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TDMS Study 05103-05 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                       2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL                         DATE: 05/19/95       
EXPERIMENT: 05103 TEST: 05                                                                                     TIME: 20:08:39       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-85234                              ROUTE: DOSED FEED                                              NTP C#: 55516C       
PATHOLOGIST: DR. D. FARNELL                                                                                    CAS: 3296-90-0       
------------------------------------------------------------------------------------------------------------------------------------
               REASONS FOR REMOVAL:    ALL                                                                                          
               REMOVAL DATE RANGE:     ALL                                                                                          
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                       2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL                         DATE: 05/19/95       
EXPERIMENT: 05103 TEST: 05                                                                                     TIME: 20:08:39       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-85234                              ROUTE: DOSED FEED                                              NTP C#: 55516C       
PATHOLOGIST: DR. D. FARNELL                                                                                    CAS: 3296-90-0       
                                                    RATS(FISCHER344)
                                              ----------------------------
             FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
             IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
                                                    ----------------
                                                    Adrenal Cortex
                                                    Adrenal Medulla
                                                    Bone Marrow
                                                    Brain
                                                    Clitoral Gland
                                                    Clitoral/Preputial Gland
                                                    Epididymis
                                                    Heart
                                                    Islets, Pancreatic
                                                    Kidney
                                                    Liver
                                                    Lung
                                                    Nose
                                                    Ovary
                                                    Pancreas
                                                    Parathyroid Gland
                                                    Pituitary Gland
                                                    Preputial Gland
                                                    Prostate
                                                    Salivary Glands
                                                    Spleen
                                                    Testes
                                                    Thymus
                                                    Thyroid Gland
                                                    Urinary Bladder
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                       2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL                         DATE: 05/19/95       
EXPERIMENT: 05103 TEST: 05                                                                                     TIME: 20:08:39       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-85234                              ROUTE: DOSED FEED                                              NTP C#: 55516C       
PATHOLOGIST: DR. D. FARNELL                                                                                    CAS: 3296-90-0       
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                              IN THE ANALYSIS OF THE STUDY OF 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
              ====================================================================================================
                                                           MALE RATS
                                                          -------------
                  ORGAN                               MORPHOLOGY
                 -------                             ------------
              Adrenal Medulla               Pheochromocytoma Benign
                                            Pheochromocytoma Malignant
                                            Pheochromocytoma: Benign, Complex, Malignant, NOS
              Clitoral/Preputial Gland      Adenoma
                                            Carcinoma or Adenoma
              Esophagus                     Squamous Cell Papilloma
              Intestine Large: Colon/Rectum Carcinoma
                                            Polyp Adenomatous
              Intestine Small: Ileum        Carcinoma
              Intestine Small: Jejunum      Carcinoma
              Intestine Small: Site Unspecified
                                            Carcinoma
              Islets, Pancreatic            Adenoma
                                            Carcinoma or Adenoma
              Kidney: Renal Tubule          Adenoma
              Liver                         Hepatocellular Carcinoma or Hepatocellular Adenoma
                                            Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
              Lung                          Alveolar/Bronchiolar Adenoma
                                            Alveolar/Bronchiolar Carcinoma
                                            Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
                                            Squamous Cell Carcinoma
              Mammary Gland                 Fibroadenoma
                                            Fibroma, Fibroadenoma or Adenoma
                                            Fibroma, Fibroadenoma, Carcinoma, or Adenoma
              Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva)
                                            Papilloma Squamous or Papilloma
                                            Squamous Cell Carcinoma
                                            Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma
              Pancreas                      Adenoma
              Pharynx                       Squamous Cell Carcinoma
                                            Squamous Cell Papilloma
              Pituitary Gland: Pars Distalis or Unspecified Site
                                            Adenoma
                                            Carcinoma or Adenoma
              Skin                          Basal Cell Adenoma
                                            Basal Cell Adenoma, Basosquamous Tumor Benign, or Trichoepithelioma
                                            Basal Cell Carcinoma
                                            Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous Tumor (benign,
                                             malignant or NOS), or Trichoepithelioma
                                            Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal
                                             Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepithelioma
                                            Fibroma
                                            Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma
                                            Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma
                                            Keratoacanthoma
                                            Sarcoma
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                       2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL                         DATE: 05/19/95       
EXPERIMENT: 05103 TEST: 05                                                                                     TIME: 20:08:39       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-85234                              ROUTE: DOSED FEED                                              NTP C#: 55516C       
PATHOLOGIST: DR. D. FARNELL                                                                                    CAS: 3296-90-0       
                                            Squamous Cell Carcinoma, Basal Cell Carcinoma, Basosquamous Tumor
                                             (malignant or NOS), or Carcinoma
                                            Squamous Cell Papilloma
                                            Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma
                                            Squamous Cell Papilloma, Papilloma, or Keratoacanthoma
              Skin: Sebaceous Gland         Adenoma
              Stomach, Forestomach          Squamous Cell Papilloma
              Testes                        Adenoma
              Thyroid Gland: C-Cell         Adenoma
                                            Carcinoma
                                            Carcinoma or Adenoma
              Thyroid Gland: Follicular Cell
                                            Adenoma
                                            Carcinoma
                                            Carcinoma or Adenoma
              Tongue                        Squamous Cell Carcinoma or Papilloma Squamous
                                            Squamous Cell Papilloma
              Urinary Bladder               Papilloma
              Zymbal's Gland                Adenoma
                                            Carcinoma
                                            Carcinoma or Adenoma
              All Organs                    Hemangiosarcoma or Hemangioma
                                            Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
                                            Mesothelioma: Benign, Malignant, NOS
                                            Benign Tumors
                                            Malignant Tumors
                                            Malignant and Benign Tumors
              ====================================================================================================
                                                           FEMALE RATS
                                                          -------------
                  ORGAN                               MORPHOLOGY
                 -------                             ------------
              Clitoral/Preputial Gland      Carcinoma or Adenoma
              Esophagus                     Squamous Cell Papilloma
              Lung                          Alveolar/Bronchiolar Carcinoma
                                            Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
              Mammary Gland                 Fibroadenoma
                                            Fibroma, Fibroadenoma or Adenoma
                                            Fibroma, Fibroadenoma, Carcinoma, or Adenoma
              Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva)
                                            Papilloma Squamous or Papilloma
                                            Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma
              Pituitary Gland: Pars Distalis or Unspecified Site
                                            Adenoma
                                            Carcinoma or Adenoma
              Skin                          Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma
                                            Fibrosarcoma
                                            Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma
              Stomach, Forestomach          Squamous Cell Papilloma
              Thyroid Gland: Follicular Cell
                                            Adenoma
                                            Carcinoma
                                            Carcinoma or Adenoma
              Tongue                        Squamous Cell Carcinoma or Papilloma Squamous
                                            Squamous Cell Papilloma
              Uterus                        Polyp Stromal
                                            Sarcoma Stromal or Polyp Stromal
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                       2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL                         DATE: 05/19/95       
EXPERIMENT: 05103 TEST: 05                                                                                     TIME: 20:08:39       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-85234                              ROUTE: DOSED FEED                                              NTP C#: 55516C       
PATHOLOGIST: DR. D. FARNELL                                                                                    CAS: 3296-90-0       
              All Organs                    Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
                                            Benign Tumors
                                            Malignant Tumors
                                            Malignant and Benign Tumors
              ====================================================================================================
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE   1
                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |         UNTREATD           0.25%              0.50%              1.00%              2.00%               |
|                       |         CONTROL                                                                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |        7/70 (10%)        12/60 (20%)         4/60 (7%)          4/59 (7%)          0/70 (0%)            |
|ADJUSTED (b)           |        21.0%              42.2%              18.5%              18.3%               0.0%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        1/9 (11%)          0/7 (0%)           0/9 (0%)           0/5 (0%)           0/0                  |
|TERMINAL (d)           |        3/26 (12%)         6/20 (30%)         1/13 (8%)          0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         456 (I)            543                656                576                ---                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.543N           P=0.069            P=0.567N           P=0.170            P=0.673N             |
|INCIDENTAL TUMOR       |        P=0.016N*          P=0.129            P=0.268N           P=0.299N           P=0.084N             |
|LOGISTIC REGRESSION    |        P=0.022N*          P=0.100            P=0.328N           P=0.489N           P=0.048N*            |
|COCHRAN-ARMITAGE       |        P=0.001N**                                                                                       |
|FISHER EXACT           |                           P=0.087            P=0.361N           P=0.372N           P=0.007N**           |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Malignant                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |        3/70 (4%)          3/60 (5%)          1/60 (2%)          1/59 (2%)          0/70 (0%)            |
|ADJUSTED (b)           |        11.0%              14.1%               2.7%               3.3%               0.0%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           0/7 (0%)           0/9 (0%)           0/5 (0%)           0/0                  |
|TERMINAL (d)           |        2/26 (8%)          2/20 (10%)         0/13 (0%)          0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         725                725                641                577                ---                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.622N           P=0.540            P=0.504N           P=0.520            P=0.995N             |
|INCIDENTAL TUMOR       |        P=0.158N           P=0.591            P=0.316N           P=0.572N           P=0.545N             |
|LOGISTIC REGRESSION    |        P=0.245N           P=0.549            P=0.393N           P=0.624N           P=0.877N             |
|COCHRAN-ARMITAGE       |        P=0.050N*                                                                                        |
|FISHER EXACT           |                           P=0.584            P=0.370N           P=0.377N           P=0.122N             |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE   2
                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |         UNTREATD           0.25%              0.50%              1.00%              2.00%               |
|                       |         CONTROL                                                                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |       10/70 (14%)        14/60 (23%)         5/60 (8%)          5/59 (8%)          0/70 (0%)            |
|ADJUSTED (b)           |        30.4%              48.8%              20.7%              21.2%               0.0%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        1/9 (11%)          0/7 (0%)           0/9 (0%)           0/5 (0%)           0/0                  |
|TERMINAL (d)           |        5/26 (19%)         7/20 (35%)         1/13 (8%)          0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         456 (I)            543                641                576                ---                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.506N           P=0.102            P=0.451N           P=0.112            P=0.637N             |
|INCIDENTAL TUMOR       |        P=0.004N**         P=0.187            P=0.139N           P=0.229N           P=0.047N*            |
|LOGISTIC REGRESSION    |        P=0.010N**         P=0.144            P=0.195N           P=0.400N           P=0.028N*            |
|COCHRAN-ARMITAGE       |        P<0.001N**                                                                                       |
|FISHER EXACT           |                           P=0.136            P=0.218N           P=0.228N           P<0.001N**           |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |        3/70 (4%)          3/59 (5%)          4/60 (7%)          4/60 (7%)          4/70 (6%)            |
|ADJUSTED (b)           |        11.5%              11.6%              19.5%              31.7%             100.0%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           0/7 (0%)           0/9 (0%)           0/5 (0%)           0/0                  |
|TERMINAL (d)           |        3/26 (12%)         1/20 (5%)          2/13 (15%)         0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         736 (T)            648                620                542                659                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P<0.001 **         P=0.546            P=0.237            P=0.017 *          P<0.001 **           |
|INCIDENTAL TUMOR       |        P=0.096            P=0.580            P=0.357            P=0.305            P=0.033 *            |
|LOGISTIC REGRESSION    |        P=0.027 *          P=0.562            P=0.389            P=0.277            P<0.001 **           |
|COCHRAN-ARMITAGE       |        P=0.442                                                                                          |
|FISHER EXACT           |                           P=0.576            P=0.414            P=0.414            P=0.500              |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE   3
                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |         UNTREATD           0.25%              0.50%              1.00%              2.00%               |
|                       |         CONTROL                                                                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |        2/70 (3%)          1/59 (2%)          1/60 (2%)          1/60 (2%)          0/70 (0%)            |
|ADJUSTED (b)           |         5.2%               5.0%               4.5%               5.9%               0.0%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           0/7 (0%)           0/9 (0%)           0/5 (0%)           0/0                  |
|TERMINAL (d)           |        0/26 (0%)          1/20 (5%)          0/13 (0%)          0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         628                736 (T)            695                647                ---                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.650N           P=0.585N           P=0.629N           P=0.626            P=0.635N             |
|INCIDENTAL TUMOR       |        P=0.225N           P=0.497N           P=0.329N           P=0.339N           P=0.151N             |
|LOGISTIC REGRESSION    |        P=0.343N           P=0.547N           P=0.533N           P=0.634N           P=0.373N             |
|COCHRAN-ARMITAGE       |        P=0.164N                                                                                         |
|FISHER EXACT           |                           P=0.564N           P=0.558N           P=0.558N           P=0.248N             |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |        5/70 (7%)          4/59 (7%)          5/60 (8%)          5/60 (8%)          4/70 (6%)            |
|ADJUSTED (b)           |        16.2%              16.2%              23.2%              35.7%             100.0%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           0/7 (0%)           0/9 (0%)           0/5 (0%)           0/0                  |
|TERMINAL (d)           |        3/26 (12%)         2/20 (10%)         2/13 (15%)         0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         628                648                620                542                659                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P<0.001 **         P=0.622            P=0.330            P=0.029 *          P<0.001 **           |
|INCIDENTAL TUMOR       |        P=0.282            P=0.570N           P=0.619            P=0.624            P=0.314              |
|LOGISTIC REGRESSION    |        P=0.094            P=0.612N           P=0.535            P=0.372            P=0.050              |
|COCHRAN-ARMITAGE       |        P=0.424N                                                                                         |
|FISHER EXACT           |                           P=0.607N           P=0.527            P=0.527            P=0.500N             |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE   4
                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |         UNTREATD           0.25%              0.50%              1.00%              2.00%               |
|                       |         CONTROL                                                                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Esophagus                                                                                                                        |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/70 (0%)          0/60 (0%)          1/60 (2%)          5/60 (8%)          0/70 (0%)            |
|ADJUSTED (b)           |         0.0%               0.0%               3.2%              62.6%               0.0%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           0/7 (0%)           0/9 (0%)           0/5 (0%)           0/0                  |
|TERMINAL (d)           |        0/26 (0%)          0/20 (0%)          0/13 (0%)          0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         ---                ---                662                549                ---                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.037 *            (e)              P=0.454            P<0.001 **           (e)                |
|INCIDENTAL TUMOR       |        P=0.489              (e)              P=0.567            P=0.134              (e)                |
|LOGISTIC REGRESSION    |        P=0.240              (e)              P=0.483            P=0.013 *            (e)                |
|COCHRAN-ARMITAGE       |        P=0.409                                                                                          |
|FISHER EXACT           |                             (e)              P=0.462            P=0.019 *            (e)                |
|=================================================================================================================================|
|                                                                                                                                 |
|Intestine Large: Colon/Rectum                                                                                                    |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/70 (0%)          0/60 (0%)          0/60 (0%)          0/60 (0%)          2/70 (3%)            |
|ADJUSTED (b)           |         0.0%               0.0%               0.0%               0.0%              12.8%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           0/7 (0%)           0/9 (0%)           0/5 (0%)           0/0                  |
|TERMINAL (d)           |        0/26 (0%)          0/20 (0%)          0/13 (0%)          0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         ---                ---                ---                ---                410                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.004 **           (e)                (e)                (e)              P=0.091              |
|INCIDENTAL TUMOR       |        P=0.065              (e)                (e)                (e)              P=0.398              |
|LOGISTIC REGRESSION    |        P=0.035 *            (e)                (e)                (e)              P=0.228              |
|COCHRAN-ARMITAGE       |        P=0.028 *                                                                                        |
|FISHER EXACT           |                             (e)                (e)                (e)              P=0.248              |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE   5
                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |         UNTREATD           0.25%              0.50%              1.00%              2.00%               |
|                       |         CONTROL                                                                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Intestine Large: Colon/Rectum                                                                                                    |
|     Polyp Adenomatous                                                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/70 (0%)          0/60 (0%)          3/60 (5%)          4/60 (7%)         10/70 (14%)           |
|ADJUSTED (b)           |         0.0%               0.0%              15.3%              46.0%              35.8%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           0/7 (0%)           0/9 (0%)           0/5 (0%)           0/0                  |
|TERMINAL (d)           |        0/26 (0%)          0/20 (0%)          1/13 (8%)          0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         ---                ---                684                495                365                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P<0.001 **           (e)              P=0.055            P=0.003 **         P<0.001 **           |
|INCIDENTAL TUMOR       |        P<0.001 **           (e)              P=0.115            P=0.169            P=0.053              |
|LOGISTIC REGRESSION    |        P<0.001 **           (e)              P=0.082            P=0.038 *          P=0.001 **           |
|COCHRAN-ARMITAGE       |        P<0.001 **                                                                                       |
|FISHER EXACT           |                             (e)              P=0.096            P=0.043 *          P<0.001 **           |
|=================================================================================================================================|
|                                                                                                                                 |
|Intestine Small: Ileum                                                                                                           |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/70 (0%)          0/60 (0%)          0/60 (0%)          0/60 (0%)          2/70 (3%)            |
|ADJUSTED (b)           |         0.0%               0.0%               0.0%               0.0%               7.7%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           0/7 (0%)           0/9 (0%)           0/5 (0%)           0/0                  |
|TERMINAL (d)           |        0/26 (0%)          0/20 (0%)          0/13 (0%)          0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         ---                ---                ---                ---                576                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.005 **           (e)                (e)                (e)              P=0.119              |
|INCIDENTAL TUMOR       |        P=0.049 *            (e)                (e)                (e)              P=0.486              |
|LOGISTIC REGRESSION    |        P=0.022 *            (e)                (e)                (e)              P=0.194              |
|COCHRAN-ARMITAGE       |        P=0.028 *                                                                                        |
|FISHER EXACT           |                             (e)                (e)                (e)              P=0.248              |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE   6
                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |         UNTREATD           0.25%              0.50%              1.00%              2.00%               |
|                       |         CONTROL                                                                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Intestine Small: Jejunum                                                                                                         |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/70 (0%)          0/60 (0%)          0/60 (0%)          2/60 (3%)          2/70 (3%)            |
|ADJUSTED (b)           |         0.0%               0.0%               0.0%              12.3%               7.2%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           0/7 (0%)           0/9 (0%)           0/5 (0%)           0/0                  |
|TERMINAL (d)           |        0/26 (0%)          0/20 (0%)          0/13 (0%)          0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         ---                ---                ---                619                366                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.003 **           (e)                (e)              P=0.073            P=0.141              |
|INCIDENTAL TUMOR       |        P=0.128              (e)                (e)              P=0.387            P=0.609              |
|LOGISTIC REGRESSION    |        P=0.044 *            (e)                (e)              P=0.167            P=0.249              |
|COCHRAN-ARMITAGE       |        P=0.047 *                                                                                        |
|FISHER EXACT           |                             (e)                (e)              P=0.211            P=0.248              |
|=================================================================================================================================|
|                                                                                                                                 |
|Intestine Small: Site Unspecified                                                                                                |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/70 (0%)          0/60 (0%)          0/60 (0%)          2/60 (3%)          4/70 (6%)            |
|ADJUSTED (b)           |         0.0%               0.0%               0.0%              12.3%              14.3%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           0/7 (0%)           0/9 (0%)           0/5 (0%)           0/0                  |
|TERMINAL (d)           |        0/26 (0%)          0/20 (0%)          0/13 (0%)          0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         ---                ---                ---                619                366                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P<0.001 **           (e)                (e)              P=0.073            P=0.017 *            |
|INCIDENTAL TUMOR       |        P=0.014 *            (e)                (e)              P=0.387            P=0.315              |
|LOGISTIC REGRESSION    |        P=0.002 **           (e)                (e)              P=0.167            P=0.056              |
|COCHRAN-ARMITAGE       |        P=0.003 **                                                                                       |
|FISHER EXACT           |                             (e)                (e)              P=0.211            P=0.060              |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE   7
                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |         UNTREATD           0.25%              0.50%              1.00%              2.00%               |
