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TDMS Study 05094-02 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                              BUTYL BENZYL PHTHALATE                                DATE: 04/03/96       
EXPERIMENT: 05094 TEST: 02                                                                                     TIME: 07:12:48       
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: 02                                                                                     TIME: 07:12:48       
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: 02                                                                                     TIME: 07:12:48       
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
              ====================================================================================================
                                                           MALE RATS
                                                          -------------
                  ORGAN                               MORPHOLOGY
                 -------                             ------------
              Adrenal Medulla               Pheochromocytoma Benign
                                            Pheochromocytoma: Benign, Complex, Malignant, NOS
              Clitoral/Preputial Gland      Adenoma
                                            Carcinoma
                                            Carcinoma or Adenoma
              Lung                          Alveolar/Bronchiolar Adenoma
              Mammary Gland                 Fibroma, Fibroadenoma, Carcinoma, or Adenoma
              Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva)
                                            Papilloma Squamous or Papilloma
                                            Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma
              Pancreas                      Adenoma
                                            Carcinoma or Adenoma
              Testes                        Adenoma
              Thymus                        Thymoma: Benign, Malignant, NOS
              Thyroid Gland: Follicular Cell
                                            Carcinoma
                                            Carcinoma or Adenoma
              All Organs                    Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
                                            Benign Tumors
                                            Malignant Tumors
                                            Malignant and Benign Tumors
              ====================================================================================================
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                              BUTYL BENZYL PHTHALATE                                DATE: 04/03/96       
EXPERIMENT: 05094 TEST: 02                                                                                     TIME: 07:12:48       
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
                 -------                             ------------
              Adrenal Cortex                Adenoma
              Clitoral/Preputial Gland      Carcinoma or Adenoma
              Liver                         Hepatocellular Adenoma
                                            Hepatocellular Carcinoma or Hepatocellular Adenoma
                                            Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
              Mammary Gland                 Fibroadenoma
                                            Fibroma, Fibroadenoma or Adenoma
                                            Fibroma, Fibroadenoma, Carcinoma, or Adenoma
              Pancreas                      Adenoma
                                            Carcinoma or Adenoma
              Pituitary Gland: Pars Distalis or Unspecified Site
                                            Adenoma
                                            Carcinoma or Adenoma
              Uterus                        Sarcoma Stromal or Polyp Stromal
              All Organs                    Benign Tumors
                                            Malignant and Benign Tumors
              ====================================================================================================
         DATE: 04/03/96                     EXPERIMENT: 05094 TEST: 02                                                 PAGE   1
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.3%         0.6%         1.2%      |   CONTROL      0.6%         1.2%         2.4%      |
|                       |   FEED RTD                                         |   FEED RTD                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Cortex                                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/120 (0%)   0/60 (0%)    0/60 (0%)    0/60 (0%)  |  1/120 (1%)   5/60 (8%)    1/60 (2%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   1.1%        15.6%         3.4%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/61 (0%)    0/20 (0%)    0/22 (0%)    0/22 (0%)  |  0/66 (0%)    3/29 (10%)   1/29 (3%)    0/29 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   681          725          736 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.375N     P=0.010 **   P=0.562      P=0.662N   |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.370N     P=0.010 *    P=0.593      P=0.674N   |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.372N     P=0.010 **   P=0.586      P=0.646N   |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.323N                                          |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.016 *    P=0.557      P=0.667N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 13/120 (11%) 10/60 (17%)  10/60 (17%)   8/60 (13%) |  1/119 (1%)   2/59 (3%)    0/60 (0%)    1/60 (2%)  |
|ADJUSTED (b)           |  18.5%        38.8%        35.6%        25.4%      |   1.0%         5.5%         0.0%         3.4%      |
|INTERIM SACRIFICE 1 (c)|  1/20 (5%)    0/10 (0%)    1/10 (10%)   0/10 (0%)  |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  8/61 (13%)   6/20 (30%)   6/22 (27%)   3/22 (14%) |  0/66 (0%)    0/29 (0%)    0/29 (0%)    1/29 (3%)  |
|FIRST INCIDENCE (DAYS) |   458 (I)      544          458 (I)      639       |   512          703          ---          736 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.183      P=0.044 *    P=0.078      P=0.252    |  P=0.541      P=0.251      P=0.642N     P=0.573    |
|INCIDENTAL TUMOR       |  P=0.388      P=0.140      P=0.207      P=0.497    |  P=0.613N     P=0.343      P=0.443N     P=0.763    |
|LOGISTIC REGRESSION    |  P=0.338      P=0.111      P=0.192      P=0.384    |  P=0.578      P=0.266      P=0.653N     P=0.607    |
|COCHRAN-ARMITAGE       |  P=0.343                                           |  P=0.583                                           |
|FISHER EXACT           |               P=0.191      P=0.191      P=0.395    |               P=0.255      P=0.665N     P=0.559    |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05094 TEST: 02                                                 PAGE   2
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.3%         0.6%         1.2%      |   CONTROL      0.6%         1.2%         2.4%      |
|                       |   FEED RTD                                         |   FEED RTD                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Malignant                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/120 (3%)   0/60 (0%)    2/60 (3%)    2/60 (3%)  |  0/119 (0%)   0/59 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   4.3%         0.0%         6.1%         9.1%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/61 (2%)    0/20 (0%)    0/22 (0%)    2/22 (9%)  |  0/66 (0%)    0/29 (0%)    0/29 (0%)    0/29 (0%)  |
|FIRST INCIDENCE (DAYS) |   614          ---          681          729 (T)   |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.325      P=0.342N     P=0.537      P=0.485    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.478      P=0.218N     P=0.587N     P=0.562    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.377      P=0.287N     P=0.567      P=0.553    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.380                                           |    (e)                                             |
|FISHER EXACT           |               P=0.294N     P=0.541      P=0.541    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 14/120 (12%) 10/60 (17%)  12/60 (20%)  10/60 (17%) |  2/119 (2%)   2/59 (3%)    0/60 (0%)    1/60 (2%)  |
|ADJUSTED (b)           |  19.5%        38.8%        39.7%        33.3%      |   2.5%         5.5%         0.0%         3.4%      |
|INTERIM SACRIFICE 1 (c)|  1/20 (5%)    0/10 (0%)    1/10 (10%)   0/10 (0%)  |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  8/61 (13%)   6/20 (30%)   6/22 (27%)   5/22 (23%) |  1/66 (2%)    0/29 (0%)    0/29 (0%)    1/29 (3%)  |
|FIRST INCIDENCE (DAYS) |   458 (I)      544          458 (I)      639       |   512          703          ---          736 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.078      P=0.063      P=0.038 *    P=0.124    |  P=0.545N     P=0.400      P=0.419N     P=0.703    |
|INCIDENTAL TUMOR       |  P=0.225      P=0.207      P=0.151      P=0.288    |  P=0.441N     P=0.488      P=0.289N     P=0.610N   |
|LOGISTIC REGRESSION    |  P=0.172      P=0.154      P=0.101      P=0.224    |  P=0.510N     P=0.425      P=0.396N     P=0.732N   |
|COCHRAN-ARMITAGE       |  P=0.179                                           |  P=0.496N                                          |
|FISHER EXACT           |               P=0.240      P=0.103      P=0.240    |               P=0.404      P=0.441N     P=0.740N   |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05094 TEST: 02                                                 PAGE   3
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.3%         0.6%         1.2%      |   CONTROL      0.6%         1.2%         2.4%      |
|                       |   FEED RTD                                         |   FEED RTD                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Brain                                                                                                                            |
|     Oligodendroglioma Malignant                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/120 (3%)   0/60 (0%)    0/60 (0%)    0/60 (0%)  |  0/120 (0%)   0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   3.8%         0.0%         0.0%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/61 (2%)    0/20 (0%)    0/22 (0%)    0/22 (0%)  |  0/66 (0%)    0/29 (0%)    0/29 (0%)    0/29 (0%)  |
|FIRST INCIDENCE (DAYS) |   261          ---          ---          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.120N     P=0.325N     P=0.288N     P=0.292N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.094N     P=0.310N     P=0.311N     P=0.194N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.107N     P=0.257N     P=0.294N     P=0.257N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.107N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.294N     P=0.294N     P=0.294N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Brain                                                                                                                            |
|     Oligodendroglioma, Glioma, or Astrocytoma                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/120 (3%)   1/60 (2%)    1/60 (2%)    0/60 (0%)  |  0/120 (0%)   0/60 (0%)    1/60 (2%)    1/60 (2%)  |
|ADJUSTED (b)           |   3.8%         5.0%         4.2%         0.0%      |   0.0%         0.0%         1.7%         1.7%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/20 (0%)    0/10 (0%)    1/10 (10%)   0/10 (0%)  |
