Share This:
https://ntp.niehs.nih.gov/go/3254

TDMS Study 05094-99 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: SOUTHERN RESEARCH INST                              BUTYL BENZYL PHTHALATE                                DATE: 05/10/95       
EXPERIMENT: 05094 TEST: 99                                                                                     TIME: 17:39:41       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-85222                              ROUTE: DOSED FEED                                              NTP C#: 54375C       
PATHOLOGIST: DR J. E. HEATH                                                                                    CAS: 85-68-7         
                                             05094/02 -VS- 05094/03 COMPARISON 



                                                    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
                                                    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: 05/10/95       
EXPERIMENT: 05094 TEST: 99                                                                                     TIME: 17:39:41       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-85222                              ROUTE: DOSED FEED                                              NTP C#: 54375C       
PATHOLOGIST: DR J. E. HEATH                                                                                    CAS: 85-68-7         




                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                     IN THE ANALYSIS OF THE STUDY OF BUTYL BENZYL PHTHALATE

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

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

                             Skin                          Fibroma
                             All Organs                    Leukemia: Lymphocytic, Monocytic, Mononuclear,
                                                            or Undifferentiated

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

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

                             Mammary Gland                 Fibroadenoma
                                                           Fibroma, Fibroadenoma or Adenoma
                                                           Fibroma, Fibroadenoma, Carcinoma, or Adenoma
                             Uterus                        Polyp Stromal
                             All Organs                    Benign Tumors
                                                           Malignant and Benign Tumors

              ====================================================================================================
         DATE: 05/11/95                     EXPERIMENT: 05094 TEST: 99                                                 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                   |          AD LIB              RTD                   |          AD LIB              RTD                   |
|                       |          CONTROL             CONTROL               |          CONTROL             CONTROL               |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         9/50 (18%)          3/50 (6%)              |         1/49 (2%)           1/51 (2%)              |
|ADJUSTED (b)           |         28.2%                7.3%                  |          2.1%                2.9%                  |
|INTERIM SACRIFICE 1 (c)|         0/0                 1/34 (3%)              |         0/0                 1/35 (3%)              |
|TERMINAL (d)           |         6/28 (21%)          0/1 (0%)               |         0/25 (0%)           0/0                    |
|FIRST INCIDENCE (DAYS) |          607                 467                   |          512                 730 (I)               |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.361N               |                             P=0.492N               |
|INCIDENTAL TUMOR       |                             P=0.563N               |           (e)                 (e)                  |
|LOGISTIC REGRESSION    |                             P=0.051N               |                             P=0.757                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.061N               |                             P=0.742N               |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Malignant                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         2/50 (4%)           1/50 (2%)              |         0/49 (0%)           1/51 (2%)              |
|ADJUSTED (b)           |          6.2%                2.8%                  |          0.0%                2.2%                  |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/34 (0%)              |         0/0                 0/35 (0%)              |
|TERMINAL (d)           |         1/28 (4%)           0/1 (0%)               |         0/25 (0%)           0/0                    |
|FIRST INCIDENCE (DAYS) |          614                 723                   |          ---                 624                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.690N               |                             P=0.509                |
|INCIDENTAL TUMOR       |                             P=0.731                |                             P=0.682                |
|LOGISTIC REGRESSION    |                             P=0.484N               |                             P=0.491                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.500N               |                             P=0.510                |
|=================================================================================================================================|
         DATE: 05/11/95                     EXPERIMENT: 05094 TEST: 99                                                 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                   |          AD LIB              RTD                   |          AD LIB              RTD                   |
|                       |          CONTROL             CONTROL               |          CONTROL             CONTROL               |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |        10/50 (20%)          4/50 (8%)              |         1/49 (2%)           3/51 (6%)              |
|ADJUSTED (b)           |         30.1%                9.9%                  |          2.1%                7.8%                  |
|INTERIM SACRIFICE 1 (c)|         0/0                 1/34 (3%)              |         0/0                 2/35 (6%)              |
|TERMINAL (d)           |         6/28 (21%)          0/1 (0%)               |         0/25 (0%)           0/0                    |
|FIRST INCIDENCE (DAYS) |          607                 467                   |          512                 624                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.351N               |                             P=0.751N               |
|INCIDENTAL TUMOR       |                             P=0.598N               |                             P=0.682                |
|LOGISTIC REGRESSION    |                             P=0.064N               |                             P=0.303                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.074N               |                             P=0.324                |
|=================================================================================================================================|
|                                                                                                                                 |
|Brain                                                                                                                            |
|     Oligodendroglioma, Glioma, or Astrocytoma                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         1/50 (2%)           0/50 (0%)              |         0/50 (0%)           2/52 (4%)              |