|                       |         CONTROL                                                                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |        1/70 (1%)          6/60 (10%)         1/60 (2%)          0/60 (0%)          0/69 (0%)            |
|ADJUSTED (b)           |         3.8%              25.8%               1.7%               0.0%               0.0%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           0/7 (0%)           1/9 (11%)          0/5 (0%)           0/0                  |
|TERMINAL (d)           |        1/26 (4%)          4/20 (20%)         0/13 (0%)          0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         736 (T)            648                456 (I)            ---                ---                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.665N           P=0.028 *          P=0.686            P=0.993N             (e)                |
|INCIDENTAL TUMOR       |        P=0.398N           P=0.035 *          P=0.686            P=0.993N             (e)                |
|LOGISTIC REGRESSION    |        P=0.133N           P=0.030 *          P=0.728            P=0.993N             (e)                |
|COCHRAN-ARMITAGE       |        P=0.039N*                                                                                        |
|FISHER EXACT           |                           P=0.037 *          P=0.712            P=0.538N           P=0.504N             |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/70 (0%)          2/60 (3%)          1/60 (2%)          0/60 (0%)          0/69 (0%)            |
|ADJUSTED (b)           |         0.0%               6.5%               2.0%               0.0%               0.0%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           0/7 (0%)           0/9 (0%)           0/5 (0%)           0/0                  |
|TERMINAL (d)           |        0/26 (0%)          0/20 (0%)          0/13 (0%)          0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         ---                543                536                ---                ---                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.480N           P=0.214            P=0.512              (e)                (e)                |
|INCIDENTAL TUMOR       |        P=0.069N           P=0.351            P=0.500              (e)                (e)                |
|LOGISTIC REGRESSION    |        P=0.278N           P=0.214            P=0.432              (e)                (e)                |
|COCHRAN-ARMITAGE       |        P=0.266N                                                                                         |
|FISHER EXACT           |                           P=0.211            P=0.462              (e)                (e)                |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE   8
                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |         UNTREATD           0.25%              0.50%              1.00%              2.00%               |
|                       |         CONTROL                                                                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |        1/70 (1%)          8/60 (13%)         2/60 (3%)          0/60 (0%)          0/69 (0%)            |
|ADJUSTED (b)           |         3.8%              30.6%               3.7%               0.0%               0.0%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           0/7 (0%)           1/9 (11%)          0/5 (0%)           0/0                  |
|TERMINAL (d)           |        1/26 (4%)          4/20 (20%)         0/13 (0%)          0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         736 (T)            543                456 (I)            ---                ---                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.444N           P=0.008 **         P=0.429            P=0.993N             (e)                |
|INCIDENTAL TUMOR       |        P=0.055N           P=0.016 *          P=0.422            P=0.993N             (e)                |
|LOGISTIC REGRESSION    |        P=0.053N           P=0.010 **         P=0.424            P=0.993N             (e)                |
|COCHRAN-ARMITAGE       |        P=0.020N*                                                                                        |
|FISHER EXACT           |                           P=0.009 **         P=0.442            P=0.538N           P=0.504N             |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney: Renal Tubule                                                                                                             |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/70 (0%)          0/60 (0%)          1/60 (2%)          3/60 (5%)          1/69 (1%)            |
|ADJUSTED (b)           |         0.0%               0.0%               4.5%              41.7%               6.7%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           0/7 (0%)           0/9 (0%)           0/5 (0%)           0/0                  |
|TERMINAL (d)           |        0/26 (0%)          0/20 (0%)          0/13 (0%)          0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         ---                ---                695                690                620                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P<0.001 **           (e)              P=0.413            P<0.001 **         P=0.286              |
|INCIDENTAL TUMOR       |        P=0.181              (e)              P=0.567            P=0.128            P=0.707              |
|LOGISTIC REGRESSION    |        P=0.029 *            (e)              P=0.469            P=0.009 **         P=0.428              |
|COCHRAN-ARMITAGE       |        P=0.231                                                                                          |
|FISHER EXACT           |                             (e)              P=0.462            P=0.096            P=0.496              |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE   9
                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |         UNTREATD           0.25%              0.50%              1.00%              2.00%               |
|                       |         CONTROL                                                                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/70 (0%)          2/60 (3%)          0/60 (0%)          0/60 (0%)          0/70 (0%)            |
|ADJUSTED (b)           |         0.0%              10.0%               0.0%               0.0%               0.0%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           0/7 (0%)           0/9 (0%)           0/5 (0%)           0/0                  |
|TERMINAL (d)           |        0/26 (0%)          2/20 (10%)         0/13 (0%)          0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         ---                736 (T)            ---                ---                ---                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.912            P=0.182              (e)                (e)                (e)                |
|INCIDENTAL TUMOR       |        P=0.912            P=0.182              (e)                (e)                (e)                |
|LOGISTIC REGRESSION    |        P=0.912            P=0.182              (e)                (e)                (e)                |
|COCHRAN-ARMITAGE       |        P=0.303N                                                                                         |
|FISHER EXACT           |                           P=0.211              (e)                (e)                (e)                |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/70 (0%)          2/60 (3%)          0/60 (0%)          0/60 (0%)          1/70 (1%)            |
|ADJUSTED (b)           |         0.0%              10.0%               0.0%               0.0%               9.1%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           0/7 (0%)           0/9 (0%)           0/5 (0%)           0/0                  |
|TERMINAL (d)           |        0/26 (0%)          2/20 (10%)         0/13 (0%)          0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         ---                736 (T)            ---                ---                653                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.038 *          P=0.182              (e)                (e)              P=0.240              |
|INCIDENTAL TUMOR       |        P=0.103            P=0.182              (e)                (e)              P=0.455              |
|LOGISTIC REGRESSION    |        P=0.189            P=0.182              (e)                (e)              P=0.374              |
|COCHRAN-ARMITAGE       |        P=0.593                                                                                          |
|FISHER EXACT           |                           P=0.211              (e)                (e)              P=0.500              |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  10
                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |         UNTREATD           0.25%              0.50%              1.00%              2.00%               |
|                       |         CONTROL                                                                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/70 (0%)          2/60 (3%)          0/60 (0%)          0/60 (0%)          1/70 (1%)            |
|ADJUSTED (b)           |         0.0%              10.0%               0.0%               0.0%               9.1%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           0/7 (0%)           0/9 (0%)           0/5 (0%)           0/0                  |
|TERMINAL (d)           |        0/26 (0%)          2/20 (10%)         0/13 (0%)          0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         ---                736 (T)            ---                ---                653                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.038 *          P=0.182              (e)                (e)              P=0.240              |
|INCIDENTAL TUMOR       |        P=0.103            P=0.182              (e)                (e)              P=0.455              |
|LOGISTIC REGRESSION    |        P=0.189            P=0.182              (e)                (e)              P=0.374              |
|COCHRAN-ARMITAGE       |        P=0.593                                                                                          |
|FISHER EXACT           |                           P=0.211              (e)                (e)              P=0.500              |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |        1/70 (1%)          0/60 (0%)          3/60 (5%)          1/60 (2%)          4/70 (6%)            |
|ADJUSTED (b)           |         2.9%               0.0%              18.6%              10.0%             100.0%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           0/7 (0%)           0/9 (0%)           0/5 (0%)           0/0                  |
|TERMINAL (d)           |        0/26 (0%)          0/20 (0%)          2/13 (15%)         0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         696                ---                684                682                513                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P<0.001 **         P=0.553N           P=0.143            P=0.408            P=0.003 **           |
|INCIDENTAL TUMOR       |        P=0.013 *          P=0.487N           P=0.242            P=0.750N           P=0.297              |
|LOGISTIC REGRESSION    |        P=0.003 **         P=0.525N           P=0.206            P=0.613            P=0.059              |
|COCHRAN-ARMITAGE       |        P=0.075                                                                                          |
|FISHER EXACT           |                           P=0.538N           P=0.254            P=0.712            P=0.183              |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  11
                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |         UNTREATD           0.25%              0.50%              1.00%              2.00%               |
|                       |         CONTROL                                                                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/70 (0%)          1/60 (2%)          0/60 (0%)          3/60 (5%)          3/70 (4%)            |
|ADJUSTED (b)           |         0.0%               5.0%               0.0%              59.3%              21.4%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           0/7 (0%)           0/9 (0%)           0/5 (0%)           0/0                  |
|TERMINAL (d)           |        0/26 (0%)          1/20 (5%)          0/13 (0%)          0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         ---                736 (T)            ---                620                522                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P<0.001 **         P=0.448              (e)              P=0.001 **         P=0.015 *            |
|INCIDENTAL TUMOR       |        P=0.025 *          P=0.448              (e)              P=0.202            P=0.286              |
|LOGISTIC REGRESSION    |        P=0.003 **         P=0.448              (e)              P=0.024 *          P=0.072              |
|COCHRAN-ARMITAGE       |        P=0.038 *                                                                                        |
|FISHER EXACT           |                           P=0.462              (e)              P=0.096            P=0.122              |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |        1/70 (1%)          1/60 (2%)          3/60 (5%)          4/60 (7%)          7/70 (10%)           |
|ADJUSTED (b)           |         2.9%               5.0%              18.6%              63.4%             100.0%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           0/7 (0%)           0/9 (0%)           0/5 (0%)           0/0                  |
|TERMINAL (d)           |        0/26 (0%)          1/20 (5%)          2/13 (15%)         0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         696                736 (T)            684                620                513                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P<0.001 **         P=0.700            P=0.143            P=0.001 **         P<0.001 **           |
|INCIDENTAL TUMOR       |        P<0.001 **         P=0.739            P=0.242            P=0.268            P=0.114              |
|LOGISTIC REGRESSION    |        P<0.001 **         P=0.723            P=0.206            P=0.027 *          P=0.005 **           |
|COCHRAN-ARMITAGE       |        P=0.007 **                                                                                       |
|FISHER EXACT           |                           P=0.712            P=0.254            P=0.138            P=0.031 *            |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  12
                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |         UNTREATD           0.25%              0.50%              1.00%              2.00%               |
|                       |         CONTROL                                                                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Squamous Cell Carcinoma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/70 (0%)          0/60 (0%)          0/60 (0%)          0/60 (0%)          3/70 (4%)            |
|ADJUSTED (b)           |         0.0%               0.0%               0.0%               0.0%              13.2%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           0/7 (0%)           0/9 (0%)           0/5 (0%)           0/0                  |
|TERMINAL (d)           |        0/26 (0%)          0/20 (0%)          0/13 (0%)          0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         ---                ---                ---                ---                365                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P<0.001 **           (e)                (e)                (e)              P=0.047 *            |
|INCIDENTAL TUMOR       |        P=0.030 *            (e)                (e)                (e)              P=0.258              |
|LOGISTIC REGRESSION    |        P=0.010 **           (e)                (e)                (e)              P=0.121              |
|COCHRAN-ARMITAGE       |        P=0.006 **                                                                                       |
|FISHER EXACT           |                             (e)                (e)                (e)              P=0.122              |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/70 (0%)          0/60 (0%)          1/60 (2%)          1/60 (2%)          0/70 (0%)            |
|ADJUSTED (b)           |         0.0%               0.0%               3.8%               3.4%               0.0%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           0/7 (0%)           0/9 (0%)           0/5 (0%)           0/0                  |
|TERMINAL (d)           |        0/26 (0%)          0/20 (0%)          0/13 (0%)          0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         ---                ---                684                585                ---                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.483              (e)              P=0.447            P=0.404              (e)                |
|INCIDENTAL TUMOR       |        P=0.646N             (e)              P=0.567            P=0.773              (e)                |
|LOGISTIC REGRESSION    |        P=0.650              (e)              P=0.477            P=0.469              (e)                |
|COCHRAN-ARMITAGE       |        P=0.675N                                                                                         |
|FISHER EXACT           |                             (e)              P=0.462            P=0.462              (e)                |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  13
                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |         UNTREATD           0.25%              0.50%              1.00%              2.00%               |
|                       |         CONTROL                                                                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/70 (0%)          0/60 (0%)          0/60 (0%)          0/60 (0%)          0/70 (0%)            |
|ADJUSTED (b)           |         0.0%               0.0%               0.0%               0.0%               0.0%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           0/7 (0%)           0/9 (0%)           0/5 (0%)           0/0                  |
|TERMINAL (d)           |        0/26 (0%)          0/20 (0%)          0/13 (0%)          0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         ---                ---                ---                ---                ---                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |          (e)                (e)                (e)                (e)                (e)                |
|INCIDENTAL TUMOR       |          (e)                (e)                (e)                (e)                (e)                |
|LOGISTIC REGRESSION    |          (e)                (e)                (e)                (e)                (e)                |
|COCHRAN-ARMITAGE       |          (e)                                                                                            |
|FISHER EXACT           |                             (e)                (e)                (e)                (e)                |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/70 (0%)          0/60 (0%)          1/60 (2%)          1/60 (2%)          0/70 (0%)            |
|ADJUSTED (b)           |         0.0%               0.0%               3.8%               3.4%               0.0%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           0/7 (0%)           0/9 (0%)           0/5 (0%)           0/0                  |
|TERMINAL (d)           |        0/26 (0%)          0/20 (0%)          0/13 (0%)          0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         ---                ---                684                585                ---                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.483              (e)              P=0.447            P=0.404              (e)                |
|INCIDENTAL TUMOR       |        P=0.646N             (e)              P=0.567            P=0.773              (e)                |
|LOGISTIC REGRESSION    |        P=0.650              (e)              P=0.477            P=0.469              (e)                |
|COCHRAN-ARMITAGE       |        P=0.675N                                                                                         |
|FISHER EXACT           |                             (e)              P=0.462            P=0.462              (e)                |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  14
                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |         UNTREATD           0.25%              0.50%              1.00%              2.00%               |
|                       |         CONTROL                                                                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroadenoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/70 (0%)          4/60 (7%)          6/60 (10%)         6/60 (10%)         5/70 (7%)            |
|ADJUSTED (b)           |         0.0%              18.9%              42.6%              51.6%              57.6%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           0/7 (0%)           0/9 (0%)           0/5 (0%)           0/0                  |
|TERMINAL (d)           |        0/26 (0%)          3/20 (15%)         5/13 (38%)         0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         ---                725                726                576                592                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P<0.001 **         P=0.036 *          P<0.001 **         P<0.001 **         P<0.001 **           |
|INCIDENTAL TUMOR       |        P<0.001 **         P=0.043 *          P=0.002 **         P=0.029 *          P=0.027 *            |
|LOGISTIC REGRESSION    |        P<0.001 **         P=0.034 *          P<0.001 **         P=0.002 **         P=0.001 **           |
|COCHRAN-ARMITAGE       |        P=0.145                                                                                          |
|FISHER EXACT           |                           P=0.043 *          P=0.008 **         P=0.008 **         P=0.029 *            |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma or Adenoma                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/70 (0%)          4/60 (7%)          7/60 (12%)         7/60 (12%)         5/70 (7%)            |
|ADJUSTED (b)           |         0.0%              18.9%              44.8%              53.2%              57.6%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           0/7 (0%)           0/9 (0%)           0/5 (0%)           0/0                  |
|TERMINAL (d)           |        0/26 (0%)          3/20 (15%)         5/13 (38%)         0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         ---                725                684                576                592                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P<0.001 **         P=0.036 *          P<0.001 **         P<0.001 **         P<0.001 **           |
|INCIDENTAL TUMOR       |        P<0.001 **         P=0.043 *          P=0.001 **         P=0.025 *          P=0.027 *            |
|LOGISTIC REGRESSION    |        P<0.001 **         P=0.034 *          P<0.001 **         P=0.002 **         P=0.001 **           |
|COCHRAN-ARMITAGE       |        P=0.158                                                                                          |
|FISHER EXACT           |                           P=0.043 *          P=0.004 **         P=0.004 **         P=0.029 *            |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  15
                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |         UNTREATD           0.25%              0.50%              1.00%              2.00%               |
|                       |         CONTROL                                                                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/70 (0%)          4/60 (7%)          7/60 (12%)         7/60 (12%)         5/70 (7%)            |
|ADJUSTED (b)           |         0.0%              18.9%              44.8%              53.2%              57.6%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           0/7 (0%)           0/9 (0%)           0/5 (0%)           0/0                  |
|TERMINAL (d)           |        0/26 (0%)          3/20 (15%)         5/13 (38%)         0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         ---                725                684                576                592                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P<0.001 **         P=0.036 *          P<0.001 **         P<0.001 **         P<0.001 **           |
|INCIDENTAL TUMOR       |        P<0.001 **         P=0.043 *          P=0.001 **         P=0.025 *          P=0.027 *            |
|LOGISTIC REGRESSION    |        P<0.001 **         P=0.034 *          P<0.001 **         P=0.002 **         P=0.001 **           |
|COCHRAN-ARMITAGE       |        P=0.158                                                                                          |
|FISHER EXACT           |                           P=0.043 *          P=0.004 **         P=0.004 **         P=0.029 *            |
|=================================================================================================================================|
|                                                                                                                                 |
|Mesentery                                                                                                                        |
|     Sarcoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/70 (0%)          0/60 (0%)          0/60 (0%)          2/60 (3%)          0/70 (0%)            |
|ADJUSTED (b)           |         0.0%               0.0%               0.0%               4.4%               0.0%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           0/7 (0%)           0/9 (0%)           0/5 (0%)           0/0                  |
|TERMINAL (d)           |        0/26 (0%)          0/20 (0%)          0/13 (0%)          0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         ---                ---                ---                471                ---                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.451              (e)                (e)              P=0.224              (e)                |
|INCIDENTAL TUMOR       |        P=0.579N             (e)                (e)              P=0.580              (e)                |
|LOGISTIC REGRESSION    |        P=0.558              (e)                (e)              P=0.188              (e)                |
|COCHRAN-ARMITAGE       |        P=0.512                                                                                          |
|FISHER EXACT           |                             (e)                (e)              P=0.211              (e)                |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  16
                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |         UNTREATD           0.25%              0.50%              1.00%              2.00%               |
|                       |         CONTROL                                                                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva)                                                                       |
|     Papilloma Squamous or Papilloma                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/70 (0%)          4/60 (7%)          8/60 (13%)        10/60 (17%)        12/70 (17%)           |
|ADJUSTED (b)           |         0.0%              20.0%              35.7%              44.1%             100.0%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           0/7 (0%)           0/9 (0%)           0/5 (0%)           0/0                  |
|TERMINAL (d)           |        0/26 (0%)          4/20 (20%)         3/13 (23%)         0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         ---                736 (T)            536                381                511                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P<0.001 **         P=0.033 *          P<0.001 **         P<0.001 **         P<0.001 **           |
|INCIDENTAL TUMOR       |        P=0.002 **         P=0.033 *          P=0.004 **         P=0.051            P=0.025 *            |
|LOGISTIC REGRESSION    |        P<0.001 **         P=0.033 *          P=0.003 **         P<0.001 **         P<0.001 **           |
|COCHRAN-ARMITAGE       |        P<0.001 **                                                                                       |
|FISHER EXACT           |                           P=0.043 *          P=0.002 **         P<0.001 **         P<0.001 **           |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva)                                                                       |
|     Squamous Cell Carcinoma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/70 (0%)          0/60 (0%)          1/60 (2%)          0/60 (0%)          2/70 (3%)            |
|ADJUSTED (b)           |         0.0%               0.0%               5.3%               0.0%               9.1%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           0/7 (0%)           0/9 (0%)           0/5 (0%)           0/0                  |
|TERMINAL (d)           |        0/26 (0%)          0/20 (0%)          0/13 (0%)          0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         ---                ---                697                ---                516                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.007 **           (e)              P=0.390              (e)              P=0.114              |
|INCIDENTAL TUMOR       |        P=0.196              (e)              P=0.567              (e)              P=0.609              |
|LOGISTIC REGRESSION    |        P=0.054              (e)              P=0.467              (e)              P=0.205              |
|COCHRAN-ARMITAGE       |        P=0.088                                                                                          |
|FISHER EXACT           |                             (e)              P=0.462              (e)              P=0.248              |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  17
                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |         UNTREATD           0.25%              0.50%              1.00%              2.00%               |
|                       |         CONTROL                                                                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva)                                                                       |
|     Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/70 (0%)          4/60 (7%)          9/60 (15%)        10/60 (17%)        13/70 (19%)           |
|ADJUSTED (b)           |         0.0%              20.0%              39.0%              44.1%             100.0%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           0/7 (0%)           0/9 (0%)           0/5 (0%)           0/0                  |
|TERMINAL (d)           |        0/26 (0%)          4/20 (20%)         3/13 (23%)         0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         ---                736 (T)            536                381                511                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P<0.001 **         P=0.033 *          P<0.001 **         P<0.001 **         P<0.001 **           |
|INCIDENTAL TUMOR       |        P=0.001 **         P=0.033 *          P=0.002 **         P=0.051            P=0.019 *            |
|LOGISTIC REGRESSION    |        P<0.001 **         P=0.033 *          P=0.001 **         P<0.001 **         P<0.001 **           |
|COCHRAN-ARMITAGE       |        P<0.001 **                                                                                       |
|FISHER EXACT           |                           P=0.043 *          P<0.001 **         P<0.001 **         P<0.001 **           |
|=================================================================================================================================|
|                                                                                                                                 |
|Pancreas                                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |        1/70 (1%)          2/60 (3%)          4/60 (7%)          3/58 (5%)          3/69 (4%)            |
|ADJUSTED (b)           |         3.8%              10.0%              30.8%              34.1%               8.5%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           0/7 (0%)           0/9 (0%)           0/5 (0%)           0/0                  |
|TERMINAL (d)           |        1/26 (4%)          2/20 (10%)         4/13 (31%)         0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         736 (T)            736 (T)            736 (T)            604                507                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P<0.001 **         P=0.408            P=0.033 *          P=0.007 **         P=0.077              |
|INCIDENTAL TUMOR       |        P=0.021 *          P=0.408            P=0.033 *          P=0.210            P=0.530              |