|TERMINAL (d)           |  1/61 (2%)    1/20 (5%)    0/22 (0%)    0/22 (0%)  |  0/66 (0%)    0/29 (0%)    0/29 (0%)    0/29 (0%)  |
|FIRST INCIDENCE (DAYS) |   261          729 (T)      722          ---       |   ---          ---          459 (I)      404       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.228N     P=0.674N     P=0.618N     P=0.292N   |  P=0.151        (e)        P=0.362      P=0.367    |
|INCIDENTAL TUMOR       |  P=0.136N     P=0.659N     P=0.553N     P=0.194N   |  P=0.256        (e)        P=0.362      P=0.638    |
|LOGISTIC REGRESSION    |  P=0.183N     P=0.557N     P=0.588N     P=0.257N   |  P=0.096        (e)        P=0.325      P=0.294    |
|COCHRAN-ARMITAGE       |  P=0.183N                                          |  P=0.149                                           |
|FISHER EXACT           |               P=0.593N     P=0.593N     P=0.294N   |                 (e)        P=0.333      P=0.333    |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05094 TEST: 02                                                 PAGE   4
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.3%         0.6%         1.2%      |   CONTROL      0.6%         1.2%         2.4%      |
|                       |   FEED RTD                                         |   FEED RTD                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  7/120 (6%)   3/60 (5%)    1/60 (2%)    0/60 (0%)  |  5/120 (4%)   4/60 (7%)    4/60 (7%)    4/60 (7%)  |
|ADJUSTED (b)           |  10.5%        15.0%         4.5%         0.0%      |   7.4%        13.0%        12.5%        13.8%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  4/61 (7%)    3/20 (15%)   1/22 (5%)    0/22 (0%)  |  4/66 (6%)    3/29 (10%)   3/29 (10%)   4/29 (14%) |
|FIRST INCIDENCE (DAYS) |   644          729 (T)      729 (T)      ---       |   725          725          646          736 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.054N     P=0.512      P=0.266N     P=0.105N   |  P=0.223      P=0.296      P=0.296      P=0.283    |
|INCIDENTAL TUMOR       |  P=0.031N*    P=0.638N     P=0.160N     P=0.050N   |  P=0.223      P=0.303      P=0.313      P=0.283    |
|LOGISTIC REGRESSION    |  P=0.031N*    P=0.599      P=0.192N     P=0.071N   |  P=0.211      P=0.295      P=0.307      P=0.261    |
|COCHRAN-ARMITAGE       |  P=0.027N*                                         |  P=0.297                                           |
|FISHER EXACT           |               P=0.559N     P=0.189N     P=0.055N   |               P=0.347      P=0.347      P=0.347    |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/120 (3%)   6/60 (10%)   1/60 (2%)    0/60 (0%)  |  5/120 (4%)   6/60 (10%)   5/60 (8%)    0/60 (0%)  |
|ADJUSTED (b)           |   5.6%        25.1%         4.5%         0.0%      |   7.2%        19.2%        14.9%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  2/61 (3%)    3/20 (15%)   1/22 (5%)    0/22 (0%)  |  4/66 (6%)    5/29 (17%)   3/29 (10%)   0/29 (0%)  |
|FIRST INCIDENCE (DAYS) |   607          626          729 (T)      ---       |   702          618          572          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.150N     P=0.019 *    P=0.508N     P=0.215N   |  P=0.233N     P=0.074      P=0.161      P=0.159N   |
|INCIDENTAL TUMOR       |  P=0.100N     P=0.082      P=0.530N     P=0.229N   |  P=0.193N     P=0.099      P=0.186      P=0.158N   |
|LOGISTIC REGRESSION    |  P=0.097N     P=0.038 *    P=0.434N     P=0.188N   |  P=0.220N     P=0.088      P=0.177      P=0.160N   |
|COCHRAN-ARMITAGE       |  P=0.094N                                          |  P=0.177N                                          |
|FISHER EXACT           |               P=0.071      P=0.459N     P=0.194N   |               P=0.115      P=0.207      P=0.128N   |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05094 TEST: 02                                                 PAGE   5
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.3%         0.6%         1.2%      |   CONTROL      0.6%         1.2%         2.4%      |
|                       |   FEED RTD                                         |   FEED RTD                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 11/120 (9%)   8/60 (13%)   2/60 (3%)    0/60 (0%)  | 10/120 (8%)  10/60 (17%)   9/60 (15%)   4/60 (7%)  |
|ADJUSTED (b)           |  15.7%        33.9%         9.1%         0.0%      |  14.4%        31.4%        26.5%        13.8%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  6/61 (10%)   5/20 (25%)   2/22 (9%)    0/22 (0%)  |  8/66 (12%)   8/29 (28%)   6/29 (21%)   4/29 (14%) |
|FIRST INCIDENCE (DAYS) |   607          626          729 (T)      ---       |   702          618          572          736 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.020N*    P=0.082      P=0.213N     P=0.034N*  |  P=0.536      P=0.041 *    P=0.084      P=0.561N   |
|INCIDENTAL TUMOR       |  P=0.007N**   P=0.257      P=0.141N     P=0.016N*  |  P=0.523N     P=0.053      P=0.100      P=0.561N   |
|LOGISTIC REGRESSION    |  P=0.007N**   P=0.152      P=0.131N     P=0.019N*  |  P=0.541      P=0.047 *    P=0.093      P=0.590N   |
|COCHRAN-ARMITAGE       |  P=0.007N**                                        |  P=0.441N                                          |
|FISHER EXACT           |               P=0.270      P=0.129N     P=0.010N** |               P=0.079      P=0.133      P=0.472N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Heart                                                                                                                            |
|     Schwannoma Malignant                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/120 (0%)   0/60 (0%)    0/60 (0%)    0/60 (0%)  |  2/120 (2%)   0/60 (0%)    0/60 (0%)    1/60 (2%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   3.0%         0.0%         0.0%         3.4%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/61 (0%)    0/20 (0%)    0/22 (0%)    0/22 (0%)  |  2/66 (3%)    0/29 (0%)    0/29 (0%)    1/29 (3%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   736 (T)      ---          ---          736 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.649      P=0.432N     P=0.432N     P=0.701    |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.649      P=0.432N     P=0.432N     P=0.701    |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.649      P=0.432N     P=0.432N     P=0.701    |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.622N                                          |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.443N     P=0.443N     P=0.742N   |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05094 TEST: 02                                                 PAGE   6
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.3%         0.6%         1.2%      |   CONTROL      0.6%         1.2%         2.4%      |
|                       |   FEED RTD                                         |   FEED RTD                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  6/120 (5%)   2/59 (3%)    4/60 (7%)    1/60 (2%)  |  1/119 (1%)   1/60 (2%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   9.8%         6.8%        15.2%         4.5%      |   1.5%         3.4%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  6/61 (10%)   0/20 (0%)    2/22 (9%)    1/22 (5%)  |  1/66 (2%)    1/29 (3%)    0/29 (0%)    0/29 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      607          701          729 (T)   |   736 (T)      736 (T)      ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.401N     P=0.646N     P=0.284      P=0.376N   |  P=0.378N     P=0.568      P=0.664N     P=0.664N   |
|INCIDENTAL TUMOR       |  P=0.277N     P=0.541N     P=0.427      P=0.376N   |  P=0.378N     P=0.568      P=0.664N     P=0.664N   |
|LOGISTIC REGRESSION    |  P=0.291N     P=0.566N     P=0.384      P=0.376N   |  P=0.378N     P=0.568      P=0.664N     P=0.664N   |
|COCHRAN-ARMITAGE       |  P=0.271N                                          |  P=0.351N                                          |
|FISHER EXACT           |               P=0.475N     P=0.441      P=0.258N   |               P=0.559      P=0.665N     P=0.665N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/120 (0%)   0/59 (0%)    0/60 (0%)    0/60 (0%)  |  0/119 (0%)   0/60 (0%)    2/60 (3%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   0.0%         0.0%         5.9%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/61 (0%)    0/20 (0%)    0/22 (0%)    0/22 (0%)  |  0/66 (0%)    0/29 (0%)    1/29 (3%)    0/29 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   ---          ---          666          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.433        (e)        P=0.085        (e)      |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.433        (e)        P=0.102        (e)      |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.447        (e)        P=0.098        (e)      |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.464                                           |
|FISHER EXACT           |                 (e)          (e)          (e)      |                 (e)        P=0.111        (e)      |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05094 TEST: 02                                                 PAGE   7
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.3%         0.6%         1.2%      |   CONTROL      0.6%         1.2%         2.4%      |
|                       |   FEED RTD                                         |   FEED RTD                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  6/120 (5%)   2/59 (3%)    4/60 (7%)    1/60 (2%)  |  1/119 (1%)   1/60 (2%)    2/60 (3%)    0/60 (0%)  |
|ADJUSTED (b)           |   9.8%         6.8%        15.2%         4.5%      |   1.5%         3.4%         5.9%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  6/61 (10%)   0/20 (0%)    2/22 (9%)    1/22 (5%)  |  1/66 (2%)    1/29 (3%)    1/29 (3%)    0/29 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      607          701          729 (T)   |   736 (T)      736 (T)      666          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.401N     P=0.646N     P=0.284      P=0.376N   |  P=0.594N     P=0.568      P=0.230      P=0.664N   |
|INCIDENTAL TUMOR       |  P=0.277N     P=0.541N     P=0.427      P=0.376N   |  P=0.594N     P=0.568      P=0.252      P=0.664N   |
|LOGISTIC REGRESSION    |  P=0.291N     P=0.566N     P=0.384      P=0.376N   |  P=0.589N     P=0.568      P=0.249      P=0.664N   |
|COCHRAN-ARMITAGE       |  P=0.271N                                          |  P=0.551N                                          |
|FISHER EXACT           |               P=0.475N     P=0.441      P=0.258N   |               P=0.559      P=0.260      P=0.665N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney: Renal Tubule                                                                                                             |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/120 (2%)   2/60 (3%)    0/60 (0%)    0/60 (0%)  |  1/120 (1%)   0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   3.0%         7.6%         0.0%         0.0%      |   1.4%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/61 (2%)    1/20 (5%)    0/22 (0%)    0/22 (0%)  |  0/66 (0%)    0/29 (0%)    0/29 (0%)    0/29 (0%)  |
|FIRST INCIDENCE (DAYS) |   654          607          ---          ---       |   722          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.220N     P=0.310      P=0.433N     P=0.433N   |  P=0.415N     P=0.649N     P=0.644N     P=0.673N   |
|INCIDENTAL TUMOR       |  P=0.180N     P=0.451      P=0.311N     P=0.319N   |  P=0.411N     P=0.638N     P=0.622N     P=0.674N   |
|LOGISTIC REGRESSION    |  P=0.192N     P=0.390      P=0.401N     P=0.406N   |  P=0.412N     P=0.653N     P=0.656N     P=0.664N   |
|COCHRAN-ARMITAGE       |  P=0.191N                                          |  P=0.394N                                          |
