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TDMS Study 05094-03 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                              BUTYL BENZYL PHTHALATE                                DATE: 04/03/96       
EXPERIMENT: 05094 TEST: 03                                                                                     TIME: 18:14:41       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-85222                              ROUTE: DOSED FEED                                              NTP C#: 54375C       
PATHOLOGIST: DR J. E. HEATH                                                                                    CAS: 85-68-7         
------------------------------------------------------------------------------------------------------------------------------------
               REASONS FOR REMOVAL:    ALL                                                                                          
               REMOVAL DATE RANGE:     ALL                                                                                          
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                              BUTYL BENZYL PHTHALATE                                DATE: 04/03/96       
EXPERIMENT: 05094 TEST: 03                                                                                     TIME: 18:14:41       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-85222                              ROUTE: DOSED FEED                                              NTP C#: 54375C       
PATHOLOGIST: DR J. E. HEATH                                                                                    CAS: 85-68-7         
                                                    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                              BUTYL BENZYL PHTHALATE                                DATE: 04/03/96       
EXPERIMENT: 05094 TEST: 03                                                                                     TIME: 18:14:41       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-85222                              ROUTE: DOSED FEED                                              NTP C#: 54375C       
PATHOLOGIST: DR J. E. HEATH                                                                                    CAS: 85-68-7         
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                     IN THE ANALYSIS OF THE STUDY OF BUTYL BENZYL PHTHALATE
              ====================================================================================================
                                                           FEMALE RATS
                                                          -------------
                  ORGAN                               MORPHOLOGY
                 -------                             ------------
              Clitoral/Preputial Gland      Carcinoma
                                            Carcinoma or Adenoma
              Mammary Gland                 Fibroadenoma
                                            Fibroma, Fibroadenoma, Carcinoma, or Adenoma
              Pituitary Gland: Pars Distalis or Unspecified Site
                                            Adenoma
                                            Carcinoma or Adenoma
              Skin                          Fibroma
                                            Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma
              Urinary Bladder               Carcinoma or Papilloma
              All Organs                    Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
                                            Benign Tumors
                                            Malignant and Benign Tumors
              ====================================================================================================
         DATE: 04/03/96                     EXPERIMENT: 05094 TEST: 03                                                 PAGE   1
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
                                                 MALE TERMINAL SACRIFICE AT 129 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 140 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          UNTREATD            1.2%                  |          UNTREATD            2.4%                  |
|                       |          CONTROL                                   |          CONTROL                                   |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |        12/110 (11%)        10/110 (9%)             |         3/108 (3%)          5/110 (5%)             |
|ADJUSTED (b)           |         49.6%               42.5%                  |         16.8%               16.9%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|INTERIM SACRIFICE 2 (c)|         1/34 (3%)           4/31 (13%)             |         1/35 (3%)           0/39 (0%)              |
|TERMINAL (d)           |         3/10 (30%)          4/13 (31%)             |         1/10 (10%)          1/11 (9%)              |
|FIRST INCIDENCE (DAYS) |          467                 729 (I)               |          730 (I)             716                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.289N               |                             P=0.444                |
|INCIDENTAL TUMOR       |                             P=0.426N               |                             P=0.396                |
|LOGISTIC REGRESSION    |                             P=0.396N               |                             P=0.416                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.411N               |                             P=0.371                |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Malignant                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         1/110 (1%)          2/110 (2%)             |         1/108 (1%)          0/110 (0%)             |
|ADJUSTED (b)           |          1.4%                9.2%                  |          1.1%                0.0%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|INTERIM SACRIFICE 2 (c)|         0/34 (0%)           1/31 (3%)              |         0/35 (0%)           0/39 (0%)              |
|TERMINAL (d)           |         0/10 (0%)           1/13 (8%)              |         0/10 (0%)           0/11 (0%)              |
|FIRST INCIDENCE (DAYS) |          723                 729 (I)               |          624                 ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.511                |                             P=0.487N               |
|INCIDENTAL TUMOR       |                             P=0.490                |                             P=0.581N               |
|LOGISTIC REGRESSION    |                             P=0.502                |                             P=0.528N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.500                |                             P=0.495N               |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05094 TEST: 03                                                 PAGE   2
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
                                                 MALE TERMINAL SACRIFICE AT 129 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 140 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          UNTREATD            1.2%                  |          UNTREATD            2.4%                  |
|                       |          CONTROL                                   |          CONTROL                                   |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |        13/110 (12%)        11/110 (10%)            |         5/108 (5%)          5/110 (5%)             |
|ADJUSTED (b)           |         50.3%               43.5%                  |         19.0%               16.9%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|INTERIM SACRIFICE 2 (c)|         1/34 (3%)           5/31 (16%)             |         2/35 (6%)           0/39 (0%)              |
|TERMINAL (d)           |         3/10 (30%)          4/13 (31%)             |         1/10 (10%)          1/11 (9%)              |
|FIRST INCIDENCE (DAYS) |          467                 729 (I)               |          624                 716                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.304N               |                             P=0.539N               |
|INCIDENTAL TUMOR       |                             P=0.444N               |                             P=0.612N               |
|LOGISTIC REGRESSION    |                             P=0.406N               |                             P=0.575N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.415N               |                             P=0.614N               |
|=================================================================================================================================|
|                                                                                                                                 |
|Brain                                                                                                                            |
|     Astrocytoma Malignant                                                                                                       |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         2/110 (2%)          1/109 (1%)             |         1/110 (1%)          1/109 (1%)             |
|ADJUSTED (b)           |         12.2%                1.5%                  |          1.1%                4.3%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|INTERIM SACRIFICE 2 (c)|         0/34 (0%)           0/31 (0%)              |         0/35 (0%)           0/39 (0%)              |
|TERMINAL (d)           |         0/10 (0%)           0/13 (0%)              |         0/10 (0%)           0/11 (0%)              |
|FIRST INCIDENCE (DAYS) |          746                 716                   |          564                 872                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.499N               |                             P=0.740N               |
|INCIDENTAL TUMOR       |                             P=0.600N               |                             P=0.700                |
|LOGISTIC REGRESSION    |                             P=0.500N               |                             P=0.756                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.503N               |                             P=0.749                |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05094 TEST: 03                                                 PAGE   3
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
                                                 MALE TERMINAL SACRIFICE AT 129 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 140 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          UNTREATD            1.2%                  |          UNTREATD            2.4%                  |
|                       |          CONTROL                                   |          CONTROL                                   |
|=================================================================================================================================|
|                                                                                                                                 |