|LOGISTIC REGRESSION    |        P=0.035 *          P=0.408            P=0.033 *          P=0.082            P=0.234              |
|COCHRAN-ARMITAGE       |        P=0.333                                                                                          |
|FISHER EXACT           |                           P=0.442            P=0.138            P=0.242            P=0.304              |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  18
                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |         UNTREATD           0.25%              0.50%              1.00%              2.00%               |
|                       |         CONTROL                                                                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Pharynx                                                                                                                          |
|     Squamous Cell Carcinoma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/70 (0%)          0/60 (0%)          0/60 (0%)          0/60 (0%)          2/70 (3%)            |
|ADJUSTED (b)           |         0.0%               0.0%               0.0%               0.0%               9.1%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           0/7 (0%)           0/9 (0%)           0/5 (0%)           0/0                  |
|TERMINAL (d)           |        0/26 (0%)          0/20 (0%)          0/13 (0%)          0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         ---                ---                ---                ---                516                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.005 **           (e)                (e)                (e)              P=0.114              |
|INCIDENTAL TUMOR       |        P=0.116              (e)                (e)                (e)              P=0.609              |
|LOGISTIC REGRESSION    |        P=0.026 *            (e)                (e)                (e)              P=0.205              |
|COCHRAN-ARMITAGE       |        P=0.028 *                                                                                        |
|FISHER EXACT           |                             (e)                (e)                (e)              P=0.248              |
|=================================================================================================================================|
|                                                                                                                                 |
|Pharynx                                                                                                                          |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/70 (0%)          2/60 (3%)          3/60 (5%)          2/60 (3%)          7/70 (10%)           |
|ADJUSTED (b)           |         0.0%              10.0%              13.5%              18.4%              46.5%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           0/7 (0%)           0/9 (0%)           0/5 (0%)           0/0                  |
|TERMINAL (d)           |        0/26 (0%)          2/20 (10%)         1/13 (8%)          0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         ---                736 (T)            641                509                516                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P<0.001 **         P=0.182            P=0.069            P=0.085            P<0.001 **           |
|INCIDENTAL TUMOR       |        P=0.005 **         P=0.182            P=0.141            P=0.393            P=0.087              |
|LOGISTIC REGRESSION    |        P<0.001 **         P=0.182            P=0.099            P=0.201            P=0.003 **           |
|COCHRAN-ARMITAGE       |        P=0.006 **                                                                                       |
|FISHER EXACT           |                           P=0.211            P=0.096            P=0.211            P=0.007 **           |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  19
                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |         UNTREATD           0.25%              0.50%              1.00%              2.00%               |
|                       |         CONTROL                                                                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |        9/69 (13%)        10/58 (17%)         6/59 (10%)         6/58 (10%)         5/67 (7%)            |
|ADJUSTED (b)           |        25.0%              35.3%              31.1%              70.2%              43.2%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        2/9 (22%)          1/7 (14%)          0/9 (0%)           0/5 (0%)           0/0                  |
|TERMINAL (d)           |        3/25 (12%)         5/20 (25%)         3/13 (23%)         0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         456 (I)            456 (I)            576                604                507                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P<0.001 **         P=0.309            P=0.588            P=0.027 *          P=0.010 *            |
|INCIDENTAL TUMOR       |        P=0.531N           P=0.395            P=0.338N           P=0.554N           P=0.507N             |
|LOGISTIC REGRESSION    |        P=0.493N           P=0.399            P=0.350N           P=0.603            P=0.473N             |
|COCHRAN-ARMITAGE       |        P=0.098N                                                                                         |
|FISHER EXACT           |                           P=0.339            P=0.412N           P=0.426N           P=0.216N             |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |        9/69 (13%)        11/58 (19%)         6/59 (10%)         6/58 (10%)         5/67 (7%)            |
|ADJUSTED (b)           |        25.0%              39.6%              31.1%              70.2%              43.2%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        2/9 (22%)          1/7 (14%)          0/9 (0%)           0/5 (0%)           0/0                  |
|TERMINAL (d)           |        3/25 (12%)         6/20 (30%)         3/13 (23%)         0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         456 (I)            456 (I)            576                604                507                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P<0.001 **         P=0.225            P=0.588            P=0.027 *          P=0.010 *            |
|INCIDENTAL TUMOR       |        P=0.535N           P=0.295            P=0.338N           P=0.554N           P=0.507N             |
|LOGISTIC REGRESSION    |        P=0.474N           P=0.304            P=0.350N           P=0.603            P=0.473N             |
|COCHRAN-ARMITAGE       |        P=0.081N                                                                                         |
|FISHER EXACT           |                           P=0.252            P=0.412N           P=0.426N           P=0.216N             |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  20
                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |         UNTREATD           0.25%              0.50%              1.00%              2.00%               |
|                       |         CONTROL                                                                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Basal Cell Adenoma                                                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/70 (0%)          1/60 (2%)          0/60 (0%)          3/60 (5%)          6/70 (9%)            |
|ADJUSTED (b)           |         0.0%               2.9%               0.0%              62.5%              56.1%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           0/7 (0%)           0/9 (0%)           0/5 (0%)           0/0                  |
|TERMINAL (d)           |        0/26 (0%)          0/20 (0%)          0/13 (0%)          0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         ---                659                ---                690                519                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P<0.001 **         P=0.463              (e)              P<0.001 **         P<0.001 **           |
|INCIDENTAL TUMOR       |        P<0.001 **         P=0.513              (e)              P=0.128            P=0.047 *            |
|LOGISTIC REGRESSION    |        P<0.001 **         P=0.481              (e)              P=0.005 **         P=0.003 **           |
|COCHRAN-ARMITAGE       |        P<0.001 **                                                                                       |
|FISHER EXACT           |                           P=0.462              (e)              P=0.096            P=0.014 *            |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Basal Cell Adenoma, Basosquamous Tumor Benign, or Trichoepithelioma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/70 (0%)          1/60 (2%)          0/60 (0%)          4/60 (7%)          7/70 (10%)           |
|ADJUSTED (b)           |         0.0%               2.9%               0.0%              63.3%              64.9%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           0/7 (0%)           0/9 (0%)           0/5 (0%)           0/0                  |
|TERMINAL (d)           |        0/26 (0%)          0/20 (0%)          0/13 (0%)          0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         ---                659                ---                516                519                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P<0.001 **         P=0.463              (e)              P<0.001 **         P<0.001 **           |
|INCIDENTAL TUMOR       |        P<0.001 **         P=0.513              (e)              P=0.109            P=0.021 *            |
|LOGISTIC REGRESSION    |        P<0.001 **         P=0.481              (e)              P=0.019 *          P<0.001 **           |
|COCHRAN-ARMITAGE       |        P<0.001 **                                                                                       |
|FISHER EXACT           |                           P=0.462              (e)              P=0.043 *          P=0.007 **           |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  21
                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |         UNTREATD           0.25%              0.50%              1.00%              2.00%               |
|                       |         CONTROL                                                                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Basal Cell Carcinoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/70 (0%)          0/60 (0%)          2/60 (3%)          2/60 (3%)          0/70 (0%)            |
|ADJUSTED (b)           |         0.0%               0.0%               8.7%              40.0%               0.0%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           0/7 (0%)           0/9 (0%)           0/5 (0%)           0/0                  |
|TERMINAL (d)           |        0/26 (0%)          0/20 (0%)          0/13 (0%)          0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         ---                ---                694                709                ---                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.054              (e)              P=0.155            P=0.004 **           (e)                |
|INCIDENTAL TUMOR       |        P=0.571              (e)              P=0.314            P=0.250              (e)                |
|LOGISTIC REGRESSION    |        P=0.248              (e)              P=0.202            P=0.029 *            (e)                |
|COCHRAN-ARMITAGE       |        P=0.618N                                                                                         |
|FISHER EXACT           |                             (e)              P=0.211            P=0.211              (e)                |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous Tumor (benign,                                                       |
|     malignant or NOS), or Trichoepithelioma                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/70 (0%)          1/60 (2%)          2/60 (3%)          6/60 (10%)         7/70 (10%)           |
|ADJUSTED (b)           |         0.0%               2.9%               8.7%              78.0%              64.9%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           0/7 (0%)           0/9 (0%)           0/5 (0%)           0/0                  |
|TERMINAL (d)           |        0/26 (0%)          0/20 (0%)          0/13 (0%)          0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         ---                659                694                516                519                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P<0.001 **         P=0.463            P=0.155            P<0.001 **         P<0.001 **           |
|INCIDENTAL TUMOR       |        P<0.001 **         P=0.513            P=0.314            P=0.029 *          P=0.021 *            |
|LOGISTIC REGRESSION    |        P<0.001 **         P=0.481            P=0.202            P<0.001 **         P<0.001 **           |
|COCHRAN-ARMITAGE       |        P=0.001 **                                                                                       |
|FISHER EXACT           |                           P=0.462            P=0.211            P=0.008 **         P=0.007 **           |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  22
                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |         UNTREATD           0.25%              0.50%              1.00%              2.00%               |
|                       |         CONTROL                                                                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal                                                       |
|     Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepithelioma                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        4/70 (6%)          7/60 (12%)        14/60 (23%)        25/60 (42%)        21/70 (30%)           |
|ADJUSTED (b)           |        13.5%              27.2%              50.4%             100.0%             100.0%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           1/7 (14%)          0/9 (0%)           1/5 (20%)          0/0                  |
|TERMINAL (d)           |        3/26 (12%)         4/20 (20%)         3/13 (23%)         1/1 (100%)         0/0                  |
|FIRST INCIDENCE (DAYS) |         619                456 (I)            633                393                425                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P<0.001 **         P=0.143            P<0.001 **         P<0.001 **         P<0.001 **           |
|INCIDENTAL TUMOR       |        P<0.001 **         P=0.184            P=0.012 *          P<0.001 **         P=0.001 **           |
|LOGISTIC REGRESSION    |        P<0.001 **         P=0.199            P=0.004 **         P<0.001 **         P<0.001 **           |
|COCHRAN-ARMITAGE       |        P<0.001 **                                                                                       |
|FISHER EXACT           |                           P=0.184            P=0.004 **         P<0.001 **         P<0.001 **           |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        2/70 (3%)          8/60 (13%)        11/60 (18%)        15/60 (25%)         7/70 (10%)           |
|ADJUSTED (b)           |         6.3%              26.5%              35.2%             100.0%              30.2%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           0/7 (0%)           0/9 (0%)           0/5 (0%)           0/0                  |
|TERMINAL (d)           |        1/26 (4%)          3/20 (15%)         1/13 (8%)          1/1 (100%)         0/0                  |
|FIRST INCIDENCE (DAYS) |         660                576                536                381                388                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P<0.001 **         P=0.026 *          P=0.003 **         P<0.001 **         P=0.002 **           |
|INCIDENTAL TUMOR       |        P=0.409            P=0.045 *          P=0.031 *          P=0.003 **         P=0.230              |
|LOGISTIC REGRESSION    |        P=0.057            P=0.034 *          P=0.006 **         P<0.001 **         P=0.046 *            |
|COCHRAN-ARMITAGE       |        P=0.245                                                                                          |
|FISHER EXACT           |                           P=0.027 *          P=0.004 **         P<0.001 **         P=0.083              |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  23
                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |         UNTREATD           0.25%              0.50%              1.00%              2.00%               |
|                       |         CONTROL                                                                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        2/70 (3%)          9/60 (15%)        13/60 (22%)        16/60 (27%)        10/70 (14%)           |
|ADJUSTED (b)           |         6.3%              30.8%              39.3%             100.0%              37.1%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           0/7 (0%)           0/9 (0%)           0/5 (0%)           0/0                  |
|TERMINAL (d)           |        1/26 (4%)          4/20 (20%)         1/13 (8%)          1/1 (100%)         0/0                  |
|FIRST INCIDENCE (DAYS) |         660                576                536                381                388                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P<0.001 **         P=0.013 *          P<0.001 **         P<0.001 **         P<0.001 **           |
|INCIDENTAL TUMOR       |        P=0.204            P=0.024 *          P=0.014 *          P=0.002 **         P=0.130              |
|LOGISTIC REGRESSION    |        P=0.011 *          P=0.018 *          P=0.015 *          P<0.001 **         P=0.008 **           |
|COCHRAN-ARMITAGE       |        P=0.104                                                                                          |
|FISHER EXACT           |                           P=0.014 *          P<0.001 **         P<0.001 **         P=0.015 *            |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibrosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/70 (0%)          1/60 (2%)          0/60 (0%)          0/60 (0%)          1/70 (1%)            |
|ADJUSTED (b)           |         0.0%               5.0%               0.0%               0.0%               3.6%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           0/7 (0%)           0/9 (0%)           0/5 (0%)           0/0                  |
|TERMINAL (d)           |        0/26 (0%)          1/20 (5%)          0/13 (0%)          0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         ---                736 (T)            ---                ---                575                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.091            P=0.448              (e)                (e)              P=0.397              |
|INCIDENTAL TUMOR       |        P=0.209            P=0.448              (e)                (e)              P=0.707              |
|LOGISTIC REGRESSION    |        P=0.278            P=0.448              (e)                (e)              P=0.473              |
|COCHRAN-ARMITAGE       |        P=0.416                                                                                          |
|FISHER EXACT           |                           P=0.462              (e)                (e)              P=0.500              |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  24
                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |         UNTREATD           0.25%              0.50%              1.00%              2.00%               |
|                       |         CONTROL                                                                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/70 (0%)          1/60 (2%)          2/60 (3%)          3/60 (5%)          3/70 (4%)            |
|ADJUSTED (b)           |         0.0%               5.0%               6.2%              56.5%               9.8%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           0/7 (0%)           0/9 (0%)           0/5 (0%)           0/0                  |
|TERMINAL (d)           |        0/26 (0%)          1/20 (5%)          0/13 (0%)          0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         ---                736 (T)            621                577                439                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P<0.001 **         P=0.448            P=0.203            P=0.004 **         P=0.053              |
|INCIDENTAL TUMOR       |        P=0.112            P=0.448            P=0.374            P=0.202            P=0.432              |
|LOGISTIC REGRESSION    |        P=0.032 *          P=0.448            P=0.219            P=0.046 *          P=0.111              |
|COCHRAN-ARMITAGE       |        P=0.093                                                                                          |
|FISHER EXACT           |                           P=0.462            P=0.211            P=0.096            P=0.122              |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Keratoacanthoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        3/70 (4%)          5/60 (8%)         11/60 (18%)        16/60 (27%)        10/70 (14%)           |
|ADJUSTED (b)           |         9.7%              23.6%              41.0%              83.0%              69.4%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           0/7 (0%)           0/9 (0%)           0/5 (0%)           0/0                  |
|TERMINAL (d)           |        2/26 (8%)          4/20 (20%)         2/13 (15%)         0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         619                725                633                495                507                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P<0.001 **         P=0.227            P=0.004 **         P<0.001 **         P<0.001 **           |
|INCIDENTAL TUMOR       |        P=0.021 *          P=0.275            P=0.037 *          P=0.011 *          P=0.051              |
|LOGISTIC REGRESSION    |        P=0.004 **         P=0.253            P=0.012 *          P<0.001 **         P=0.003 **           |
|COCHRAN-ARMITAGE       |        P=0.043 *                                                                                        |
|FISHER EXACT           |                           P=0.277            P=0.010 *          P<0.001 **         P=0.039 *            |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  25
                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |         UNTREATD           0.25%              0.50%              1.00%              2.00%               |
|                       |         CONTROL                                                                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Lipoma                                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/70 (0%)          0/60 (0%)          1/60 (2%)          0/60 (0%)          0/70 (0%)            |
|ADJUSTED (b)           |         0.0%               0.0%               7.7%               0.0%               0.0%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           0/7 (0%)           0/9 (0%)           0/5 (0%)           0/0                  |
|TERMINAL (d)           |        0/26 (0%)          0/20 (0%)          1/13 (8%)          0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         ---                ---                736 (T)            ---                ---                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.829              (e)              P=0.362              (e)                (e)                |
|INCIDENTAL TUMOR       |        P=0.829              (e)              P=0.362              (e)                (e)                |
|LOGISTIC REGRESSION    |        P=0.829              (e)              P=0.362              (e)                (e)                |
|COCHRAN-ARMITAGE       |        P=0.626N                                                                                         |
|FISHER EXACT           |                             (e)              P=0.462              (e)                (e)                |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Sarcoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/70 (0%)          0/60 (0%)          2/60 (3%)          3/60 (5%)          2/70 (3%)            |
|ADJUSTED (b)           |         0.0%               0.0%               6.2%              56.5%               6.5%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           0/7 (0%)           0/9 (0%)           0/5 (0%)           0/0                  |
|TERMINAL (d)           |        0/26 (0%)          0/20 (0%)          0/13 (0%)          0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         ---                ---                621                577                439                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.002 **           (e)              P=0.203            P=0.004 **         P=0.143              |
|INCIDENTAL TUMOR       |        P=0.244              (e)              P=0.374            P=0.202            P=0.609              |
|LOGISTIC REGRESSION    |        P=0.068              (e)              P=0.219            P=0.046 *          P=0.238              |
|COCHRAN-ARMITAGE       |        P=0.132                                                                                          |
|FISHER EXACT           |                             (e)              P=0.211            P=0.096            P=0.248              |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  26
                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |         UNTREATD           0.25%              0.50%              1.00%              2.00%               |
|                       |         CONTROL                                                                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Schwannoma Malignant                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/70 (0%)          2/60 (3%)          0/60 (0%)          0/60 (0%)          0/70 (0%)            |
|ADJUSTED (b)           |         0.0%               8.3%               0.0%               0.0%               0.0%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           0/7 (0%)           0/9 (0%)           0/5 (0%)           0/0                  |
|TERMINAL (d)           |        0/26 (0%)          1/20 (5%)          0/13 (0%)          0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         ---                681                ---                ---                ---                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.801N           P=0.192              (e)                (e)                (e)                |
|INCIDENTAL TUMOR       |        P=0.565N           P=0.218              (e)                (e)                (e)                |
|LOGISTIC REGRESSION    |        P=0.586N           P=0.203              (e)                (e)                (e)                |
|COCHRAN-ARMITAGE       |        P=0.303N                                                                                         |
|FISHER EXACT           |                           P=0.211              (e)                (e)                (e)                |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Carcinoma, Basal Cell Carcinoma, Basosquamous Tumor                                                           |
|     (malignant or NOS), or Carcinoma                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/70 (0%)          0/60 (0%)          2/60 (3%)          2/60 (3%)          1/70 (1%)            |
|ADJUSTED (b)           |         0.0%               0.0%               8.7%              40.0%             100.0%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           0/7 (0%)           0/9 (0%)           0/5 (0%)           0/0                  |
|TERMINAL (d)           |        0/26 (0%)          0/20 (0%)          0/13 (0%)          0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         ---                ---                694                709                726                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P<0.001 **           (e)              P=0.155            P=0.004 **         P=0.006 **           |
|INCIDENTAL TUMOR       |        P=0.218              (e)              P=0.314            P=0.250            P=0.455              |
|LOGISTIC REGRESSION    |        P=0.013 *            (e)              P=0.202            P=0.029 *          P=0.046 *            |
|COCHRAN-ARMITAGE       |        P=0.339                                                                                          |
|FISHER EXACT           |                             (e)              P=0.211            P=0.211            P=0.500              |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  27
                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |         UNTREATD           0.25%              0.50%              1.00%              2.00%               |
|                       |         CONTROL                                                                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        1/70 (1%)          1/60 (2%)          2/60 (3%)          6/60 (10%)        11/70 (16%)           |
|ADJUSTED (b)           |         3.8%               1.8%              10.5%             100.0%              60.9%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           1/7 (14%)          0/9 (0%)           1/5 (20%)          0/0                  |
|TERMINAL (d)           |        1/26 (4%)          0/20 (0%)          1/13 (8%)          1/1 (100%)         0/0                  |
|FIRST INCIDENCE (DAYS) |         736 (T)            456 (I)            654                393                425                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P<0.001 **         P=0.702            P=0.319            P=0.001 **         P<0.001 **           |
|INCIDENTAL TUMOR       |        P<0.001 **         P=0.702            P=0.381            P=0.016 *          P=0.014 *            |
|LOGISTIC REGRESSION    |        P<0.001 **         P=0.729            P=0.415            P=0.038 *          P<0.001 **           |
|COCHRAN-ARMITAGE       |        P<0.001 **                                                                                       |
|FISHER EXACT           |                           P=0.712            P=0.442            P=0.037 *          P=0.002 **           |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        4/70 (6%)          6/60 (10%)        13/60 (22%)        21/60 (35%)        19/70 (27%)           |
|ADJUSTED (b)           |        13.5%              25.0%              48.0%             100.0%             100.0%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           1/7 (14%)          0/9 (0%)           1/5 (20%)          0/0                  |
|TERMINAL (d)           |        3/26 (12%)         4/20 (20%)         3/13 (23%)         1/1 (100%)         0/0                  |
|FIRST INCIDENCE (DAYS) |         619                456 (I)            633                393                425                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P<0.001 **         P=0.224            P=0.002 **         P<0.001 **         P<0.001 **           |
|INCIDENTAL TUMOR       |        P<0.001 **         P=0.266            P=0.020 *          P<0.001 **         P=0.002 **           |
|LOGISTIC REGRESSION    |        P<0.001 **         P=0.295            P=0.007 **         P<0.001 **         P<0.001 **           |
|COCHRAN-ARMITAGE       |        P<0.001 **                                                                                       |
|FISHER EXACT           |                           P=0.279            P=0.007 **         P<0.001 **         P<0.001 **           |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  28
                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |         UNTREATD           0.25%              0.50%              1.00%              2.00%               |
|                       |         CONTROL                                                                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma, Papilloma, or Keratoacanthoma                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        4/70 (6%)          6/60 (10%)        13/60 (22%)        21/60 (35%)        18/70 (26%)           |
|ADJUSTED (b)           |        13.5%              25.0%              48.0%             100.0%              80.7%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           1/7 (14%)          0/9 (0%)           1/5 (20%)          0/0                  |
|TERMINAL (d)           |        3/26 (12%)         4/20 (20%)         3/13 (23%)         1/1 (100%)         0/0                  |
|FIRST INCIDENCE (DAYS) |         619                456 (I)            633                393                425                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P<0.001 **         P=0.224            P=0.002 **         P<0.001 **         P<0.001 **           |
|INCIDENTAL TUMOR       |        P<0.001 **         P=0.266            P=0.020 *          P<0.001 **         P=0.004 **           |
|LOGISTIC REGRESSION    |        P<0.001 **         P=0.295            P=0.007 **         P<0.001 **         P<0.001 **           |
|COCHRAN-ARMITAGE       |        P<0.001 **                                                                                       |