|ADJUSTED (b)           |          2.0%                0.0%                  |          0.0%                4.8%                  |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/34 (0%)              |         0/0                 1/35 (3%)              |
|TERMINAL (d)           |         0/28 (0%)           0/1 (0%)               |         0/25 (0%)           0/0                    |
|FIRST INCIDENCE (DAYS) |          261                 ---                   |          ---                 564                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.496N               |                             P=0.508                |
|INCIDENTAL TUMOR       |           (e)                 (e)                  |                             P=0.638                |
|LOGISTIC REGRESSION    |           (e)                 (e)                  |                             P=0.235                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.500N               |                             P=0.257                |
|=================================================================================================================================|
         DATE: 05/11/95                     EXPERIMENT: 05094 TEST: 99                                                 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                   |          AD LIB              RTD                   |          AD LIB              RTD                   |
|                       |          CONTROL             CONTROL               |          CONTROL             CONTROL               |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         4/50 (8%)           1/50 (2%)              |         3/50 (6%)           3/52 (6%)              |
|ADJUSTED (b)           |         12.8%                2.9%                  |         11.2%               16.3%                  |
|INTERIM SACRIFICE 1 (c)|         0/0                 1/34 (3%)              |         0/0                 2/35 (6%)              |
|TERMINAL (d)           |         2/28 (7%)           0/1 (0%)               |         2/25 (8%)           0/0                    |
|FIRST INCIDENCE (DAYS) |          644                 729 (T)               |          725                 677                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.182N               |                             P=0.737N               |
|INCIDENTAL TUMOR       |                             P=0.260N               |                             P=0.587                |
|LOGISTIC REGRESSION    |                             P=0.138N               |                             P=0.662N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.181N               |                             P=0.642N               |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         1/50 (2%)           0/50 (0%)              |         4/50 (8%)           0/52 (0%)              |
|ADJUSTED (b)           |          2.7%                0.0%                  |         14.3%                0.0%                  |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/34 (0%)              |         0/0                 0/35 (0%)              |
|TERMINAL (d)           |         0/28 (0%)           0/1 (0%)               |         3/25 (12%)          0/0                    |
|FIRST INCIDENCE (DAYS) |          614                 ---                   |          702                 ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.465N               |                             P=0.505N               |
|INCIDENTAL TUMOR       |                             P=0.739N               |                             P=0.649N               |
|LOGISTIC REGRESSION    |                             P=0.554N               |                             P=0.066N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.500N               |                             P=0.054N               |
|=================================================================================================================================|
         DATE: 05/11/95                     EXPERIMENT: 05094 TEST: 99                                                 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                   |          AD LIB              RTD                   |          AD LIB              RTD                   |
|                       |          CONTROL             CONTROL               |          CONTROL             CONTROL               |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         5/50 (10%)          1/50 (2%)              |         7/50 (14%)          3/52 (6%)              |
|ADJUSTED (b)           |         15.1%                2.9%                  |         24.7%               16.3%                  |
|INTERIM SACRIFICE 1 (c)|         0/0                 1/34 (3%)              |         0/0                 2/35 (6%)              |
|TERMINAL (d)           |         2/28 (7%)           0/1 (0%)               |         5/25 (20%)          0/0                    |
|FIRST INCIDENCE (DAYS) |          614                 729 (T)               |          702                 677                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.087N               |                             P=0.479N               |
|INCIDENTAL TUMOR       |                             P=0.196N               |                             P=0.725                |
|LOGISTIC REGRESSION    |                             P=0.086N               |                             P=0.159N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.102N               |                             P=0.144N               |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         5/50 (10%)          4/50 (8%)              |         1/50 (2%)           0/49 (0%)              |
|ADJUSTED (b)           |         17.9%               11.0%                  |          4.0%                0.0%                  |
|INTERIM SACRIFICE 1 (c)|         0/0                 2/34 (6%)              |         0/0                 0/35 (0%)              |
|TERMINAL (d)           |         5/28 (18%)          1/1 (100%)             |         1/25 (4%)           0/0                    |
|FIRST INCIDENCE (DAYS) |          729 (T)             719                   |          736 (T)             ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.129                |           (e)                 (e)                  |
|INCIDENTAL TUMOR       |                             P=0.150                |           (e)                 (e)                  |
|LOGISTIC REGRESSION    |                             P=0.362N               |           (e)                 (e)                  |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.500N               |                             P=0.505N               |
|=================================================================================================================================|
         DATE: 05/11/95                     EXPERIMENT: 05094 TEST: 99                                                 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                   |          AD LIB              RTD                   |          AD LIB              RTD                   |
|                       |          CONTROL             CONTROL               |          CONTROL             CONTROL               |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         5/50 (10%)          5/50 (10%)             |         1/50 (2%)           1/49 (2%)              |
|ADJUSTED (b)           |         17.9%               13.8%                  |          4.0%                7.1%                  |
|INTERIM SACRIFICE 1 (c)|         0/0                 3/34 (9%)              |         0/0                 1/35 (3%)              |
|TERMINAL (d)           |         5/28 (18%)          1/1 (100%)             |         1/25 (4%)           0/0                    |
|FIRST INCIDENCE (DAYS) |          729 (T)             719                   |          736 (T)             731 (I)               |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.129                |           (e)                 (e)                  |