|Brain                                                                                                                            |
|     Oligodendroglioma, Glioma, or Astrocytoma                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         2/110 (2%)          1/109 (1%)             |         3/110 (3%)          2/109 (2%)             |
|ADJUSTED (b)           |         12.2%                1.5%                  |          6.7%                5.3%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|INTERIM SACRIFICE 2 (c)|         0/34 (0%)           0/31 (0%)              |         1/35 (3%)           0/39 (0%)              |
|TERMINAL (d)           |         0/10 (0%)           0/13 (0%)              |         0/10 (0%)           0/11 (0%)              |
|FIRST INCIDENCE (DAYS) |          746                 716                   |          564                 498                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.499N               |                             P=0.457N               |
|INCIDENTAL TUMOR       |                             P=0.600N               |                             P=0.539N               |
|LOGISTIC REGRESSION    |                             P=0.500N               |                             P=0.522N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.503N               |                             P=0.504N               |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         1/110 (1%)          3/110 (3%)             |         9/110 (8%)          5/109 (5%)             |
|ADJUSTED (b)           |          1.5%                8.6%                  |         18.3%               15.0%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         1/10 (10%)          0/10 (0%)              |
|INTERIM SACRIFICE 2 (c)|         1/34 (3%)           1/31 (3%)              |         2/35 (6%)           3/39 (8%)              |
|TERMINAL (d)           |         0/10 (0%)           0/13 (0%)              |         0/10 (0%)           1/11 (9%)              |
|FIRST INCIDENCE (DAYS) |          729 (I)             723                   |          457 (I)             730 (I)               |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.319                |                             P=0.155N               |
|INCIDENTAL TUMOR       |                             P=0.247                |                             P=0.181N               |
|LOGISTIC REGRESSION    |                             P=0.301                |                             P=0.205N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.311                |                             P=0.209N               |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05094 TEST: 03                                                 PAGE   4
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
                                                 MALE TERMINAL SACRIFICE AT 129 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 140 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          UNTREATD            1.2%                  |          UNTREATD            2.4%                  |
|                       |          CONTROL                                   |          CONTROL                                   |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         1/110 (1%)          0/110 (0%)             |         5/110 (5%)          0/109 (0%)             |
|ADJUSTED (b)           |         10.0%                0.0%                  |         38.5%                0.0%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|INTERIM SACRIFICE 2 (c)|         0/34 (0%)           0/31 (0%)              |         0/35 (0%)           0/39 (0%)              |
|TERMINAL (d)           |         1/10 (10%)          0/13 (0%)              |         3/10 (30%)          0/11 (0%)              |
|FIRST INCIDENCE (DAYS) |          897 (T)             ---                   |          829                 ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.448N               |                             P=0.023N*              |
|INCIDENTAL TUMOR       |                             P=0.448N               |                             P=0.028N*              |
|LOGISTIC REGRESSION    |                             P=0.448N               |                             P=0.021N*              |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.500N               |                             P=0.031N*              |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         2/110 (2%)          3/110 (3%)             |        14/110 (13%)         5/109 (5%)             |
|ADJUSTED (b)           |         11.4%                8.6%                  |         49.8%               15.0%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         1/10 (10%)          0/10 (0%)              |
|INTERIM SACRIFICE 2 (c)|         1/34 (3%)           1/31 (3%)              |         2/35 (6%)           3/39 (8%)              |
|TERMINAL (d)           |         1/10 (10%)          0/13 (0%)              |         3/10 (30%)          1/11 (9%)              |
|FIRST INCIDENCE (DAYS) |          729 (I)             723                   |          457 (I)             730 (I)               |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.536                |                             P=0.016N*              |
|INCIDENTAL TUMOR       |                             P=0.461                |                             P=0.021N*              |
|LOGISTIC REGRESSION    |                             P=0.503                |                             P=0.020N*              |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.500                |                             P=0.027N*              |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05094 TEST: 03                                                 PAGE   5
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
                                                 MALE TERMINAL SACRIFICE AT 129 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 140 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          UNTREATD            1.2%                  |          UNTREATD            2.4%                  |
|                       |          CONTROL                                   |          CONTROL                                   |
|=================================================================================================================================|
|                                                                                                                                 |
|Intestine Small: Jejunum                                                                                                         |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         2/110 (2%)          0/110 (0%)             |         0/110 (0%)          0/110 (0%)             |
|ADJUSTED (b)           |          2.3%                0.0%                  |          0.0%                0.0%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|INTERIM SACRIFICE 2 (c)|         0/34 (0%)           0/31 (0%)              |         0/35 (0%)           0/39 (0%)              |
|TERMINAL (d)           |         0/10 (0%)           0/13 (0%)              |         0/10 (0%)           0/11 (0%)              |
|FIRST INCIDENCE (DAYS) |          516                 ---                   |          ---                 ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.255N               |           (e)                 (e)                  |
|INCIDENTAL TUMOR       |                             P=0.204N               |           (e)                 (e)                  |
|LOGISTIC REGRESSION    |                             P=0.203N               |           (e)                 (e)                  |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.249N               |                               (e)                  |
|=================================================================================================================================|
|                                                                                                                                 |
|Intestine Small: Site Unspecified                                                                                                |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         2/110 (2%)          0/110 (0%)             |         0/110 (0%)          0/110 (0%)             |
|ADJUSTED (b)           |          2.3%                0.0%                  |          0.0%                0.0%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|INTERIM SACRIFICE 2 (c)|         0/34 (0%)           0/31 (0%)              |         0/35 (0%)           0/39 (0%)              |
|TERMINAL (d)           |         0/10 (0%)           0/13 (0%)              |         0/10 (0%)           0/11 (0%)              |
|FIRST INCIDENCE (DAYS) |          516                 ---                   |          ---                 ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.255N               |           (e)                 (e)                  |
|INCIDENTAL TUMOR       |                             P=0.204N               |           (e)                 (e)                  |
|LOGISTIC REGRESSION    |                             P=0.203N               |           (e)                 (e)                  |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.249N               |                               (e)                  |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05094 TEST: 03                                                 PAGE   6
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
                                                 MALE TERMINAL SACRIFICE AT 129 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 140 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          UNTREATD            1.2%                  |          UNTREATD            2.4%                  |
|                       |          CONTROL                                   |          CONTROL                                   |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         7/110 (6%)          6/109 (6%)             |         1/107 (1%)          1/110 (1%)             |
|ADJUSTED (b)           |         20.0%               33.0%                  |         10.0%                5.9%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|INTERIM SACRIFICE 2 (c)|         2/34 (6%)           1/31 (3%)              |         0/35 (0%)           0/39 (0%)              |
|TERMINAL (d)           |         0/10 (0%)           4/13 (31%)             |         1/10 (10%)          0/11 (0%)              |
|FIRST INCIDENCE (DAYS) |          719                 723                   |          977 (T)             928                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.445N               |                             P=0.736N               |
|INCIDENTAL TUMOR       |                             P=0.545N               |                             P=0.747N               |
|LOGISTIC REGRESSION    |                             P=0.489N               |                             P=0.741N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.507N               |                             P=0.744N               |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         3/110 (3%)          3/109 (3%)             |         1/107 (1%)          0/110 (0%)             |