|FISHER EXACT           |                           P=0.279            P=0.007 **         P<0.001 **         P<0.001 **           |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Sebaceous Gland                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/70 (0%)          1/60 (2%)          0/60 (0%)          2/60 (3%)          2/70 (3%)            |
|ADJUSTED (b)           |         0.0%               5.0%               0.0%              19.6%              22.1%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           0/7 (0%)           0/9 (0%)           0/5 (0%)           0/0                  |
|TERMINAL (d)           |        0/26 (0%)          1/20 (5%)          0/13 (0%)          0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         ---                736 (T)            ---                654                653                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P<0.001 **         P=0.448              (e)              P=0.037 *          P=0.018 *            |
|INCIDENTAL TUMOR       |        P=0.014 *          P=0.448              (e)              P=0.250            P=0.188              |
|LOGISTIC REGRESSION    |        P=0.007 **         P=0.448              (e)              P=0.110            P=0.090              |
|COCHRAN-ARMITAGE       |        P=0.118                                                                                          |
|FISHER EXACT           |                           P=0.462              (e)              P=0.211            P=0.248              |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  29
                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |         UNTREATD           0.25%              0.50%              1.00%              2.00%               |
|                       |         CONTROL                                                                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/70 (0%)          0/60 (0%)          0/60 (0%)          1/60 (2%)          5/70 (7%)            |
|ADJUSTED (b)           |         0.0%               0.0%               0.0%               3.8%              26.7%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           0/7 (0%)           0/9 (0%)           0/5 (0%)           0/0                  |
|TERMINAL (d)           |        0/26 (0%)          0/20 (0%)          0/13 (0%)          0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         ---                ---                ---                604                511                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P<0.001 **           (e)                (e)              P=0.382            P=0.002 **           |
|INCIDENTAL TUMOR       |        P=0.002 **           (e)                (e)              P=0.773            P=0.157              |
|LOGISTIC REGRESSION    |        P<0.001 **           (e)                (e)              P=0.466            P=0.013 *            |
|COCHRAN-ARMITAGE       |        P<0.001 **                                                                                       |
|FISHER EXACT           |                             (e)                (e)              P=0.462            P=0.029 *            |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |       57/70 (81%)        54/60 (90%)        60/60 (100%)       56/60 (93%)        59/70 (84%)           |
|ADJUSTED (b)           |       100.0%              96.3%             100.0%             100.0%             100.0%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        8/9 (89%)          6/7 (86%)          9/9 (100%)         5/5 (100%)         0/0                  |
|TERMINAL (d)           |       26/26 (100%)       18/20 (90%)        13/13 (100%)        1/1 (100%)         0/0                  |
|FIRST INCIDENCE (DAYS) |         456 (I)            450                451                432                365                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P<0.001 **         P=0.149            P=0.002 **         P<0.001 **         P<0.001 **           |
|INCIDENTAL TUMOR       |        P=0.077            P=0.173N           P=0.203            P=0.687            P=0.343              |
|LOGISTIC REGRESSION    |        P=0.032 *          P=0.488N           P=0.130            P=0.669N           P=0.043 *            |
|COCHRAN-ARMITAGE       |        P=0.405N                                                                                         |
|FISHER EXACT           |                           P=0.129            P<0.001 **         P=0.038 *          P=0.411              |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  30
                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |         UNTREATD           0.25%              0.50%              1.00%              2.00%               |
|                       |         CONTROL                                                                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |        7/70 (10%)         5/60 (8%)          4/60 (7%)          4/60 (7%)          4/69 (6%)            |
|ADJUSTED (b)           |        23.1%              19.8%              20.4%              70.5%              17.5%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           1/7 (14%)          0/9 (0%)           1/5 (20%)          0/0                  |
|TERMINAL (d)           |        5/26 (19%)         3/20 (15%)         2/13 (15%)         0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         619                456 (I)            641                456 (I)            471                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P<0.001 **         P=0.559N           P=0.593N           P=0.028 *          P=0.062              |
|INCIDENTAL TUMOR       |        P=0.252            P=0.495N           P=0.393N           P=0.469            P=0.627N             |
|LOGISTIC REGRESSION    |        P=0.440            P=0.468N           P=0.386N           P=0.571            P=0.631              |
|COCHRAN-ARMITAGE       |        P=0.231N                                                                                         |
|FISHER EXACT           |                           P=0.493N           P=0.361N           P=0.361N           P=0.274N             |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |        1/70 (1%)          1/60 (2%)          1/60 (2%)          3/60 (5%)          0/69 (0%)            |
|ADJUSTED (b)           |         3.4%               4.0%               3.2%              20.5%               0.0%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           0/7 (0%)           0/9 (0%)           0/5 (0%)           0/0                  |
|TERMINAL (d)           |        0/26 (0%)          0/20 (0%)          0/13 (0%)          0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         722                711                662                604                ---                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.210            P=0.710            P=0.667            P=0.030 *          P=0.995N             |
|INCIDENTAL TUMOR       |        P=0.396N           P=0.750N           P=0.686N           P=0.559            P=0.545N             |
|LOGISTIC REGRESSION    |        P=0.559            P=0.723            P=0.733            P=0.152            P=0.927N             |
|COCHRAN-ARMITAGE       |        P=0.428N                                                                                         |
|FISHER EXACT           |                           P=0.712            P=0.712            P=0.254            P=0.504N             |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  31
                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |         UNTREATD           0.25%              0.50%              1.00%              2.00%               |
|                       |         CONTROL                                                                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |        8/70 (11%)         5/60 (8%)          5/60 (8%)          7/60 (12%)         4/69 (6%)            |
|ADJUSTED (b)           |        25.7%              19.8%              23.0%              76.6%              17.5%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           1/7 (14%)          0/9 (0%)           1/5 (20%)          0/0                  |
|TERMINAL (d)           |        5/26 (19%)         3/20 (15%)         2/13 (15%)         0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         619                456 (I)            641                456 (I)            471                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P<0.001 **         P=0.453N           P=0.604            P=0.001 **         P=0.068              |
|INCIDENTAL TUMOR       |        P=0.342            P=0.376N           P=0.363N           P=0.375            P=0.457N             |
|LOGISTIC REGRESSION    |        P=0.382            P=0.362N           P=0.407N           P=0.232            P=0.599N             |
|COCHRAN-ARMITAGE       |        P=0.224N                                                                                         |
|FISHER EXACT           |                           P=0.387N           P=0.387N           P=0.590            P=0.190N             |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/70 (0%)          1/60 (2%)          2/60 (3%)          2/60 (3%)          7/69 (10%)           |
|ADJUSTED (b)           |         0.0%               5.0%               8.4%               8.8%              39.9%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           0/7 (0%)           0/9 (0%)           0/5 (0%)           0/0                  |
|TERMINAL (d)           |        0/26 (0%)          1/20 (5%)          0/13 (0%)          0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         ---                736 (T)            666                608                432                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P<0.001 **         P=0.448            P=0.158            P=0.103            P<0.001 **           |
|INCIDENTAL TUMOR       |        P=0.004 **         P=0.448            P=0.314            P=0.571            P=0.086              |
|LOGISTIC REGRESSION    |        P<0.001 **         P=0.448            P=0.213            P=0.196            P=0.005 **           |
|COCHRAN-ARMITAGE       |        P=0.001 **                                                                                       |
|FISHER EXACT           |                           P=0.462            P=0.211            P=0.211            P=0.006 **           |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  32
                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |         UNTREATD           0.25%              0.50%              1.00%              2.00%               |
|                       |         CONTROL                                                                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/70 (0%)          1/60 (2%)          4/60 (7%)          1/60 (2%)          2/69 (3%)            |
|ADJUSTED (b)           |         0.0%               2.6%              20.8%               5.9%              26.3%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           0/7 (0%)           0/9 (0%)           0/5 (0%)           0/0                  |
|TERMINAL (d)           |        0/26 (0%)          0/20 (0%)          2/13 (15%)         0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         ---                610                633                647                388                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.008 **         P=0.462            P=0.023 *          P=0.325            P=0.064              |
|INCIDENTAL TUMOR       |        P=0.267            P=0.557            P=0.050 *          P=0.513            P=0.396              |
|LOGISTIC REGRESSION    |        P=0.194            P=0.473            P=0.042 *          P=0.437            P=0.218              |
|COCHRAN-ARMITAGE       |        P=0.374                                                                                          |
|FISHER EXACT           |                           P=0.462            P=0.043 *          P=0.462            P=0.245              |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/70 (0%)          2/60 (3%)          6/60 (10%)         3/60 (5%)          9/69 (13%)           |
|ADJUSTED (b)           |         0.0%               7.5%              27.5%              14.2%              55.7%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           0/7 (0%)           0/9 (0%)           0/5 (0%)           0/0                  |
|TERMINAL (d)           |        0/26 (0%)          1/20 (5%)          2/13 (15%)         0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         ---                610                633                608                388                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P<0.001 **         P=0.191            P=0.004 **         P=0.027 *          P<0.001 **           |
|INCIDENTAL TUMOR       |        P=0.003 **         P=0.240            P=0.019 *          P=0.304            P=0.038 *            |
|LOGISTIC REGRESSION    |        P<0.001 **         P=0.217            P=0.010 *          P=0.083            P=0.001 **           |
|COCHRAN-ARMITAGE       |        P=0.003 **                                                                                       |
|FISHER EXACT           |                           P=0.211            P=0.008 **         P=0.096            P=0.001 **           |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  33
                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |         UNTREATD           0.25%              0.50%              1.00%              2.00%               |
|                       |         CONTROL                                                                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Tongue                                                                                                                           |
|     Squamous Cell Carcinoma or Papilloma Squamous                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/70 (0%)          2/60 (3%)          5/60 (8%)          8/60 (13%)         6/70 (9%)            |
|ADJUSTED (b)           |         0.0%              10.0%              24.5%              31.5%             100.0%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           0/7 (0%)           0/9 (0%)           0/5 (0%)           0/0                  |
|TERMINAL (d)           |        0/26 (0%)          2/20 (10%)         2/13 (15%)         0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         ---                736 (T)            536                381                511                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P<0.001 **         P=0.182            P=0.009 **         P<0.001 **         P<0.001 **           |
|INCIDENTAL TUMOR       |        P=0.050            P=0.182            P=0.022 *          P=0.105            P=0.176              |
|LOGISTIC REGRESSION    |        P=0.004 **         P=0.182            P=0.025 *          P=0.003 **         P=0.009 **           |
|COCHRAN-ARMITAGE       |        P=0.024 *                                                                                        |
|FISHER EXACT           |                           P=0.211            P=0.019 *          P=0.002 **         P=0.014 *            |
|=================================================================================================================================|
|                                                                                                                                 |
|Tongue                                                                                                                           |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/70 (0%)          2/60 (3%)          5/60 (8%)          8/60 (13%)         6/70 (9%)            |
|ADJUSTED (b)           |         0.0%              10.0%              24.5%              31.5%             100.0%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           0/7 (0%)           0/9 (0%)           0/5 (0%)           0/0                  |
|TERMINAL (d)           |        0/26 (0%)          2/20 (10%)         2/13 (15%)         0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         ---                736 (T)            536                381                511                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P<0.001 **         P=0.182            P=0.009 **         P<0.001 **         P<0.001 **           |
|INCIDENTAL TUMOR       |        P=0.050            P=0.182            P=0.022 *          P=0.105            P=0.176              |
|LOGISTIC REGRESSION    |        P=0.004 **         P=0.182            P=0.025 *          P=0.003 **         P=0.009 **           |
|COCHRAN-ARMITAGE       |        P=0.024 *                                                                                        |
|FISHER EXACT           |                           P=0.211            P=0.019 *          P=0.002 **         P=0.014 *            |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  34
                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |         UNTREATD           0.25%              0.50%              1.00%              2.00%               |
|                       |         CONTROL                                                                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Urinary Bladder                                                                                                                  |
|     Papilloma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/70 (0%)          0/60 (0%)          1/60 (2%)          3/60 (5%)          1/69 (1%)            |
|ADJUSTED (b)           |         0.0%               0.0%               7.7%               7.7%              14.3%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           0/7 (0%)           0/9 (0%)           1/5 (20%)          0/0                  |
|TERMINAL (d)           |        0/26 (0%)          0/20 (0%)          1/13 (8%)          0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         ---                ---                736 (T)            456 (I)            660                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.007 **           (e)              P=0.362            P=0.059            P=0.162              |
|INCIDENTAL TUMOR       |        P=0.069              (e)              P=0.362            P=0.230            P=0.455              |
|LOGISTIC REGRESSION    |        P=0.186              (e)              P=0.362            P=0.089            P=0.356              |
|COCHRAN-ARMITAGE       |        P=0.231                                                                                          |
|FISHER EXACT           |                             (e)              P=0.462            P=0.096            P=0.496              |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |                                                                                                         |
|ADJUSTED (b)           |                                                                                                         |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|                                                                                                         |
|TERMINAL (d)           |                                                                                                         |
|FIRST INCIDENCE (DAYS) |                                                                                                         |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |                                                                                                         |
|INCIDENTAL TUMOR       |                                                                                                         |
|LOGISTIC REGRESSION    |                                                                                                         |
|COCHRAN-ARMITAGE       |                                                                                                         |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  35
                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |         UNTREATD           0.25%              0.50%              1.00%              2.00%               |
|                       |         CONTROL                                                                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal or Polyp Stromal                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |                                                                                                         |
|ADJUSTED (b)           |                                                                                                         |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|                                                                                                         |
|TERMINAL (d)           |                                                                                                         |
|FIRST INCIDENCE (DAYS) |                                                                                                         |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |                                                                                                         |
|INCIDENTAL TUMOR       |                                                                                                         |
|LOGISTIC REGRESSION    |                                                                                                         |
|COCHRAN-ARMITAGE       |                                                                                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Zymbal's Gland                                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/70 (0%)          0/60 (0%)          1/60 (2%)          3/60 (5%)          2/70 (3%)            |
|ADJUSTED (b)           |         0.0%               0.0%               4.3%              52.6%               7.9%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           0/7 (0%)           0/9 (0%)           0/5 (0%)           0/0                  |
|TERMINAL (d)           |        0/26 (0%)          0/20 (0%)          0/13 (0%)          0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         ---                ---                694                556                513                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.002 **           (e)              P=0.422            P=0.020 *          P=0.129              |
|INCIDENTAL TUMOR       |        P=0.197              (e)              P=0.567            P=0.304            P=0.609              |
|LOGISTIC REGRESSION    |        P=0.045 *            (e)              P=0.470            P=0.086            P=0.207              |
|COCHRAN-ARMITAGE       |        P=0.088                                                                                          |
|FISHER EXACT           |                             (e)              P=0.462            P=0.096            P=0.248              |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  36
                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |         UNTREATD           0.25%              0.50%              1.00%              2.00%               |
|                       |         CONTROL                                                                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Zymbal's Gland                                                                                                                   |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        2/70 (3%)          1/60 (2%)          3/60 (5%)          2/60 (3%)         15/70 (21%)           |
|ADJUSTED (b)           |         3.8%               3.8%               7.2%               5.8%              44.7%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           0/7 (0%)           0/9 (0%)           0/5 (0%)           0/0                  |
|TERMINAL (d)           |        0/26 (0%)          0/20 (0%)          0/13 (0%)          0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         334                696                592                516                222                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P<0.001 **         P=0.558N           P=0.467            P=0.574            P<0.001 **           |
|INCIDENTAL TUMOR       |        P=0.006 **         P=0.460N           P=0.581            P=0.312N           P=0.260              |
|LOGISTIC REGRESSION    |        P<0.001 **         P=0.590N           P=0.381            P=0.619            P=0.030 *            |
|COCHRAN-ARMITAGE       |        P<0.001 **                                                                                       |
|FISHER EXACT           |                           P=0.558N           P=0.427            P=0.630            P<0.001 **           |
|=================================================================================================================================|
|                                                                                                                                 |
|Zymbal's Gland                                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        2/70 (3%)          1/60 (2%)          4/60 (7%)          5/60 (8%)         15/70 (21%)           |
|ADJUSTED (b)           |         3.8%               3.8%              11.2%              55.4%              44.7%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           0/7 (0%)           0/9 (0%)           0/5 (0%)           0/0                  |
|TERMINAL (d)           |        0/26 (0%)          0/20 (0%)          0/13 (0%)          0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         334                696                592                516                222                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P<0.001 **         P=0.558N           P=0.286            P=0.065            P<0.001 **           |
|INCIDENTAL TUMOR       |        P=0.008 **         P=0.460N           P=0.409            P=0.665N           P=0.260              |
|LOGISTIC REGRESSION    |        P<0.001 **         P=0.590N           P=0.246            P=0.159            P=0.030 *            |
|COCHRAN-ARMITAGE       |        P<0.001 **                                                                                       |
|FISHER EXACT           |                           P=0.558N           P=0.270            P=0.162            P<0.001 **           |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  37
                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |         UNTREATD           0.25%              0.50%              1.00%              2.00%               |
|                       |         CONTROL                                                                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma or Hemangioma                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/70 (0%)          0/60 (0%)          1/60 (2%)          2/60 (3%)          1/70 (1%)            |
|ADJUSTED (b)           |         0.0%               0.0%               1.7%              58.3%               1.8%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           0/7 (0%)           0/9 (0%)           0/5 (0%)           0/0                  |
|TERMINAL (d)           |        0/26 (0%)          0/20 (0%)          0/13 (0%)          0/1 (0%)           0/0                  |
|FIRST INCIDENCE (DAYS) |         ---                ---                451                697                396                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.035 *            (e)              P=0.503            P=0.002 **         P=0.490              |
|INCIDENTAL TUMOR       |        P=0.507              (e)              P=0.500            P=0.250            P=0.918              |
|LOGISTIC REGRESSION    |        P=0.260              (e)              P=0.367            P=0.020 *          P=0.533              |
|COCHRAN-ARMITAGE       |        P=0.259                                                                                          |
|FISHER EXACT           |                             (e)              P=0.462            P=0.211            P=0.500              |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |       28/70 (40%)        29/60 (48%)        40/60 (67%)        34/60 (57%)        25/70 (36%)           |
|ADJUSTED (b)           |        59.7%              76.3%              97.3%             100.0%              92.5%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        1/9 (11%)          0/7 (0%)           0/9 (0%)           0/5 (0%)           0/0                  |
|TERMINAL (d)           |        8/26 (31%)        12/20 (60%)        12/13 (92%)         1/1 (100%)         0/0                  |
|FIRST INCIDENCE (DAYS) |         456 (I)            480                536                432                366                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P<0.001 **         P=0.200            P<0.001 **         P<0.001 **         P<0.001 **           |
|INCIDENTAL TUMOR       |        P=0.194N           P=0.503N           P=0.057            P=0.334N           P=0.054N             |
|LOGISTIC REGRESSION    |        P=0.442            P=0.542            P=0.054            P=0.497            P=0.356N             |
|COCHRAN-ARMITAGE       |        P=0.120N                                                                                         |
|FISHER EXACT           |                           P=0.218            P=0.002 **         P=0.043 *          P=0.364N             |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  38
                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |         UNTREATD           0.25%              0.50%              1.00%              2.00%               |
|                       |         CONTROL                                                                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Mesothelioma: Benign, Malignant, NOS                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/70 (0%)          4/60 (7%)          9/60 (15%)         9/60 (15%)        26/70 (37%)           |
|ADJUSTED (b)           |         0.0%               9.3%              44.3%             100.0%              91.5%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        0/9 (0%)           1/7 (14%)          1/9 (11%)          0/5 (0%)           0/0                  |
|TERMINAL (d)           |        0/26 (0%)          0/20 (0%)          4/13 (31%)         1/1 (100%)         0/0                  |
|FIRST INCIDENCE (DAYS) |         ---                456 (I)            456 (I)            495                365                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P<0.001 **         P=0.045 *          P<0.001 **         P<0.001 **         P<0.001 **           |
|INCIDENTAL TUMOR       |        P<0.001 **         P=0.075            P<0.001 **         P=0.008 **         P<0.001 **           |
|LOGISTIC REGRESSION    |        P<0.001 **         P=0.038 *          P=0.001 **         P<0.001 **         P<0.001 **           |
|COCHRAN-ARMITAGE       |        P<0.001 **                                                                                       |
|FISHER EXACT           |                           P=0.043 *          P<0.001 **         P<0.001 **         P<0.001 **           |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |       59/70 (84%)        59/60 (98%)        60/60 (100%)       59/60 (98%)        59/70 (84%)           |
|ADJUSTED (b)           |       100.0%             100.0%             100.0%             100.0%             100.0%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        9/9 (100%)         7/7 (100%)         9/9 (100%)         5/5 (100%)         0/0                  |
|TERMINAL (d)           |       26/26 (100%)       20/20 (100%)       13/13 (100%)        1/1 (100%)         0/0                  |
|FIRST INCIDENCE (DAYS) |         456 (I)            450                451                381                365                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P<0.001 **         P=0.059            P=0.003 **         P<0.001 **         P<0.001 **           |
|INCIDENTAL TUMOR       |        P=0.297              (e)                (e)                (e)              P=0.638              |
|LOGISTIC REGRESSION    |        P=0.297              (e)                (e)                (e)              P=0.638              |
|COCHRAN-ARMITAGE       |        P=0.102N                                                                                         |
|FISHER EXACT           |                           P=0.005 **         P<0.001 **         P=0.005 **         P=0.592N             |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  39
                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |         UNTREATD           0.25%              0.50%              1.00%              2.00%               |
|                       |         CONTROL                                                                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |       33/70 (47%)        37/60 (62%)        47/60 (78%)        50/60 (83%)        55/70 (79%)           |
|ADJUSTED (b)           |        65.3%              83.1%              97.9%             100.0%             100.0%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        1/9 (11%)          1/7 (14%)          1/9 (11%)          1/5 (20%)          0/0                  |