|INCIDENTAL TUMOR       |                             P=0.150                |           (e)                 (e)                  |
|LOGISTIC REGRESSION    |                             P=0.488N               |                             P=0.698                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.630N               |                             P=0.747                |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         2/50 (4%)           1/50 (2%)              |         0/50 (0%)           1/52 (2%)              |
|ADJUSTED (b)           |          6.5%                2.3%                  |          0.0%                2.9%                  |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/34 (0%)              |         0/0                 1/35 (3%)              |
|TERMINAL (d)           |         1/28 (4%)           0/1 (0%)               |         0/25 (0%)           0/0                    |
|FIRST INCIDENCE (DAYS) |          662                 645                   |          ---                 730 (I)               |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.681N               |           (e)                 (e)                  |
|INCIDENTAL TUMOR       |                             P=0.605N               |           (e)                 (e)                  |
|LOGISTIC REGRESSION    |                             P=0.498N               |                             P=0.480                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.500N               |                             P=0.510                |
|=================================================================================================================================|
         DATE: 05/11/95                     EXPERIMENT: 05094 TEST: 99                                                 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                   |          AD LIB              RTD                   |          AD LIB              RTD                   |
|                       |          CONTROL             CONTROL               |          CONTROL             CONTROL               |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         0/50 (0%)           0/50 (0%)              |         2/50 (4%)           1/52 (2%)              |
|ADJUSTED (b)           |          0.0%                0.0%                  |          6.9%                2.9%                  |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/34 (0%)              |         0/0                 1/35 (3%)              |
|TERMINAL (d)           |         0/28 (0%)           0/1 (0%)               |         1/25 (4%)           0/0                    |
|FIRST INCIDENCE (DAYS) |          ---                 ---                   |          717                 730 (I)               |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |           (e)                 (e)                  |                             P=0.488N               |
|INCIDENTAL TUMOR       |           (e)                 (e)                  |                             P=0.649N               |
|LOGISTIC REGRESSION    |           (e)                 (e)                  |                             P=0.514N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                               (e)                  |                             P=0.485N               |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         0/50 (0%)           0/50 (0%)              |         2/50 (4%)           0/52 (0%)              |
|ADJUSTED (b)           |          0.0%                0.0%                  |          8.0%                0.0%                  |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/34 (0%)              |         0/0                 0/35 (0%)              |
|TERMINAL (d)           |         0/28 (0%)           0/1 (0%)               |         2/25 (8%)           0/0                    |
|FIRST INCIDENCE (DAYS) |          ---                 ---                   |          736 (T)             ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |           (e)                 (e)                  |           (e)                 (e)                  |
|INCIDENTAL TUMOR       |           (e)                 (e)                  |           (e)                 (e)                  |
|LOGISTIC REGRESSION    |           (e)                 (e)                  |           (e)                 (e)                  |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                               (e)                  |                             P=0.238N               |
|=================================================================================================================================|
         DATE: 05/11/95                     EXPERIMENT: 05094 TEST: 99                                                 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                   |          AD LIB              RTD                   |          AD LIB              RTD                   |
|                       |          CONTROL             CONTROL               |          CONTROL             CONTROL               |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         0/50 (0%)           0/50 (0%)              |         2/50 (4%)           1/52 (2%)              |
|ADJUSTED (b)           |          0.0%                0.0%                  |          6.8%                2.8%                  |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/34 (0%)              |         0/0                 0/35 (0%)              |
|TERMINAL (d)           |         0/28 (0%)           0/1 (0%)               |         1/25 (4%)           0/0                    |
|FIRST INCIDENCE (DAYS) |          ---                 ---                   |          716                 712                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |           (e)                 (e)                  |                             P=0.754N               |
|INCIDENTAL TUMOR       |           (e)                 (e)                  |                             P=0.587                |
|LOGISTIC REGRESSION    |           (e)                 (e)                  |                             P=0.497N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                               (e)                  |                             P=0.485N               |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         0/50 (0%)           0/50 (0%)              |         4/50 (8%)           1/52 (2%)              |
|ADJUSTED (b)           |          0.0%                0.0%                  |         14.6%                2.8%                  |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/34 (0%)              |         0/0                 0/35 (0%)              |
|TERMINAL (d)           |         0/28 (0%)           0/1 (0%)               |         3/25 (12%)          0/0                    |
|FIRST INCIDENCE (DAYS) |          ---                 ---                   |          716                 712                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |           (e)                 (e)                  |                             P=0.754N               |
|INCIDENTAL TUMOR       |           (e)                 (e)                  |                             P=0.587                |
|LOGISTIC REGRESSION    |           (e)                 (e)                  |                             P=0.187N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                               (e)                  |                             P=0.169N               |
|=================================================================================================================================|
         DATE: 05/11/95                     EXPERIMENT: 05094 TEST: 99                                                 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                   |          AD LIB              RTD                   |          AD LIB              RTD                   |