|FISHER EXACT           |               P=0.407      P=0.443N     P=0.443N   |               P=0.667N     P=0.667N     P=0.667N   |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05094 TEST: 02                                                 PAGE   8
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.3%         0.6%         1.2%      |   CONTROL      0.6%         1.2%         2.4%      |
|                       |   FEED RTD                                         |   FEED RTD                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney: Renal Tubule                                                                                                             |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/120 (2%)   2/60 (3%)    0/60 (0%)    1/60 (2%)  |  2/120 (2%)   0/60 (0%)    1/60 (2%)    0/60 (0%)  |
|ADJUSTED (b)           |   3.0%         7.6%         0.0%         3.8%      |   2.5%         0.0%         2.9%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/61 (2%)    1/20 (5%)    0/22 (0%)    0/22 (0%)  |  0/66 (0%)    0/29 (0%)    0/29 (0%)    0/29 (0%)  |
|FIRST INCIDENCE (DAYS) |   654          607          ---          716       |   670          ---          724          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.550N     P=0.310      P=0.433N     P=0.689    |  P=0.355N     P=0.421N     P=0.713      P=0.439N   |
|INCIDENTAL TUMOR       |  P=0.425N     P=0.451      P=0.311N     P=0.567N   |  P=0.346N     P=0.400N     P=0.711N     P=0.445N   |
|LOGISTIC REGRESSION    |  P=0.501N     P=0.390      P=0.401N     P=0.725    |  P=0.339N     P=0.409N     P=0.720      P=0.416N   |
|COCHRAN-ARMITAGE       |  P=0.500N                                          |  P=0.321N                                          |
|FISHER EXACT           |               P=0.407      P=0.443N     P=0.742N   |               P=0.443N     P=0.742N     P=0.443N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/120 (3%)   2/60 (3%)    0/60 (0%)    4/60 (7%)  |  0/120 (0%)   0/60 (0%)    2/60 (3%)    2/60 (3%)  |
|ADJUSTED (b)           |   4.6%         8.5%         0.0%        14.2%      |   0.0%         0.0%         5.1%         6.9%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/20 (0%)    0/10 (0%)    1/10 (10%)   0/10 (0%)  |
|TERMINAL (d)           |  2/61 (3%)    1/20 (5%)    0/22 (0%)    2/22 (9%)  |  0/66 (0%)    0/29 (0%)    1/29 (3%)    2/29 (7%)  |
|FIRST INCIDENCE (DAYS) |   662          678          ---          464       |   ---          ---          459 (I)      736 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.114      P=0.416      P=0.315N     P=0.109    |  P=0.029 *      (e)        P=0.096      P=0.085    |
|INCIDENTAL TUMOR       |  P=0.185      P=0.509      P=0.228N     P=0.179    |  P=0.029 *      (e)        P=0.096      P=0.085    |
|LOGISTIC REGRESSION    |  P=0.160      P=0.486      P=0.272N     P=0.164    |  P=0.033 *      (e)        P=0.105      P=0.085    |
|COCHRAN-ARMITAGE       |  P=0.160                                           |  P=0.035 *                                         |
|FISHER EXACT           |               P=0.541      P=0.294N     P=0.169    |                 (e)        P=0.110      P=0.110    |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05094 TEST: 02                                                 PAGE   9
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.3%         0.6%         1.2%      |   CONTROL      0.6%         1.2%         2.4%      |
|                       |   FEED RTD                                         |   FEED RTD                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/120 (3%)   2/60 (3%)    1/60 (2%)    4/60 (7%)  |  0/120 (0%)   0/60 (0%)    2/60 (3%)    2/60 (3%)  |
|ADJUSTED (b)           |   6.2%         8.5%         4.2%        14.2%      |   0.0%         0.0%         5.1%         6.9%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/20 (0%)    0/10 (0%)    1/10 (10%)   0/10 (0%)  |
|TERMINAL (d)           |  3/61 (5%)    1/20 (5%)    0/22 (0%)    2/22 (9%)  |  0/66 (0%)    0/29 (0%)    1/29 (3%)    2/29 (7%)  |
|FIRST INCIDENCE (DAYS) |   662          678          722          464       |   ---          ---          459 (I)      736 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.156      P=0.516      P=0.533N     P=0.171    |  P=0.029 *      (e)        P=0.096      P=0.085    |
|INCIDENTAL TUMOR       |  P=0.284      P=0.599      P=0.341N     P=0.256    |  P=0.029 *      (e)        P=0.096      P=0.085    |
|LOGISTIC REGRESSION    |  P=0.228      P=0.586      P=0.453N     P=0.252    |  P=0.033 *      (e)        P=0.105      P=0.085    |
|COCHRAN-ARMITAGE       |  P=0.230                                           |  P=0.035 *                                         |
|FISHER EXACT           |               P=0.682N     P=0.459N     P=0.255    |                 (e)        P=0.110      P=0.110    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/120 (3%)   2/60 (3%)    1/60 (2%)    4/60 (7%)  |  0/120 (0%)   0/60 (0%)    2/60 (3%)    2/60 (3%)  |
|ADJUSTED (b)           |   6.2%         8.5%         4.2%        14.2%      |   0.0%         0.0%         5.1%         6.9%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/20 (0%)    0/10 (0%)    1/10 (10%)   0/10 (0%)  |
|TERMINAL (d)           |  3/61 (5%)    1/20 (5%)    0/22 (0%)    2/22 (9%)  |  0/66 (0%)    0/29 (0%)    1/29 (3%)    2/29 (7%)  |
|FIRST INCIDENCE (DAYS) |   662          678          722          464       |   ---          ---          459 (I)      736 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.156      P=0.516      P=0.533N     P=0.171    |  P=0.029 *      (e)        P=0.096      P=0.085    |
|INCIDENTAL TUMOR       |  P=0.284      P=0.599      P=0.341N     P=0.256    |  P=0.029 *      (e)        P=0.096      P=0.085    |
|LOGISTIC REGRESSION    |  P=0.228      P=0.586      P=0.453N     P=0.252    |  P=0.033 *      (e)        P=0.105      P=0.085    |
|COCHRAN-ARMITAGE       |  P=0.230                                           |  P=0.035 *                                         |
|FISHER EXACT           |               P=0.682N     P=0.459N     P=0.255    |                 (e)        P=0.110      P=0.110    |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05094 TEST: 02                                                 PAGE  10
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.3%         0.6%         1.2%      |   CONTROL      0.6%         1.2%         2.4%      |
|                       |   FEED RTD                                         |   FEED RTD                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/120 (0%)   2/60 (3%)    0/60 (0%)    0/60 (0%)  |  2/120 (2%)   1/60 (2%)    1/60 (2%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%        10.0%         0.0%         0.0%      |   2.8%         2.6%         3.4%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/61 (0%)    2/20 (10%)   0/22 (0%)    0/22 (0%)  |  1/66 (2%)    0/29 (0%)    1/29 (3%)    0/29 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          729 (T)      ---          ---       |   717          689          736 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.607N     P=0.048 *      (e)          (e)      |  P=0.338N     P=0.704      P=0.703      P=0.442N   |
|INCIDENTAL TUMOR       |  P=0.607N     P=0.048 *      (e)          (e)      |  P=0.328N     P=0.722      P=0.717      P=0.439N   |
|LOGISTIC REGRESSION    |  P=0.607N     P=0.048 *      (e)          (e)      |  P=0.325N     P=0.719      P=0.707      P=0.436N   |
|COCHRAN-ARMITAGE       |  P=0.538N                                          |  P=0.295N                                          |
|FISHER EXACT           |               P=0.110        (e)          (e)      |               P=0.742N     P=0.742N     P=0.443N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/120 (2%)   1/60 (2%)    0/60 (0%)    1/60 (2%)  |  0/120 (0%)   0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   3.3%         5.0%         0.0%         4.5%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  2/61 (3%)    1/20 (5%)    0/22 (0%)    1/22 (5%)  |  0/66 (0%)    0/29 (0%)    0/29 (0%)    0/29 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      729 (T)      ---          729 (T)   |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.616      P=0.628      P=0.481N     P=0.652    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.616      P=0.628      P=0.481N     P=0.652    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.616      P=0.628      P=0.481N     P=0.652    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.554N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.742N     P=0.443N     P=0.742N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05094 TEST: 02                                                 PAGE  11
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.3%         0.6%         1.2%      |   CONTROL      0.6%         1.2%         2.4%      |
|                       |   FEED RTD                                         |   FEED RTD                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/120 (2%)   3/60 (5%)    0/60 (0%)    1/60 (2%)  |  2/120 (2%)   1/60 (2%)    1/60 (2%)    0/60 (0%)  |
|ADJUSTED (b)           |   3.3%        15.0%         0.0%         4.5%      |   2.8%         2.6%         3.4%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  2/61 (3%)    3/20 (15%)   0/22 (0%)    1/22 (5%)  |  1/66 (2%)    0/29 (0%)    1/29 (3%)    0/29 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      729 (T)      ---          729 (T)   |   717          689          736 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.578N     P=0.089      P=0.481N     P=0.652    |  P=0.338N     P=0.704      P=0.703      P=0.442N   |
|INCIDENTAL TUMOR       |  P=0.578N     P=0.089      P=0.481N     P=0.652    |  P=0.328N     P=0.722      P=0.717      P=0.439N   |
|LOGISTIC REGRESSION    |  P=0.578N     P=0.089      P=0.481N     P=0.652    |  P=0.325N     P=0.719      P=0.707      P=0.436N   |
|COCHRAN-ARMITAGE       |  P=0.456N                                          |  P=0.295N                                          |
|FISHER EXACT           |               P=0.207      P=0.443N     P=0.742N   |               P=0.742N     P=0.742N     P=0.443N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/120 (0%)   0/60 (0%)    0/60 (0%)    0/60 (0%)  |  2/120 (2%)   0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   3.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/61 (0%)    0/20 (0%)    0/22 (0%)    0/22 (0%)  |  2/66 (3%)    0/29 (0%)    0/29 (0%)    0/29 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   736 (T)      ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.216N     P=0.432N     P=0.432N     P=0.432N   |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.216N     P=0.432N     P=0.432N     P=0.432N   |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.216N     P=0.432N     P=0.432N     P=0.432N   |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.197N                                          |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.443N     P=0.443N     P=0.443N   |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05094 TEST: 02                                                 PAGE  12
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.3%         0.6%         1.2%      |   CONTROL      0.6%         1.2%         2.4%      |