|ADJUSTED (b)           |         16.3%                9.8%                  |          1.4%                0.0%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|INTERIM SACRIFICE 2 (c)|         1/34 (3%)           1/31 (3%)              |         1/35 (3%)           0/39 (0%)              |
|TERMINAL (d)           |         1/10 (10%)          0/13 (0%)              |         0/10 (0%)           0/11 (0%)              |
|FIRST INCIDENCE (DAYS) |          729 (I)             729 (I)               |          730 (I)             ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.614N               |                             P=0.478N               |
|INCIDENTAL TUMOR       |                             P=0.607                |                             P=0.478N               |
|LOGISTIC REGRESSION    |                             P=0.660N               |                             P=0.496N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.654                |                             P=0.493N               |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05094 TEST: 03                                                 PAGE   7
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
                                                 MALE TERMINAL SACRIFICE AT 129 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 140 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          UNTREATD            1.2%                  |          UNTREATD            2.4%                  |
|                       |          CONTROL                                   |          CONTROL                                   |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |        10/110 (9%)          9/109 (8%)             |         2/107 (2%)          1/110 (1%)             |
|ADJUSTED (b)           |         33.3%               39.5%                  |         11.3%                5.9%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|INTERIM SACRIFICE 2 (c)|         3/34 (9%)           2/31 (6%)              |         1/35 (3%)           0/39 (0%)              |
|TERMINAL (d)           |         1/10 (10%)          4/13 (31%)             |         1/10 (10%)          0/11 (0%)              |
|FIRST INCIDENCE (DAYS) |          719                 723                   |          730 (I)             928                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.426N               |                             P=0.462N               |
|INCIDENTAL TUMOR       |                             P=0.571N               |                             P=0.474N               |
|LOGISTIC REGRESSION    |                             P=0.491N               |                             P=0.459N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.508N               |                             P=0.490N               |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         2/110 (2%)          1/109 (1%)             |         2/110 (2%)          4/110 (4%)             |
|ADJUSTED (b)           |          2.5%                1.4%                  |         11.3%               20.2%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|INTERIM SACRIFICE 2 (c)|         0/34 (0%)           0/31 (0%)              |         1/35 (3%)           1/39 (3%)              |
|TERMINAL (d)           |         0/10 (0%)           0/13 (0%)              |         1/10 (10%)          2/11 (18%)             |
|FIRST INCIDENCE (DAYS) |          645                 698                   |          730 (I)             696                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.536N               |                             P=0.387                |
|INCIDENTAL TUMOR       |                             P=0.590N               |                             P=0.378                |
|LOGISTIC REGRESSION    |                             P=0.499N               |                             P=0.384                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.503N               |                             P=0.342                |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05094 TEST: 03                                                 PAGE   8
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
                                                 MALE TERMINAL SACRIFICE AT 129 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 140 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          UNTREATD            1.2%                  |          UNTREATD            2.4%                  |
|                       |          CONTROL                                   |          CONTROL                                   |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         2/110 (2%)          0/109 (0%)             |         0/110 (0%)          3/110 (3%)             |
|ADJUSTED (b)           |         11.3%                0.0%                  |          0.0%               13.0%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|INTERIM SACRIFICE 2 (c)|         0/34 (0%)           0/31 (0%)              |         0/35 (0%)           1/39 (3%)              |
|TERMINAL (d)           |         1/10 (10%)          0/13 (0%)              |         0/10 (0%)           0/11 (0%)              |
|FIRST INCIDENCE (DAYS) |          719                 ---                   |          ---                 730 (I)               |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.222N               |                             P=0.150                |
|INCIDENTAL TUMOR       |                             P=0.237N               |                             P=0.132                |
|LOGISTIC REGRESSION    |                             P=0.229N               |                             P=0.140                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.251N               |                             P=0.123                |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         4/110 (4%)          1/109 (1%)             |         2/110 (2%)          7/110 (6%)             |
|ADJUSTED (b)           |         13.5%                1.4%                  |         11.3%               30.6%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|INTERIM SACRIFICE 2 (c)|         0/34 (0%)           0/31 (0%)              |         1/35 (3%)           2/39 (5%)              |
|TERMINAL (d)           |         1/10 (10%)          0/13 (0%)              |         1/10 (10%)          2/11 (18%)             |
|FIRST INCIDENCE (DAYS) |          645                 698                   |          730 (I)             696                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.194N               |                             P=0.118                |
|INCIDENTAL TUMOR       |                             P=0.229N               |                             P=0.105                |
|LOGISTIC REGRESSION    |                             P=0.190N               |                             P=0.110                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.187N               |                             P=0.085                |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05094 TEST: 03                                                 PAGE   9
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
                                                 MALE TERMINAL SACRIFICE AT 129 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 140 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          UNTREATD            1.2%                  |          UNTREATD            2.4%                  |
|                       |          CONTROL                                   |          CONTROL                                   |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         4/110 (4%)          1/109 (1%)             |         2/110 (2%)          7/110 (6%)             |
|ADJUSTED (b)           |         13.5%                1.4%                  |         11.3%               30.6%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|INTERIM SACRIFICE 2 (c)|         0/34 (0%)           0/31 (0%)              |         1/35 (3%)           2/39 (5%)              |
|TERMINAL (d)           |         1/10 (10%)          0/13 (0%)              |         1/10 (10%)          2/11 (18%)             |
|FIRST INCIDENCE (DAYS) |          645                 698                   |          730 (I)             696                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.194N               |                             P=0.118                |
|INCIDENTAL TUMOR       |                             P=0.229N               |                             P=0.105                |
|LOGISTIC REGRESSION    |                             P=0.190N               |                             P=0.110                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.187N               |                             P=0.085                |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         1/110 (1%)          2/110 (2%)             |         1/110 (1%)          1/110 (1%)             |
|ADJUSTED (b)           |          0.9%               10.5%                  |          1.4%                2.9%                  |
|INTERIM SACRIFICE 1 (c)|         1/10 (10%)          0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|INTERIM SACRIFICE 2 (c)|         0/34 (0%)           0/31 (0%)              |         1/35 (3%)           0/39 (0%)              |
|TERMINAL (d)           |         0/10 (0%)           0/13 (0%)              |         0/10 (0%)           0/11 (0%)              |
|FIRST INCIDENCE (DAYS) |          457 (I)             827                   |          730 (I)             796                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.590                |                             P=0.722N               |
|INCIDENTAL TUMOR       |                             P=0.441                |                             P=0.746N               |
|LOGISTIC REGRESSION    |                             P=0.497                |                             P=0.755N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.500                |                             P=0.751N               |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05094 TEST: 03                                                 PAGE  10
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
                                                 MALE TERMINAL SACRIFICE AT 129 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 140 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          UNTREATD            1.2%                  |          UNTREATD            2.4%                  |
|                       |          CONTROL                                   |          CONTROL                                   |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         2/110 (2%)          3/110 (3%)             |         2/110 (2%)          1/110 (1%)             |
|ADJUSTED (b)           |         10.8%               17.4%                  |          2.7%                2.9%                  |
|INTERIM SACRIFICE 1 (c)|         1/10 (10%)          0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|INTERIM SACRIFICE 2 (c)|         0/34 (0%)           0/31 (0%)              |         1/35 (3%)           0/39 (0%)              |