|                       |          CONTROL             CONTROL               |          CONTROL             CONTROL               |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroadenoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         2/50 (4%)           2/50 (4%)              |        28/50 (56%)         12/52 (23%)             |
|ADJUSTED (b)           |          7.1%                5.7%                  |         71.0%               44.9%                  |
|INTERIM SACRIFICE 1 (c)|         0/0                 2/34 (6%)              |         0/0                12/35 (34%)             |
|TERMINAL (d)           |         2/28 (7%)           0/1 (0%)               |        14/25 (56%)          0/0                    |
|FIRST INCIDENCE (DAYS) |          729 (T)             729 (T)               |          587                 730 (I)               |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.956N               |                             P<0.001N**             |
|INCIDENTAL TUMOR       |                             P=0.956N               |                             P<0.001N**             |
|LOGISTIC REGRESSION    |                             P=0.956N               |                             P<0.001N**             |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.691N               |                             P<0.001N**             |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma or Adenoma                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         2/50 (4%)           2/50 (4%)              |        28/50 (56%)         12/52 (23%)             |
|ADJUSTED (b)           |          7.1%                5.7%                  |         71.0%               44.9%                  |
|INTERIM SACRIFICE 1 (c)|         0/0                 2/34 (6%)              |         0/0                12/35 (34%)             |
|TERMINAL (d)           |         2/28 (7%)           0/1 (0%)               |        14/25 (56%)          0/0                    |
|FIRST INCIDENCE (DAYS) |          729 (T)             729 (T)               |          587                 730 (I)               |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.956N               |                             P<0.001N**             |
|INCIDENTAL TUMOR       |                             P=0.956N               |                             P<0.001N**             |
|LOGISTIC REGRESSION    |                             P=0.956N               |                             P<0.001N**             |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.691N               |                             P<0.001N**             |
|=================================================================================================================================|
         DATE: 05/11/95                     EXPERIMENT: 05094 TEST: 99                                                 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                   |          AD LIB              RTD                   |          AD LIB              RTD                   |
|                       |          CONTROL             CONTROL               |          CONTROL             CONTROL               |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         2/50 (4%)           2/50 (4%)              |        29/50 (58%)         13/52 (25%)             |
|ADJUSTED (b)           |          7.1%                5.7%                  |         71.8%               46.4%                  |
|INTERIM SACRIFICE 1 (c)|         0/0                 2/34 (6%)              |         0/0                12/35 (34%)             |
|TERMINAL (d)           |         2/28 (7%)           0/1 (0%)               |        14/25 (56%)          0/0                    |
|FIRST INCIDENCE (DAYS) |          729 (T)             729 (T)               |          587                 712                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.956N               |                             P<0.001N**             |
|INCIDENTAL TUMOR       |                             P=0.956N               |                             P=0.001N**             |
|LOGISTIC REGRESSION    |                             P=0.956N               |                             P<0.001N**             |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.691N               |                             P<0.001N**             |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva)                                                                       |
|     Papilloma Squamous or Papilloma                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         0/50 (0%)           0/50 (0%)              |         2/50 (4%)           0/52 (0%)              |
|ADJUSTED (b)           |          0.0%                0.0%                  |          8.0%                0.0%                  |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/34 (0%)              |         0/0                 0/35 (0%)              |
|TERMINAL (d)           |         0/28 (0%)           0/1 (0%)               |         2/25 (8%)           0/0                    |
|FIRST INCIDENCE (DAYS) |          ---                 ---                   |          736 (T)             ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |           (e)                 (e)                  |           (e)                 (e)                  |
|INCIDENTAL TUMOR       |           (e)                 (e)                  |           (e)                 (e)                  |
|LOGISTIC REGRESSION    |           (e)                 (e)                  |           (e)                 (e)                  |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                               (e)                  |                             P=0.238N               |
|=================================================================================================================================|
         DATE: 05/11/95                     EXPERIMENT: 05094 TEST: 99                                                 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                   |          AD LIB              RTD                   |          AD LIB              RTD                   |
|                       |          CONTROL             CONTROL               |          CONTROL             CONTROL               |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva)                                                                       |
|     Squamous Cell Carcinoma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         0/50 (0%)           2/50 (4%)              |         0/50 (0%)           0/52 (0%)              |
|ADJUSTED (b)           |          0.0%                4.8%                  |          0.0%                0.0%                  |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/34 (0%)              |         0/0                 0/35 (0%)              |
|TERMINAL (d)           |         0/28 (0%)           0/1 (0%)               |         0/25 (0%)           0/0                    |
|FIRST INCIDENCE (DAYS) |          ---                 549                   |          ---                 ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.281                |           (e)                 (e)                  |
|INCIDENTAL TUMOR       |                             P=0.163                |           (e)                 (e)                  |
|LOGISTIC REGRESSION    |                             P=0.191                |           (e)                 (e)                  |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.247                |                               (e)                  |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva)                                                                       |