|                       |   FEED RTD                                         |   FEED RTD                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/120 (0%)   1/60 (2%)    0/60 (0%)    0/60 (0%)  |  2/120 (2%)   1/60 (2%)    2/60 (3%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         5.0%         0.0%         0.0%      |   2.7%         1.7%         6.9%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/61 (0%)    1/20 (5%)    0/22 (0%)    0/22 (0%)  |  1/66 (2%)    0/29 (0%)    2/29 (7%)    0/29 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          729 (T)      ---          ---       |   716          424          736 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.701N     P=0.279        (e)          (e)      |  P=0.420N     P=0.711      P=0.382      P=0.444N   |
|INCIDENTAL TUMOR       |  P=0.701N     P=0.279        (e)          (e)      |  P=0.327N     P=0.669N     P=0.400      P=0.439N   |
|LOGISTIC REGRESSION    |  P=0.701N     P=0.279        (e)          (e)      |  P=0.388N     P=0.728N     P=0.387      P=0.435N   |
|COCHRAN-ARMITAGE       |  P=0.656N                                          |  P=0.382N                                          |
|FISHER EXACT           |               P=0.333        (e)          (e)      |               P=0.742N     P=0.407      P=0.443N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/120 (0%)   1/60 (2%)    0/60 (0%)    0/60 (0%)  |  4/120 (3%)   1/60 (2%)    2/60 (3%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         5.0%         0.0%         0.0%      |   5.7%         1.7%         6.9%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/61 (0%)    1/20 (5%)    0/22 (0%)    0/22 (0%)  |  3/66 (5%)    0/29 (0%)    2/29 (7%)    0/29 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          729 (T)      ---          ---       |   716          424          736 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.701N     P=0.279        (e)          (e)      |  P=0.197N     P=0.478N     P=0.619      P=0.220N   |
|INCIDENTAL TUMOR       |  P=0.701N     P=0.279        (e)          (e)      |  P=0.144N     P=0.406N     P=0.633      P=0.218N   |
|LOGISTIC REGRESSION    |  P=0.701N     P=0.279        (e)          (e)      |  P=0.177N     P=0.440N     P=0.625      P=0.221N   |
|COCHRAN-ARMITAGE       |  P=0.656N                                          |  P=0.166N                                          |
|FISHER EXACT           |               P=0.333        (e)          (e)      |               P=0.459N     P=0.682N     P=0.194N   |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05094 TEST: 02                                                 PAGE  13
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.3%         0.6%         1.2%      |   CONTROL      0.6%         1.2%         2.4%      |
|                       |   FEED RTD                                         |   FEED RTD                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroadenoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/120 (4%)   5/60 (8%)    2/60 (3%)    0/60 (0%)  | 35/120 (29%) 31/60 (52%)  32/60 (53%)  11/60 (18%) |
|ADJUSTED (b)           |   8.2%        19.8%         9.1%         0.0%      |  42.4%        73.3%        72.2%        28.9%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/20 (0%)    1/10 (10%)   1/10 (10%)   0/10 (0%)  |
|TERMINAL (d)           |  5/61 (8%)    2/20 (10%)   2/22 (9%)    0/22 (0%)  | 20/66 (30%)  18/29 (62%)  17/29 (59%)   5/29 (17%) |
|FIRST INCIDENCE (DAYS) |   729 (T)      645          729 (T)      ---       |   587          459 (I)      459 (I)      487       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.157N     P=0.073      P=0.624      P=0.196N   |  P=0.375N     P=0.001 **   P<0.001 **   P=0.200N   |
|INCIDENTAL TUMOR       |  P=0.088N     P=0.120      P=0.624      P=0.196N   |  P=0.173N     P<0.001 **   P<0.001 **   P=0.089N   |
|LOGISTIC REGRESSION    |  P=0.101N     P=0.112      P=0.624      P=0.196N   |  P=0.188N     P=0.001 **   P<0.001 **   P=0.084N   |
|COCHRAN-ARMITAGE       |  P=0.090N                                          |  P=0.156N                                          |
|FISHER EXACT           |               P=0.207      P=0.571N     P=0.128N   |               P=0.003 **   P=0.001 **   P=0.081N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma or Adenoma                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/120 (4%)   5/60 (8%)    2/60 (3%)    0/60 (0%)  | 35/120 (29%) 31/60 (52%)  32/60 (53%)  11/60 (18%) |
|ADJUSTED (b)           |   8.2%        19.8%         9.1%         0.0%      |  42.4%        73.3%        72.2%        28.9%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/20 (0%)    1/10 (10%)   1/10 (10%)   0/10 (0%)  |
|TERMINAL (d)           |  5/61 (8%)    2/20 (10%)   2/22 (9%)    0/22 (0%)  | 20/66 (30%)  18/29 (62%)  17/29 (59%)   5/29 (17%) |
|FIRST INCIDENCE (DAYS) |   729 (T)      645          729 (T)      ---       |   587          459 (I)      459 (I)      487       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.157N     P=0.073      P=0.624      P=0.196N   |  P=0.375N     P=0.001 **   P<0.001 **   P=0.200N   |
|INCIDENTAL TUMOR       |  P=0.088N     P=0.120      P=0.624      P=0.196N   |  P=0.173N     P<0.001 **   P<0.001 **   P=0.089N   |
|LOGISTIC REGRESSION    |  P=0.101N     P=0.112      P=0.624      P=0.196N   |  P=0.188N     P=0.001 **   P<0.001 **   P=0.084N   |
|COCHRAN-ARMITAGE       |  P=0.090N                                          |  P=0.156N                                          |
|FISHER EXACT           |               P=0.207      P=0.571N     P=0.128N   |               P=0.003 **   P=0.001 **   P=0.081N   |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05094 TEST: 02                                                 PAGE  14
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.3%         0.6%         1.2%      |   CONTROL      0.6%         1.2%         2.4%      |
|                       |   FEED RTD                                         |   FEED RTD                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/120 (4%)   6/60 (10%)   2/60 (3%)    0/60 (0%)  | 36/120 (30%) 32/60 (53%)  33/60 (55%)  11/60 (18%) |
|ADJUSTED (b)           |   8.2%        24.3%         9.1%         0.0%      |  43.1%        73.7%        74.5%        28.9%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/20 (0%)    1/10 (10%)   1/10 (10%)   0/10 (0%)  |
|TERMINAL (d)           |  5/61 (8%)    3/20 (15%)   2/22 (9%)    0/22 (0%)  | 20/66 (30%)  18/29 (62%)  18/29 (62%)   5/29 (17%) |
|FIRST INCIDENCE (DAYS) |   729 (T)      645          729 (T)      ---       |   587          424          459 (I)      487       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.156N     P=0.027 *    P=0.624      P=0.196N   |  P=0.349N     P<0.001 **   P<0.001 **   P=0.177N   |
|INCIDENTAL TUMOR       |  P=0.089N     P=0.049 *    P=0.624      P=0.196N   |  P=0.136N     P<0.001 **   P<0.001 **   P=0.072N   |
|LOGISTIC REGRESSION    |  P=0.098N     P=0.046 *    P=0.624      P=0.196N   |  P=0.166N     P<0.001 **   P<0.001 **   P=0.066N   |
|COCHRAN-ARMITAGE       |  P=0.086N                                          |  P=0.136N                                          |
|FISHER EXACT           |               P=0.115      P=0.571N     P=0.128N   |               P=0.002 **   P=0.001 **   P=0.065N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva)                                                                       |
|     Papilloma Squamous or Papilloma                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/120 (0%)   1/60 (2%)    3/60 (5%)    0/60 (0%)  |  4/120 (3%)   0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         5.0%        11.9%         0.0%      |   6.1%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/61 (0%)    1/20 (5%)    2/22 (9%)    0/22 (0%)  |  4/66 (6%)    0/29 (0%)    0/29 (0%)    0/29 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          729 (T)      697          ---       |   736 (T)      ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.370      P=0.279      P=0.017 *      (e)      |  P=0.072N     P=0.213N     P=0.213N     P=0.213N   |
|INCIDENTAL TUMOR       |  P=0.446      P=0.279      P=0.038 *      (e)      |  P=0.072N     P=0.213N     P=0.213N     P=0.213N   |
|LOGISTIC REGRESSION    |  P=0.420      P=0.279      P=0.026 *      (e)      |  P=0.072N     P=0.213N     P=0.213N     P=0.213N   |
|COCHRAN-ARMITAGE       |  P=0.446                                           |  P=0.061N                                          |
|FISHER EXACT           |               P=0.333      P=0.036 *      (e)      |               P=0.194N     P=0.194N     P=0.194N   |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05094 TEST: 02                                                 PAGE  15
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.3%         0.6%         1.2%      |   CONTROL      0.6%         1.2%         2.4%      |
|                       |   FEED RTD                                         |   FEED RTD                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva)                                                                       |
|     Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/120 (0%)   1/60 (2%)    3/60 (5%)    0/60 (0%)  |  4/120 (3%)   1/60 (2%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         5.0%        11.9%         0.0%      |   6.1%         2.8%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/61 (0%)    1/20 (5%)    2/22 (9%)    0/22 (0%)  |  4/66 (6%)    0/29 (0%)    0/29 (0%)    0/29 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          729 (T)      697          ---       |   736 (T)      718          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.370      P=0.279      P=0.017 *      (e)      |  P=0.081N     P=0.483N     P=0.213N     P=0.213N   |
|INCIDENTAL TUMOR       |  P=0.446      P=0.279      P=0.038 *      (e)      |  P=0.079N     P=0.479N     P=0.213N     P=0.213N   |
|LOGISTIC REGRESSION    |  P=0.420      P=0.279      P=0.026 *      (e)      |  P=0.082N     P=0.480N     P=0.213N     P=0.213N   |
|COCHRAN-ARMITAGE       |  P=0.446                                           |  P=0.066N                                          |
|FISHER EXACT           |               P=0.333      P=0.036 *      (e)      |               P=0.459N     P=0.194N     P=0.194N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Mucosa                                                                                                                      |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/120 (0%)   1/60 (2%)    2/60 (3%)    0/60 (0%)  |  1/120 (1%)   0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         5.0%         9.1%         0.0%      |   1.5%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/61 (0%)    1/20 (5%)    2/22 (9%)    0/22 (0%)  |  1/66 (2%)    0/29 (0%)    0/29 (0%)    0/29 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          729 (T)      729 (T)      ---       |   736 (T)      ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.445      P=0.279      P=0.059        (e)      |  P=0.413N     P=0.664N     P=0.664N     P=0.664N   |
|INCIDENTAL TUMOR       |  P=0.445      P=0.279      P=0.059        (e)      |  P=0.413N     P=0.664N     P=0.664N     P=0.664N   |
|LOGISTIC REGRESSION    |  P=0.445      P=0.279      P=0.059        (e)      |  P=0.413N     P=0.664N     P=0.664N     P=0.664N   |
|COCHRAN-ARMITAGE       |  P=0.531                                           |  P=0.394N                                          |
|FISHER EXACT           |               P=0.333      P=0.110        (e)      |               P=0.667N     P=0.667N     P=0.667N   |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05094 TEST: 02                                                 PAGE  16
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.3%         0.6%         1.2%      |   CONTROL      0.6%         1.2%         2.4%      |
