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TDMS Study 05103-04 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: 04                                                                                     TIME: 19:23:07       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-85234                              ROUTE: DOSED FEED                                              NTP C#: 55516C       
PATHOLOGIST: DR J. HEATH                     LEININGER, JOEL                                                   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: 04                                                                                     TIME: 19:23:07       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-85234                              ROUTE: DOSED FEED                                              NTP C#: 55516C       
PATHOLOGIST: DR J. HEATH                     LEININGER, JOEL                                                   CAS: 3296-90-0       
                                                    MICE(B6C3F1)
                                              ----------------------------
             FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
             IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
                                                    ----------------
                                                    Adrenal Cortex
                                                    Adrenal Medulla
                                                    Bone Marrow
                                                    Brain
                                                    Clitoral Gland
                                                    Epididymis
                                                    Gallbladder
                                                    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: 04                                                                                     TIME: 19:23:07       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-85234                              ROUTE: DOSED FEED                                              NTP C#: 55516C       
PATHOLOGIST: DR J. HEATH                     LEININGER, JOEL                                                   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 MICE
                                                          -------------
                  ORGAN                               MORPHOLOGY
                 -------                             ------------
              Harderian Gland               Adenoma
                                            Carcinoma
                                            Carcinoma or Adenoma
              Intestine Small: Jejunum      Carcinoma
              Lung                          Alveolar/Bronchiolar Adenoma
                                            Alveolar/Bronchiolar Carcinoma
                                            Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
              Stomach, Forestomach          Squamous Cell Carcinoma
                                            Squamous Cell Carcinoma or Papilloma Squamous
              Thyroid Gland: Follicular Cell
                                            Adenoma
              All Organs                    Benign Tumors
                                            Malignant Tumors
                                            Malignant and Benign Tumors
              ====================================================================================================
                                                           FEMALE MICE
                                                          -------------
                  ORGAN                               MORPHOLOGY
                 -------                             ------------
              Harderian Gland               Adenoma
                                            Carcinoma
                                            Carcinoma or Adenoma
              Liver                         Hepatocellular Adenoma
                                            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
              Mammary Gland                 Carcinoma
              Skin                          Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma
                                            Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma
                                            Hemangiosarcoma
                                            Sarcoma
              Stomach, Forestomach          Squamous Cell Carcinoma or Papilloma Squamous
                                            Squamous Cell Papilloma
              Uterus                        Carcinoma
                                            Sarcoma Stromal
              All Organs                    Hemangiosarcoma
                                            Hemangiosarcoma or Hemangioma
                                            Malignant Lymphoma And Histiocytic Sarcoma
                                            Benign Tumors
                                            Malignant Tumors
                                            Malignant and Benign Tumors
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: 04                                                                                     TIME: 19:23:07       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-85234                              ROUTE: DOSED FEED                                              NTP C#: 55516C       
PATHOLOGIST: DR J. HEATH                     LEININGER, JOEL                                                   CAS: 3296-90-0       
              ====================================================================================================