|TERMINAL (d)           |        9/26 (35%)        13/20 (65%)        12/13 (92%)         1/1 (100%)         0/0                  |
|FIRST INCIDENCE (DAYS) |         334                450                451                432                222                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P<0.001 **         P=0.096            P<0.001 **         P<0.001 **         P<0.001 **           |
|INCIDENTAL TUMOR       |        P=0.002 **         P=0.494            P=0.019 *          P=0.580            P=0.599              |
|LOGISTIC REGRESSION    |        P<0.001 **         P=0.329            P=0.018 *          P=0.048 *          P<0.001 **           |
|COCHRAN-ARMITAGE       |        P<0.001 **                                                                                       |
|FISHER EXACT           |                           P=0.069            P<0.001 **         P<0.001 **         P<0.001 **           |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |       60/70 (86%)        59/60 (98%)        60/60 (100%)       59/60 (98%)        60/70 (86%)           |
|ADJUSTED (b)           |       100.0%             100.0%             100.0%             100.0%             100.0%                |
|INTERIM SACRIFICE 1 (c)|        0/10 (0%)          0/0                0/0                0/0                0/10 (0%)            |
|INTERIM SACRIFICE 2 (c)|        9/9 (100%)         7/7 (100%)         9/9 (100%)         5/5 (100%)         0/0                  |
|TERMINAL (d)           |       26/26 (100%)       20/20 (100%)       13/13 (100%)        1/1 (100%)         0/0                  |
|FIRST INCIDENCE (DAYS) |         334                450                451                381                222                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P<0.001 **         P=0.078            P=0.005 **         P<0.001 **         P<0.001 **           |
|INCIDENTAL TUMOR       |        P=0.367            P=0.500N             (e)              P=0.500N             (e)                |
|LOGISTIC REGRESSION    |        P=0.212            P=0.500N             (e)              P=0.500N             (e)                |
|COCHRAN-ARMITAGE       |        P=0.119N                                                                                         |
|FISHER EXACT           |                           P=0.009 **         P=0.001 **         P=0.009 **         P=0.595N             |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  40
                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |            UNTREATD              0.25%                 0.50%                 1.00%                      |
|                       |            CONTROL                                                                                      |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           1/60 (2%)             1/60 (2%)             1/60 (2%)             0/60 (0%)                   |
|ADJUSTED (b)           |            2.8%                  3.7%                  4.3%                  0.0%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              0/7 (0%)              0/8 (0%)                    |
|TERMINAL (d)           |           1/36 (3%)             1/27 (4%)             1/23 (4%)             0/5 (0%)                    |
|FIRST INCIDENCE (DAYS) |            738 (T)               738 (T)               738 (T)               ---                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |           P=0.695N              P=0.697               P=0.659               P=0.876N                    |
|INCIDENTAL TUMOR       |           P=0.695N              P=0.697               P=0.659               P=0.876N                    |
|LOGISTIC REGRESSION    |           P=0.695N              P=0.697               P=0.659               P=0.876N                    |
|COCHRAN-ARMITAGE       |           P=0.312N                                                                                      |
|FISHER EXACT           |                                 P=0.752N              P=0.752N              P=0.500N                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Malignant                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           0/60 (0%)             0/60 (0%)             0/60 (0%)             0/60 (0%)                   |
|ADJUSTED (b)           |            0.0%                  0.0%                  0.0%                  0.0%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              0/7 (0%)              0/8 (0%)                    |
|TERMINAL (d)           |           0/36 (0%)             0/27 (0%)             0/23 (0%)             0/5 (0%)                    |
|FIRST INCIDENCE (DAYS) |            ---                   ---                   ---                   ---                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |             (e)                   (e)                   (e)                   (e)                       |
|INCIDENTAL TUMOR       |             (e)                   (e)                   (e)                   (e)                       |
|LOGISTIC REGRESSION    |             (e)                   (e)                   (e)                   (e)                       |
|COCHRAN-ARMITAGE       |             (e)                                                                                         |
|FISHER EXACT           |                                   (e)                   (e)                   (e)                       |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  41
                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |            UNTREATD              0.25%                 0.50%                 1.00%                      |
|                       |            CONTROL                                                                                      |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           2/60 (3%)             1/60 (2%)             1/60 (2%)             0/60 (0%)                   |
|ADJUSTED (b)           |            5.0%                  3.7%                  4.3%                  0.0%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              0/7 (0%)              0/8 (0%)                    |
|TERMINAL (d)           |           1/36 (3%)             1/27 (4%)             1/23 (4%)             0/5 (0%)                    |
|FIRST INCIDENCE (DAYS) |            690                   738 (T)               738 (T)               ---                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |           P=0.451N              P=0.578N              P=0.633N              P=0.619N                    |
|INCIDENTAL TUMOR       |           P=0.317N              P=0.483N              P=0.532N              P=0.291N                    |
|LOGISTIC REGRESSION    |           P=0.310N              P=0.518N              P=0.565N              P=0.396N                    |
|COCHRAN-ARMITAGE       |           P=0.153N                                                                                      |
|FISHER EXACT           |                                 P=0.500N              P=0.500N              P=0.248N                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           4/58 (7%)             3/58 (5%)             7/56 (13%)            3/60 (5%)                   |
|ADJUSTED (b)           |           10.6%                 11.1%                 24.4%                 15.6%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              1/7 (14%)             0/8 (0%)                    |
|TERMINAL (d)           |           3/34 (9%)             3/27 (11%)            4/21 (19%)            0/5 (0%)                    |
|FIRST INCIDENCE (DAYS) |            460                   738 (T)               456 (I)               610                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |           P=0.067               P=0.607N              P=0.104               P=0.272                     |
|INCIDENTAL TUMOR       |           P=0.388               P=0.607N              P=0.185               P=0.541N                    |
|LOGISTIC REGRESSION    |           P=0.508               P=0.508N              P=0.233               P=0.581N                    |
|COCHRAN-ARMITAGE       |           P=0.497N                                                                                      |
|FISHER EXACT           |                                 P=0.500N              P=0.244               P=0.481N                    |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  42
                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |            UNTREATD              0.25%                 0.50%                 1.00%                      |
|                       |            CONTROL                                                                                      |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           1/58 (2%)             0/58 (0%)             0/56 (0%)             1/60 (2%)                   |
|ADJUSTED (b)           |            2.9%                  0.0%                  0.0%                  2.0%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              0/7 (0%)              0/8 (0%)                    |
|TERMINAL (d)           |           1/34 (3%)             0/27 (0%)             0/21 (0%)             0/5 (0%)                    |
|FIRST INCIDENCE (DAYS) |            738 (T)               ---                   ---                   474                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |           P=0.451               P=0.546N              P=0.596N              P=0.584                     |
|INCIDENTAL TUMOR       |           P=0.583               P=0.546N              P=0.596N              P=0.738                     |
|LOGISTIC REGRESSION    |           P=0.633               P=0.546N              P=0.596N              P=0.731N                    |
|COCHRAN-ARMITAGE       |           P=0.600                                                                                       |
|FISHER EXACT           |                                 P=0.500N              P=0.509N              P=0.744N                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           5/58 (9%)             3/58 (5%)             7/56 (13%)            4/60 (7%)                   |
|ADJUSTED (b)           |           13.5%                 11.1%                 24.4%                 17.4%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              1/7 (14%)             0/8 (0%)                    |
|TERMINAL (d)           |           4/34 (12%)            3/27 (11%)            4/21 (19%)            0/5 (0%)                    |
|FIRST INCIDENCE (DAYS) |            460                   738 (T)               456 (I)               474                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |           P=0.050 *             P=0.471N              P=0.163               P=0.202                     |
|INCIDENTAL TUMOR       |           P=0.350               P=0.471N              P=0.266               P=0.587N                    |
|LOGISTIC REGRESSION    |           P=0.500               P=0.367N              P=0.336               P=0.536N                    |
|COCHRAN-ARMITAGE       |           P=0.527N                                                                                      |
|FISHER EXACT           |                                 P=0.358N              P=0.356               P=0.478N                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Esophagus                                                                                                                        |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    1/60 (2%)   10/60 (17%) |                                                    |
|ADJUSTED (b)           |   0.0%         0.0%         4.3%        42.4%      |                                                    |
|INTERIM SACRIFICE 1 (c)|                                                    |                                                    |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/9 (0%)     0/7 (0%)     0/8 (0%)   |                                                    |
|TERMINAL (d)           |  0/36 (0%)    0/27 (0%)    1/23 (4%)    0/5 (0%)   |                                                    |
|FIRST INCIDENCE (DAYS) |   ---          ---          738 (T)      474       |                                                    |
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  43
                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                                                 TERMINAL SACRIFICE AT 106 WEEKS
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **     (e)        P=0.411      P<0.001 ** |                                                    |
|INCIDENTAL TUMOR       |  P<0.001 **     (e)        P=0.411      P=0.058    |                                                    |
|LOGISTIC REGRESSION    |  P<0.001 **     (e)        P=0.411      P<0.001 ** |                                                    |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |                                                    |
|FISHER EXACT           |                 (e)        P=0.500      P<0.001 ** |                                                    |
|Intestine Large: Colon/Rectum                                                                                                    |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |             #                     #                     #                     #                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           0/60 (0%)             0/60 (0%)             0/60 (0%)             0/60 (0%)                   |
|ADJUSTED (b)           |            0.0%                  0.0%                  0.0%                  0.0%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              0/7 (0%)              0/8 (0%)                    |
|TERMINAL (d)           |           0/36 (0%)             0/27 (0%)             0/23 (0%)             0/5 (0%)                    |
|FIRST INCIDENCE (DAYS) |            ---                   ---                   ---                   ---                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |             (e)                   (e)                   (e)                   (e)                       |
|INCIDENTAL TUMOR       |             (e)                   (e)                   (e)                   (e)                       |
|LOGISTIC REGRESSION    |             (e)                   (e)                   (e)                   (e)                       |
|COCHRAN-ARMITAGE       |             (e)                                                                                         |
|FISHER EXACT           |                                   (e)                   (e)                   (e)                       |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  44
                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |            UNTREATD              0.25%                 0.50%                 1.00%                      |
|                       |            CONTROL                                                                                      |
|=================================================================================================================================|
|                                                                                                                                 |
|Intestine Large: Colon/Rectum                                                                                                    |
|     Polyp Adenomatous                                                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |             #                     #                     #                     #                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           0/60 (0%)             1/60 (2%)             0/60 (0%)             0/60 (0%)                   |
|ADJUSTED (b)           |            0.0%                  2.0%                  0.0%                  0.0%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              0/7 (0%)              0/8 (0%)                    |
|TERMINAL (d)           |           0/36 (0%)             0/27 (0%)             0/23 (0%)             0/5 (0%)                    |
|FIRST INCIDENCE (DAYS) |            ---                   509                   ---                   ---                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |           P=0.568N              P=0.504                 (e)                   (e)                       |
|INCIDENTAL TUMOR       |           P=0.405N              P=0.500                 (e)                   (e)                       |
|LOGISTIC REGRESSION    |           P=0.510N              P=0.505                 (e)                   (e)                       |
|COCHRAN-ARMITAGE       |           P=0.567N                                                                                      |
|FISHER EXACT           |                                 P=0.500                 (e)                   (e)                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Intestine Small: Ileum                                                                                                           |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |             #                     #                     #                     #                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           0/60 (0%)             0/60 (0%)             0/60 (0%)             0/60 (0%)                   |
|ADJUSTED (b)           |            0.0%                  0.0%                  0.0%                  0.0%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              0/7 (0%)              0/8 (0%)                    |
|TERMINAL (d)           |           0/36 (0%)             0/27 (0%)             0/23 (0%)             0/5 (0%)                    |
|FIRST INCIDENCE (DAYS) |            ---                   ---                   ---                   ---                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |             (e)                   (e)                   (e)                   (e)                       |
|INCIDENTAL TUMOR       |             (e)                   (e)                   (e)                   (e)                       |
|LOGISTIC REGRESSION    |             (e)                   (e)                   (e)                   (e)                       |
|COCHRAN-ARMITAGE       |             (e)                                                                                         |
|FISHER EXACT           |                                   (e)                   (e)                   (e)                       |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  45
                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |            UNTREATD              0.25%                 0.50%                 1.00%                      |
|                       |            CONTROL                                                                                      |
|=================================================================================================================================|
|                                                                                                                                 |
|Intestine Small: Jejunum                                                                                                         |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |             #                     #                     #                     #                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           0/60 (0%)             0/60 (0%)             1/60 (2%)             0/60 (0%)                   |
|ADJUSTED (b)           |            0.0%                  0.0%                  2.8%                  0.0%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              0/7 (0%)              0/8 (0%)                    |
|TERMINAL (d)           |           0/36 (0%)             0/27 (0%)             0/23 (0%)             0/5 (0%)                    |
|FIRST INCIDENCE (DAYS) |            ---                   ---                   673                   ---                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |           P=0.610                 (e)                 P=0.460                 (e)                       |
|INCIDENTAL TUMOR       |           P=0.746N                (e)                 P=0.627                 (e)                       |
|LOGISTIC REGRESSION    |           P=0.683                 (e)                 P=0.495                 (e)                       |
|COCHRAN-ARMITAGE       |           P=0.694                                                                                       |
|FISHER EXACT           |                                   (e)                 P=0.500                 (e)                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Intestine Small: Site Unspecified                                                                                                |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |             #                     #                     #                     #                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           0/60 (0%)             0/60 (0%)             1/60 (2%)             0/60 (0%)                   |
|ADJUSTED (b)           |            0.0%                  0.0%                  2.8%                  0.0%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              0/7 (0%)              0/8 (0%)                    |
|TERMINAL (d)           |           0/36 (0%)             0/27 (0%)             0/23 (0%)             0/5 (0%)                    |
|FIRST INCIDENCE (DAYS) |            ---                   ---                   673                   ---                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |           P=0.610                 (e)                 P=0.460                 (e)                       |
|INCIDENTAL TUMOR       |           P=0.746N                (e)                 P=0.627                 (e)                       |
|LOGISTIC REGRESSION    |           P=0.683                 (e)                 P=0.495                 (e)                       |
|COCHRAN-ARMITAGE       |           P=0.694                                                                                       |
|FISHER EXACT           |                                   (e)                 P=0.500                 (e)                       |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  46
                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |            UNTREATD              0.25%                 0.50%                 1.00%                      |
|                       |            CONTROL                                                                                      |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           0/60 (0%)             2/60 (3%)             1/60 (2%)             0/60 (0%)                   |
|ADJUSTED (b)           |            0.0%                  6.2%                  2.6%                  0.0%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              0/7 (0%)              0/8 (0%)                    |
|TERMINAL (d)           |           0/36 (0%)             1/27 (4%)             0/23 (0%)             0/5 (0%)                    |
|FIRST INCIDENCE (DAYS) |            ---                   695                   670                   ---                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |           P=0.613               P=0.203               P=0.471                 (e)                       |
|INCIDENTAL TUMOR       |           P=0.480N              P=0.282               P=0.627                 (e)                       |
|LOGISTIC REGRESSION    |           P=0.573N              P=0.229               P=0.497                 (e)                       |
|COCHRAN-ARMITAGE       |           P=0.461N                                                                                      |
|FISHER EXACT           |                                 P=0.248               P=0.500                 (e)                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           1/60 (2%)             0/60 (0%)             0/60 (0%)             0/60 (0%)                   |
|ADJUSTED (b)           |            2.4%                  0.0%                  0.0%                  0.0%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              0/7 (0%)              0/8 (0%)                    |
|TERMINAL (d)           |           0/36 (0%)             0/27 (0%)             0/23 (0%)             0/5 (0%)                    |
|FIRST INCIDENCE (DAYS) |            696                   ---                   ---                   ---                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |           P=0.445N              P=0.520N              P=0.562N              P=0.778N                    |
|INCIDENTAL TUMOR       |           P=0.234N              P=0.351N              P=0.373N              P=0.341N                    |
|LOGISTIC REGRESSION    |           P=0.339N              P=0.503N              P=0.515N              P=0.598N                    |
|COCHRAN-ARMITAGE       |           P=0.306N                                                                                      |
|FISHER EXACT           |                                 P=0.500N              P=0.500N              P=0.500N                    |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  47
                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |            UNTREATD              0.25%                 0.50%                 1.00%                      |
|                       |            CONTROL                                                                                      |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           1/60 (2%)             2/60 (3%)             1/60 (2%)             0/60 (0%)                   |
|ADJUSTED (b)           |            2.4%                  6.2%                  2.6%                  0.0%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              0/7 (0%)              0/8 (0%)                    |
|TERMINAL (d)           |           0/36 (0%)             1/27 (4%)             0/23 (0%)             0/5 (0%)                    |
|FIRST INCIDENCE (DAYS) |            696                   695                   670                   ---                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |           P=0.544N              P=0.449               P=0.709               P=0.778N                    |
|INCIDENTAL TUMOR       |           P=0.210N              P=0.637               P=0.615N              P=0.341N                    |
|LOGISTIC REGRESSION    |           P=0.333N              P=0.491               P=0.754               P=0.598N                    |
|COCHRAN-ARMITAGE       |           P=0.248N                                                                                      |
|FISHER EXACT           |                                 P=0.500               P=0.752N              P=0.500N                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney: Renal Tubule                                                                                                             |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           0/60 (0%)             1/60 (2%)             0/60 (0%)             0/60 (0%)                   |
|ADJUSTED (b)           |            0.0%                  3.7%                  0.0%                  0.0%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              0/7 (0%)              0/8 (0%)                    |
|TERMINAL (d)           |           0/36 (0%)             1/27 (4%)             0/23 (0%)             0/5 (0%)                    |
|FIRST INCIDENCE (DAYS) |            ---                   738 (T)               ---                   ---                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |           P=0.820N              P=0.443                 (e)                   (e)                       |
|INCIDENTAL TUMOR       |           P=0.820N              P=0.443                 (e)                   (e)                       |
|LOGISTIC REGRESSION    |           P=0.820N              P=0.443                 (e)                   (e)                       |
|COCHRAN-ARMITAGE       |           P=0.567N                                                                                      |
|FISHER EXACT           |                                 P=0.500                 (e)                   (e)                       |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  48
                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |            UNTREATD              0.25%                 0.50%                 1.00%                      |
|                       |            CONTROL                                                                                      |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           0/60 (0%)             0/60 (0%)             0/60 (0%)             0/60 (0%)                   |
|ADJUSTED (b)           |            0.0%                  0.0%                  0.0%                  0.0%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              0/7 (0%)              0/8 (0%)                    |
|TERMINAL (d)           |           0/36 (0%)             0/27 (0%)             0/23 (0%)             0/5 (0%)                    |
|FIRST INCIDENCE (DAYS) |            ---                   ---                   ---                   ---                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |             (e)                   (e)                   (e)                   (e)                       |
|INCIDENTAL TUMOR       |             (e)                   (e)                   (e)                   (e)                       |
|LOGISTIC REGRESSION    |             (e)                   (e)                   (e)                   (e)                       |
|COCHRAN-ARMITAGE       |             (e)                                                                                         |
|FISHER EXACT           |                                   (e)                   (e)                   (e)                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           0/60 (0%)             0/60 (0%)             0/60 (0%)             0/60 (0%)                   |
|ADJUSTED (b)           |            0.0%                  0.0%                  0.0%                  0.0%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              0/7 (0%)              0/8 (0%)                    |
|TERMINAL (d)           |           0/36 (0%)             0/27 (0%)             0/23 (0%)             0/5 (0%)                    |
|FIRST INCIDENCE (DAYS) |            ---                   ---                   ---                   ---                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |             (e)                   (e)                   (e)                   (e)                       |
|INCIDENTAL TUMOR       |             (e)                   (e)                   (e)                   (e)                       |
|LOGISTIC REGRESSION    |             (e)                   (e)                   (e)                   (e)                       |
|COCHRAN-ARMITAGE       |             (e)                                                                                         |
|FISHER EXACT           |                                   (e)                   (e)                   (e)                       |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  49
                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |            UNTREATD              0.25%                 0.50%                 1.00%                      |
|                       |            CONTROL                                                                                      |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           0/60 (0%)             0/60 (0%)             0/60 (0%)             0/60 (0%)                   |
|ADJUSTED (b)           |            0.0%                  0.0%                  0.0%                  0.0%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              0/7 (0%)              0/8 (0%)                    |
|TERMINAL (d)           |           0/36 (0%)             0/27 (0%)             0/23 (0%)             0/5 (0%)                    |
|FIRST INCIDENCE (DAYS) |            ---                   ---                   ---                   ---                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |             (e)                   (e)                   (e)                   (e)                       |
|INCIDENTAL TUMOR       |             (e)                   (e)                   (e)                   (e)                       |
|LOGISTIC REGRESSION    |             (e)                   (e)                   (e)                   (e)                       |
|COCHRAN-ARMITAGE       |             (e)                                                                                         |
|FISHER EXACT           |                                   (e)                   (e)                   (e)                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           0/60 (0%)             0/60 (0%)             0/60 (0%)             1/60 (2%)                   |