|                       |   FEED RTD                                         |   FEED RTD                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Granulosa Cell Tumor Benign                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  2/120 (2%)   0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |                                                    |   2.6%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|                                                    |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |                                                    |  1/66 (2%)    0/29 (0%)    0/29 (0%)    0/29 (0%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   598          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.212N     P=0.418N     P=0.424N     P=0.427N   |
|INCIDENTAL TUMOR       |                                                    |  P=0.171N     P=0.327N     P=0.394N     P=0.327N   |
|LOGISTIC REGRESSION    |                                                    |  P=0.198N     P=0.402N     P=0.402N     P=0.404N   |
|COCHRAN-ARMITAGE       |                                                    |  P=0.197N                                          |
|FISHER EXACT           |                                                    |               P=0.443N     P=0.443N     P=0.443N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Pancreas                                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/120 (3%)   2/59 (3%)    3/60 (5%)   10/60 (17%) |  0/119 (0%)   0/60 (0%)    0/60 (0%)    2/60 (3%)  |
|ADJUSTED (b)           |   4.9%         7.4%        13.6%        41.0%      |   0.0%         0.0%         0.0%         6.2%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  3/61 (5%)    1/20 (5%)    3/22 (14%)   8/22 (36%) |  0/66 (0%)    0/29 (0%)    0/29 (0%)    1/29 (3%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      569          729 (T)      709       |   ---          ---          ---          703       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.420      P=0.193      P<0.001 ** |  P=0.019 *      (e)          (e)        P=0.083    |
|INCIDENTAL TUMOR       |  P<0.001 **   P=0.495      P=0.193      P<0.001 ** |  P=0.018 *      (e)          (e)        P=0.082    |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.498      P=0.193      P<0.001 ** |  P=0.019 *      (e)          (e)        P=0.086    |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P=0.024 *                                         |
|FISHER EXACT           |               P=0.534      P=0.318      P=0.001 ** |                 (e)          (e)        P=0.111    |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05094 TEST: 02                                                 PAGE  17
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.3%         0.6%         1.2%      |   CONTROL      0.6%         1.2%         2.4%      |
|                       |   FEED RTD                                         |   FEED RTD                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Pancreas                                                                                                                         |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/120 (3%)   2/59 (3%)    3/60 (5%)   11/60 (18%) |  0/119 (0%)   0/60 (0%)    0/60 (0%)    2/60 (3%)  |
|ADJUSTED (b)           |   6.6%         7.4%        13.6%        42.7%      |   0.0%         0.0%         0.0%         6.2%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  4/61 (7%)    1/20 (5%)    3/22 (14%)   8/22 (36%) |  0/66 (0%)    0/29 (0%)    0/29 (0%)    1/29 (3%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      569          729 (T)      674       |   ---          ---          ---          703       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.520      P=0.283      P<0.001 ** |  P=0.019 *      (e)          (e)        P=0.083    |
|INCIDENTAL TUMOR       |  P<0.001 **   P=0.587      P=0.283      P<0.001 ** |  P=0.018 *      (e)          (e)        P=0.082    |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.598      P=0.283      P<0.001 ** |  P=0.019 *      (e)          (e)        P=0.086    |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P=0.024 *                                         |
|FISHER EXACT           |               P=0.645      P=0.429      P=0.001 ** |                 (e)          (e)        P=0.111    |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 23/119 (19%) 13/60 (22%)  11/60 (18%)  11/59 (19%) | 28/116 (24%) 27/60 (45%)  26/58 (45%)  13/60 (22%) |
|ADJUSTED (b)           |  29.2%        44.2%        37.9%        36.3%      |  35.8%        64.0%        71.7%        36.1%      |
|INTERIM SACRIFICE 1 (c)|  3/19 (16%)   2/10 (20%)   0/10 (0%)    1/10 (10%) |  1/20 (5%)    1/10 (10%)   1/10 (10%)   0/10 (0%)  |
|TERMINAL (d)           | 12/61 (20%)   7/20 (35%)   6/22 (27%)   5/22 (23%) | 16/63 (25%)  15/29 (52%)  19/29 (66%)   7/29 (24%) |
|FIRST INCIDENCE (DAYS) |   438          458 (I)      569          458 (I)   |   459 (I)      459 (I)      459 (I)      592       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.394      P=0.160      P=0.422      P=0.411    |  P=0.380      P=0.002 **   P=0.002 **   P=0.526    |
|INCIDENTAL TUMOR       |  P=0.440N     P=0.379      P=0.481N     P=0.475N   |  P=0.502      P=0.004 **   P=0.001 **   P=0.563N   |
|LOGISTIC REGRESSION    |  P=0.450N     P=0.401      P=0.509N     P=0.536N   |  P=0.516      P=0.004 **   P=0.001 **   P=0.475N   |
|COCHRAN-ARMITAGE       |  P=0.462N                                          |  P=0.467N                                          |
|FISHER EXACT           |               P=0.427      P=0.522N     P=0.543N   |               P=0.004 **   P=0.005 **   P=0.433N   |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05094 TEST: 02                                                 PAGE  18
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.3%         0.6%         1.2%      |   CONTROL      0.6%         1.2%         2.4%      |
|                       |   FEED RTD                                         |   FEED RTD                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/119 (0%)   1/60 (2%)    0/60 (0%)    0/59 (0%)  |  2/116 (2%)   0/60 (0%)    0/58 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         1.7%         0.0%         0.0%      |   2.8%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/19 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/61 (0%)    0/20 (0%)    0/22 (0%)    0/22 (0%)  |  1/63 (2%)    0/29 (0%)    0/29 (0%)    0/29 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          303          ---          ---       |   717          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.659N     P=0.365        (e)          (e)      |  P=0.215N     P=0.423N     P=0.423N     P=0.437N   |
|INCIDENTAL TUMOR       |  P=0.741N     P=0.282        (e)          (e)      |  P=0.214N     P=0.411N     P=0.422N     P=0.433N   |
|LOGISTIC REGRESSION    |  P=0.739      P=0.192        (e)          (e)      |  P=0.211N     P=0.411N     P=0.422N     P=0.426N   |
|COCHRAN-ARMITAGE       |  P=0.657N                                          |  P=0.194N                                          |
|FISHER EXACT           |               P=0.335        (e)          (e)      |               P=0.433N     P=0.443N     P=0.433N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 23/119 (19%) 14/60 (23%)  11/60 (18%)  11/59 (19%) | 30/116 (26%) 27/60 (45%)  26/58 (45%)  13/60 (22%) |
|ADJUSTED (b)           |  29.2%        45.1%        37.9%        36.3%      |  38.0%        64.0%        71.7%        36.1%      |
|INTERIM SACRIFICE 1 (c)|  3/19 (16%)   2/10 (20%)   0/10 (0%)    1/10 (10%) |  1/20 (5%)    1/10 (10%)   1/10 (10%)   0/10 (0%)  |
|TERMINAL (d)           | 12/61 (20%)   7/20 (35%)   6/22 (27%)   5/22 (23%) | 17/63 (27%)  15/29 (52%)  19/29 (66%)   7/29 (24%) |
|FIRST INCIDENCE (DAYS) |   438          303          569          458 (I)   |   459 (I)      459 (I)      459 (I)      592       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.409      P=0.108      P=0.422      P=0.411    |  P=0.462      P=0.004 **   P=0.004 **   P=0.531N   |
|INCIDENTAL TUMOR       |  P=0.440N     P=0.274      P=0.481N     P=0.475N   |  P=0.476N     P=0.008 **   P=0.003 **   P=0.466N   |
|LOGISTIC REGRESSION    |  P=0.437N     P=0.322      P=0.509N     P=0.536N   |  P=0.460N     P=0.008 **   P=0.003 **   P=0.377N   |
|COCHRAN-ARMITAGE       |  P=0.447N                                          |  P=0.375N                                          |
|FISHER EXACT           |               P=0.330      P=0.522N     P=0.543N   |               P=0.009 **   P=0.010 **   P=0.337N   |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05094 TEST: 02                                                 PAGE  19
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.3%         0.6%         1.2%      |   CONTROL      0.6%         1.2%         2.4%      |
|                       |   FEED RTD                                         |   FEED RTD                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Basal Cell Adenoma                                                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/120 (2%)   0/60 (0%)    0/60 (0%)    2/60 (3%)  |  1/120 (1%)   0/60 (0%)    0/60 (0%)    1/60 (2%)  |
|ADJUSTED (b)           |   3.3%         0.0%         0.0%         6.9%      |   1.5%         0.0%         0.0%         3.4%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  2/61 (3%)    0/20 (0%)    0/22 (0%)    1/22 (5%)  |  0/66 (0%)    0/29 (0%)    0/29 (0%)    1/29 (3%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      ---          ---          639       |   733          ---          ---          736 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.262      P=0.504N     P=0.481N     P=0.344    |  P=0.434      P=0.667N     P=0.660N     P=0.566    |
|INCIDENTAL TUMOR       |  P=0.237      P=0.504N     P=0.481N     P=0.330    |  P=0.433      P=0.638N     P=0.622N     P=0.561    |
|LOGISTIC REGRESSION    |  P=0.314      P=0.504N     P=0.481N     P=0.413    |  P=0.425      P=0.661N     P=0.661N     P=0.556    |
|COCHRAN-ARMITAGE       |  P=0.319                                           |  P=0.462                                           |
|FISHER EXACT           |               P=0.443N     P=0.443N     P=0.407    |               P=0.667N     P=0.667N     P=0.557    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Basal Cell Adenoma, Basosquamous Tumor Benign, or Trichoepithelioma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/120 (2%)   0/60 (0%)    0/60 (0%)    2/60 (3%)  |  2/120 (2%)   0/60 (0%)    0/60 (0%)    1/60 (2%)  |
|ADJUSTED (b)           |   3.3%         0.0%         0.0%         6.9%      |   3.0%         0.0%         0.0%         3.4%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  2/61 (3%)    0/20 (0%)    0/22 (0%)    1/22 (5%)  |  1/66 (2%)    0/29 (0%)    0/29 (0%)    1/29 (3%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      ---          ---          639       |   733          ---          ---          736 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.262      P=0.504N     P=0.481N     P=0.344    |  P=0.648      P=0.434N     P=0.430N     P=0.698    |
|INCIDENTAL TUMOR       |  P=0.237      P=0.504N     P=0.481N     P=0.330    |  P=0.649      P=0.417N     P=0.407N     P=0.695    |
|LOGISTIC REGRESSION    |  P=0.314      P=0.504N     P=0.481N     P=0.413    |  P=0.643      P=0.429N     P=0.427N     P=0.691    |
|COCHRAN-ARMITAGE       |  P=0.319                                           |  P=0.622N                                          |
|FISHER EXACT           |               P=0.443N     P=0.443N     P=0.407    |               P=0.443N     P=0.443N     P=0.742N   |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05094 TEST: 02                                                 PAGE  20
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.3%         0.6%         1.2%      |   CONTROL      0.6%         1.2%         2.4%      |