|TERMINAL (d)           |         1/10 (10%)          1/13 (8%)              |         0/10 (0%)           0/11 (0%)              |
|FIRST INCIDENCE (DAYS) |          457 (I)             827                   |          687                 796                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.616                |                             P=0.453N               |
|INCIDENTAL TUMOR       |                             P=0.501                |                             P=0.482N               |
|LOGISTIC REGRESSION    |                             P=0.503                |                             P=0.499N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.500                |                             P=0.500N               |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         0/110 (0%)          1/110 (1%)             |         5/110 (5%)          1/110 (1%)             |
|ADJUSTED (b)           |          0.0%                5.3%                  |         15.0%                9.1%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|INTERIM SACRIFICE 2 (c)|         0/34 (0%)           0/31 (0%)              |         0/35 (0%)           0/39 (0%)              |
|TERMINAL (d)           |         0/10 (0%)           0/13 (0%)              |         0/10 (0%)           1/11 (9%)              |
|FIRST INCIDENCE (DAYS) |          ---                 827                   |          694                 977 (T)               |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.576                |                             P=0.083N               |
|INCIDENTAL TUMOR       |                             P=0.449                |                             P=0.098N               |
|LOGISTIC REGRESSION    |                             P=0.515                |                             P=0.090N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.500                |                             P=0.106N               |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05094 TEST: 03                                                 PAGE  11
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
                                                 MALE TERMINAL SACRIFICE AT 129 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 140 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          UNTREATD            1.2%                  |          UNTREATD            2.4%                  |
|                       |          CONTROL                                   |          CONTROL                                   |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroadenoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         5/110 (5%)          3/110 (3%)             |        33/110 (30%)         7/110 (6%)             |
|ADJUSTED (b)           |         17.2%               12.0%                  |         82.1%               27.8%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|INTERIM SACRIFICE 2 (c)|         2/34 (6%)           0/31 (0%)              |        12/35 (34%)          1/39 (3%)              |
|TERMINAL (d)           |         0/10 (0%)           1/13 (8%)              |         5/10 (50%)          2/11 (18%)             |
|FIRST INCIDENCE (DAYS) |          729 (I)             687                   |          687                 600                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.337N               |                             P<0.001N**             |
|INCIDENTAL TUMOR       |                             P=0.443N               |                             P<0.001N**             |
|LOGISTIC REGRESSION    |                             P=0.362N               |                             P<0.001N**             |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.361N               |                             P<0.001N**             |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         5/110 (5%)          4/110 (4%)             |        37/110 (34%)         8/110 (7%)             |
|ADJUSTED (b)           |         17.2%               16.7%                  |         84.3%               35.9%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|INTERIM SACRIFICE 2 (c)|         2/34 (6%)           0/31 (0%)              |        12/35 (34%)          1/39 (3%)              |
|TERMINAL (d)           |         0/10 (0%)           1/13 (8%)              |         5/10 (50%)          3/11 (27%)             |
|FIRST INCIDENCE (DAYS) |          729 (I)             687                   |          687                 600                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.450N               |                             P<0.001N**             |
|INCIDENTAL TUMOR       |                             P=0.599N               |                             P<0.001N**             |
|LOGISTIC REGRESSION    |                             P=0.502N               |                             P<0.001N**             |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.500N               |                             P<0.001N**             |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05094 TEST: 03                                                 PAGE  12
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
                                                 MALE TERMINAL SACRIFICE AT 129 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 140 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          UNTREATD            1.2%                  |          UNTREATD            2.4%                  |
|                       |          CONTROL                                   |          CONTROL                                   |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva)                                                                       |
|     Papilloma Squamous or Papilloma                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         1/110 (1%)          2/110 (2%)             |         1/110 (1%)          0/110 (0%)             |
|ADJUSTED (b)           |          4.0%                9.2%                  |          1.2%                0.0%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|INTERIM SACRIFICE 2 (c)|         0/34 (0%)           1/31 (3%)              |         0/35 (0%)           0/39 (0%)              |
|TERMINAL (d)           |         0/10 (0%)           1/13 (8%)              |         0/10 (0%)           0/11 (0%)              |
|FIRST INCIDENCE (DAYS) |          761                 729 (I)               |          685                 ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.524                |                             P=0.488N               |
|INCIDENTAL TUMOR       |                             P=0.490                |                             P=0.495N               |
|LOGISTIC REGRESSION    |                             P=0.507                |                             P=0.512N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.500                |                             P=0.500N               |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva)                                                                       |
|     Squamous Cell Carcinoma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         3/110 (3%)          0/110 (0%)             |         0/110 (0%)          0/110 (0%)             |
|ADJUSTED (b)           |          6.5%                0.0%                  |          0.0%                0.0%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|INTERIM SACRIFICE 2 (c)|         0/34 (0%)           0/31 (0%)              |         0/35 (0%)           0/39 (0%)              |
|TERMINAL (d)           |         0/10 (0%)           0/13 (0%)              |         0/10 (0%)           0/11 (0%)              |
|FIRST INCIDENCE (DAYS) |          549                 ---                   |          ---                 ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.129N               |           (e)                 (e)                  |
|INCIDENTAL TUMOR       |                             P=0.127N               |           (e)                 (e)                  |
|LOGISTIC REGRESSION    |                             P=0.118N               |           (e)                 (e)                  |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.123N               |                               (e)                  |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05094 TEST: 03                                                 PAGE  13
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
                                                 MALE TERMINAL SACRIFICE AT 129 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 140 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          UNTREATD            1.2%                  |          UNTREATD            2.4%                  |
|                       |          CONTROL                                   |          CONTROL                                   |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva)                                                                       |
|     Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         4/110 (4%)          2/110 (2%)             |         1/110 (1%)          0/110 (0%)             |
|ADJUSTED (b)           |         10.2%                9.2%                  |          1.2%                0.0%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|INTERIM SACRIFICE 2 (c)|         0/34 (0%)           1/31 (3%)              |         0/35 (0%)           0/39 (0%)              |
|TERMINAL (d)           |         0/10 (0%)           1/13 (8%)              |         0/10 (0%)           0/11 (0%)              |
|FIRST INCIDENCE (DAYS) |          549                 729 (I)               |          685                 ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.332N               |                             P=0.488N               |
|INCIDENTAL TUMOR       |                             P=0.355N               |                             P=0.495N               |
|LOGISTIC REGRESSION    |                             P=0.348N               |                             P=0.512N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.342N               |                             P=0.500N               |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Mucosa                                                                                                                      |
|     Squamous Cell Carcinoma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         2/110 (2%)          0/110 (0%)             |         0/110 (0%)          0/110 (0%)             |
|ADJUSTED (b)           |          5.5%                0.0%                  |          0.0%                0.0%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|INTERIM SACRIFICE 2 (c)|         0/34 (0%)           0/31 (0%)              |         0/35 (0%)           0/39 (0%)              |
|TERMINAL (d)           |         0/10 (0%)           0/13 (0%)              |         0/10 (0%)           0/11 (0%)              |
|FIRST INCIDENCE (DAYS) |          719                 ---                   |          ---                 ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.242N               |           (e)                 (e)                  |
