urinary Bladder
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                               T-BUTYLHYDROQUINONE                                  DATE: 04/04/96       
EXPERIMENT: 05217 TEST: 04                                                                                     TIME: 08:26:28       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1ES85219                                ROUTE: DOSED FEED                                              NTP C#: C62157       
PATHOLOGIST: J. E. HEATH                                                                                       CAS: 1948330         




                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                      IN THE ANALYSIS OF THE STUDY OF T-BUTYLHYDROQUINONE

              ====================================================================================================

                                                           MALE RATS
                                                          -------------
                  ORGAN                               MORPHOLOGY
                 -------                             ------------

              Adrenal Medulla               Pheochromocytoma: Benign, Complex, Malignant, NOS
              Skin                          Fibroma
              Testes                        Adenoma
              Thyroid Gland: C-Cell         Carcinoma
              All Organs                    Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
                                            Benign Tumors
                                            Malignant Tumors
                                            Malignant and Benign Tumors

              ====================================================================================================

                                                           FEMALE RATS
                                                          -------------
                  ORGAN                               MORPHOLOGY
                 -------                             ------------

              Clitoral/Preputial Gland      Adenoma
                                            Carcinoma or Adenoma
              Mammary Gland                 Fibroadenoma
                                            Fibroma, Fibroadenoma, Carcinoma, or Adenoma
              Pituitary Gland: Pars Distalis or Unspecified Site
                                            Adenoma

              ====================================================================================================
         DATE: 04/04/96                     EXPERIMENT: 05217 TEST: 04                                                 PAGE   1
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE

                                                 TERMINAL SACRIFICE AT 131 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          UNTREATD            0.5%                  |          UNTREATD            0.5%                  |
|                       |          CONTROL                                   |          CONTROL                                   |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |        12/69 (17%)         12/70 (17%)             |         4/67 (6%)           4/70 (6%)              |
|ADJUSTED (b)           |         57.5%               42.5%                  |         17.1%               12.9%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|TERMINAL (d)           |         3/10 (30%)          7/22 (32%)             |         2/18 (11%)          2/24 (8%)              |
|FIRST INCIDENCE (DAYS) |          707                 732                   |          677                 499                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.066N               |                             P=0.530N               |
|INCIDENTAL TUMOR       |                             P=0.255N               |                             P=0.503N               |
|LOGISTIC REGRESSION    |                             P=0.163N               |                             P=0.598N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.573N               |                             P=0.616N               |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Malignant                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         2/69 (3%)           2/70 (3%)              |         0/67 (0%)           1/70 (1%)              |
|ADJUSTED (b)           |         12.0%                5.3%                  |          0.0%                2.5%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|TERMINAL (d)           |         1/10 (10%)          0/22 (0%)              |         0/18 (0%)           0/24 (0%)              |
|FIRST INCIDENCE (DAYS) |          661                 712                   |          ---                 823                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.494N               |                             P=0.538                |
|INCIDENTAL TUMOR       |                             P=0.626N               |                             P=0.488                |
|LOGISTIC REGRESSION    |                             P=0.646N               |                             P=0.517                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.685N               |                             P=0.511                |
|=================================================================================================================================|
         DATE: 04/04/96                     EXPERIMENT: 05217 TEST: 04                                                 PAGE   2
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE

                                                 TERMINAL SACRIFICE AT 131 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          UNTREATD            0.5%                  |          UNTREATD            0.5%                  |
|                       |          CONTROL                                   |          CONTROL                                   |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |        15/69 (22%)         14/70 (20%)             |         4/67 (6%)           5/70 (7%)              |
|ADJUSTED (b)           |         65.0%               45.5%                  |         17.1%               15.1%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|TERMINAL (d)           |         4/10 (40%)          7/22 (32%)             |         2/18 (11%)          2/24 (8%)              |
|FIRST INCIDENCE (DAYS) |          552                 712                   |          677                 499                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.037N*              |                             P=0.619                |
|INCIDENTAL TUMOR       |                             P=0.217N               |                             P=0.630                |
|LOGISTIC REGRESSION    |                             P=0.157N               |                             P=0.551                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.483N               |                             P=0.528                |
|=================================================================================================================================|
|                                                                                                                                 |
|Bone                                                                                                                             |
|     Osteosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         0/70 (0%)           2/70 (3%)              |         0/70 (0%)           0/70 (0%)              |
|ADJUSTED (b)           |          0.0%                5.4%                  |          0.0%                0.0%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|TERMINAL (d)           |         0/10 (0%)           0/22 (0%)              |         0/18 (0%)           0/24 (0%)              |
|FIRST INCIDENCE (DAYS) |          ---                 796                   |          ---                 ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.356                |           (e)                 (e)                  |
|INCIDENTAL TUMOR       |                             P=0.232                |           (e)                 (e)                  |
|LOGISTIC REGRESSION    |                             P=0.272                |           (e)                 (e)                  |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.248                |                               (e)                  |
|=================================================================================================================================|
         DATE: 04/04/96                     EXPERIMENT: 05217 TEST: 04                                                 PAGE   3
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE

                                                 TERMINAL SACRIFICE AT 131 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          UNTREATD            0.5%                  |          UNTREATD            0.5%                  |
|                       |          CONTROL                                   |          CONTROL                                   |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         1/70 (1%)           1/69 (1%)              |         3/69 (4%)          10/69 (14%)             |
|ADJUSTED (b)           |          3.8%                2.0%                  |         13.4%               27.5%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|TERMINAL (d)           |         0/10 (0%)           0/21 (0%)              |         1/18 (6%)           3/23 (13%)             |
|FIRST INCIDENCE (DAYS) |          786                 731                   |          866                 673                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.673N               |                             P=0.093                |
|INCIDENTAL TUMOR       |                             P=0.756                |                             P=0.040 *              |
|LOGISTIC REGRESSION    |                             P=0.750N               |                             P=0.047 *              |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.748                |                             P=0.039 *              |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         1/70 (1%)           2/69 (3%)              |         2/69 (3%)           5/69 (7%)              |
|ADJUSTED (b)           |          3.8%                6.2%                  |          6.2%               21.7%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|TERMINAL (d)           |         0/10 (0%)           0/21 (0%)              |         0/18 (0%)           5/23 (22%)             |
|FIRST INCIDENCE (DAYS) |          786                 793                   |          788                 911 (T)               |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.686                |                             P=0.310                |
|INCIDENTAL TUMOR       |                             P=0.490                |                             P=0.279                |
|LOGISTIC REGRESSION    |                             P=0.568                |                             P=0.279                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.495                |                             P=0.220                |
|=================================================================================================================================|
         DATE: 04/04/96                     EXPERIMENT: 05217 TEST: 04                                                 PAGE   4
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE

                                                 TERMINAL SACRIFICE AT 131 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          UNTREATD            0.5%                  |          UNTREATD            0.5%                  |
|                       |          CONTROL                                   |          CONTROL                                   |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         2/70 (3%)           3/69 (4%)              |         5/69 (7%)          15/69 (22%)             |
|ADJUSTED (b)           |          7.7%                8.0%                  |         18.8%               45.6%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|TERMINAL (d)           |         0/10 (0%)           0/21 (0%)              |         1/18 (6%)           8/23 (35%)             |
|FIRST INCIDENCE (DAYS) |          786                 731                   |          788                 673                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.647N               |                             P=0.051                |
|INCIDENTAL TUMOR       |                             P=0.487                |                             P=0.019 *              |
|LOGISTIC REGRESSION    |                             P=0.560                |                             P=0.019 *              |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.493                |                             P=0.014 *              |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         2/68 (3%)           6/70 (9%)              |         1/70 (1%)           2/69 (3%)              |
|ADJUSTED (b)           |          8.3%               20.6%                  |          1.9%                5.0%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|TERMINAL (d)           |         0/10 (0%)           3/22 (14%)             |         0/18 (0%)           0/24 (0%)              |
|FIRST INCIDENCE (DAYS) |          707                 778                   |          677                 780                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.394                |                             P=0.538                |
|INCIDENTAL TUMOR       |                             P=0.241                |                             P=0.457                |
|LOGISTIC REGRESSION    |                             P=0.244                |                             P=0.501                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.147                |                             P=0.495                |
|=================================================================================================================================|
         DATE: 04/04/96                     EXPERIMENT: 05217 TEST: 04                                                 PAGE   5
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE

                                                 TERMINAL SACRIFICE AT 131 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          UNTREATD            0.5%                  |          UNTREATD            0.5%                  |
|                       |          CONTROL                                   |          CONTROL                                   |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         1/70 (1%)           2/70 (3%)              |         2/70 (3%)           2/70 (3%)              |
|ADJUSTED (b)           |         10.0%                7.4%                  |          9.1%                5.5%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|TERMINAL (d)           |         1/10 (10%)          1/22 (5%)              |         0/18 (0%)           0/24 (0%)              |
|FIRST INCIDENCE (DAYS) |          911 (T)             820                   |          870                 841                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.724N               |                             P=0.593N               |
|INCIDENTAL TUMOR       |                             P=0.674                |                             P=0.651                |
|LOGISTIC REGRESSION    |                             P=0.688                |                             P=0.662N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.500                |                             P=0.690N               |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         1/70 (1%)           3/70 (4%)              |         3/70 (4%)           2/70 (3%)              |
|ADJUSTED (b)           |         10.0%               11.8%                  |         11.0%                5.5%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|TERMINAL (d)           |         1/10 (10%)          2/22 (9%)              |         0/18 (0%)           0/24 (0%)              |
|FIRST INCIDENCE (DAYS) |          911 (T)             820                   |          711                 841                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.591                |                             P=0.402N               |
|INCIDENTAL TUMOR       |                             P=0.524                |                             P=0.556N               |
|LOGISTIC REGRESSION    |                             P=0.530                |                             P=0.478N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.310                |                             P=0.500N               |
|=================================================================================================================================|
         DATE: 04/04/96                     EXPERIMENT: 05217 TEST: 04                                                 PAGE   6
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE

                                                 TERMINAL SACRIFICE AT 131 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          UNTREATD            0.5%                  |          UNTREATD            0.5%                  |
|                       |          CONTROL                                   |          CONTROL                                   |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroadenoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         4/70 (6%)           6/70 (9%)              |        30/70 (43%)         17/70 (24%)             |
|ADJUSTED (b)           |         19.9%               19.6%                  |         86.8%               56.1%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|TERMINAL (d)           |         1/10 (10%)          3/22 (14%)             |        14/18 (78%)         12/24 (50%)             |
|FIRST INCIDENCE (DAYS) |          745                 745                   |          688                 780                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.565N               |                             P<0.001N**             |
|INCIDENTAL TUMOR       |                             P=0.556                |                             P=0.002N**             |
|LOGISTIC REGRESSION    |                             P=0.530                |                             P=0.002N**             |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.372                |                             P=0.016N*              |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         5/70 (7%)           7/70 (10%)             |        31/70 (44%)         17/70 (24%)             |
|ADJUSTED (b)           |         28.8%               23.0%                  |         87.5%               56.1%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|TERMINAL (d)           |         2/10 (20%)          3/22 (14%)             |        14/18 (78%)         12/24 (50%)             |
|FIRST INCIDENCE (DAYS) |          745                 745                   |          688                 780                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.463N               |                             P<0.001N**             |
|INCIDENTAL TUMOR       |                             P=0.596                |                             P=0.001N**             |
|LOGISTIC REGRESSION    |                             P=0.602                |                             P<0.001N**             |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.382                |                             P=0.010N*              |
|=================================================================================================================================|
         DATE: 04/04/96                     EXPERIMENT: 05217 TEST: 04                                                 PAGE   7
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE

                                                 TERMINAL SACRIFICE AT 131 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          UNTREATD            0.5%                  |          UNTREATD            0.5%                  |
|                       |          CONTROL                                   |          CONTROL                                   |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva)                                                                       |
|     Papilloma Squamous or Papilloma                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         0/70 (0%)           2/70 (3%)              |         0/70 (0%)           0/70 (0%)              |
|ADJUSTED (b)           |          0.0%                6.4%                  |          0.0%                0.0%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|TERMINAL (d)           |         0/10 (0%)           1/22 (5%)              |         0/18 (0%)           0/24 (0%)              |
|FIRST INCIDENCE (DAYS) |          ---                 730                   |          ---                 ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.371                |           (e)                 (e)                  |
|INCIDENTAL TUMOR       |                             P=0.320                |           (e)                 (e)                  |
|LOGISTIC REGRESSION    |                             P=0.285                |           (e)                 (e)                  |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.248                |                               (e)                  |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva)                                                                       |
|     Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         1/70 (1%)           2/70 (3%)              |         0/70 (0%)           0/70 (0%)              |
|ADJUSTED (b)           |          4.3%                6.4%                  |          0.0%                0.0%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|TERMINAL (d)           |         0/10 (0%)           1/22 (5%)              |         0/18 (0%)           0/24 (0%)              |
|FIRST INCIDENCE (DAYS) |          796                 730                   |          ---                 ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.685                |           (e)                 (e)                  |
|INCIDENTAL TUMOR       |                             P=0.582                |           (e)                 (e)                  |
|LOGISTIC REGRESSION    |                             P=0.572                |           (e)                 (e)                  |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.500                |                               (e)                  |
|=================================================================================================================================|
         DATE: 04/04/96                     EXPERIMENT: 05217 TEST: 04                                                 PAGE   8
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE

                                                 TERMINAL SACRIFICE AT 131 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          UNTREATD            0.5%                  |          UNTREATD            0.5%                  |
|                       |          CONTROL                                   |          CONTROL                                   |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Granulosa Cell Tumor Benign                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |         2/70 (3%)           1/70 (1%)              |
|ADJUSTED (b)           |                                                    |          7.0%                4.2%                  |
|INTERIM SACRIFICE 1 (c)|                                                    |         0/10 (0%)           0/10 (0%)              |
|TERMINAL (d)           |                                                    |         0/18 (0%)           1/24 (4%)              |
|FIRST INCIDENCE (DAYS) |                                                    |          837                 911 (T)               |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |                             P=0.414N               |
|INCIDENTAL TUMOR       |                                                    |                             P=0.495N               |
|LOGISTIC REGRESSION    |                                                    |                             P=0.459N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                                                    |                             P=0.500N               |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Granulosa Cell Tumor: Benign, Malignant, NOS                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |         3/70 (4%)           1/70 (1%)              |
|ADJUSTED (b)           |                                                    |          9.7%                4.2%                  |
|INTERIM SACRIFICE 1 (c)|                                                    |         0/10 (0%)           0/10 (0%)              |
|TERMINAL (d)           |                                                    |         0/18 (0%)           1/24 (4%)              |
|FIRST INCIDENCE (DAYS) |                                                    |          820                 911 (T)               |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |                             P=0.234N               |
|INCIDENTAL TUMOR       |                                                    |                             P=0.313N               |
|LOGISTIC REGRESSION    |                                                    |                             P=0.274N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                                                    |                             P=0.310N               |
|=================================================================================================================================|
         DATE: 04/04/96                     EXPERIMENT: 05217 TEST: 04                                                 PAGE   9
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE

                                                 TERMINAL SACRIFICE AT 131 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          UNTREATD            0.5%                  |          UNTREATD            0.5%                  |
|                       |          CONTROL                                   |          CONTROL                                   |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |        13/67 (19%)         16/66 (24%)             |        30/69 (43%)         18/70 (26%)             |
|ADJUSTED (b)           |         46.6%               47.2%                  |         81.1%               50.8%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|TERMINAL (d)           |         2/10 (20%)          6/20 (30%)             |        11/17 (65%)          9/24 (38%)             |
|FIRST INCIDENCE (DAYS) |          569                 641                   |          638                 649                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.286N               |                             P=0.004N**             |
|INCIDENTAL TUMOR       |                             P=0.342                |                             P=0.009N**             |
|LOGISTIC REGRESSION    |                             P=0.488                |                             P=0.007N**             |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.321                |                             P=0.021N*              |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous Tumor (benign,                                                       |
|     malignant or NOS), or Trichoepithelioma                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         1/70 (1%)           1/70 (1%)              |         2/70 (3%)           0/70 (0%)              |
|ADJUSTED (b)           |         10.0%                1.9%                  |          7.5%                0.0%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|TERMINAL (d)           |         1/10 (10%)          0/22 (0%)              |         0/18 (0%)           0/24 (0%)              |
|FIRST INCIDENCE (DAYS) |          911 (T)             712                   |          777                 ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.633N               |                             P=0.199N               |
|INCIDENTAL TUMOR       |                             P=0.680N               |                             P=0.265N               |
|LOGISTIC REGRESSION    |                             P=0.722N               |                             P=0.226N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.752N               |                             P=0.248N               |
|=================================================================================================================================|
         DATE: 04/04/96                     EXPERIMENT: 05217 TEST: 04                                                 PAGE  10
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE

                                                 TERMINAL SACRIFICE AT 131 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          UNTREATD            0.5%                  |          UNTREATD            0.5%                  |
|                       |          CONTROL                                   |          CONTROL                                   |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal                                                       |
|     Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepithelioma                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         2/70 (3%)           2/70 (3%)              |         2/70 (3%)           0/70 (0%)              |
|ADJUSTED (b)           |         18.2%                4.9%                  |          7.5%                0.0%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|TERMINAL (d)           |         1/10 (10%)          0/22 (0%)              |         0/18 (0%)           0/24 (0%)              |
|FIRST INCIDENCE (DAYS) |          900                 712                   |          777                 ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.457N               |                             P=0.199N               |
|INCIDENTAL TUMOR       |                             P=0.634N               |                             P=0.265N               |
|LOGISTIC REGRESSION    |                             P=0.589N               |                             P=0.226N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.690N               |                             P=0.248N               |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         6/70 (9%)           3/70 (4%)              |         1/70 (1%)           1/70 (1%)              |
|ADJUSTED (b)           |         33.6%               12.5%                  |          3.7%                2.6%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|TERMINAL (d)           |         1/10 (10%)          2/22 (9%)              |         0/18 (0%)           0/24 (0%)              |
|FIRST INCIDENCE (DAYS) |          730                 866                   |          856                 837                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.043N*              |                             P=0.708N               |
|INCIDENTAL TUMOR       |                             P=0.141N               |                             P=0.735                |
|LOGISTIC REGRESSION    |                             P=0.077N               |                             P=0.748N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.247N               |                             P=0.752N               |
|=================================================================================================================================|
         DATE: 04/04/96                     EXPERIMENT: 05217 TEST: 04                                                 PAGE  11
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE

                                                 TERMINAL SACRIFICE AT 131 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          UNTREATD            0.5%                  |          UNTREATD            0.5%                  |
|                       |          CONTROL                                   |          CONTROL                                   |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         6/70 (9%)           4/70 (6%)              |         1/70 (1%)           1/70 (1%)              |
|ADJUSTED (b)           |         33.6%               14.0%                  |          3.7%                2.6%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|TERMINAL (d)           |         1/10 (10%)          2/22 (9%)              |         0/18 (0%)           0/24 (0%)              |
|FIRST INCIDENCE (DAYS) |          730                 671                   |          856                 837                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.093N               |                             P=0.708N               |
|INCIDENTAL TUMOR       |                             P=0.247N               |                             P=0.735                |
|LOGISTIC REGRESSION    |                             P=0.185N               |                             P=0.748N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.372N               |                             P=0.752N               |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         0/70 (0%)           3/70 (4%)              |         0/70 (0%)           2/70 (3%)              |
|ADJUSTED (b)           |          0.0%                9.7%                  |          0.0%                7.1%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|TERMINAL (d)           |         0/10 (0%)           1/22 (5%)              |         0/18 (0%)           1/24 (4%)              |
|FIRST INCIDENCE (DAYS) |          ---                 743                   |          ---                 855                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.235                |                             P=0.295                |
|INCIDENTAL TUMOR       |                             P=0.163                |                             P=0.257                |
|LOGISTIC REGRESSION    |                             P=0.167                |                             P=0.274                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.122                |                             P=0.248                |
|=================================================================================================================================|
         DATE: 04/04/96                     EXPERIMENT: 05217 TEST: 04                                                 PAGE  12
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE

                                                 TERMINAL SACRIFICE AT 131 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          UNTREATD            0.5%                  |          UNTREATD            0.5%                  |
|                       |          CONTROL                                   |          CONTROL                                   |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |        59/70 (84%)         60/70 (86%)             |                                                    |
|ADJUSTED (b)           |        100.0%              100.0%                  |                                                    |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |                                                    |
|TERMINAL (d)           |        10/10 (100%)        22/22 (100%)            |                                                    |
|FIRST INCIDENCE (DAYS) |          484                 600                   |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.002N**             |                                                    |
|INCIDENTAL TUMOR       |                             P=0.506                |                                                    |
|LOGISTIC REGRESSION    |                             P=0.758                |                                                    |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.500                |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         7/70 (10%)          6/69 (9%)              |         3/70 (4%)           6/69 (9%)              |
|ADJUSTED (b)           |         30.0%               17.9%                  |         11.4%               16.5%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|TERMINAL (d)           |         1/10 (10%)          2/22 (9%)              |         1/18 (6%)           1/24 (4%)              |
|FIRST INCIDENCE (DAYS) |          604                 730                   |          677                 499                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.191N               |                             P=0.348                |
|INCIDENTAL TUMOR       |                             P=0.616N               |                             P=0.273                |
|LOGISTIC REGRESSION    |                             P=0.409N               |                             P=0.254                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.511N               |                             P=0.239                |
|=================================================================================================================================|
         DATE: 04/04/96                     EXPERIMENT: 05217 TEST: 04                                                 PAGE  13
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE

                                                 TERMINAL SACRIFICE AT 131 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          UNTREATD            0.5%                  |          UNTREATD            0.5%                  |
|                       |          CONTROL                                   |          CONTROL                                   |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         0/70 (0%)           5/69 (7%)              |         0/70 (0%)           1/69 (1%)              |
|ADJUSTED (b)           |          0.0%               12.1%                  |          0.0%                4.2%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|TERMINAL (d)           |         0/10 (0%)           0/22 (0%)              |         0/18 (0%)           1/24 (4%)              |
|FIRST INCIDENCE (DAYS) |          ---                 641                   |          ---                 911 (T)               |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.082                |                             P=0.557                |
|INCIDENTAL TUMOR       |                             P=0.012 *              |                             P=0.557                |
|LOGISTIC REGRESSION    |                             P=0.038 *              |                             P=0.557                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.028 *              |                             P=0.496                |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         7/70 (10%)         11/69 (16%)             |         3/70 (4%)           7/69 (10%)             |
|ADJUSTED (b)           |         30.0%               27.8%                  |         11.4%               20.1%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|TERMINAL (d)           |         1/10 (10%)          2/22 (9%)              |         1/18 (6%)           2/24 (8%)              |
|FIRST INCIDENCE (DAYS) |          604                 641                   |          677                 499                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.595                |                             P=0.259                |
|INCIDENTAL TUMOR       |                             P=0.103                |                             P=0.196                |
|LOGISTIC REGRESSION    |                             P=0.293                |                             P=0.172                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.215                |                             P=0.157                |
|=================================================================================================================================|
         DATE: 04/04/96                     EXPERIMENT: 05217 TEST: 04                                                 PAGE  14
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE

                                                 TERMINAL SACRIFICE AT 131 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          UNTREATD            0.5%                  |          UNTREATD            0.5%                  |
|                       |          CONTROL                                   |          CONTROL                                   |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         2/70 (3%)           0/69 (0%)              |         0/70 (0%)           0/69 (0%)              |
|ADJUSTED (b)           |         12.6%                0.0%                  |          0.0%                0.0%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|TERMINAL (d)           |         1/10 (10%)          0/22 (0%)              |         0/18 (0%)           0/24 (0%)              |
|FIRST INCIDENCE (DAYS) |          732                 ---                   |          ---                 ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.127N               |           (e)                 (e)                  |
|INCIDENTAL TUMOR       |                             P=0.162N               |           (e)                 (e)                  |
|LOGISTIC REGRESSION    |                             P=0.184N               |           (e)                 (e)                  |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.252N               |                               (e)                  |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |         8/70 (11%)          6/70 (9%)              |
|ADJUSTED (b)           |                                                    |         21.2%               18.5%                  |
|INTERIM SACRIFICE 1 (c)|                                                    |         0/10 (0%)           0/10 (0%)              |
|TERMINAL (d)           |                                                    |         1/18 (6%)           2/24 (8%)              |
|FIRST INCIDENCE (DAYS) |                                                    |          562                 672                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |                             P=0.281N               |
|INCIDENTAL TUMOR       |                                                    |                             P=0.463N               |
|LOGISTIC REGRESSION    |                                                    |                             P=0.369N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                                                    |                             P=0.390N               |
|=================================================================================================================================|
         DATE: 04/04/96                     EXPERIMENT: 05217 TEST: 04                                                 PAGE  15
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE

                                                 TERMINAL SACRIFICE AT 131 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          UNTREATD            0.5%                  |          UNTREATD            0.5%                  |
|                       |          CONTROL                                   |          CONTROL                                   |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal or Polyp Stromal                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |         8/70 (11%)          7/70 (10%)             |
|ADJUSTED (b)           |                                                    |         21.2%               22.2%                  |
|INTERIM SACRIFICE 1 (c)|                                                    |         0/10 (0%)           0/10 (0%)              |
|TERMINAL (d)           |                                                    |         1/18 (6%)           3/24 (13%)             |
|FIRST INCIDENCE (DAYS) |                                                    |          562                 672                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |                             P=0.368N               |
|INCIDENTAL TUMOR       |                                                    |                             P=0.559N               |
|LOGISTIC REGRESSION    |                                                    |                             P=0.476N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                                                    |                             P=0.500N               |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |        46/70 (66%)         39/70 (56%)             |        37/70 (53%)         34/70 (49%)             |
|ADJUSTED (b)           |         86.9%               78.2%                  |         74.3%               64.6%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|TERMINAL (d)           |         4/10 (40%)         12/22 (55%)             |         8/18 (44%)          7/24 (29%)             |
|FIRST INCIDENCE (DAYS) |          484                 641                   |          504                 540                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.002N**             |                             P=0.178N               |
|INCIDENTAL TUMOR       |                             P=0.277N               |                             P=0.528                |
|LOGISTIC REGRESSION    |                             P=0.036N*              |                             P=0.552                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.150N               |                             P=0.368N               |
|=================================================================================================================================|
         DATE: 04/04/96                     EXPERIMENT: 05217 TEST: 04                                                 PAGE  16
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE

                                                 TERMINAL SACRIFICE AT 131 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          UNTREATD            0.5%                  |          UNTREATD            0.5%                  |
|                       |          CONTROL                                   |          CONTROL                                   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Mesothelioma: Benign, Malignant, NOS                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         3/70 (4%)           4/70 (6%)              |         0/70 (0%)           0/70 (0%)              |
|ADJUSTED (b)           |          6.0%               18.2%                  |          0.0%                0.0%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|TERMINAL (d)           |         0/10 (0%)           4/22 (18%)             |         0/18 (0%)           0/24 (0%)              |
|FIRST INCIDENCE (DAYS) |          552                 911 (T)               |          ---                 ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.545N               |           (e)                 (e)                  |
|INCIDENTAL TUMOR       |                             P=0.541                |           (e)                 (e)                  |
|LOGISTIC REGRESSION    |                             P=0.575                |           (e)                 (e)                  |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.500                |                               (e)                  |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Osteosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         0/70 (0%)           2/70 (3%)              |         0/70 (0%)           0/70 (0%)              |
|ADJUSTED (b)           |          0.0%                5.4%                  |          0.0%                0.0%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|TERMINAL (d)           |         0/10 (0%)           0/22 (0%)              |         0/18 (0%)           0/24 (0%)              |
|FIRST INCIDENCE (DAYS) |          ---                 796                   |          ---                 ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.356                |           (e)                 (e)                  |
|INCIDENTAL TUMOR       |                             P=0.232                |           (e)                 (e)                  |
|LOGISTIC REGRESSION    |                             P=0.272                |           (e)                 (e)                  |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.248                |                               (e)                  |
|=================================================================================================================================|
         DATE: 04/04/96                     EXPERIMENT: 05217 TEST: 04                                                 PAGE  17
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE

                                                 TERMINAL SACRIFICE AT 131 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          UNTREATD            0.5%                  |          UNTREATD            0.5%                  |
|                       |          CONTROL                                   |          CONTROL                                   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Osteosarcoma or Osteoma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         0/70 (0%)           2/70 (3%)              |         0/70 (0%)           0/70 (0%)              |
|ADJUSTED (b)           |          0.0%                5.4%                  |          0.0%                0.0%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|TERMINAL (d)           |         0/10 (0%)           0/22 (0%)              |         0/18 (0%)           0/24 (0%)              |
|FIRST INCIDENCE (DAYS) |          ---                 796                   |          ---                 ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.356                |           (e)                 (e)                  |
|INCIDENTAL TUMOR       |                             P=0.232                |           (e)                 (e)                  |
|LOGISTIC REGRESSION    |                             P=0.272                |           (e)                 (e)                  |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.248                |                               (e)                  |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |        59/70 (84%)         60/70 (86%)             |        46/70 (66%)         42/70 (60%)             |
|ADJUSTED (b)           |        100.0%              100.0%                  |         95.6%               86.9%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|TERMINAL (d)           |        10/10 (100%)        22/22 (100%)            |        16/18 (89%)         18/24 (75%)             |
|FIRST INCIDENCE (DAYS) |          484                 600                   |          562                 499                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.002N**             |                             P=0.061N               |
|INCIDENTAL TUMOR       |                             P=0.506                |                             P=0.172N               |
|LOGISTIC REGRESSION    |                             P=0.758                |                             P=0.179N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.500                |                             P=0.300N               |
|=================================================================================================================================|
         DATE: 04/04/96                     EXPERIMENT: 05217 TEST: 04                                                 PAGE  18
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE

                                                 TERMINAL SACRIFICE AT 131 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          UNTREATD            0.5%                  |          UNTREATD            0.5%                  |
|                       |          CONTROL                                   |          CONTROL                                   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |        52/70 (74%)         49/70 (70%)             |        40/70 (57%)         41/70 (59%)             |
|ADJUSTED (b)           |         94.0%               86.8%                  |         76.7%               77.6%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|TERMINAL (d)           |         7/10 (70%)         15/22 (68%)             |         8/18 (44%)         13/24 (54%)             |
|FIRST INCIDENCE (DAYS) |          484                 600                   |          504                 540                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.003N**             |                             P=0.293N               |
|INCIDENTAL TUMOR       |                             P=0.604                |                             P=0.267                |
|LOGISTIC REGRESSION    |                             P=0.583N               |                             P=0.271                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.353N               |                             P=0.500                |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |        59/70 (84%)         60/70 (86%)             |        59/70 (84%)         57/70 (81%)             |
|ADJUSTED (b)           |        100.0%              100.0%                  |         98.3%               96.6%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|TERMINAL (d)           |        10/10 (100%)        22/22 (100%)            |        17/18 (94%)         22/24 (92%)             |
|FIRST INCIDENCE (DAYS) |          484                 600                   |          504                 499                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.002N**             |                             P=0.098N               |
|INCIDENTAL TUMOR       |                             P=0.506                |                             P=0.485N               |
|LOGISTIC REGRESSION    |                             P=0.758                |                             P=0.353N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.500                |                             P=0.411N               |
|=================================================================================================================================|
         DATE: 04/04/96                     EXPERIMENT: 05217 TEST: 04                                                 PAGE  19
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE

                                                 TERMINAL SACRIFICE AT 131 WEEKS
                                                                           

 (a)  Number of tumor-bearing animals / number of animals examined at site.
 (b)  Kaplan-Meier estimated lifetime tumor incidence after adjustment for 
      intercurrent mortality.
 (c)  Observed incidence at interim kill.
          Male interim sacrifices(days):   92
          Female interim sacrifices(days): 92
 (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).