|     Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         0/50 (0%)           2/50 (4%)              |         2/50 (4%)           0/52 (0%)              |
|ADJUSTED (b)           |          0.0%                4.8%                  |          8.0%                0.0%                  |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/34 (0%)              |         0/0                 0/35 (0%)              |
|TERMINAL (d)           |         0/28 (0%)           0/1 (0%)               |         2/25 (8%)           0/0                    |
|FIRST INCIDENCE (DAYS) |          ---                 549                   |          736 (T)             ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.281                |           (e)                 (e)                  |
|INCIDENTAL TUMOR       |                             P=0.163                |           (e)                 (e)                  |
|LOGISTIC REGRESSION    |                             P=0.191                |           (e)                 (e)                  |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.247                |                             P=0.238N               |
|=================================================================================================================================|
         DATE: 05/11/95                     EXPERIMENT: 05094 TEST: 99                                                 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                   |          AD LIB              RTD                   |          AD LIB              RTD                   |
|                       |          CONTROL             CONTROL               |          CONTROL             CONTROL               |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Granulosa Cell Tumor Benign                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |         2/50 (4%)           1/52 (2%)              |
|ADJUSTED (b)           |                                                    |          6.1%                2.8%                  |
|INTERIM SACRIFICE 1 (c)|                                                    |         0/0                 0/35 (0%)              |
|TERMINAL (d)           |                                                    |         1/25 (4%)           0/0                    |
|FIRST INCIDENCE (DAYS) |                                                    |          598                 712                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |                             P=0.752N               |
|INCIDENTAL TUMOR       |                                                    |                             P=0.769                |
|LOGISTIC REGRESSION    |                                                    |                             P=0.488N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                                                    |                             P=0.485N               |
|=================================================================================================================================|
|                                                                                                                                 |
|Pancreas                                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         3/50 (6%)           0/50 (0%)              |         0/50 (0%)           0/49 (0%)              |
|ADJUSTED (b)           |         10.7%                0.0%                  |          0.0%                0.0%                  |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/34 (0%)              |         0/0                 0/35 (0%)              |
|TERMINAL (d)           |         3/28 (11%)          0/1 (0%)               |         0/25 (0%)           0/0                    |
|FIRST INCIDENCE (DAYS) |          729 (T)             ---                   |          ---                 ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.904N               |           (e)                 (e)                  |
|INCIDENTAL TUMOR       |                             P=0.904N               |           (e)                 (e)                  |
|LOGISTIC REGRESSION    |                             P=0.904N               |           (e)                 (e)                  |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.121N               |                               (e)                  |
|=================================================================================================================================|
         DATE: 05/11/95                     EXPERIMENT: 05094 TEST: 99                                                 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                   |          AD LIB              RTD                   |          AD LIB              RTD                   |
|                       |          CONTROL             CONTROL               |          CONTROL             CONTROL               |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |        10/50 (20%)          4/46 (9%)              |        20/49 (41%)         17/52 (33%)             |
|ADJUSTED (b)           |         30.6%               11.0%                  |         57.0%               48.5%                  |
|INTERIM SACRIFICE 1 (c)|         0/0                 3/33 (9%)              |         0/0                12/35 (34%)             |
|TERMINAL (d)           |         7/28 (25%)          0/0                    |        11/25 (44%)          0/0                    |
|FIRST INCIDENCE (DAYS) |          438                 681                   |          598                 564                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.259N               |                             P=0.175N               |
|INCIDENTAL TUMOR       |                             P=0.468N               |                             P=0.542N               |
|LOGISTIC REGRESSION    |                             P=0.084N               |                             P=0.279N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.100N               |                             P=0.261N               |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         0/50 (0%)           0/46 (0%)              |         2/49 (4%)           0/52 (0%)              |
|ADJUSTED (b)           |          0.0%                0.0%                  |          6.9%                0.0%                  |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/33 (0%)              |         0/0                 0/35 (0%)              |
|TERMINAL (d)           |         0/28 (0%)           0/0                    |         1/25 (4%)           0/0                    |
|FIRST INCIDENCE (DAYS) |          ---                 ---                   |          717                 ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |           (e)                 (e)                  |                             P=0.488N               |
|INCIDENTAL TUMOR       |           (e)                 (e)                  |                             P=0.649N               |
|LOGISTIC REGRESSION    |           (e)                 (e)                  |                             P=0.241N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                               (e)                  |                             P=0.233N               |
|=================================================================================================================================|
         DATE: 05/11/95                     EXPERIMENT: 05094 TEST: 99                                                 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                   |          AD LIB              RTD                   |          AD LIB              RTD                   |
|                       |          CONTROL             CONTROL               |          CONTROL             CONTROL               |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |        10/50 (20%)          4/46 (9%)              |        22/49 (45%)         17/52 (33%)             |