|ADJUSTED (b)           |            0.0%                  0.0%                  0.0%                  5.9%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              0/7 (0%)              0/8 (0%)                    |
|TERMINAL (d)           |           0/36 (0%)             0/27 (0%)             0/23 (0%)             0/5 (0%)                    |
|FIRST INCIDENCE (DAYS) |            ---                   ---                   ---                   683                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |           P=0.089                 (e)                   (e)                 P=0.311                     |
|INCIDENTAL TUMOR       |           P=0.254                 (e)                   (e)                 P=0.659                     |
|LOGISTIC REGRESSION    |           P=0.158                 (e)                   (e)                 P=0.433                     |
|COCHRAN-ARMITAGE       |           P=0.199                                                                                       |
|FISHER EXACT           |                                   (e)                   (e)                 P=0.500                     |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  50
                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |            UNTREATD              0.25%                 0.50%                 1.00%                      |
|                       |            CONTROL                                                                                      |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           0/60 (0%)             1/60 (2%)             0/60 (0%)             2/60 (3%)                   |
|ADJUSTED (b)           |            0.0%                  3.7%                  0.0%                  8.4%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              0/7 (0%)              0/8 (0%)                    |
|TERMINAL (d)           |           0/36 (0%)             1/27 (4%)             0/23 (0%)             0/5 (0%)                    |
|FIRST INCIDENCE (DAYS) |            ---                   738 (T)               ---                   594                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |           P=0.031 *             P=0.443                 (e)                 P=0.122                     |
|INCIDENTAL TUMOR       |           P=0.196               P=0.443                 (e)                 P=0.568                     |
|LOGISTIC REGRESSION    |           P=0.108               P=0.443                 (e)                 P=0.228                     |
|COCHRAN-ARMITAGE       |           P=0.140                                                                                       |
|FISHER EXACT           |                                 P=0.500                 (e)                 P=0.248                     |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           0/60 (0%)             1/60 (2%)             0/60 (0%)             2/60 (3%)                   |
|ADJUSTED (b)           |            0.0%                  3.7%                  0.0%                  8.4%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              0/7 (0%)              0/8 (0%)                    |
|TERMINAL (d)           |           0/36 (0%)             1/27 (4%)             0/23 (0%)             0/5 (0%)                    |
|FIRST INCIDENCE (DAYS) |            ---                   738 (T)               ---                   594                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |           P=0.031 *             P=0.443                 (e)                 P=0.122                     |
|INCIDENTAL TUMOR       |           P=0.196               P=0.443                 (e)                 P=0.568                     |
|LOGISTIC REGRESSION    |           P=0.108               P=0.443                 (e)                 P=0.228                     |
|COCHRAN-ARMITAGE       |           P=0.140                                                                                       |
|FISHER EXACT           |                                 P=0.500                 (e)                 P=0.248                     |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  51
                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |            UNTREATD              0.25%                 0.50%                 1.00%                      |
|                       |            CONTROL                                                                                      |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Squamous Cell Carcinoma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           0/60 (0%)             0/60 (0%)             0/60 (0%)             0/60 (0%)                   |
|ADJUSTED (b)           |            0.0%                  0.0%                  0.0%                  0.0%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              0/7 (0%)              0/8 (0%)                    |
|TERMINAL (d)           |           0/36 (0%)             0/27 (0%)             0/23 (0%)             0/5 (0%)                    |
|FIRST INCIDENCE (DAYS) |            ---                   ---                   ---                   ---                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |             (e)                   (e)                   (e)                   (e)                       |
|INCIDENTAL TUMOR       |             (e)                   (e)                   (e)                   (e)                       |
|LOGISTIC REGRESSION    |             (e)                   (e)                   (e)                   (e)                       |
|COCHRAN-ARMITAGE       |             (e)                                                                                         |
|FISHER EXACT           |                                   (e)                   (e)                   (e)                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |             #                     #                     #                     #                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           0/60 (0%)             2/60 (3%)             0/60 (0%)             0/60 (0%)                   |
|ADJUSTED (b)           |            0.0%                  7.4%                  0.0%                  0.0%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              0/7 (0%)              0/8 (0%)                    |
|TERMINAL (d)           |           0/36 (0%)             2/27 (7%)             0/23 (0%)             0/5 (0%)                    |
|FIRST INCIDENCE (DAYS) |            ---                   738 (T)               ---                   ---                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |           P=0.738N              P=0.177                 (e)                   (e)                       |
|INCIDENTAL TUMOR       |           P=0.738N              P=0.177                 (e)                   (e)                       |
|LOGISTIC REGRESSION    |           P=0.738N              P=0.177                 (e)                   (e)                       |
|COCHRAN-ARMITAGE       |           P=0.405N                                                                                      |
|FISHER EXACT           |                                 P=0.248                 (e)                   (e)                       |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  52
                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |            UNTREATD              0.25%                 0.50%                 1.00%                      |
|                       |            CONTROL                                                                                      |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |             #                     #                     #                     #                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           4/60 (7%)             4/60 (7%)             3/60 (5%)             4/60 (7%)                   |
|ADJUSTED (b)           |            9.7%                 12.6%                  7.0%                 10.3%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              0/7 (0%)              0/8 (0%)                    |
|TERMINAL (d)           |           1/36 (3%)             3/27 (11%)            0/23 (0%)             0/5 (0%)                    |
|FIRST INCIDENCE (DAYS) |            624                   404                   388                   432                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |           P=0.193               P=0.540               P=0.621N              P=0.275                     |
|INCIDENTAL TUMOR       |           P=0.330N              P=0.624N              P=0.218N              P=0.245N                    |
|LOGISTIC REGRESSION    |           P=0.474N              P=0.641               P=0.491N              P=0.587N                    |
|COCHRAN-ARMITAGE       |           P=0.554N                                                                                      |
|FISHER EXACT           |                                 P=0.641N              P=0.500N              P=0.641N                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |             #                     #                     #                     #                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           4/60 (7%)             6/60 (10%)            3/60 (5%)             4/60 (7%)                   |
|ADJUSTED (b)           |            9.7%                 19.9%                  7.0%                 10.3%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              0/7 (0%)              0/8 (0%)                    |
|TERMINAL (d)           |           1/36 (3%)             5/27 (19%)            0/23 (0%)             0/5 (0%)                    |
|FIRST INCIDENCE (DAYS) |            624                   404                   388                   432                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |           P=0.204               P=0.256               P=0.621N              P=0.275                     |
|INCIDENTAL TUMOR       |           P=0.333N              P=0.352               P=0.218N              P=0.245N                    |
|LOGISTIC REGRESSION    |           P=0.403N              P=0.365               P=0.491N              P=0.587N                    |
|COCHRAN-ARMITAGE       |           P=0.449N                                                                                      |
|FISHER EXACT           |                                 P=0.372               P=0.500N              P=0.641N                    |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  53
                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |            UNTREATD              0.25%                 0.50%                 1.00%                      |
|                       |            CONTROL                                                                                      |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroadenoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |             #                     #                     #                     #                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |          26/60 (43%)           46/60 (77%)           46/60 (77%)           48/60 (80%)                  |
|ADJUSTED (b)           |           61.3%                 95.8%                 97.9%                100.0%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           1/10 (10%)            1/9 (11%)             0/7 (0%)              3/8 (38%)                   |
|TERMINAL (d)           |          20/36 (56%)           25/27 (93%)           22/23 (96%)            5/5 (100%)                  |
|FIRST INCIDENCE (DAYS) |            456 (I)               456 (I)               565                   456 (I)                    |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |           P<0.001 **            P<0.001 **            P<0.001 **            P<0.001 **                  |
|INCIDENTAL TUMOR       |           P<0.001 **            P<0.001 **            P<0.001 **            P<0.001 **                  |
|LOGISTIC REGRESSION    |           P<0.001 **            P<0.001 **            P<0.001 **            P<0.001 **                  |
|COCHRAN-ARMITAGE       |           P<0.001 **                                                                                    |
|FISHER EXACT           |                                 P<0.001 **            P<0.001 **            P<0.001 **                  |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma or Adenoma                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |             #                     #                     #                     #                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |          26/60 (43%)           46/60 (77%)           46/60 (77%)           48/60 (80%)                  |
|ADJUSTED (b)           |           61.3%                 95.8%                 97.9%                100.0%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           1/10 (10%)            1/9 (11%)             0/7 (0%)              3/8 (38%)                   |
|TERMINAL (d)           |          20/36 (56%)           25/27 (93%)           22/23 (96%)            5/5 (100%)                  |
|FIRST INCIDENCE (DAYS) |            456 (I)               456 (I)               565                   456 (I)                    |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |           P<0.001 **            P<0.001 **            P<0.001 **            P<0.001 **                  |
|INCIDENTAL TUMOR       |           P<0.001 **            P<0.001 **            P<0.001 **            P<0.001 **                  |
|LOGISTIC REGRESSION    |           P<0.001 **            P<0.001 **            P<0.001 **            P<0.001 **                  |
|COCHRAN-ARMITAGE       |           P<0.001 **                                                                                    |
|FISHER EXACT           |                                 P<0.001 **            P<0.001 **            P<0.001 **                  |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  54
                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |            UNTREATD              0.25%                 0.50%                 1.00%                      |
|                       |            CONTROL                                                                                      |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |             #                     #                     #                     #                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |          28/60 (47%)           48/60 (80%)           47/60 (78%)           50/60 (83%)                  |
|ADJUSTED (b)           |           63.1%                 97.9%                 97.9%                100.0%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           1/10 (10%)            1/9 (11%)             0/7 (0%)              3/8 (38%)                   |
|TERMINAL (d)           |          20/36 (56%)           26/27 (96%)           22/23 (96%)            5/5 (100%)                  |
|FIRST INCIDENCE (DAYS) |            456 (I)               404                   388                   432                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |           P<0.001 **            P<0.001 **            P<0.001 **            P<0.001 **                  |
|INCIDENTAL TUMOR       |           P<0.001 **            P<0.001 **            P<0.001 **            P<0.001 **                  |
|LOGISTIC REGRESSION    |           P<0.001 **            P<0.001 **            P<0.001 **            P<0.001 **                  |
|COCHRAN-ARMITAGE       |           P<0.001 **                                                                                    |
|FISHER EXACT           |                                 P<0.001 **            P<0.001 **            P<0.001 **                  |
|=================================================================================================================================|
|                                                                                                                                 |
|Mesentery                                                                                                                        |
|     Sarcoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |             #                     #                     #                     #                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           0/60 (0%)             0/60 (0%)             0/60 (0%)             0/60 (0%)                   |
|ADJUSTED (b)           |            0.0%                  0.0%                  0.0%                  0.0%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              0/7 (0%)              0/8 (0%)                    |
|TERMINAL (d)           |           0/36 (0%)             0/27 (0%)             0/23 (0%)             0/5 (0%)                    |
|FIRST INCIDENCE (DAYS) |            ---                   ---                   ---                   ---                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |             (e)                   (e)                   (e)                   (e)                       |
|INCIDENTAL TUMOR       |             (e)                   (e)                   (e)                   (e)                       |
|LOGISTIC REGRESSION    |             (e)                   (e)                   (e)                   (e)                       |
|COCHRAN-ARMITAGE       |             (e)                                                                                         |
|FISHER EXACT           |                                   (e)                   (e)                   (e)                       |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  55
                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |            UNTREATD              0.25%                 0.50%                 1.00%                      |
|                       |            CONTROL                                                                                      |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva)                                                                       |
|     Papilloma Squamous or Papilloma                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |             #                     #                     #                     #                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           2/60 (3%)             2/60 (3%)             4/60 (7%)             5/60 (8%)                   |
|ADJUSTED (b)           |            5.6%                  7.4%                 11.5%                 47.0%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              0/7 (0%)              0/8 (0%)                    |
|TERMINAL (d)           |           2/36 (6%)             2/27 (7%)             1/23 (4%)             2/5 (40%)                   |
|FIRST INCIDENCE (DAYS) |            738 (T)               738 (T)               627                   577                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |           P=0.001 **            P=0.588               P=0.219               P=0.003 **                  |
|INCIDENTAL TUMOR       |           P=0.061               P=0.588               P=0.422               P=0.043 *                   |
|LOGISTIC REGRESSION    |           P=0.033 *             P=0.588               P=0.302               P=0.071                     |
|COCHRAN-ARMITAGE       |           P=0.114                                                                                       |
|FISHER EXACT           |                                 P=0.691N              P=0.340               P=0.219                     |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva)                                                                       |
|     Squamous Cell Carcinoma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |             #                     #                     #                     #                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           0/60 (0%)             1/60 (2%)             1/60 (2%)             1/60 (2%)                   |
|ADJUSTED (b)           |            0.0%                  3.2%                  2.6%                  3.6%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              0/7 (0%)              0/8 (0%)                    |
|TERMINAL (d)           |           0/36 (0%)             0/27 (0%)             0/23 (0%)             0/5 (0%)                    |
|FIRST INCIDENCE (DAYS) |            ---                   723                   662                   631                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |           P=0.184               P=0.470               P=0.476               P=0.401                     |
|INCIDENTAL TUMOR       |           P=0.642N              P=0.649               P=0.627               P=0.916                     |
|LOGISTIC REGRESSION    |           P=0.340               P=0.489               P=0.499               P=0.507                     |
|COCHRAN-ARMITAGE       |           P=0.384                                                                                       |
|FISHER EXACT           |                                 P=0.500               P=0.500               P=0.500                     |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  56
                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |            UNTREATD              0.25%                 0.50%                 1.00%                      |
|                       |            CONTROL                                                                                      |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva)                                                                       |
|     Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |             #                     #                     #                     #                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           2/60 (3%)             3/60 (5%)             5/60 (8%)             6/60 (10%)                  |
|ADJUSTED (b)           |            5.6%                 10.4%                 13.8%                 48.9%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              0/7 (0%)              0/8 (0%)                    |
|TERMINAL (d)           |           2/36 (6%)             2/27 (7%)             1/23 (4%)             2/5 (40%)                   |
|FIRST INCIDENCE (DAYS) |            738 (T)               723                   627                   577                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |           P<0.001 **            P=0.383               P=0.131               P=0.001 **                  |
|INCIDENTAL TUMOR       |           P=0.090               P=0.460               P=0.320               P=0.040 *                   |
|LOGISTIC REGRESSION    |           P=0.022 *             P=0.424               P=0.192               P=0.043 *                   |
|COCHRAN-ARMITAGE       |           P=0.081                                                                                       |
|FISHER EXACT           |                                 P=0.500               P=0.219               P=0.136                     |
|=================================================================================================================================|
|                                                                                                                                 |
|Pancreas                                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           0/60 (0%)             0/60 (0%)             0/60 (0%)             0/60 (0%)                   |
|ADJUSTED (b)           |            0.0%                  0.0%                  0.0%                  0.0%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              0/7 (0%)              0/8 (0%)                    |
|TERMINAL (d)           |           0/36 (0%)             0/27 (0%)             0/23 (0%)             0/5 (0%)                    |
|FIRST INCIDENCE (DAYS) |            ---                   ---                   ---                   ---                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |             (e)                   (e)                   (e)                   (e)                       |
|INCIDENTAL TUMOR       |             (e)                   (e)                   (e)                   (e)                       |
|LOGISTIC REGRESSION    |             (e)                   (e)                   (e)                   (e)                       |
|COCHRAN-ARMITAGE       |             (e)                                                                                         |
|FISHER EXACT           |                                   (e)                   (e)                   (e)                       |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  57
                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |            UNTREATD              0.25%                 0.50%                 1.00%                      |
|                       |            CONTROL                                                                                      |
|=================================================================================================================================|
|                                                                                                                                 |
|Pharynx                                                                                                                          |
|     Squamous Cell Carcinoma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |             #                     #                     #                     #                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           0/60 (0%)             1/60 (2%)             1/60 (2%)             0/60 (0%)                   |
|ADJUSTED (b)           |            0.0%                  3.2%                  2.6%                  0.0%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              0/7 (0%)              0/8 (0%)                    |
|TERMINAL (d)           |           0/36 (0%)             0/27 (0%)             0/23 (0%)             0/5 (0%)                    |
|FIRST INCIDENCE (DAYS) |            ---                   723                   662                   ---                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |           P=0.618               P=0.470               P=0.476                 (e)                       |
|INCIDENTAL TUMOR       |           P=0.482N              P=0.649               P=0.627                 (e)                       |
|LOGISTIC REGRESSION    |           P=0.672N              P=0.489               P=0.499                 (e)                       |
|COCHRAN-ARMITAGE       |           P=0.595N                                                                                      |
|FISHER EXACT           |                                 P=0.500               P=0.500                 (e)                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Pharynx                                                                                                                          |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |             #                     #                     #                     #                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           1/60 (2%)             0/60 (0%)             0/60 (0%)             1/60 (2%)                   |
|ADJUSTED (b)           |            2.8%                  0.0%                  0.0%                 20.0%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              0/7 (0%)              0/8 (0%)                    |
|TERMINAL (d)           |           1/36 (3%)             0/27 (0%)             0/23 (0%)             1/5 (20%)                   |
|FIRST INCIDENCE (DAYS) |            738 (T)               ---                   ---                   738 (T)                    |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |           P=0.262               P=0.557N              P=0.589N              P=0.288                     |
|INCIDENTAL TUMOR       |           P=0.262               P=0.557N              P=0.589N              P=0.288                     |
|LOGISTIC REGRESSION    |           P=0.262               P=0.557N              P=0.589N              P=0.288                     |
|COCHRAN-ARMITAGE       |           P=0.595                                                                                       |
|FISHER EXACT           |                                 P=0.500N              P=0.500N              P=0.752N                    |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  58
                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |            UNTREATD              0.25%                 0.50%                 1.00%                      |
|                       |            CONTROL                                                                                      |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |          16/58 (28%)           24/60 (40%)           24/59 (41%)           16/59 (27%)                  |
|ADJUSTED (b)           |           38.8%                 65.0%                 69.8%                 60.9%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/9 (0%)              0/9 (0%)              0/7 (0%)              1/8 (13%)                   |
|TERMINAL (d)           |          11/35 (31%)           15/27 (56%)           13/22 (59%)            1/5 (20%)                   |
|FIRST INCIDENCE (DAYS) |            460                   619                   481                   456 (I)                    |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |           P<0.001 **            P=0.023 *             P=0.006 **            P=0.002 **                  |
|INCIDENTAL TUMOR       |           P=0.533               P=0.078               P=0.103               P=0.428N                    |
|LOGISTIC REGRESSION    |           P=0.260               P=0.080               P=0.047 *             P=0.401                     |
|COCHRAN-ARMITAGE       |           P=0.378N                                                                                      |
|FISHER EXACT           |                                 P=0.109               P=0.097               P=0.560N                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |          16/58 (28%)           24/60 (40%)           24/59 (41%)           16/59 (27%)                  |
|ADJUSTED (b)           |           38.8%                 65.0%                 69.8%                 60.9%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/9 (0%)              0/9 (0%)              0/7 (0%)              1/8 (13%)                   |
|TERMINAL (d)           |          11/35 (31%)           15/27 (56%)           13/22 (59%)            1/5 (20%)                   |
|FIRST INCIDENCE (DAYS) |            460                   619                   481                   456 (I)                    |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |           P<0.001 **            P=0.023 *             P=0.006 **            P=0.002 **                  |
|INCIDENTAL TUMOR       |           P=0.533               P=0.078               P=0.103               P=0.428N                    |
|LOGISTIC REGRESSION    |           P=0.260               P=0.080               P=0.047 *             P=0.401                     |
|COCHRAN-ARMITAGE       |           P=0.378N                                                                                      |
|FISHER EXACT           |                                 P=0.109               P=0.097               P=0.560N                    |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  59
                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |            UNTREATD              0.25%                 0.50%                 1.00%                      |
|                       |            CONTROL                                                                                      |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Basal Cell Adenoma                                                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |             #                     #                     #                     #                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           0/60 (0%)             0/60 (0%)             0/60 (0%)             0/60 (0%)                   |
|ADJUSTED (b)           |            0.0%                  0.0%                  0.0%                  0.0%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              0/7 (0%)              0/8 (0%)                    |
|TERMINAL (d)           |           0/36 (0%)             0/27 (0%)             0/23 (0%)             0/5 (0%)                    |
|FIRST INCIDENCE (DAYS) |            ---                   ---                   ---                   ---                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |             (e)                   (e)                   (e)                   (e)                       |
|INCIDENTAL TUMOR       |             (e)                   (e)                   (e)                   (e)                       |
|LOGISTIC REGRESSION    |             (e)                   (e)                   (e)                   (e)                       |
|COCHRAN-ARMITAGE       |             (e)                                                                                         |