|INCIDENTAL TUMOR       |                             P=0.297N               |           (e)                 (e)                  |
|LOGISTIC REGRESSION    |                             P=0.243N               |           (e)                 (e)                  |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.249N               |                               (e)                  |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05094 TEST: 03                                                 PAGE  14
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
                                                 MALE TERMINAL SACRIFICE AT 129 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 140 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          UNTREATD            1.2%                  |          UNTREATD            2.4%                  |
|                       |          CONTROL                                   |          CONTROL                                   |
|=================================================================================================================================|
|                                                                                                                                 |
|Pancreas                                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         0/110 (0%)          3/109 (3%)             |         0/107 (0%)          1/110 (1%)             |
|ADJUSTED (b)           |          0.0%               23.1%                  |          0.0%                9.1%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|INTERIM SACRIFICE 2 (c)|         0/34 (0%)           0/31 (0%)              |         0/35 (0%)           0/39 (0%)              |
|TERMINAL (d)           |         0/10 (0%)           3/13 (23%)             |         0/10 (0%)           1/11 (9%)              |
|FIRST INCIDENCE (DAYS) |          ---                 897 (T)               |          ---                 977 (T)               |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.163                |                             P=0.519                |
|INCIDENTAL TUMOR       |                             P=0.163                |                             P=0.519                |
|LOGISTIC REGRESSION    |                             P=0.163                |                             P=0.519                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.122                |                             P=0.507                |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |        11/106 (10%)        13/105 (12%)            |        41/110 (37%)        22/109 (20%)            |
|ADJUSTED (b)           |         35.5%               42.8%                  |         87.6%               82.9%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         1/10 (10%)          0/10 (0%)              |
|INTERIM SACRIFICE 2 (c)|         3/33 (9%)           5/31 (16%)             |        12/35 (34%)          4/39 (10%)             |
|TERMINAL (d)           |         2/10 (20%)          4/13 (31%)             |         7/10 (70%)          8/11 (73%)             |
|FIRST INCIDENCE (DAYS) |          597                 350                   |          457 (I)             600                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.464                |                             P<0.001N**             |
|INCIDENTAL TUMOR       |                             P=0.476                |                             P=0.001N**             |
|LOGISTIC REGRESSION    |                             P=0.383                |                             P<0.001N**             |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.405                |                             P=0.004N**             |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05094 TEST: 03                                                 PAGE  15
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
                                                 MALE TERMINAL SACRIFICE AT 129 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 140 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          UNTREATD            1.2%                  |          UNTREATD            2.4%                  |
|                       |          CONTROL                                   |          CONTROL                                   |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |        11/106 (10%)        13/105 (12%)            |        42/110 (38%)        22/109 (20%)            |
|ADJUSTED (b)           |         35.5%               42.8%                  |         88.1%               82.9%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         1/10 (10%)          0/10 (0%)              |
|INTERIM SACRIFICE 2 (c)|         3/33 (9%)           5/31 (16%)             |        12/35 (34%)          4/39 (10%)             |
|TERMINAL (d)           |         2/10 (20%)          4/13 (31%)             |         7/10 (70%)          8/11 (73%)             |
|FIRST INCIDENCE (DAYS) |          597                 350                   |          457 (I)             600                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.464                |                             P<0.001N**             |
|INCIDENTAL TUMOR       |                             P=0.476                |                             P<0.001N**             |
|LOGISTIC REGRESSION    |                             P=0.383                |                             P<0.001N**             |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.405                |                             P=0.003N**             |
|=================================================================================================================================|
|                                                                                                                                 |
|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)            |         5/110 (5%)          4/110 (4%)             |         5/110 (5%)          1/110 (1%)             |
|ADJUSTED (b)           |         25.7%                5.8%                  |         25.3%                9.1%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|INTERIM SACRIFICE 2 (c)|         2/34 (6%)           2/31 (6%)              |         2/35 (6%)           0/39 (0%)              |
|TERMINAL (d)           |         2/10 (20%)          0/13 (0%)              |         2/10 (20%)          1/11 (9%)              |
|FIRST INCIDENCE (DAYS) |          729 (I)             521                   |          730 (I)             977 (T)               |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.491N               |                             P=0.080N               |
|INCIDENTAL TUMOR       |                             P=0.487N               |                             P=0.085N               |
|LOGISTIC REGRESSION    |                             P=0.511N               |                             P=0.081N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.500N               |                             P=0.106N               |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05094 TEST: 03                                                 PAGE  16
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
                                                 MALE TERMINAL SACRIFICE AT 129 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 140 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          UNTREATD            1.2%                  |          UNTREATD            2.4%                  |
|                       |          CONTROL                                   |          CONTROL                                   |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         5/110 (5%)          3/110 (3%)             |         5/110 (5%)          0/110 (0%)             |
|ADJUSTED (b)           |         25.3%                8.3%                  |         28.1%                0.0%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|INTERIM SACRIFICE 2 (c)|         0/34 (0%)           1/31 (3%)              |         1/35 (3%)           0/39 (0%)              |
|TERMINAL (d)           |         0/10 (0%)           0/13 (0%)              |         2/10 (20%)          0/11 (0%)              |
|FIRST INCIDENCE (DAYS) |          703                 674                   |          687                 ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.312N               |                             P=0.028N*              |
|INCIDENTAL TUMOR       |                             P=0.492N               |                             P=0.029N*              |
|LOGISTIC REGRESSION    |                             P=0.355N               |                             P=0.025N*              |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.361N               |                             P=0.030N*              |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         6/110 (5%)          4/110 (4%)             |         5/110 (5%)          0/110 (0%)             |
|ADJUSTED (b)           |         30.3%                9.9%                  |         28.1%                0.0%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|INTERIM SACRIFICE 2 (c)|         0/34 (0%)           2/31 (6%)              |         1/35 (3%)           0/39 (0%)              |
|TERMINAL (d)           |         0/10 (0%)           0/13 (0%)              |         2/10 (20%)          0/11 (0%)              |
|FIRST INCIDENCE (DAYS) |          703                 674                   |          687                 ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.322N               |                             P=0.028N*              |
|INCIDENTAL TUMOR       |                             P=0.516N               |                             P=0.029N*              |
|LOGISTIC REGRESSION    |                             P=0.370N               |                             P=0.025N*              |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.374N               |                             P=0.030N*              |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05094 TEST: 03                                                 PAGE  17
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
                                                 MALE TERMINAL SACRIFICE AT 129 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 140 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          UNTREATD            1.2%                  |          UNTREATD            2.4%                  |
|                       |          CONTROL                                   |          CONTROL                                   |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Keratoacanthoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         4/110 (4%)          4/110 (4%)             |         3/110 (3%)          1/110 (1%)             |
|ADJUSTED (b)           |         16.4%                5.8%                  |         14.7%                9.1%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|INTERIM SACRIFICE 2 (c)|         2/34 (6%)           2/31 (6%)              |         1/35 (3%)           0/39 (0%)              |
|TERMINAL (d)           |         1/10 (10%)          0/13 (0%)              |         1/10 (10%)          1/11 (9%)              |