|ADJUSTED (b)           |         30.6%               11.0%                  |         61.3%               48.5%                  |
|INTERIM SACRIFICE 1 (c)|         0/0                 3/33 (9%)              |         0/0                12/35 (34%)             |
|TERMINAL (d)           |         7/28 (25%)          0/0                    |        12/25 (48%)          0/0                    |
|FIRST INCIDENCE (DAYS) |          438                 681                   |          598                 564                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.259N               |                             P=0.121N               |
|INCIDENTAL TUMOR       |                             P=0.468N               |                             P=0.448N               |
|LOGISTIC REGRESSION    |                             P=0.084N               |                             P=0.158N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.100N               |                             P=0.146N               |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         5/50 (10%)          0/50 (0%)              |         1/50 (2%)           1/52 (2%)              |
|ADJUSTED (b)           |         16.0%                0.0%                  |          2.8%                2.9%                  |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/34 (0%)              |         0/0                 1/35 (3%)              |
|TERMINAL (d)           |         3/28 (11%)          0/1 (0%)               |         0/25 (0%)           0/0                    |
|FIRST INCIDENCE (DAYS) |          614                 ---                   |          711                 730 (I)               |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.181N               |                             P=0.500N               |
|INCIDENTAL TUMOR       |                             P=0.250N               |                             P=0.649N               |
|LOGISTIC REGRESSION    |                             P=0.023N*              |                             P=0.761N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.028N*              |                             P=0.743N               |
|=================================================================================================================================|
         DATE: 05/11/95                     EXPERIMENT: 05094 TEST: 99                                                 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                   |          AD LIB              RTD                   |          AD LIB              RTD                   |
|                       |          CONTROL             CONTROL               |          CONTROL             CONTROL               |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Keratoacanthoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         2/50 (4%)           2/50 (4%)              |         1/50 (2%)           1/52 (2%)              |
|ADJUSTED (b)           |          7.1%                5.7%                  |          4.0%                7.1%                  |
|INTERIM SACRIFICE 1 (c)|         0/0                 2/34 (6%)              |         0/0                 1/35 (3%)              |
|TERMINAL (d)           |         2/28 (7%)           0/1 (0%)               |         1/25 (4%)           0/0                    |
|FIRST INCIDENCE (DAYS) |          729 (T)             729 (T)               |          736 (T)             731 (I)               |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.956N               |           (e)                 (e)                  |
|INCIDENTAL TUMOR       |                             P=0.956N               |           (e)                 (e)                  |
|LOGISTIC REGRESSION    |                             P=0.956N               |                             P=0.698                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.691N               |                             P=0.743N               |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma,                                                                |
|     Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         4/50 (8%)           2/50 (4%)              |         1/50 (2%)           2/52 (4%)              |
|ADJUSTED (b)           |         12.9%                5.7%                  |          4.0%               14.3%                  |
|INTERIM SACRIFICE 1 (c)|         0/0                 2/34 (6%)              |         0/0                 2/35 (6%)              |
|TERMINAL (d)           |         3/28 (11%)          0/1 (0%)               |         1/25 (4%)           0/0                    |
|FIRST INCIDENCE (DAYS) |          593                 729 (T)               |          736 (T)             731 (I)               |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.410N               |           (e)                 (e)                  |
|INCIDENTAL TUMOR       |                             P=0.625N               |           (e)                 (e)                  |
|LOGISTIC REGRESSION    |                             P=0.280N               |                             P=0.410                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.339N               |                             P=0.515                |
|=================================================================================================================================|
         DATE: 05/11/95                     EXPERIMENT: 05094 TEST: 99                                                 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                   |          AD LIB              RTD                   |          AD LIB              RTD                   |
|                       |          CONTROL             CONTROL               |          CONTROL             CONTROL               |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |        44/50 (88%)         47/50 (94%)             |                                                    |
|ADJUSTED (b)           |         97.8%              100.0%                  |                                                    |
|INTERIM SACRIFICE 1 (c)|         0/0                34/34 (100%)            |                                                    |
|TERMINAL (d)           |        27/28 (96%)          1/1 (100%)             |                                                    |
|FIRST INCIDENCE (DAYS) |          477                 549                   |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.110N               |                                                    |
|INCIDENTAL TUMOR       |                             P=0.372N               |                                                    |
|LOGISTIC REGRESSION    |                             P=0.685N               |                                                    |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.243                |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         5/50 (10%)          4/50 (8%)              |         4/49 (8%)           2/51 (4%)              |
|ADJUSTED (b)           |         14.1%                9.9%                  |         11.4%                5.1%                  |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/34 (0%)              |         0/0                 0/35 (0%)              |
|TERMINAL (d)           |         2/28 (7%)           0/1 (0%)               |         1/25 (4%)           0/0                    |
|FIRST INCIDENCE (DAYS) |          438                 549                   |          702                 687                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.608                |                             P=0.498N               |
|INCIDENTAL TUMOR       |                             P=0.492                |                             P=0.544                |