|                       |   FEED RTD                                         |   FEED RTD                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous Tumor (benign,                                                       |
|     malignant or NOS), or Trichoepithelioma                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/120 (3%)   0/60 (0%)    1/60 (2%)    3/60 (5%)  |  2/120 (2%)   0/60 (0%)    1/60 (2%)    1/60 (2%)  |
|ADJUSTED (b)           |   4.4%         0.0%         4.5%        11.3%      |   3.0%         0.0%         3.4%         3.4%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  2/61 (3%)    0/20 (0%)    1/22 (5%)    2/22 (9%)  |  1/66 (2%)    0/29 (0%)    1/29 (3%)    1/29 (3%)  |
|FIRST INCIDENCE (DAYS) |   593          ---          729 (T)      639       |   733          ---          736 (T)      736 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.152      P=0.347N     P=0.659N     P=0.247    |  P=0.541      P=0.434N     P=0.701      P=0.698    |
|INCIDENTAL TUMOR       |  P=0.125      P=0.265N     P=0.670N     P=0.226    |  P=0.541      P=0.417N     P=0.717      P=0.695    |
|LOGISTIC REGRESSION    |  P=0.205      P=0.293N     P=0.572N     P=0.319    |  P=0.533      P=0.429N     P=0.707      P=0.691    |
|COCHRAN-ARMITAGE       |  P=0.207                                           |  P=0.580                                           |
|FISHER EXACT           |               P=0.294N     P=0.593N     P=0.318    |               P=0.443N     P=0.742N     P=0.742N   |
|=================================================================================================================================|
|                                                                                                                                 |
|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)            |  8/120 (7%)   2/60 (3%)    4/60 (7%)    5/60 (8%)  |  3/120 (3%)   1/60 (2%)    2/60 (3%)    1/60 (2%)  |
|ADJUSTED (b)           |  11.5%        10.0%        13.8%        20.2%      |   4.5%         3.4%         6.9%         3.4%      |
|INTERIM SACRIFICE 1 (c)|  1/20 (5%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  5/61 (8%)    2/20 (10%)   2/22 (9%)    4/22 (18%) |  2/66 (3%)    1/29 (3%)    2/29 (7%)    1/29 (3%)  |
|FIRST INCIDENCE (DAYS) |   458 (I)      729 (T)      655          639       |   733          736 (T)      736 (T)      736 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.222      P=0.464N     P=0.500      P=0.297    |  P=0.573N     P=0.621N     P=0.512      P=0.621N   |
|INCIDENTAL TUMOR       |  P=0.293      P=0.372N     P=0.579N     P=0.351    |  P=0.574N     P=0.608N     P=0.528      P=0.625N   |
|LOGISTIC REGRESSION    |  P=0.347      P=0.341N     P=0.621N     P=0.445    |  P=0.582N     P=0.619N     P=0.520      P=0.636N   |
|COCHRAN-ARMITAGE       |  P=0.352                                           |  P=0.520N                                          |
|FISHER EXACT           |               P=0.292N     P=0.634N     P=0.448    |               P=0.593N     P=0.541      P=0.593N   |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05094 TEST: 02                                                 PAGE  21
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.3%         0.6%         1.2%      |   CONTROL      0.6%         1.2%         2.4%      |
|                       |   FEED RTD                                         |   FEED RTD                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  6/120 (5%)   2/60 (3%)    5/60 (8%)    5/60 (8%)  |  2/120 (2%)   1/60 (2%)    2/60 (3%)    0/60 (0%)  |
|ADJUSTED (b)           |   9.1%         8.3%        15.9%        17.3%      |   2.7%         2.6%         6.9%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  4/61 (7%)    1/20 (5%)    1/22 (5%)    2/22 (9%)  |  1/66 (2%)    0/29 (0%)    2/29 (7%)    0/29 (0%)  |
|FIRST INCIDENCE (DAYS) |   614          645          628          668       |   711          701          736 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.116      P=0.645N     P=0.191      P=0.181    |  P=0.435N     P=0.700      P=0.380      P=0.447N   |
|INCIDENTAL TUMOR       |  P=0.303      P=0.495N     P=0.422      P=0.394    |  P=0.424N     P=0.722      P=0.400      P=0.439N   |
|LOGISTIC REGRESSION    |  P=0.168      P=0.544N     P=0.286      P=0.267    |  P=0.424N     P=0.718      P=0.388      P=0.433N   |
|COCHRAN-ARMITAGE       |  P=0.173                                           |  P=0.382N                                          |
|FISHER EXACT           |               P=0.466N     P=0.284      P=0.284    |               P=0.742N     P=0.407      P=0.443N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Keratoacanthoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/120 (3%)   2/60 (3%)    2/60 (3%)    1/60 (2%)  |  2/120 (2%)   1/60 (2%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   5.6%        10.0%         7.1%         4.5%      |   3.0%         3.4%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  1/20 (5%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  2/61 (3%)    2/20 (10%)   1/22 (5%)    1/22 (5%)  |  2/66 (3%)    1/29 (3%)    0/29 (0%)    0/29 (0%)  |
|FIRST INCIDENCE (DAYS) |   458 (I)      729 (T)      670          729 (T)   |   736 (T)      736 (T)      ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.471N     P=0.529      P=0.591      P=0.546N   |  P=0.220N     P=0.701      P=0.432N     P=0.432N   |
|INCIDENTAL TUMOR       |  P=0.359N     P=0.578      P=0.587N     P=0.431N   |  P=0.220N     P=0.701      P=0.432N     P=0.432N   |
|LOGISTIC REGRESSION    |  P=0.362N     P=0.629      P=0.667N     P=0.441N   |  P=0.220N     P=0.701      P=0.432N     P=0.432N   |
|COCHRAN-ARMITAGE       |  P=0.359N                                          |  P=0.197N                                          |
|FISHER EXACT           |               P=0.682N     P=0.682N     P=0.459N   |               P=0.742N     P=0.443N     P=0.443N   |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05094 TEST: 02                                                 PAGE  22
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.3%         0.6%         1.2%      |   CONTROL      0.6%         1.2%         2.4%      |
|                       |   FEED RTD                                         |   FEED RTD                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Neurofibrosarcoma, Neurofibroma, or Schwannoma (benign, malignant or NOS)                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/120 (1%)   2/60 (3%)    0/60 (0%)    1/60 (2%)  |  0/120 (0%)   0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   1.2%         5.7%         0.0%         4.3%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/61 (0%)    0/20 (0%)    0/22 (0%)    0/22 (0%)  |  0/66 (0%)    0/29 (0%)    0/29 (0%)    0/29 (0%)  |
|FIRST INCIDENCE (DAYS) |   584          544          ---          718       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.565      P=0.233      P=0.631N     P=0.561    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.589N     P=0.421      P=0.654N     P=0.704    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.589      P=0.279      P=0.650N     P=0.598    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.580                                           |    (e)                                             |
|FISHER EXACT           |               P=0.258      P=0.667N     P=0.557    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/120 (4%)   2/60 (3%)    3/60 (5%)    2/60 (3%)  |  2/120 (2%)   1/60 (2%)    1/60 (2%)    0/60 (0%)  |
|ADJUSTED (b)           |   7.2%        10.0%         9.4%         9.1%      |   3.0%         3.4%         3.4%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  1/20 (5%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  3/61 (5%)    2/20 (10%)   1/22 (5%)    2/22 (9%)  |  2/66 (3%)    1/29 (3%)    1/29 (3%)    0/29 (0%)  |
|FIRST INCIDENCE (DAYS) |   458 (I)      729 (T)      655          729 (T)   |   736 (T)      736 (T)      736 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.516      P=0.612      P=0.458      P=0.640    |  P=0.329N     P=0.701      P=0.701      P=0.432N   |
|INCIDENTAL TUMOR       |  P=0.502N     P=0.654      P=0.627N     P=0.598N   |  P=0.329N     P=0.701      P=0.701      P=0.432N   |
|LOGISTIC REGRESSION    |  P=0.520N     P=0.619N     P=0.555      P=0.565N   |  P=0.329N     P=0.701      P=0.701      P=0.432N   |
|COCHRAN-ARMITAGE       |  P=0.516N                                          |  P=0.295N                                          |
|FISHER EXACT           |               P=0.571N     P=0.534      P=0.571N   |               P=0.742N     P=0.742N     P=0.443N   |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05094 TEST: 02                                                 PAGE  23
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.3%         0.6%         1.2%      |   CONTROL      0.6%         1.2%         2.4%      |
|                       |   FEED RTD                                         |   FEED RTD                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma, Papilloma, or Keratoacanthoma                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/120 (4%)   2/60 (3%)    3/60 (5%)    2/60 (3%)  |  2/120 (2%)   1/60 (2%)    1/60 (2%)    0/60 (0%)  |
|ADJUSTED (b)           |   7.2%        10.0%         9.4%         9.1%      |   3.0%         3.4%         3.4%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  1/20 (5%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  3/61 (5%)    2/20 (10%)   1/22 (5%)    2/22 (9%)  |  2/66 (3%)    1/29 (3%)    1/29 (3%)    0/29 (0%)  |
|FIRST INCIDENCE (DAYS) |   458 (I)      729 (T)      655          729 (T)   |   736 (T)      736 (T)      736 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.516      P=0.612      P=0.458      P=0.640    |  P=0.329N     P=0.701      P=0.701      P=0.432N   |
|INCIDENTAL TUMOR       |  P=0.502N     P=0.654      P=0.627N     P=0.598N   |  P=0.329N     P=0.701      P=0.701      P=0.432N   |
|LOGISTIC REGRESSION    |  P=0.520N     P=0.619N     P=0.555      P=0.565N   |  P=0.329N     P=0.701      P=0.701      P=0.432N   |
|COCHRAN-ARMITAGE       |  P=0.516N                                          |  P=0.295N                                          |
|FISHER EXACT           |               P=0.571N     P=0.534      P=0.571N   |               P=0.742N     P=0.742N     P=0.443N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |105/120 (88%) 51/60 (85%)  57/60 (95%)  54/60 (90%) |                                                    |
|ADJUSTED (b)           |  99.0%        98.0%        98.3%       100.0%      |                                                    |
|INTERIM SACRIFICE 1 (c)| 16/20 (80%)   5/10 (50%)   9/10 (90%)   9/10 (90%) |                                                    |
|TERMINAL (d)           | 60/61 (98%)  19/20 (95%)  21/22 (95%)  22/22 (100%)|                                                    |
|FIRST INCIDENCE (DAYS) |   422          450          458 (I)      458 (I)   |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.032 *    P=0.018 *    P=0.011 *    P=0.029 *  |                                                    |
|INCIDENTAL TUMOR       |  P=0.194      P=0.489N     P=0.221      P=0.352    |                                                    |
|LOGISTIC REGRESSION    |  P=0.196      P=0.455N     P=0.154      P=0.351    |                                                    |
|COCHRAN-ARMITAGE       |  P=0.222                                           |                                                    |
|FISHER EXACT           |               P=0.401N     P=0.090      P=0.411    |                                                    |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05094 TEST: 02                                                 PAGE  24