|FIRST INCIDENCE (DAYS) |          729 (I)             521                   |          730 (I)             977 (T)               |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.632                |                             P=0.265N               |
|INCIDENTAL TUMOR       |                             P=0.636                |                             P=0.278N               |
|LOGISTIC REGRESSION    |                             P=0.632                |                             P=0.266N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.639N               |                             P=0.311N               |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Melanoma Benign                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         0/110 (0%)          2/110 (2%)             |         0/110 (0%)          0/110 (0%)             |
|ADJUSTED (b)           |          0.0%                4.4%                  |          0.0%                0.0%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|INTERIM SACRIFICE 2 (c)|         0/34 (0%)           0/31 (0%)              |         0/35 (0%)           0/39 (0%)              |
|TERMINAL (d)           |         0/10 (0%)           0/13 (0%)              |         0/10 (0%)           0/11 (0%)              |
|FIRST INCIDENCE (DAYS) |          ---                 508                   |          ---                 ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.234                |           (e)                 (e)                  |
|INCIDENTAL TUMOR       |                             P=0.268                |           (e)                 (e)                  |
|LOGISTIC REGRESSION    |                             P=0.260                |           (e)                 (e)                  |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.249                |                               (e)                  |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05094 TEST: 03                                                 PAGE  18
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
                                                 MALE TERMINAL SACRIFICE AT 129 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 140 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          UNTREATD            1.2%                  |          UNTREATD            2.4%                  |
|                       |          CONTROL                                   |          CONTROL                                   |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         0/110 (0%)          0/110 (0%)             |         2/110 (2%)          0/110 (0%)             |
|ADJUSTED (b)           |          0.0%                0.0%                  |         11.3%                0.0%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|INTERIM SACRIFICE 2 (c)|         0/34 (0%)           0/31 (0%)              |         1/35 (3%)           0/39 (0%)              |
|TERMINAL (d)           |         0/10 (0%)           0/13 (0%)              |         1/10 (10%)          0/11 (0%)              |
|FIRST INCIDENCE (DAYS) |          ---                 ---                   |          730 (I)             ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |           (e)                 (e)                  |                             P=0.218N               |
|INCIDENTAL TUMOR       |           (e)                 (e)                  |                             P=0.218N               |
|LOGISTIC REGRESSION    |           (e)                 (e)                  |                             P=0.216N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                               (e)                  |                             P=0.249N               |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         4/110 (4%)          4/110 (4%)             |         5/110 (5%)          1/110 (1%)             |
|ADJUSTED (b)           |         16.4%                5.8%                  |         25.3%                9.1%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|INTERIM SACRIFICE 2 (c)|         2/34 (6%)           2/31 (6%)              |         2/35 (6%)           0/39 (0%)              |
|TERMINAL (d)           |         1/10 (10%)          0/13 (0%)              |         2/10 (20%)          1/11 (9%)              |
|FIRST INCIDENCE (DAYS) |          729 (I)             521                   |          730 (I)             977 (T)               |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.632                |                             P=0.080N               |
|INCIDENTAL TUMOR       |                             P=0.636                |                             P=0.085N               |
|LOGISTIC REGRESSION    |                             P=0.632                |                             P=0.081N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.639N               |                             P=0.106N               |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05094 TEST: 03                                                 PAGE  19
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
                                                 MALE TERMINAL SACRIFICE AT 129 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 140 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          UNTREATD            1.2%                  |          UNTREATD            2.4%                  |
|                       |          CONTROL                                   |          CONTROL                                   |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma, Papilloma, or Keratoacanthoma                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         4/110 (4%)          4/110 (4%)             |         5/110 (5%)          1/110 (1%)             |
|ADJUSTED (b)           |         16.4%                5.8%                  |         25.3%                9.1%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|INTERIM SACRIFICE 2 (c)|         2/34 (6%)           2/31 (6%)              |         2/35 (6%)           0/39 (0%)              |
|TERMINAL (d)           |         1/10 (10%)          0/13 (0%)              |         2/10 (20%)          1/11 (9%)              |
|FIRST INCIDENCE (DAYS) |          729 (I)             521                   |          730 (I)             977 (T)               |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.632                |                             P=0.080N               |
|INCIDENTAL TUMOR       |                             P=0.636                |                             P=0.085N               |
|LOGISTIC REGRESSION    |                             P=0.632                |                             P=0.081N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.639N               |                             P=0.106N               |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         5/110 (5%)          1/110 (1%)             |         0/110 (0%)          0/110 (0%)             |
|ADJUSTED (b)           |         19.0%                1.6%                  |          0.0%                0.0%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|INTERIM SACRIFICE 2 (c)|         0/34 (0%)           1/31 (3%)              |         0/35 (0%)           0/39 (0%)              |
|TERMINAL (d)           |         1/10 (10%)          0/13 (0%)              |         0/10 (0%)           0/11 (0%)              |
|FIRST INCIDENCE (DAYS) |          719                 729 (I)               |          ---                 ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.111N               |           (e)                 (e)                  |
|INCIDENTAL TUMOR       |                             P=0.142N               |           (e)                 (e)                  |
|LOGISTIC REGRESSION    |                             P=0.109N               |           (e)                 (e)                  |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.106N               |                               (e)                  |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05094 TEST: 03                                                 PAGE  20
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
                                                 MALE TERMINAL SACRIFICE AT 129 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 140 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          UNTREATD            1.2%                  |          UNTREATD            2.4%                  |
|                       |          CONTROL                                   |          CONTROL                                   |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |       100/110 (91%)        99/110 (90%)            |                                                    |
|ADJUSTED (b)           |        100.0%              100.0%                  |                                                    |
|INTERIM SACRIFICE 1 (c)|         7/10 (70%)          6/10 (60%)             |                                                    |
|INTERIM SACRIFICE 2 (c)|        34/34 (100%)        31/31 (100%)            |                                                    |
|TERMINAL (d)           |        10/10 (100%)        13/13 (100%)            |                                                    |
|FIRST INCIDENCE (DAYS) |          457 (I)             457 (I)               |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.471N               |                                                    |
|INCIDENTAL TUMOR       |                             P=0.278                |                                                    |
|LOGISTIC REGRESSION    |                             P=0.411                |                                                    |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.500N               |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thymus                                                                                                                           |
|     Thymoma Benign                                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         0/102 (0%)          2/103 (2%)             |         1/109 (1%)          0/106 (0%)             |
|ADJUSTED (b)           |          0.0%                5.3%                  |          1.4%                0.0%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|INTERIM SACRIFICE 2 (c)|         0/31 (0%)           1/30 (3%)              |         1/35 (3%)           0/39 (0%)              |
|TERMINAL (d)           |         0/9 (0%)            0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|FIRST INCIDENCE (DAYS) |          ---                 729 (I)               |          730 (I)             ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.236                |                             P=0.478N               |
|INCIDENTAL TUMOR       |                             P=0.210                |                             P=0.478N               |
|LOGISTIC REGRESSION    |                             P=0.232                |                             P=0.506N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.251                |                             P=0.507N               |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05094 TEST: 03                                                 PAGE  21