|FISHER EXACT           |                                   (e)                   (e)                   (e)                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Basal Cell Adenoma, Basosquamous Tumor Benign, or Trichoepithelioma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |             #                     #                     #                     #                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           1/60 (2%)             0/60 (0%)             0/60 (0%)             0/60 (0%)                   |
|ADJUSTED (b)           |            2.8%                  0.0%                  0.0%                  0.0%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              0/7 (0%)              0/8 (0%)                    |
|TERMINAL (d)           |           1/36 (3%)             0/27 (0%)             0/23 (0%)             0/5 (0%)                    |
|FIRST INCIDENCE (DAYS) |            738 (T)               ---                   ---                   ---                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |           P=0.492N              P=0.557N              P=0.589N              P=0.876N                    |
|INCIDENTAL TUMOR       |           P=0.492N              P=0.557N              P=0.589N              P=0.876N                    |
|LOGISTIC REGRESSION    |           P=0.492N              P=0.557N              P=0.589N              P=0.876N                    |
|COCHRAN-ARMITAGE       |           P=0.306N                                                                                      |
|FISHER EXACT           |                                 P=0.500N              P=0.500N              P=0.500N                    |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  60
                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |            UNTREATD              0.25%                 0.50%                 1.00%                      |
|                       |            CONTROL                                                                                      |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Basal Cell Carcinoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |             #                     #                     #                     #                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           0/60 (0%)             0/60 (0%)             0/60 (0%)             0/60 (0%)                   |
|ADJUSTED (b)           |            0.0%                  0.0%                  0.0%                  0.0%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              0/7 (0%)              0/8 (0%)                    |
|TERMINAL (d)           |           0/36 (0%)             0/27 (0%)             0/23 (0%)             0/5 (0%)                    |
|FIRST INCIDENCE (DAYS) |            ---                   ---                   ---                   ---                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |             (e)                   (e)                   (e)                   (e)                       |
|INCIDENTAL TUMOR       |             (e)                   (e)                   (e)                   (e)                       |
|LOGISTIC REGRESSION    |             (e)                   (e)                   (e)                   (e)                       |
|COCHRAN-ARMITAGE       |             (e)                                                                                         |
|FISHER EXACT           |                                   (e)                   (e)                   (e)                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous Tumor (benign,                                                       |
|     malignant or NOS), or Trichoepithelioma                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |             #                     #                     #                     #                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           1/60 (2%)             0/60 (0%)             0/60 (0%)             0/60 (0%)                   |
|ADJUSTED (b)           |            2.8%                  0.0%                  0.0%                  0.0%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              0/7 (0%)              0/8 (0%)                    |
|TERMINAL (d)           |           1/36 (3%)             0/27 (0%)             0/23 (0%)             0/5 (0%)                    |
|FIRST INCIDENCE (DAYS) |            738 (T)               ---                   ---                   ---                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |           P=0.492N              P=0.557N              P=0.589N              P=0.876N                    |
|INCIDENTAL TUMOR       |           P=0.492N              P=0.557N              P=0.589N              P=0.876N                    |
|LOGISTIC REGRESSION    |           P=0.492N              P=0.557N              P=0.589N              P=0.876N                    |
|COCHRAN-ARMITAGE       |           P=0.306N                                                                                      |
|FISHER EXACT           |                                 P=0.500N              P=0.500N              P=0.500N                    |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  61
                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |            UNTREATD              0.25%                 0.50%                 1.00%                      |
|                       |            CONTROL                                                                                      |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal                                                       |
|     Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepithelioma                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |             #                     #                     #                     #                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           4/60 (7%)             1/60 (2%)             2/60 (3%)             0/60 (0%)                   |
|ADJUSTED (b)           |           10.5%                  2.9%                  7.2%                  0.0%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              0/7 (0%)              0/8 (0%)                    |
|TERMINAL (d)           |           3/36 (8%)             0/27 (0%)             1/23 (4%)             0/5 (0%)                    |
|FIRST INCIDENCE (DAYS) |            690                   704                   683                   ---                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |           P=0.277N              P=0.252N              P=0.524N              P=0.452N                    |
|INCIDENTAL TUMOR       |           P=0.096N              P=0.141N              P=0.375N              P=0.220N                    |
|LOGISTIC REGRESSION    |           P=0.125N              P=0.193N              P=0.418N              P=0.236N                    |
|COCHRAN-ARMITAGE       |           P=0.053N                                                                                      |
|FISHER EXACT           |                                 P=0.182N              P=0.340N              P=0.059N                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |             #                     #                     #                     #                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           1/60 (2%)             4/60 (7%)             1/60 (2%)             2/60 (3%)                   |
|ADJUSTED (b)           |            2.8%                 12.7%                  4.3%                 21.9%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              0/7 (0%)              0/8 (0%)                    |
|TERMINAL (d)           |           1/36 (3%)             2/27 (7%)             1/23 (4%)             1/5 (20%)                   |
|FIRST INCIDENCE (DAYS) |            738 (T)               683                   738 (T)               577                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |           P=0.122               P=0.122               P=0.659               P=0.123                     |
|INCIDENTAL TUMOR       |           P=0.410               P=0.210               P=0.659               P=0.259                     |
|LOGISTIC REGRESSION    |           P=0.364               P=0.162               P=0.659               P=0.379                     |
|COCHRAN-ARMITAGE       |           P=0.596                                                                                       |
|FISHER EXACT           |                                 P=0.182               P=0.752N              P=0.500                     |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  62
                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |            UNTREATD              0.25%                 0.50%                 1.00%                      |
|                       |            CONTROL                                                                                      |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |             #                     #                     #                     #                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           2/60 (3%)             4/60 (7%)             1/60 (2%)             6/60 (10%)                  |
|ADJUSTED (b)           |            5.6%                 12.7%                  4.3%                 37.3%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              0/7 (0%)              0/8 (0%)                    |
|TERMINAL (d)           |           2/36 (6%)             2/27 (7%)             1/23 (4%)             1/5 (20%)                   |
|FIRST INCIDENCE (DAYS) |            738 (T)               683                   738 (T)               516                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |           P=0.002 **            P=0.238               P=0.655N              P=0.004 **                  |
|INCIDENTAL TUMOR       |           P=0.117               P=0.356               P=0.655N              P=0.152                     |
|LOGISTIC REGRESSION    |           P=0.052               P=0.305               P=0.655N              P=0.092                     |
|COCHRAN-ARMITAGE       |           P=0.114                                                                                       |
|FISHER EXACT           |                                 P=0.340               P=0.500N              P=0.136                     |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibrosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |             #                     #                     #                     #                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           0/60 (0%)             0/60 (0%)             0/60 (0%)             2/60 (3%)                   |
|ADJUSTED (b)           |            0.0%                  0.0%                  0.0%                 14.4%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              0/7 (0%)              0/8 (0%)                    |
|TERMINAL (d)           |           0/36 (0%)             0/27 (0%)             0/23 (0%)             0/5 (0%)                    |
|FIRST INCIDENCE (DAYS) |            ---                   ---                   ---                   516                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |           P=0.014 *               (e)                   (e)                 P=0.096                     |
|INCIDENTAL TUMOR       |           P=0.109                 (e)                   (e)                 P=0.449                     |
|LOGISTIC REGRESSION    |           P=0.053                 (e)                   (e)                 P=0.249                     |
|COCHRAN-ARMITAGE       |           P=0.046 *                                                                                     |
|FISHER EXACT           |                                   (e)                   (e)                 P=0.248                     |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  63
                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |            UNTREATD              0.25%                 0.50%                 1.00%                      |
|                       |            CONTROL                                                                                      |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |             #                     #                     #                     #                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           1/60 (2%)             0/60 (0%)             0/60 (0%)             4/60 (7%)                   |
|ADJUSTED (b)           |            2.8%                  0.0%                  0.0%                 19.7%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              0/7 (0%)              0/8 (0%)                    |
|TERMINAL (d)           |           1/36 (3%)             0/27 (0%)             0/23 (0%)             0/5 (0%)                    |
|FIRST INCIDENCE (DAYS) |            738 (T)               ---                   ---                   516                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |           P=0.003 **            P=0.557N              P=0.589N              P=0.030 *                   |
|INCIDENTAL TUMOR       |           P=0.120               P=0.557N              P=0.589N              P=0.427                     |
|LOGISTIC REGRESSION    |           P=0.028 *             P=0.557N              P=0.589N              P=0.167                     |
|COCHRAN-ARMITAGE       |           P=0.028 *                                                                                     |
|FISHER EXACT           |                                 P=0.500N              P=0.500N              P=0.182                     |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Keratoacanthoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |             #                     #                     #                     #                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           0/60 (0%)             0/60 (0%)             2/60 (3%)             0/60 (0%)                   |
|ADJUSTED (b)           |            0.0%                  0.0%                  7.2%                  0.0%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              0/7 (0%)              0/8 (0%)                    |
|TERMINAL (d)           |           0/36 (0%)             0/27 (0%)             1/23 (4%)             0/5 (0%)                    |
|FIRST INCIDENCE (DAYS) |            ---                   ---                   683                   ---                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |           P=0.341                 (e)                 P=0.166                 (e)                       |
|INCIDENTAL TUMOR       |           P=0.515                 (e)                 P=0.252                 (e)                       |
|LOGISTIC REGRESSION    |           P=0.482                 (e)                 P=0.209                 (e)                       |
|COCHRAN-ARMITAGE       |           P=0.595                                                                                       |
|FISHER EXACT           |                                   (e)                 P=0.248                 (e)                       |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  64
                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |            UNTREATD              0.25%                 0.50%                 1.00%                      |
|                       |            CONTROL                                                                                      |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Lipoma                                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |             #                     #                     #                     #                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           0/60 (0%)             2/60 (3%)             0/60 (0%)             0/60 (0%)                   |
|ADJUSTED (b)           |            0.0%                  6.0%                  0.0%                  0.0%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              0/7 (0%)              0/8 (0%)                    |
|TERMINAL (d)           |           0/36 (0%)             1/27 (4%)             0/23 (0%)             0/5 (0%)                    |
|FIRST INCIDENCE (DAYS) |            ---                   683                   ---                   ---                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |           P=0.659N              P=0.204                 (e)                   (e)                       |
|INCIDENTAL TUMOR       |           P=0.485N              P=0.282                 (e)                   (e)                       |
|LOGISTIC REGRESSION    |           P=0.518N              P=0.231                 (e)                   (e)                       |
|COCHRAN-ARMITAGE       |           P=0.405N                                                                                      |
|FISHER EXACT           |                                 P=0.248                 (e)                   (e)                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Sarcoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |             #                     #                     #                     #                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           1/60 (2%)             0/60 (0%)             0/60 (0%)             2/60 (3%)                   |
|ADJUSTED (b)           |            2.8%                  0.0%                  0.0%                  6.2%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              0/7 (0%)              0/8 (0%)                    |
|TERMINAL (d)           |           1/36 (3%)             0/27 (0%)             0/23 (0%)             0/5 (0%)                    |
|FIRST INCIDENCE (DAYS) |            738 (T)               ---                   ---                   585                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |           P=0.103               P=0.557N              P=0.589N              P=0.238                     |
|INCIDENTAL TUMOR       |           P=0.516               P=0.557N              P=0.589N              P=0.796                     |
|LOGISTIC REGRESSION    |           P=0.234               P=0.557N              P=0.589N              P=0.470                     |
|COCHRAN-ARMITAGE       |           P=0.246                                                                                       |
|FISHER EXACT           |                                 P=0.500N              P=0.500N              P=0.500                     |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  65
                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |            UNTREATD              0.25%                 0.50%                 1.00%                      |
|                       |            CONTROL                                                                                      |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Schwannoma Malignant                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |             #                     #                     #                     #                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           0/60 (0%)             0/60 (0%)             0/60 (0%)             0/60 (0%)                   |
|ADJUSTED (b)           |            0.0%                  0.0%                  0.0%                  0.0%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              0/7 (0%)              0/8 (0%)                    |
|TERMINAL (d)           |           0/36 (0%)             0/27 (0%)             0/23 (0%)             0/5 (0%)                    |
|FIRST INCIDENCE (DAYS) |            ---                   ---                   ---                   ---                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |             (e)                   (e)                   (e)                   (e)                       |
|INCIDENTAL TUMOR       |             (e)                   (e)                   (e)                   (e)                       |
|LOGISTIC REGRESSION    |             (e)                   (e)                   (e)                   (e)                       |
|COCHRAN-ARMITAGE       |             (e)                                                                                         |
|FISHER EXACT           |                                   (e)                   (e)                   (e)                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Carcinoma, Basal Cell Carcinoma, Basosquamous Tumor                                                           |
|     (malignant or NOS), or Carcinoma                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |             #                     #                     #                     #                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           0/60 (0%)             1/60 (2%)             0/60 (0%)             0/60 (0%)                   |
|ADJUSTED (b)           |            0.0%                  2.9%                  0.0%                  0.0%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              0/7 (0%)              0/8 (0%)                    |
|TERMINAL (d)           |           0/36 (0%)             0/27 (0%)             0/23 (0%)             0/5 (0%)                    |
|FIRST INCIDENCE (DAYS) |            ---                   704                   ---                   ---                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |           P=0.762N              P=0.478                 (e)                   (e)                       |
|INCIDENTAL TUMOR       |           P=0.487N              P=0.649                 (e)                   (e)                       |
|LOGISTIC REGRESSION    |           P=0.647N              P=0.496                 (e)                   (e)                       |
|COCHRAN-ARMITAGE       |           P=0.567N                                                                                      |
|FISHER EXACT           |                                 P=0.500                 (e)                   (e)                       |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  66
                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |            UNTREATD              0.25%                 0.50%                 1.00%                      |
|                       |            CONTROL                                                                                      |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |             #                     #                     #                     #                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           3/60 (5%)             0/60 (0%)             1/60 (2%)             0/60 (0%)                   |
|ADJUSTED (b)           |            7.8%                  0.0%                  2.9%                  0.0%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              0/7 (0%)              0/8 (0%)                    |
|TERMINAL (d)           |           2/36 (6%)             0/27 (0%)             0/23 (0%)             0/5 (0%)                    |
|FIRST INCIDENCE (DAYS) |            690                   ---                   683                   ---                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |           P=0.250N              P=0.165N              P=0.439N              P=0.525N                    |
|INCIDENTAL TUMOR       |           P=0.107N              P=0.108N              P=0.268N              P=0.252N                    |
|LOGISTIC REGRESSION    |           P=0.136N              P=0.129N              P=0.350N              P=0.298N                    |
|COCHRAN-ARMITAGE       |           P=0.086N                                                                                      |
|FISHER EXACT           |                                 P=0.122N              P=0.309N              P=0.122N                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |             #                     #                     #                     #                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           3/60 (5%)             1/60 (2%)             2/60 (3%)             0/60 (0%)                   |
|ADJUSTED (b)           |            7.8%                  2.9%                  7.2%                  0.0%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              0/7 (0%)              0/8 (0%)                    |
|TERMINAL (d)           |           2/36 (6%)             0/27 (0%)             1/23 (4%)             0/5 (0%)                    |
|FIRST INCIDENCE (DAYS) |            690                   704                   683                   ---                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |           P=0.396N              P=0.379N              P=0.664N              P=0.525N                    |
|INCIDENTAL TUMOR       |           P=0.148N              P=0.226N              P=0.509N              P=0.252N                    |
|LOGISTIC REGRESSION    |           P=0.204N              P=0.319N              P=0.570N              P=0.298N                    |
|COCHRAN-ARMITAGE       |           P=0.104N                                                                                      |
|FISHER EXACT           |                                 P=0.309N              P=0.500N              P=0.122N                    |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  67
                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |            UNTREATD              0.25%                 0.50%                 1.00%                      |
|                       |            CONTROL                                                                                      |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma, Papilloma, or Keratoacanthoma                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |             #                     #                     #                     #                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           3/60 (5%)             0/60 (0%)             2/60 (3%)             0/60 (0%)                   |
|ADJUSTED (b)           |            7.8%                  0.0%                  7.2%                  0.0%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              0/7 (0%)              0/8 (0%)                    |
|TERMINAL (d)           |           2/36 (6%)             0/27 (0%)             1/23 (4%)             0/5 (0%)                    |
|FIRST INCIDENCE (DAYS) |            690                   ---                   683                   ---                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |           P=0.411N              P=0.165N              P=0.664N              P=0.525N                    |
|INCIDENTAL TUMOR       |           P=0.214N              P=0.108N              P=0.509N              P=0.252N                    |
|LOGISTIC REGRESSION    |           P=0.235N              P=0.129N              P=0.570N              P=0.298N                    |
|COCHRAN-ARMITAGE       |           P=0.126N                                                                                      |
|FISHER EXACT           |                                 P=0.122N              P=0.500N              P=0.122N                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Sebaceous Gland                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |             #                     #                     #                     #                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           0/60 (0%)             0/60 (0%)             0/60 (0%)             0/60 (0%)                   |
|ADJUSTED (b)           |            0.0%                  0.0%                  0.0%                  0.0%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              0/7 (0%)              0/8 (0%)                    |
|TERMINAL (d)           |           0/36 (0%)             0/27 (0%)             0/23 (0%)             0/5 (0%)                    |
|FIRST INCIDENCE (DAYS) |            ---                   ---                   ---                   ---                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |             (e)                   (e)                   (e)                   (e)                       |
|INCIDENTAL TUMOR       |             (e)                   (e)                   (e)                   (e)                       |
|LOGISTIC REGRESSION    |             (e)                   (e)                   (e)                   (e)                       |
|COCHRAN-ARMITAGE       |             (e)                                                                                         |
|FISHER EXACT           |                                   (e)                   (e)                   (e)                       |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  68
                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |            UNTREATD              0.25%                 0.50%                 1.00%                      |
|                       |            CONTROL                                                                                      |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |             #                     #                     #                     #                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           0/60 (0%)             0/60 (0%)             0/60 (0%)             1/60 (2%)                   |
|ADJUSTED (b)           |            0.0%                  0.0%                  0.0%                 20.0%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              0/7 (0%)              0/8 (0%)                    |
|TERMINAL (d)           |           0/36 (0%)             0/27 (0%)             0/23 (0%)             1/5 (20%)                   |
|FIRST INCIDENCE (DAYS) |            ---                   ---                   ---                   738 (T)                    |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |           P=0.032 *               (e)                   (e)                 P=0.124                     |
|INCIDENTAL TUMOR       |           P=0.032 *               (e)                   (e)                 P=0.124                     |
|LOGISTIC REGRESSION    |           P=0.032 *               (e)                   (e)                 P=0.124                     |
|COCHRAN-ARMITAGE       |           P=0.199                                                                                       |
|FISHER EXACT           |                                   (e)                   (e)                 P=0.500                     |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |                                                                                                         |
|ADJUSTED (b)           |                                                                                                         |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|                                                                                                         |
|TERMINAL (d)           |                                                                                                         |
|FIRST INCIDENCE (DAYS) |                                                                                                         |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |                                                                                                         |
|INCIDENTAL TUMOR       |                                                                                                         |
|LOGISTIC REGRESSION    |                                                                                                         |
|COCHRAN-ARMITAGE       |                                                                                                         |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  69
                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |            UNTREATD              0.25%                 0.50%                 1.00%                      |
|                       |            CONTROL                                                                                      |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           6/60 (10%)            5/60 (8%)             7/60 (12%)            4/60 (7%)                   |
|ADJUSTED (b)           |           15.0%                 15.2%                 19.6%                 44.5%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              2/7 (29%)             0/8 (0%)                    |
|TERMINAL (d)           |           4/36 (11%)            3/27 (11%)            3/23 (13%)            2/5 (40%)                   |
|FIRST INCIDENCE (DAYS) |            633                   645                   456 (I)               594                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |           P=0.113               P=0.613               P=0.271               P=0.117                     |
|INCIDENTAL TUMOR       |           P=0.560N              P=0.491N              P=0.483               P=0.653                     |
|LOGISTIC REGRESSION    |           P=0.449N              P=0.519N              P=0.509               P=0.570                     |
|COCHRAN-ARMITAGE       |           P=0.353N                                                                                      |