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.3%         0.6%         1.2%      |   CONTROL      0.6%         1.2%         2.4%      |
|                       |   FEED RTD                                         |   FEED RTD                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Thymus                                                                                                                           |
|     Thymoma: Benign, Malignant, NOS                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/117 (0%)   1/58 (2%)    0/60 (0%)    2/57 (4%)  |  0/117 (0%)   0/59 (0%)    1/60 (2%)    0/58 (0%)  |
|ADJUSTED (b)           |   0.0%         5.3%         0.0%         6.4%      |   0.0%         0.0%         3.4%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/19 (0%)    0/9 (0%)     0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/61 (0%)    1/19 (5%)    0/22 (0%)    1/21 (5%)  |  0/65 (0%)    0/29 (0%)    1/29 (3%)    0/28 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          729 (T)      ---          297       |   ---          ---          736 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.050 *    P=0.269        (e)        P=0.078    |  P=0.585        (e)        P=0.339        (e)      |
|INCIDENTAL TUMOR       |  P=0.068      P=0.269        (e)        P=0.099    |  P=0.585        (e)        P=0.339        (e)      |
|LOGISTIC REGRESSION    |  P=0.068      P=0.269        (e)        P=0.110    |  P=0.585        (e)        P=0.339        (e)      |
|COCHRAN-ARMITAGE       |  P=0.068                                           |  P=0.605                                           |
|FISHER EXACT           |               P=0.331        (e)        P=0.106    |                 (e)        P=0.339        (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  8/120 (7%)   3/60 (5%)    3/60 (5%)    2/60 (3%)  |  6/119 (5%)   5/60 (8%)    3/60 (5%)    2/60 (3%)  |
|ADJUSTED (b)           |  11.3%        12.8%         9.7%         5.2%      |   7.3%        14.5%        10.3%         6.9%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    1/10 (10%) |  1/20 (5%)    1/10 (10%)   0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  5/61 (8%)    2/20 (10%)   1/22 (5%)    0/22 (0%)  |  2/66 (3%)    3/29 (10%)   3/29 (10%)   2/29 (7%)  |
|FIRST INCIDENCE (DAYS) |   438          626          674          458 (I)   |   459 (I)      459 (I)      736 (T)      736 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.312N     P=0.622      P=0.554N     P=0.379N   |  P=0.414N     P=0.240      P=0.580      P=0.520N   |
|INCIDENTAL TUMOR       |  P=0.207N     P=0.485N     P=0.394N     P=0.282N   |  P=0.407N     P=0.258      P=0.618      P=0.520N   |
|LOGISTIC REGRESSION    |  P=0.225N     P=0.510N     P=0.451N     P=0.285N   |  P=0.370N     P=0.288      P=0.628      P=0.471N   |
|COCHRAN-ARMITAGE       |  P=0.225N                                          |  P=0.335N                                          |
|FISHER EXACT           |               P=0.470N     P=0.470N     P=0.292N   |               P=0.289      P=0.648N     P=0.461N   |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05094 TEST: 02                                                 PAGE  25
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.3%         0.6%         1.2%      |   CONTROL      0.6%         1.2%         2.4%      |
|                       |   FEED RTD                                         |   FEED RTD                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/120 (0%)   0/60 (0%)    0/60 (0%)    0/60 (0%)  |  1/119 (1%)   2/60 (3%)    0/60 (0%)    1/60 (2%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   1.5%         5.9%         0.0%         1.7%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/61 (0%)    0/20 (0%)    0/22 (0%)    0/22 (0%)  |  1/66 (2%)    1/29 (3%)    0/29 (0%)    0/29 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   736 (T)      689          ---          452       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.546      P=0.234      P=0.664N     P=0.584    |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.611N     P=0.244      P=0.664N     P=0.763    |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.583      P=0.248      P=0.664N     P=0.608    |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.582                                           |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.260      P=0.665N     P=0.559    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  8/120 (7%)   3/60 (5%)    3/60 (5%)    2/60 (3%)  |  7/119 (6%)   7/60 (12%)   3/60 (5%)    3/60 (5%)  |
|ADJUSTED (b)           |  11.3%        12.8%         9.7%         5.2%      |   8.7%        19.9%        10.3%         8.5%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    1/10 (10%) |  1/20 (5%)    1/10 (10%)   0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  5/61 (8%)    2/20 (10%)   1/22 (5%)    0/22 (0%)  |  3/66 (5%)    4/29 (14%)   3/29 (10%)   2/29 (7%)  |
|FIRST INCIDENCE (DAYS) |   438          626          674          458 (I)   |   459 (I)      459 (I)      736 (T)      452       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.312N     P=0.622      P=0.554N     P=0.379N   |  P=0.462N     P=0.103      P=0.615N     P=0.616N   |
|INCIDENTAL TUMOR       |  P=0.207N     P=0.485N     P=0.394N     P=0.282N   |  P=0.406N     P=0.113      P=0.577N     P=0.525N   |
|LOGISTIC REGRESSION    |  P=0.225N     P=0.510N     P=0.451N     P=0.285N   |  P=0.404N     P=0.133      P=0.567N     P=0.552N   |
|COCHRAN-ARMITAGE       |  P=0.225N                                          |  P=0.373N                                          |
|FISHER EXACT           |               P=0.470N     P=0.470N     P=0.292N   |               P=0.144      P=0.554N     P=0.554N   |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05094 TEST: 02                                                 PAGE  26
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.3%         0.6%         1.2%      |   CONTROL      0.6%         1.2%         2.4%      |
|                       |   FEED RTD                                         |   FEED RTD                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/120 (0%)   0/60 (0%)    0/60 (0%)    2/60 (3%)  |  1/119 (1%)   2/60 (3%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         7.6%      |   1.5%         6.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/61 (0%)    0/20 (0%)    0/22 (0%)    1/22 (5%)  |  1/66 (2%)    1/29 (3%)    0/29 (0%)    0/29 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          698       |   736 (T)      701          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.019 *      (e)          (e)        P=0.075    |  P=0.356N     P=0.233      P=0.664N     P=0.664N   |
|INCIDENTAL TUMOR       |  P=0.035 *      (e)          (e)        P=0.151    |  P=0.351N     P=0.244      P=0.664N     P=0.664N   |
|LOGISTIC REGRESSION    |  P=0.023 *      (e)          (e)        P=0.094    |  P=0.350N     P=0.245      P=0.664N     P=0.664N   |
|COCHRAN-ARMITAGE       |  P=0.023 *                                         |  P=0.319N                                          |
|FISHER EXACT           |                 (e)          (e)        P=0.110    |               P=0.260      P=0.665N     P=0.665N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/120 (0%)   1/60 (2%)    0/60 (0%)    3/60 (5%)  |  2/119 (2%)   2/60 (3%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         4.2%         0.0%        11.6%      |   2.4%         6.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  1/20 (5%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/61 (0%)    0/20 (0%)    0/22 (0%)    1/22 (5%)  |  1/66 (2%)    1/29 (3%)    0/29 (0%)    0/29 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          708          ---          698       |   459 (I)      701          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.010 *    P=0.296        (e)        P=0.016 *  |  P=0.215N     P=0.395      P=0.417N     P=0.417N   |
|INCIDENTAL TUMOR       |  P=0.048 *    P=0.412        (e)        P=0.083    |  P=0.210N     P=0.405      P=0.417N     P=0.417N   |
|LOGISTIC REGRESSION    |  P=0.015 *    P=0.320        (e)        P=0.026 *  |  P=0.190N     P=0.432      P=0.397N     P=0.392N   |
|COCHRAN-ARMITAGE       |  P=0.016 *                                         |  P=0.189N                                          |
|FISHER EXACT           |               P=0.333        (e)        P=0.036 *  |               P=0.411      P=0.441N     P=0.441N   |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05094 TEST: 02                                                 PAGE  27
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.3%         0.6%         1.2%      |   CONTROL      0.6%         1.2%         2.4%      |
|                       |   FEED RTD                                         |   FEED RTD                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Tongue                                                                                                                           |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/120 (0%)   0/60 (0%)    1/60 (2%)    0/60 (0%)  |  3/120 (3%)   0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         3.1%         0.0%      |   4.5%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/61 (0%)    0/20 (0%)    0/22 (0%)    0/22 (0%)  |  3/66 (5%)    0/29 (0%)    0/29 (0%)    0/29 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          697          ---       |   736 (T)      ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.595        (e)        P=0.350        (e)      |  P=0.122N     P=0.299N     P=0.299N     P=0.299N   |
|INCIDENTAL TUMOR       |  P=0.735        (e)        P=0.550        (e)      |  P=0.123N     P=0.299N     P=0.299N     P=0.299N   |
|LOGISTIC REGRESSION    |  P=0.603        (e)        P=0.360        (e)      |  P=0.123N     P=0.299N     P=0.299N     P=0.299N   |
|COCHRAN-ARMITAGE       |  P=0.606                                           |  P=0.107N                                          |
|FISHER EXACT           |                 (e)        P=0.333        (e)      |               P=0.294N     P=0.294N     P=0.294N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Urinary Bladder                                                                                                                  |
|     Papilloma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/120 (0%)   0/60 (0%)    0/60 (0%)    0/60 (0%)  |  1/120 (1%)   0/60 (0%)    0/60 (0%)    2/60 (3%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   1.0%         0.0%         0.0%         5.1%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/61 (0%)    0/20 (0%)    0/22 (0%)    0/22 (0%)  |  0/66 (0%)    0/29 (0%)    0/29 (0%)    1/29 (3%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   512          ---          ---          452       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.130      P=0.642N     P=0.642N     P=0.250    |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.308      P=0.500N     P=0.443N     P=0.571    |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.139      P=0.647N     P=0.655N     P=0.272    |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.139                                           |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.667N     P=0.667N     P=0.258    |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05094 TEST: 02                                                 PAGE  28
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.3%         0.6%         1.2%      |   CONTROL      0.6%         1.2%         2.4%      |
|                       |   FEED RTD                                         |   FEED RTD                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    | 11/120 (9%)  10/60 (17%)   6/60 (10%)   7/60 (12%) |