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
                                                 MALE TERMINAL SACRIFICE AT 129 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 140 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          UNTREATD            1.2%                  |          UNTREATD            2.4%                  |
|                       |          CONTROL                                   |          CONTROL                                   |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         8/110 (7%)          8/110 (7%)             |         6/109 (6%)          7/110 (6%)             |
|ADJUSTED (b)           |         16.4%               20.8%                  |         19.4%               20.7%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|INTERIM SACRIFICE 2 (c)|         0/34 (0%)           3/31 (10%)             |         0/35 (0%)           2/39 (5%)              |
|TERMINAL (d)           |         0/10 (0%)           1/13 (8%)              |         1/10 (10%)          0/11 (0%)              |
|FIRST INCIDENCE (DAYS) |          549                 498                   |          687                 634                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.595                |                             P=0.605N               |
|INCIDENTAL TUMOR       |                             P=0.553                |                             P=0.499                |
|LOGISTIC REGRESSION    |                             P=0.593                |                             P=0.542                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.602N               |                             P=0.507                |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         8/110 (7%)          8/110 (7%)             |         7/109 (6%)          7/110 (6%)             |
|ADJUSTED (b)           |         16.4%               20.8%                  |         25.6%               20.7%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|INTERIM SACRIFICE 2 (c)|         0/34 (0%)           3/31 (10%)             |         0/35 (0%)           2/39 (5%)              |
|TERMINAL (d)           |         0/10 (0%)           1/13 (8%)              |         1/10 (10%)          0/11 (0%)              |
|FIRST INCIDENCE (DAYS) |          549                 498                   |          687                 634                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.595                |                             P=0.492N               |
|INCIDENTAL TUMOR       |                             P=0.553                |                             P=0.610N               |
|LOGISTIC REGRESSION    |                             P=0.593                |                             P=0.559N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.602N               |                             P=0.601N               |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05094 TEST: 03                                                 PAGE  22
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
                                                 MALE TERMINAL SACRIFICE AT 129 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 140 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          UNTREATD            1.2%                  |          UNTREATD            2.4%                  |
|                       |          CONTROL                                   |          CONTROL                                   |
|=================================================================================================================================|
|                                                                                                                                 |
|Urinary Bladder                                                                                                                  |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         0/110 (0%)          1/110 (1%)             |         0/109 (0%)          4/110 (4%)             |
|ADJUSTED (b)           |          0.0%                5.6%                  |          0.0%               28.2%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|INTERIM SACRIFICE 2 (c)|         0/34 (0%)           0/31 (0%)              |         0/35 (0%)           0/39 (0%)              |
|TERMINAL (d)           |         0/10 (0%)           0/13 (0%)              |         0/10 (0%)           3/11 (27%)             |
|FIRST INCIDENCE (DAYS) |          ---                 844                   |          ---                 719                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.581                |                             P=0.074                |
|INCIDENTAL TUMOR       |                             P=0.449                |                             P=0.070                |
|LOGISTIC REGRESSION    |                             P=0.522                |                             P=0.077                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.500                |                             P=0.062                |
|=================================================================================================================================|
|                                                                                                                                 |
|Urinary Bladder                                                                                                                  |
|     Carcinoma or Papilloma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         0/110 (0%)          2/110 (2%)             |         1/109 (1%)          8/110 (7%)             |
|ADJUSTED (b)           |          0.0%                6.9%                  |          1.3%               41.8%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|INTERIM SACRIFICE 2 (c)|         0/34 (0%)           0/31 (0%)              |         0/35 (0%)           2/39 (5%)              |
|TERMINAL (d)           |         0/10 (0%)           0/13 (0%)              |         0/10 (0%)           4/11 (36%)             |
|FIRST INCIDENCE (DAYS) |          ---                 677                   |          694                 719                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.270                |                             P=0.028 *              |
|INCIDENTAL TUMOR       |                             P=0.184                |                             P=0.025 *              |
|LOGISTIC REGRESSION    |                             P=0.236                |                             P=0.028 *              |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.249                |                             P=0.018 *              |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05094 TEST: 03                                                 PAGE  23
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
                                                 MALE TERMINAL SACRIFICE AT 129 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 140 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          UNTREATD            1.2%                  |          UNTREATD            2.4%                  |
|                       |          CONTROL                                   |          CONTROL                                   |
|=================================================================================================================================|
|                                                                                                                                 |
|Urinary Bladder                                                                                                                  |
|     Papilloma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         0/110 (0%)          2/110 (2%)             |         1/109 (1%)          4/110 (4%)             |
|ADJUSTED (b)           |          0.0%                6.9%                  |          1.3%               15.8%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|INTERIM SACRIFICE 2 (c)|         0/34 (0%)           0/31 (0%)              |         0/35 (0%)           2/39 (5%)              |
|TERMINAL (d)           |         0/10 (0%)           0/13 (0%)              |         0/10 (0%)           1/11 (9%)              |
|FIRST INCIDENCE (DAYS) |          ---                 677                   |          694                 730 (I)               |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.270                |                             P=0.219                |
|INCIDENTAL TUMOR       |                             P=0.184                |                             P=0.209                |
|LOGISTIC REGRESSION    |                             P=0.236                |                             P=0.206                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.249                |                             P=0.187                |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |         4/110 (4%)          9/110 (8%)             |
|ADJUSTED (b)           |                                                    |         22.0%               32.7%                  |
|INTERIM SACRIFICE 1 (c)|                                                    |         0/10 (0%)           0/10 (0%)              |
|INTERIM SACRIFICE 2 (c)|                                                    |         0/35 (0%)           1/39 (3%)              |
|TERMINAL (d)           |                                                    |         2/10 (20%)          2/11 (18%)             |
|FIRST INCIDENCE (DAYS) |                                                    |          649                 683                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |                             P=0.179                |
|INCIDENTAL TUMOR       |                                                    |                             P=0.142                |
|LOGISTIC REGRESSION    |                                                    |                             P=0.159                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                                                    |                             P=0.126                |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05094 TEST: 03                                                 PAGE  24
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
                                                 MALE TERMINAL SACRIFICE AT 129 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 140 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          UNTREATD            1.2%                  |          UNTREATD            2.4%                  |
|                       |          CONTROL                                   |          CONTROL                                   |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal or Polyp Stromal                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |         4/110 (4%)          9/110 (8%)             |
|ADJUSTED (b)           |                                                    |         22.0%               32.7%                  |