|FISHER EXACT           |                                 P=0.500N              P=0.500               P=0.372N                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           2/60 (3%)             3/60 (5%)             0/60 (0%)             0/60 (0%)                   |
|ADJUSTED (b)           |            5.6%                 10.3%                  0.0%                  0.0%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              0/7 (0%)              0/8 (0%)                    |
|TERMINAL (d)           |           2/36 (6%)             2/27 (7%)             0/23 (0%)             0/5 (0%)                    |
|FIRST INCIDENCE (DAYS) |            738 (T)               722                   ---                   ---                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |           P=0.304N              P=0.384               P=0.341N              P=0.712N                    |
|INCIDENTAL TUMOR       |           P=0.201N              P=0.460               P=0.341N              P=0.712N                    |
|LOGISTIC REGRESSION    |           P=0.252N              P=0.426               P=0.341N              P=0.712N                    |
|COCHRAN-ARMITAGE       |           P=0.073N                                                                                      |
|FISHER EXACT           |                                 P=0.500               P=0.248N              P=0.248N                    |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  70
                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |            UNTREATD              0.25%                 0.50%                 1.00%                      |
|                       |            CONTROL                                                                                      |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           8/60 (13%)            8/60 (13%)            7/60 (12%)            4/60 (7%)                   |
|ADJUSTED (b)           |           20.3%                 24.7%                 19.6%                 44.5%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              2/7 (29%)             0/8 (0%)                    |
|TERMINAL (d)           |           6/36 (17%)            5/27 (19%)            3/23 (13%)            2/5 (40%)                   |
|FIRST INCIDENCE (DAYS) |            633                   645                   456 (I)               594                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |           P=0.225               P=0.423               P=0.441               P=0.173                     |
|INCIDENTAL TUMOR       |           P=0.353N              P=0.593               P=0.566N              P=0.616N                    |
|LOGISTIC REGRESSION    |           P=0.235N              P=0.576               P=0.505N              P=0.574N                    |
|COCHRAN-ARMITAGE       |           P=0.127N                                                                                      |
|FISHER EXACT           |                                 P=0.605N              P=0.500N              P=0.181N                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           0/60 (0%)             0/60 (0%)             2/60 (3%)             4/60 (7%)                   |
|ADJUSTED (b)           |            0.0%                  0.0%                  6.3%                 36.5%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              0/7 (0%)              1/8 (13%)                   |
|TERMINAL (d)           |           0/36 (0%)             0/27 (0%)             1/23 (4%)             1/5 (20%)                   |
|FIRST INCIDENCE (DAYS) |            ---                   ---                   508                   456 (I)                    |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |           P<0.001 **              (e)                 P=0.193               P=0.001 **                  |
|INCIDENTAL TUMOR       |           P=0.004 **              (e)                 P=0.240               P=0.038 *                   |
|LOGISTIC REGRESSION    |           P=0.008 **              (e)                 P=0.247               P=0.045 *                   |
|COCHRAN-ARMITAGE       |           P=0.009 **                                                                                    |
|FISHER EXACT           |                                   (e)                 P=0.248               P=0.059                     |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  71
                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |            UNTREATD              0.25%                 0.50%                 1.00%                      |
|                       |            CONTROL                                                                                      |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           0/60 (0%)             0/60 (0%)             0/60 (0%)             1/60 (2%)                   |
|ADJUSTED (b)           |            0.0%                  0.0%                  0.0%                 20.0%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              0/7 (0%)              0/8 (0%)                    |
|TERMINAL (d)           |           0/36 (0%)             0/27 (0%)             0/23 (0%)             1/5 (20%)                   |
|FIRST INCIDENCE (DAYS) |            ---                   ---                   ---                   738 (T)                    |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |           P=0.032 *               (e)                   (e)                 P=0.124                     |
|INCIDENTAL TUMOR       |           P=0.032 *               (e)                   (e)                 P=0.124                     |
|LOGISTIC REGRESSION    |           P=0.032 *               (e)                   (e)                 P=0.124                     |
|COCHRAN-ARMITAGE       |           P=0.199                                                                                       |
|FISHER EXACT           |                                   (e)                   (e)                 P=0.500                     |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           0/60 (0%)             0/60 (0%)             2/60 (3%)             5/60 (8%)                   |
|ADJUSTED (b)           |            0.0%                  0.0%                  6.3%                 52.4%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              0/7 (0%)              1/8 (13%)                   |
|TERMINAL (d)           |           0/36 (0%)             0/27 (0%)             1/23 (4%)             2/5 (40%)                   |
|FIRST INCIDENCE (DAYS) |            ---                   ---                   508                   456 (I)                    |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |           P<0.001 **              (e)                 P=0.193               P<0.001 **                  |
|INCIDENTAL TUMOR       |           P<0.001 **              (e)                 P=0.240               P=0.005 **                  |
|LOGISTIC REGRESSION    |           P=0.002 **              (e)                 P=0.247               P=0.002 **                  |
|COCHRAN-ARMITAGE       |           P=0.003 **                                                                                    |
|FISHER EXACT           |                                   (e)                 P=0.248               P=0.029 *                   |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  72
                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |            UNTREATD              0.25%                 0.50%                 1.00%                      |
|                       |            CONTROL                                                                                      |
|=================================================================================================================================|
|                                                                                                                                 |
|Tongue                                                                                                                           |
|     Squamous Cell Carcinoma or Papilloma Squamous                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |             #                     #                     #                     #                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           1/60 (2%)             2/60 (3%)             4/60 (7%)             5/60 (8%)                   |
|ADJUSTED (b)           |            2.8%                  7.4%                 11.5%                 31.8%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              0/7 (0%)              0/8 (0%)                    |
|TERMINAL (d)           |           1/36 (3%)             2/27 (7%)             1/23 (4%)             1/5 (20%)                   |
|FIRST INCIDENCE (DAYS) |            738 (T)               738 (T)               627                   577                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |           P<0.001 **            P=0.400               P=0.116               P=0.005 **                  |
|INCIDENTAL TUMOR       |           P=0.090               P=0.400               P=0.276               P=0.146                     |
|LOGISTIC REGRESSION    |           P=0.021 *             P=0.400               P=0.162               P=0.057                     |
|COCHRAN-ARMITAGE       |           P=0.055                                                                                       |
|FISHER EXACT           |                                 P=0.500               P=0.182               P=0.103                     |
|=================================================================================================================================|
|                                                                                                                                 |
|Tongue                                                                                                                           |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |             #                     #                     #                     #                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           1/60 (2%)             2/60 (3%)             4/60 (7%)             4/60 (7%)                   |
|ADJUSTED (b)           |            2.8%                  7.4%                 11.5%                 29.3%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              0/7 (0%)              0/8 (0%)                    |
|TERMINAL (d)           |           1/36 (3%)             2/27 (7%)             1/23 (4%)             1/5 (20%)                   |
|FIRST INCIDENCE (DAYS) |            738 (T)               738 (T)               627                   577                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |           P=0.003 **            P=0.400               P=0.116               P=0.012 *                   |
|INCIDENTAL TUMOR       |           P=0.124               P=0.400               P=0.276               P=0.162                     |
|LOGISTIC REGRESSION    |           P=0.049 *             P=0.400               P=0.162               P=0.102                     |
|COCHRAN-ARMITAGE       |           P=0.115                                                                                       |
|FISHER EXACT           |                                 P=0.500               P=0.182               P=0.182                     |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  73
                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |            UNTREATD              0.25%                 0.50%                 1.00%                      |
|                       |            CONTROL                                                                                      |
|=================================================================================================================================|
|                                                                                                                                 |
|Urinary Bladder                                                                                                                  |
|     Papilloma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           0/60 (0%)             1/60 (2%)             0/60 (0%)             0/60 (0%)                   |
|ADJUSTED (b)           |            0.0%                  3.7%                  0.0%                  0.0%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              0/7 (0%)              0/8 (0%)                    |
|TERMINAL (d)           |           0/36 (0%)             1/27 (4%)             0/23 (0%)             0/5 (0%)                    |
|FIRST INCIDENCE (DAYS) |            ---                   738 (T)               ---                   ---                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |           P=0.820N              P=0.443                 (e)                   (e)                       |
|INCIDENTAL TUMOR       |           P=0.820N              P=0.443                 (e)                   (e)                       |
|LOGISTIC REGRESSION    |           P=0.820N              P=0.443                 (e)                   (e)                       |
|COCHRAN-ARMITAGE       |           P=0.567N                                                                                      |
|FISHER EXACT           |                                 P=0.500                 (e)                   (e)                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |             #                     #                     #                     #                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           5/60 (8%)             8/60 (13%)            7/60 (12%)            7/60 (12%)                  |
|ADJUSTED (b)           |           13.2%                 25.0%                 22.0%                 39.5%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              1/7 (14%)             1/8 (13%)                   |
|TERMINAL (d)           |           4/36 (11%)            5/27 (19%)            3/23 (13%)            1/5 (20%)                   |
|FIRST INCIDENCE (DAYS) |            690                   684                   456 (I)               369                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |           P=0.003 **            P=0.155               P=0.166               P=0.008 **                  |
|INCIDENTAL TUMOR       |           P=0.184               P=0.286               P=0.320               P=0.259                     |
|LOGISTIC REGRESSION    |           P=0.244               P=0.237               P=0.328               P=0.116                     |
|COCHRAN-ARMITAGE       |           P=0.405                                                                                       |
|FISHER EXACT           |                                 P=0.279               P=0.381               P=0.381                     |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  74
                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |            UNTREATD              0.25%                 0.50%                 1.00%                      |
|                       |            CONTROL                                                                                      |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal or Polyp Stromal                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |             #                     #                     #                     #                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           5/60 (8%)             9/60 (15%)            7/60 (12%)            7/60 (12%)                  |
|ADJUSTED (b)           |           13.2%                 28.4%                 22.0%                 39.5%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              1/7 (14%)             1/8 (13%)                   |
|TERMINAL (d)           |           4/36 (11%)            6/27 (22%)            3/23 (13%)            1/5 (20%)                   |
|FIRST INCIDENCE (DAYS) |            690                   684                   456 (I)               369                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |           P=0.004 **            P=0.095               P=0.166               P=0.008 **                  |
|INCIDENTAL TUMOR       |           P=0.188               P=0.188               P=0.320               P=0.259                     |
|LOGISTIC REGRESSION    |           P=0.265               P=0.158               P=0.328               P=0.116                     |
|COCHRAN-ARMITAGE       |           P=0.446                                                                                       |
|FISHER EXACT           |                                 P=0.197               P=0.381               P=0.381                     |
|=================================================================================================================================|
|                                                                                                                                 |
|Zymbal's Gland                                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |             #                     #                     #                     #                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           0/60 (0%)             1/60 (2%)             0/60 (0%)             0/60 (0%)                   |
|ADJUSTED (b)           |            0.0%                  3.7%                  0.0%                  0.0%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              0/7 (0%)              0/8 (0%)                    |
|TERMINAL (d)           |           0/36 (0%)             1/27 (4%)             0/23 (0%)             0/5 (0%)                    |
|FIRST INCIDENCE (DAYS) |            ---                   738 (T)               ---                   ---                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |           P=0.820N              P=0.443                 (e)                   (e)                       |
|INCIDENTAL TUMOR       |           P=0.820N              P=0.443                 (e)                   (e)                       |
|LOGISTIC REGRESSION    |           P=0.820N              P=0.443                 (e)                   (e)                       |
|COCHRAN-ARMITAGE       |           P=0.567N                                                                                      |
|FISHER EXACT           |                                 P=0.500                 (e)                   (e)                       |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  75
                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |            UNTREATD              0.25%                 0.50%                 1.00%                      |
|                       |            CONTROL                                                                                      |
|=================================================================================================================================|
|                                                                                                                                 |
|Zymbal's Gland                                                                                                                   |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |             #                     #                     #                     #                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           0/60 (0%)             0/60 (0%)             2/60 (3%)             1/60 (2%)                   |
|ADJUSTED (b)           |            0.0%                  0.0%                  6.3%                  2.4%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              0/7 (0%)              0/8 (0%)                    |
|TERMINAL (d)           |           0/36 (0%)             0/27 (0%)             1/23 (4%)             0/5 (0%)                    |
|FIRST INCIDENCE (DAYS) |            ---                   ---                   481                   577                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |           P=0.136                 (e)                 P=0.193               P=0.478                     |
|INCIDENTAL TUMOR       |           P=0.400                 (e)                 P=0.240               P=0.916                     |
|LOGISTIC REGRESSION    |           P=0.291                 (e)                 P=0.250               P=0.547                     |
|COCHRAN-ARMITAGE       |           P=0.246                                                                                       |
|FISHER EXACT           |                                   (e)                 P=0.248               P=0.500                     |
|=================================================================================================================================|
|                                                                                                                                 |
|Zymbal's Gland                                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |             #                     #                     #                     #                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           0/60 (0%)             1/60 (2%)             2/60 (3%)             1/60 (2%)                   |
|ADJUSTED (b)           |            0.0%                  3.7%                  6.3%                  2.4%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              0/7 (0%)              0/8 (0%)                    |
|TERMINAL (d)           |           0/36 (0%)             1/27 (4%)             1/23 (4%)             0/5 (0%)                    |
|FIRST INCIDENCE (DAYS) |            ---                   738 (T)               481                   577                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |           P=0.161               P=0.443               P=0.193               P=0.478                     |
|INCIDENTAL TUMOR       |           P=0.412               P=0.443               P=0.240               P=0.916                     |
|LOGISTIC REGRESSION    |           P=0.385               P=0.443               P=0.250               P=0.547                     |
|COCHRAN-ARMITAGE       |           P=0.367                                                                                       |
|FISHER EXACT           |                                 P=0.500               P=0.248               P=0.500                     |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  76
                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |            UNTREATD              0.25%                 0.50%                 1.00%                      |
|                       |            CONTROL                                                                                      |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma or Hemangioma                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |             #                     #                     #                     #                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           0/60 (0%)             0/60 (0%)             1/60 (2%)             1/60 (2%)                   |
|ADJUSTED (b)           |            0.0%                  0.0%                  3.0%                  2.7%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              0/7 (0%)              0/8 (0%)                    |
|TERMINAL (d)           |           0/36 (0%)             0/27 (0%)             0/23 (0%)             0/5 (0%)                    |
|FIRST INCIDENCE (DAYS) |            ---                   ---                   694                   594                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |           P=0.121                 (e)                 P=0.452               P=0.452                     |
|INCIDENTAL TUMOR       |           P=0.516                 (e)                 P=0.627               P=0.916                     |
|LOGISTIC REGRESSION    |           P=0.234                 (e)                 P=0.486               P=0.537                     |
|COCHRAN-ARMITAGE       |           P=0.236                                                                                       |
|FISHER EXACT           |                                   (e)                 P=0.500               P=0.500                     |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |             #                     #                     #                     #                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |          15/60 (25%)           13/60 (22%)           19/60 (32%)           19/60 (32%)                  |
|ADJUSTED (b)           |           35.6%                 32.5%                 47.2%                 75.2%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              0/7 (0%)              0/8 (0%)                    |
|TERMINAL (d)           |           9/36 (25%)            4/27 (15%)            5/23 (22%)            2/5 (40%)                   |
|FIRST INCIDENCE (DAYS) |            654                   609                   409                   540                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |           P<0.001 **            P=0.546               P=0.066               P<0.001 **                  |
|INCIDENTAL TUMOR       |           P=0.486               P=0.162N              P=0.569               P=0.507                     |
|LOGISTIC REGRESSION    |           P=0.390               P=0.443N              P=0.221               P=0.441                     |
|COCHRAN-ARMITAGE       |           P=0.152                                                                                       |
|FISHER EXACT           |                                 P=0.415N              P=0.272               P=0.272                     |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  77
                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |            UNTREATD              0.25%                 0.50%                 1.00%                      |
|                       |            CONTROL                                                                                      |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Mesothelioma: Benign, Malignant, NOS                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |             #                     #                     #                     #                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |           0/60 (0%)             0/60 (0%)             0/60 (0%)             0/60 (0%)                   |
|ADJUSTED (b)           |            0.0%                  0.0%                  0.0%                  0.0%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              0/7 (0%)              0/8 (0%)                    |
|TERMINAL (d)           |           0/36 (0%)             0/27 (0%)             0/23 (0%)             0/5 (0%)                    |
|FIRST INCIDENCE (DAYS) |            ---                   ---                   ---                   ---                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |             (e)                   (e)                   (e)                   (e)                       |
|INCIDENTAL TUMOR       |             (e)                   (e)                   (e)                   (e)                       |
|LOGISTIC REGRESSION    |             (e)                   (e)                   (e)                   (e)                       |
|COCHRAN-ARMITAGE       |             (e)                                                                                         |
|FISHER EXACT           |                                   (e)                   (e)                   (e)                       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |             #                     #                     #                     #                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |          41/60 (68%)           50/60 (83%)           52/60 (87%)           53/60 (88%)                  |
|ADJUSTED (b)           |           85.2%                 98.0%                100.0%                100.0%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           1/10 (10%)            1/9 (11%)             3/7 (43%)             5/8 (63%)                   |
|TERMINAL (d)           |          29/36 (81%)           26/27 (96%)           23/23 (100%)           5/5 (100%)                  |
|FIRST INCIDENCE (DAYS) |            456 (I)               456 (I)               456 (I)               369                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |           P<0.001 **            P=0.004 **            P<0.001 **            P<0.001 **                  |
|INCIDENTAL TUMOR       |           P<0.001 **            P=0.028 *             P=0.012 *             P=0.012 *                   |
|LOGISTIC REGRESSION    |           P<0.001 **            P=0.021 *             P=0.001 **            P<0.001 **                  |
|COCHRAN-ARMITAGE       |           P=0.007 **                                                                                    |
|FISHER EXACT           |                                 P=0.043 *             P=0.014 *             P=0.007 **                  |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  78
                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE                   |            UNTREATD              0.25%                 0.50%                 1.00%                      |
|                       |            CONTROL                                                                                      |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |             #                     #                     #                     #                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |          21/60 (35%)           22/60 (37%)           27/60 (45%)           31/60 (52%)                  |
|ADJUSTED (b)           |           46.4%                 54.0%                 59.5%                 89.7%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           0/10 (0%)             0/9 (0%)              0/7 (0%)              0/8 (0%)                    |
|TERMINAL (d)           |          12/36 (33%)           10/27 (37%)            7/23 (30%)            3/5 (60%)                   |
|FIRST INCIDENCE (DAYS) |            481                   404                   388                   432                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |           P<0.001 **            P=0.256               P=0.032 *             P<0.001 **                  |
|INCIDENTAL TUMOR       |           P=0.212               P=0.424N              P=0.549               P=0.345                     |
|LOGISTIC REGRESSION    |           P=0.080               P=0.562N              P=0.149               P=0.202                     |
|COCHRAN-ARMITAGE       |           P=0.025 *                                                                                     |
|FISHER EXACT           |                                 P=0.500               P=0.176               P=0.048 *                   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |             #                     #                     #                     #                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |          46/60 (77%)           52/60 (87%)           56/60 (93%)           57/60 (95%)                  |
|ADJUSTED (b)           |           90.2%                100.0%                100.0%                100.0%                       |
|INTERIM SACRIFICE 1 (c)|                                                                                                         |
|INTERIM SACRIFICE 2 (c)|           1/10 (10%)            1/9 (11%)             3/7 (43%)             5/8 (63%)                   |
|TERMINAL (d)           |          31/36 (86%)           27/27 (100%)          23/23 (100%)           5/5 (100%)                  |
|FIRST INCIDENCE (DAYS) |            456 (I)               404                   388                   369                        |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |           P<0.001 **            P=0.014 *             P<0.001 **            P<0.001 **                  |
|INCIDENTAL TUMOR       |           P<0.001 **            P=0.091               P=0.021 *             P=0.024 *                   |
|LOGISTIC REGRESSION    |           P<0.001 **            P=0.063               P=0.002 **            P<0.001 **                  |
|COCHRAN-ARMITAGE       |           P=0.002 **                                                                                    |
|FISHER EXACT           |                                 P=0.119               P=0.010 **            P=0.004 **                  |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 05                                                 PAGE  79
                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                       TERMINAL SACRIFICE AT 106 WEEKS
 (a)  Number of tumor-bearing animals / number of animals examined at site.
 (b)  Kaplan-Meier estimated lifetime tumor incidence after adjustment for 
      intercurrent mortality.
 (c)  Observed incidence at interim kill.
          Male interim sacrifices(days):   92  456
          Female interim sacrifices(days): 456
 (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).