|LOGISTIC REGRESSION    |                             P=0.571N               |                             P=0.431N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.500N               |                             P=0.320N               |
|=================================================================================================================================|
         DATE: 05/11/95                     EXPERIMENT: 05094 TEST: 99                                                 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                   |          AD LIB              RTD                   |          AD LIB              RTD                   |
|                       |          CONTROL             CONTROL               |          CONTROL             CONTROL               |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         5/50 (10%)          4/50 (8%)              |         5/49 (10%)          2/51 (4%)              |
|ADJUSTED (b)           |         14.1%                9.9%                  |         15.1%                5.1%                  |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/34 (0%)              |         0/0                 0/35 (0%)              |
|TERMINAL (d)           |         2/28 (7%)           0/1 (0%)               |         2/25 (8%)           0/0                    |
|FIRST INCIDENCE (DAYS) |          438                 549                   |          702                 687                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.608                |                             P=0.498N               |
|INCIDENTAL TUMOR       |                             P=0.492                |                             P=0.544                |
|LOGISTIC REGRESSION    |                             P=0.571N               |                             P=0.199N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.500N               |                             P=0.202N               |
|=================================================================================================================================|
|                                                                                                                                 |
|Tongue                                                                                                                           |
|     Squamous Cell Carcinoma or Papilloma Squamous                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         0/50 (0%)           1/50 (2%)              |         2/50 (4%)           0/52 (0%)              |
|ADJUSTED (b)           |          0.0%                2.1%                  |          8.0%                0.0%                  |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/34 (0%)              |         0/0                 0/35 (0%)              |
|TERMINAL (d)           |         0/28 (0%)           0/1 (0%)               |         2/25 (8%)           0/0                    |
|FIRST INCIDENCE (DAYS) |          ---                 549                   |          736 (T)             ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.518                |           (e)                 (e)                  |
|INCIDENTAL TUMOR       |                             P=0.261                |           (e)                 (e)                  |
|LOGISTIC REGRESSION    |                             P=0.384                |           (e)                 (e)                  |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.500                |                             P=0.238N               |
|=================================================================================================================================|
         DATE: 05/11/95                     EXPERIMENT: 05094 TEST: 99                                                 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                   |          AD LIB              RTD                   |          AD LIB              RTD                   |
|                       |          CONTROL             CONTROL               |          CONTROL             CONTROL               |
|=================================================================================================================================|
|                                                                                                                                 |
|Tongue                                                                                                                           |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         0/50 (0%)           0/50 (0%)              |         2/50 (4%)           0/52 (0%)              |
|ADJUSTED (b)           |          0.0%                0.0%                  |          8.0%                0.0%                  |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/34 (0%)              |         0/0                 0/35 (0%)              |
|TERMINAL (d)           |         0/28 (0%)           0/1 (0%)               |         2/25 (8%)           0/0                    |
|FIRST INCIDENCE (DAYS) |          ---                 ---                   |          736 (T)             ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |           (e)                 (e)                  |           (e)                 (e)                  |
|INCIDENTAL TUMOR       |           (e)                 (e)                  |           (e)                 (e)                  |
|LOGISTIC REGRESSION    |           (e)                 (e)                  |           (e)                 (e)                  |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                               (e)                  |                             P=0.238N               |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |         6/50 (12%)          0/52 (0%)              |
|ADJUSTED (b)           |                                                    |         19.6%                0.0%                  |
|INTERIM SACRIFICE 1 (c)|                                                    |         0/0                 0/35 (0%)              |
|TERMINAL (d)           |                                                    |         3/25 (12%)          0/0                    |
|FIRST INCIDENCE (DAYS) |                                                    |          681                 ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |                             P=0.110N               |
|INCIDENTAL TUMOR       |                                                    |                             P=0.275N               |
|LOGISTIC REGRESSION    |                                                    |                             P=0.017N*              |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                                                    |                             P=0.012N*              |
|=================================================================================================================================|
         DATE: 05/11/95                     EXPERIMENT: 05094 TEST: 99                                                 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                   |          AD LIB              RTD                   |          AD LIB              RTD                   |
|                       |          CONTROL             CONTROL               |          CONTROL             CONTROL               |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Leukemia: Lymphocytic, Monocytic, Mononuclear,                                                                              |
|     or Undifferentiated                                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |        31/50 (62%)         21/50 (42%)             |        21/50 (42%)         17/52 (33%)             |
|ADJUSTED (b)           |         71.8%               47.4%                  |         51.7%               44.9%                  |
|INTERIM SACRIFICE 1 (c)|         0/0                12/34 (35%)             |         0/0                 7/35 (20%)             |