|INTERIM SACRIFICE 1 (c)|                                                    |         0/10 (0%)           0/10 (0%)              |
|INTERIM SACRIFICE 2 (c)|                                                    |         0/35 (0%)           1/39 (3%)              |
|TERMINAL (d)           |                                                    |         2/10 (20%)          2/11 (18%)             |
|FIRST INCIDENCE (DAYS) |                                                    |          649                 683                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |                             P=0.179                |
|INCIDENTAL TUMOR       |                                                    |                             P=0.142                |
|LOGISTIC REGRESSION    |                                                    |                             P=0.159                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                                                    |                             P=0.126                |
|=================================================================================================================================|
|                                                                                                                                 |
|Zymbal's Gland                                                                                                                   |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         2/110 (2%)          1/110 (1%)             |         2/110 (2%)          2/110 (2%)             |
|ADJUSTED (b)           |          2.3%                1.6%                  |          5.4%                5.8%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|INTERIM SACRIFICE 2 (c)|         0/34 (0%)           0/31 (0%)              |         0/35 (0%)           0/39 (0%)              |
|TERMINAL (d)           |         0/10 (0%)           0/13 (0%)              |         0/10 (0%)           0/11 (0%)              |
|FIRST INCIDENCE (DAYS) |          432                 723                   |          597                 683                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.521N               |                             P=0.657N               |
|INCIDENTAL TUMOR       |                             P=0.496N               |                             P=0.651                |
|LOGISTIC REGRESSION    |                             P=0.464N               |                             P=0.686N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.500N               |                             P=0.689N               |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05094 TEST: 03                                                 PAGE  25
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
                                                 MALE TERMINAL SACRIFICE AT 129 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 140 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          UNTREATD            1.2%                  |          UNTREATD            2.4%                  |
|                       |          CONTROL                                   |          CONTROL                                   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |        60/110 (55%)        64/110 (58%)            |        45/110 (41%)        58/110 (53%)            |
|ADJUSTED (b)           |         92.1%               91.1%                  |         86.5%               92.9%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           1/10 (10%)             |         0/10 (0%)           1/10 (10%)             |
|INTERIM SACRIFICE 2 (c)|        12/34 (35%)         12/31 (39%)             |         7/35 (20%)         11/39 (28%)             |
|TERMINAL (d)           |         7/10 (70%)          9/13 (69%)             |         6/10 (60%)          8/11 (73%)             |
|FIRST INCIDENCE (DAYS) |          569                 457 (I)               |          358                 457 (I)               |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.433                |                             P=0.269                |
|INCIDENTAL TUMOR       |                             P=0.196                |                             P=0.019 *              |
|LOGISTIC REGRESSION    |                             P=0.208                |                             P=0.090                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.342                |                             P=0.052                |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Mesothelioma: Benign, Malignant, NOS                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         4/110 (4%)          3/110 (3%)             |         0/110 (0%)          1/110 (1%)             |
|ADJUSTED (b)           |         14.3%                7.4%                  |          0.0%                9.1%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/10 (0%)              |         0/10 (0%)           0/10 (0%)              |
|INTERIM SACRIFICE 2 (c)|         1/34 (3%)           0/31 (0%)              |         0/35 (0%)           0/39 (0%)              |
|TERMINAL (d)           |         0/10 (0%)           0/13 (0%)              |         0/10 (0%)           1/11 (9%)              |
|FIRST INCIDENCE (DAYS) |          600                 669                   |          ---                 977 (T)               |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.482N               |                             P=0.519                |
|INCIDENTAL TUMOR       |                             P=0.575N               |                             P=0.519                |
|LOGISTIC REGRESSION    |                             P=0.510N               |                             P=0.519                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.500N               |                             P=0.500                |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05094 TEST: 03                                                 PAGE  26
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
                                                 MALE TERMINAL SACRIFICE AT 129 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 140 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          UNTREATD            1.2%                  |          UNTREATD            2.4%                  |
|                       |          CONTROL                                   |          CONTROL                                   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |       103/110 (94%)       102/110 (93%)            |        74/110 (67%)        49/110 (45%)            |
|ADJUSTED (b)           |        100.0%              100.0%                  |        100.0%               97.1%                  |
|INTERIM SACRIFICE 1 (c)|         8/10 (80%)          6/10 (60%)             |         2/10 (20%)          0/10 (0%)              |
|INTERIM SACRIFICE 2 (c)|        34/34 (100%)        31/31 (100%)            |        24/35 (69%)         12/39 (31%)             |
|TERMINAL (d)           |        10/10 (100%)        13/13 (100%)            |        10/10 (100%)        10/11 (91%)             |
|FIRST INCIDENCE (DAYS) |          457 (I)             350                   |          457 (I)             600                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.470N               |                             P<0.001N**             |
|INCIDENTAL TUMOR       |                             P=0.343                |                             P<0.001N**             |
|LOGISTIC REGRESSION    |                             P=0.411                |                             P<0.001N**             |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.500N               |                             P<0.001N**             |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |        75/110 (68%)        75/110 (68%)            |        63/110 (57%)        62/110 (56%)            |
|ADJUSTED (b)           |         96.6%               94.8%                  |         97.5%               95.6%                  |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           1/10 (10%)             |         0/10 (0%)           1/10 (10%)             |
|INTERIM SACRIFICE 2 (c)|        15/34 (44%)         15/31 (48%)             |        11/35 (31%)         12/39 (31%)             |
|TERMINAL (d)           |         8/10 (80%)         10/13 (77%)             |         9/10 (90%)          9/11 (82%)             |
|FIRST INCIDENCE (DAYS) |          432                 457 (I)               |          358                 457 (I)               |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.481N               |                             P=0.234N               |
|INCIDENTAL TUMOR       |                             P=0.386                |                             P=0.529                |
|LOGISTIC REGRESSION    |                             P=0.391                |                             P=0.342N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.558N               |                             P=0.500N               |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05094 TEST: 03                                                 PAGE  27
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
                                                 MALE TERMINAL SACRIFICE AT 129 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 140 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          UNTREATD            1.2%                  |          UNTREATD            2.4%                  |
|                       |          CONTROL                                   |          CONTROL                                   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |       107/110 (97%)       104/110 (95%)            |        94/110 (85%)        78/110 (71%)            |
|ADJUSTED (b)           |        100.0%              100.0%                  |        100.0%              100.0%                  |
|INTERIM SACRIFICE 1 (c)|         8/10 (80%)          6/10 (60%)             |         2/10 (20%)          1/10 (10%)             |
|INTERIM SACRIFICE 2 (c)|        34/34 (100%)        31/31 (100%)            |        28/35 (80%)         18/39 (46%)             |
|TERMINAL (d)           |        10/10 (100%)        13/13 (100%)            |        10/10 (100%)        11/11 (100%)            |
|FIRST INCIDENCE (DAYS) |          432                 350                   |          358                 457 (I)               |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.403N               |                             P=0.012N*              |
|INCIDENTAL TUMOR       |                             P=0.547N               |                             P=0.001N**             |
|LOGISTIC REGRESSION    |                             P=0.594N               |                             P<0.001N**             |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.249N               |                             P=0.007N**             |
|=================================================================================================================================|
 (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):   457  729
          Female interim sacrifices(days): 457  730
 (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).