|ADJUSTED (b)           |                                                    |  14.7%        27.1%        18.0%        22.4%      |
|INTERIM SACRIFICE 1 (c)|                                                    |  1/20 (5%)    1/10 (10%)   0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |                                                    |  7/66 (11%)   5/29 (17%)   3/29 (10%)   6/29 (21%) |
|FIRST INCIDENCE (DAYS) |                                                    |   459 (I)      247          722          487       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.324      P=0.076      P=0.454      P=0.298    |
|INCIDENTAL TUMOR       |                                                    |  P=0.331      P=0.079      P=0.499      P=0.363    |
|LOGISTIC REGRESSION    |                                                    |  P=0.377      P=0.101      P=0.484      P=0.334    |
|COCHRAN-ARMITAGE       |                                                    |  P=0.432                                           |
|FISHER EXACT           |                                                    |               P=0.111      P=0.526      P=0.388    |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal or Polyp Stromal                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    | 11/120 (9%)  11/60 (18%)   6/60 (10%)   7/60 (12%) |
|ADJUSTED (b)           |                                                    |  14.7%        29.2%        18.0%        22.4%      |
|INTERIM SACRIFICE 1 (c)|                                                    |  1/20 (5%)    1/10 (10%)   0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |                                                    |  7/66 (11%)   5/29 (17%)   3/29 (10%)   6/29 (21%) |
|FIRST INCIDENCE (DAYS) |                                                    |   459 (I)      247          722          487       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.340      P=0.043 *    P=0.454      P=0.298    |
|INCIDENTAL TUMOR       |                                                    |  P=0.347      P=0.043 *    P=0.499      P=0.363    |
|LOGISTIC REGRESSION    |                                                    |  P=0.395      P=0.057      P=0.484      P=0.334    |
|COCHRAN-ARMITAGE       |                                                    |  P=0.452                                           |
|FISHER EXACT           |                                                    |               P=0.066      P=0.526      P=0.388    |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05094 TEST: 02                                                 PAGE  29
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.3%         0.6%         1.2%      |   CONTROL      0.6%         1.2%         2.4%      |
|                       |   FEED RTD                                         |   FEED RTD                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Zymbal's Gland                                                                                                                   |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/120 (2%)   0/60 (0%)    0/60 (0%)    0/60 (0%)  |  0/120 (0%)   0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   2.5%         0.0%         0.0%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/61 (2%)    0/20 (0%)    0/22 (0%)    0/22 (0%)  |  0/66 (0%)    0/29 (0%)    0/29 (0%)    0/29 (0%)  |
|FIRST INCIDENCE (DAYS) |   339          ---          ---          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.222N     P=0.450N     P=0.437N     P=0.442N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.231N     P=0.502N     P=0.703N     P=0.401N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.195N     P=0.390N     P=0.434N     P=0.387N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.197N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.443N     P=0.443N     P=0.443N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 46/120 (38%) 29/60 (48%)  35/60 (58%)  30/60 (50%) | 35/120 (29%) 20/60 (33%)  21/60 (35%)  19/60 (32%) |
|ADJUSTED (b)           |  53.3%        72.5%        74.4%        65.5%      |  39.9%        46.4%        52.0%        45.9%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    1/10 (10%)   1/10 (10%)   0/10 (0%)  |  1/20 (5%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           | 22/61 (36%)  10/20 (50%)  11/22 (50%)   7/22 (32%) | 16/66 (24%)   8/29 (28%)  10/29 (34%)   8/29 (28%) |
|FIRST INCIDENCE (DAYS) |   422          458 (I)      400          180       |   368          405          509          452       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.022 *    P=0.012 *    P=0.004 **   P=0.034 *  |  P=0.206      P=0.236      P=0.171      P=0.254    |
|INCIDENTAL TUMOR       |  P=0.128      P=0.299      P=0.038 *    P=0.289    |  P=0.413      P=0.449      P=0.284      P=0.450    |
|LOGISTIC REGRESSION    |  P=0.057      P=0.236      P=0.030 *    P=0.079    |  P=0.365      P=0.380      P=0.205      P=0.437    |
|COCHRAN-ARMITAGE       |  P=0.044 *                                         |  P=0.370                                           |
|FISHER EXACT           |               P=0.131      P=0.009 **   P=0.091    |               P=0.342      P=0.264      P=0.429    |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05094 TEST: 02                                                 PAGE  30
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.3%         0.6%         1.2%      |   CONTROL      0.6%         1.2%         2.4%      |
|                       |   FEED RTD                                         |   FEED RTD                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Mesothelioma: Benign, Malignant, NOS                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/120 (2%)   3/60 (5%)    3/60 (5%)    1/60 (2%)  |  0/120 (0%)   0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   3.0%        10.9%         5.1%         2.4%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    3/10 (30%)   0/10 (0%)  |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/61 (2%)    1/20 (5%)    0/22 (0%)    0/22 (0%)  |  0/66 (0%)    0/29 (0%)    0/29 (0%)    0/29 (0%)  |
|FIRST INCIDENCE (DAYS) |   677          607          458 (I)      634       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.532      P=0.122      P=0.190      P=0.706    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.581N     P=0.242      P=0.257      P=0.676N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.555      P=0.178      P=0.177      P=0.728    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.554                                           |    (e)                                             |
|FISHER EXACT           |               P=0.207      P=0.207      P=0.742N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |111/120 (93%) 56/60 (93%)  58/60 (97%)  56/60 (93%) | 63/120 (53%) 47/60 (78%)  43/60 (72%)  31/60 (52%) |
|ADJUSTED (b)           | 100.0%       100.0%       100.0%       100.0%      |  67.1%        92.0%        93.3%        74.9%      |
|INTERIM SACRIFICE 1 (c)| 18/20 (90%)   7/10 (70%)   9/10 (90%)   9/10 (90%) |  4/20 (20%)   4/10 (40%)   2/10 (20%)   0/10 (0%)  |
|TERMINAL (d)           | 61/61 (100%) 20/20 (100%) 22/22 (100%) 22/22 (100%)| 36/66 (55%)  25/29 (86%)  26/29 (90%)  19/29 (66%) |
|FIRST INCIDENCE (DAYS) |   422          450          458 (I)      458 (I)   |   459 (I)      247          459 (I)      452       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.055      P=0.006 **   P=0.025 *    P=0.043 *  |  P=0.228      P<0.001 **   P=0.005 **   P=0.306    |
|INCIDENTAL TUMOR       |  P=0.428      P=0.525      P=0.487      P=0.590    |  P=0.461      P<0.001 **   P=0.005 **   P=0.532    |
|LOGISTIC REGRESSION    |  P=0.362      P=0.629      P=0.423      P=0.484    |  P=0.372      P<0.001 **   P=0.002 **   P=0.506    |
|COCHRAN-ARMITAGE       |  P=0.400                                           |  P=0.513N                                          |
|FISHER EXACT           |               P=0.552      P=0.226      P=0.552    |               P<0.001 **   P=0.010 *    P=0.521N   |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05094 TEST: 02                                                 PAGE  31
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.3%         0.6%         1.2%      |   CONTROL      0.6%         1.2%         2.4%      |
|                       |   FEED RTD                                         |   FEED RTD                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 66/120 (55%) 36/60 (60%)  41/60 (68%)  38/60 (63%) | 51/120 (43%) 31/60 (52%)  28/60 (47%)  22/60 (37%) |
|ADJUSTED (b)           |  68.7%        81.1%        79.2%        77.4%      |  55.5%        66.0%        64.4%        50.2%      |
|INTERIM SACRIFICE 1 (c)|  1/20 (5%)    1/10 (10%)   4/10 (40%)   0/10 (0%)  |  1/20 (5%)    0/10 (0%)    1/10 (10%)   0/10 (0%)  |
|TERMINAL (d)           | 32/61 (52%)  12/20 (60%)  12/22 (55%)  11/22 (50%) | 27/66 (41%)  14/29 (48%)  14/29 (48%)   9/29 (31%) |
|FIRST INCIDENCE (DAYS) |   255          303          400          180       |    39          247          459 (I)      404       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.050 *    P=0.032 *    P=0.027 *    P=0.060    |  P=0.514N     P=0.094      P=0.209      P=0.521N   |
|INCIDENTAL TUMOR       |  P=0.279      P=0.546      P=0.109      P=0.469    |  P=0.208N     P=0.188      P=0.345      P=0.264N   |
|LOGISTIC REGRESSION    |  P=0.107      P=0.248      P=0.065      P=0.170    |  P=0.298N     P=0.139      P=0.234      P=0.317N   |
|COCHRAN-ARMITAGE       |  P=0.109                                           |  P=0.247N                                          |
|FISHER EXACT           |               P=0.317      P=0.059      P=0.182    |               P=0.157      P=0.354      P=0.278N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |118/120 (98%) 57/60 (95%)  59/60 (98%)  59/60 (98%) | 86/120 (72%) 52/60 (87%)  48/60 (80%)  42/60 (70%) |
|ADJUSTED (b)           | 100.0%       100.0%       100.0%       100.0%      |  82.5%        96.2%        94.1%        83.8%      |
|INTERIM SACRIFICE 1 (c)| 18/20 (90%)   7/10 (70%)   9/10 (90%)   9/10 (90%) |  5/20 (25%)   4/10 (40%)   3/10 (30%)   0/10 (0%)  |
|TERMINAL (d)           | 61/61 (100%) 20/20 (100%) 22/22 (100%) 22/22 (100%)| 48/66 (73%)  27/29 (93%)  26/29 (90%)  21/29 (72%) |
|FIRST INCIDENCE (DAYS) |   255          303          400          180       |    39          247          459 (I)      404       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.077      P=0.027 *    P=0.080      P=0.066    |  P=0.250      P=0.019 *    P=0.073      P=0.288    |
|INCIDENTAL TUMOR       |  P=0.522      P=0.197N     P=0.737      P=0.737    |  P=0.347N     P=0.012 *    P=0.123      P=0.403N   |
|LOGISTIC REGRESSION    |  P=0.472      P=0.190N     P=0.649N     P=0.692    |  P=0.454      P=0.007 **   P=0.069      P=0.567    |
|COCHRAN-ARMITAGE       |  P=0.520                                           |  P=0.421N                                          |
|FISHER EXACT           |               P=0.207N     P=0.706N     P=0.706N   |               P=0.018 *    P=0.152      P=0.474N   |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05094 TEST: 02                                                 PAGE  32
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
 (a)  Number of tumor-bearing animals / number of animals examined at site.
 (b)  Kaplan-Meier estimated lifetime tumor incidence after adjustment for 
      intercurrent mortality.
 (c)  Observed incidence at interim kill.
          Male interim sacrifices(days):   458
          Female interim sacrifices(days): 459
 (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).