|TERMINAL (d)           |        16/28 (57%)          0/1 (0%)               |         7/25 (28%)          0/0                    |
|FIRST INCIDENCE (DAYS) |          479                 583                   |          368                 359                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.047N*              |                             P=0.230N               |
|INCIDENTAL TUMOR       |                             P=0.030N*              |                             P=0.491                |
|LOGISTIC REGRESSION    |                             P=0.031N*              |                             P=0.225N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.036N*              |                             P=0.222N               |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Mesothelioma Benign, Malignant, NOS                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         1/50 (2%)           2/50 (4%)              |         0/50 (0%)           0/52 (0%)              |
|ADJUSTED (b)           |          3.1%                5.0%                  |          0.0%                0.0%                  |
|INTERIM SACRIFICE 1 (c)|         0/0                 1/34 (3%)              |         0/0                 0/35 (0%)              |
|TERMINAL (d)           |         0/28 (0%)           0/1 (0%)               |         0/25 (0%)           0/0                    |
|FIRST INCIDENCE (DAYS) |          677                 600                   |          ---                 ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.716N               |           (e)                 (e)                  |
|INCIDENTAL TUMOR       |                             P=0.721                |           (e)                 (e)                  |
|LOGISTIC REGRESSION    |                             P=0.488                |           (e)                 (e)                  |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.500                |                               (e)                  |
|=================================================================================================================================|
         DATE: 05/11/95                     EXPERIMENT: 05094 TEST: 99                                                 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                   |          AD LIB              RTD                   |          AD LIB              RTD                   |
|                       |          CONTROL             CONTROL               |          CONTROL             CONTROL               |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |        46/50 (92%)         48/50 (96%)             |        40/50 (80%)         31/52 (60%)             |
|ADJUSTED (b)           |        100.0%              100.0%                  |         88.7%               85.6%                  |
|INTERIM SACRIFICE 1 (c)|         0/0                34/34 (100%)            |         0/0                24/35 (69%)             |
|TERMINAL (d)           |        28/28 (100%)         1/1 (100%)             |        20/25 (80%)          0/0                    |
|FIRST INCIDENCE (DAYS) |          438                 467                   |          512                 564                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.114N               |                             P=0.007N**             |
|INCIDENTAL TUMOR       |                             P=0.500N               |                             P=0.057N               |
|LOGISTIC REGRESSION    |                             P=0.642N               |                             P=0.017N*              |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.339                |                             P=0.021N*              |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |        37/50 (74%)         29/50 (58%)             |        30/50 (60%)         25/52 (48%)             |
|ADJUSTED (b)           |         78.5%               59.1%                  |         70.1%               58.8%                  |
|INTERIM SACRIFICE 1 (c)|         0/0                15/34 (44%)             |         0/0                11/35 (31%)             |
|TERMINAL (d)           |        18/28 (64%)          0/1 (0%)               |        13/25 (52%)          0/0                    |
|FIRST INCIDENCE (DAYS) |          255                 432                   |           39                 359                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.088N               |                             P=0.311N               |
|INCIDENTAL TUMOR       |                             P=0.597N               |                             P=0.288                |
|LOGISTIC REGRESSION    |                             P=0.141N               |                             P=0.152N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.069N               |                             P=0.157N               |
|=================================================================================================================================|
         DATE: 05/11/95                     EXPERIMENT: 05094 TEST: 99                                                 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                   |          AD LIB              RTD                   |          AD LIB              RTD                   |
|                       |          CONTROL             CONTROL               |          CONTROL             CONTROL               |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |        50/50 (100%)        49/50 (98%)             |        49/50 (98%)         44/52 (85%)             |
|ADJUSTED (b)           |        100.0%              100.0%                  |         98.0%               92.4%                  |
|INTERIM SACRIFICE 1 (c)|         0/0                34/34 (100%)            |         0/0                28/35 (80%)             |
|TERMINAL (d)           |        28/28 (100%)         1/1 (100%)             |        24/25 (96%)          0/0                    |
|FIRST INCIDENCE (DAYS) |          255                 432                   |           39                 359                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.051N               |                             P=0.079N               |
|INCIDENTAL TUMOR       |                             P=0.398N               |                             P=0.638N               |
|LOGISTIC REGRESSION    |                             P=0.339N               |                             P=0.021N*              |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.500N               |                             P=0.018N*              |
|=================================================================================================================================|

 (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):   729
          Female interim sacrifices(days): 730
 (d)  Observed incidence at terminal kill.
 (f)  Beneath the control incidence are the P-values associated with the trend 
      test.  Beneath the dosed group incidence are the P-values corresponding to 
      pairwise comparisons between the controls and that dosed group.  The life
      table analysis regards tumors in animals dying  prior to terminal kill as
      being (directly or indirectly) the cause of death.  The incidental tumor 
      test regards these lesions as non-fatal.  Logistic regression is an alternative
      method for analyzing the incidence of non-fatal tumors.  The Cochran-Armitage
      and Fisher's exact tests compare directly the overall incidence rates.  
      For all tests, a negative trend is indicated by "N".
 (e)  Value of Statistic cannot be computed. 
 (I)  Interim sacrifice
 (T)  Terminal sacrifice
  #   Tumor rates based on number of animals necropsied.

  *   To the right of any statistical result, indicates significance at (P<=0.05).
  **  To the right of any statistical result, indicates significance at (P<=0.01).