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 04                                                 PAGE   1
                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                                                 MALE TERMINAL SACRIFICE AT 106 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 107 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.0312%      0.0625%      0.125%    |   UNTREATD     0.0312%      0.0625%      0.125%    |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/59 (0%)    2/59 (3%)    0/60 (0%)    0/59 (0%)  |  0/59 (0%)    1/60 (2%)    0/60 (0%)    0/59 (0%)  |
|ADJUSTED (b)           |   0.0%         5.7%         0.0%         0.0%      |   0.0%         3.3%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/10 (0%)  |  0/8 (0%)     0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  0/42 (0%)    2/35 (6%)    0/35 (0%)    0/30 (0%)  |  0/37 (0%)    1/30 (3%)    0/26 (0%)    0/11 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          736 (T)      ---          ---       |   ---          743 (T)      ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.467N     P=0.199        (e)          (e)      |  P=0.739N     P=0.458        (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.467N     P=0.199        (e)          (e)      |  P=0.739N     P=0.458        (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.467N     P=0.199        (e)          (e)      |  P=0.739N     P=0.458        (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.404N                                          |  P=0.568N                                          |
|FISHER EXACT           |               P=0.248        (e)          (e)      |               P=0.504        (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Bone Marrow                                                                                                                      |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/59 (0%)    2/60 (3%)    0/60 (0%)    0/59 (0%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    1/60 (2%)  |
|ADJUSTED (b)           |   0.0%         5.6%         0.0%         0.0%      |   0.0%         0.0%         0.0%         7.1%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/10 (0%)  |  0/8 (0%)     0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  0/42 (0%)    2/36 (6%)    0/35 (0%)    0/30 (0%)  |  0/37 (0%)    0/30 (0%)    0/26 (0%)    0/11 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          736 (T)      ---          ---       |   ---          ---          ---          677       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.468N     P=0.205        (e)          (e)      |  P=0.087        (e)          (e)        P=0.301    |
|INCIDENTAL TUMOR       |  P=0.468N     P=0.205        (e)          (e)      |  P=0.331        (e)          (e)        P=0.826    |
|LOGISTIC REGRESSION    |  P=0.468N     P=0.205        (e)          (e)      |  P=0.167        (e)          (e)        P=0.445    |
|COCHRAN-ARMITAGE       |  P=0.405N                                          |  P=0.198                                           |
|FISHER EXACT           |               P=0.252        (e)          (e)      |                 (e)          (e)        P=0.500    |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 04                                                 PAGE   2
                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                                                 MALE TERMINAL SACRIFICE AT 106 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 107 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.0312%      0.0625%      0.125%    |   UNTREATD     0.0312%      0.0625%      0.125%    |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/60 (5%)    6/60 (10%)  13/60 (22%)  21/59 (36%) |  3/60 (5%)    7/60 (12%)   8/60 (13%)  19/60 (32%) |
|ADJUSTED (b)           |   7.1%        15.6%        32.2%        50.3%      |   5.7%        19.1%        23.7%        58.9%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     1/10 (10%)   3/10 (30%) |  1/8 (13%)    1/10 (10%)   0/9 (0%)     4/10 (40%) |
|TERMINAL (d)           |  3/42 (7%)    4/36 (11%)   9/35 (26%)  11/30 (37%) |  0/37 (0%)    3/30 (10%)   4/26 (15%)   3/11 (27%) |
|FIRST INCIDENCE (DAYS) |   736 (T)      656          456 (I)      456 (I)   |   447          456 (I)      557          456 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.182      P=0.003 **   P<0.001 ** |  P<0.001 **   P=0.147      P=0.072      P<0.001 ** |
|INCIDENTAL TUMOR       |  P<0.001 **   P=0.290      P=0.011 *    P<0.001 ** |  P<0.001 **   P=0.262      P=0.096      P=0.002 ** |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.205      P=0.006 **   P<0.001 ** |  P<0.001 **   P=0.245      P=0.103      P<0.001 ** |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P<0.001 **                                        |
|FISHER EXACT           |               P=0.245      P=0.007 **   P<0.001 ** |               P=0.161      P=0.102      P<0.001 ** |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    1/60 (2%)    4/60 (7%)    4/59 (7%)  |  1/60 (2%)    6/60 (10%)   5/60 (8%)    7/60 (12%) |
|ADJUSTED (b)           |   2.3%         2.8%        10.1%        10.9%      |   2.5%        17.6%        16.1%        25.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/10 (0%)  |  0/8 (0%)     0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  0/42 (0%)    1/36 (3%)    2/35 (6%)    1/30 (3%)  |  0/37 (0%)    4/30 (13%)   3/26 (12%)   0/11 (0%)  |
|FIRST INCIDENCE (DAYS) |   674          736 (T)      666          589       |   646          627          669          575       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.047 *    P=0.732      P=0.153      P=0.127    |  P=0.002 **   P=0.043 *    P=0.073      P=0.007 ** |
|INCIDENTAL TUMOR       |  P=0.163      P=0.669N     P=0.460      P=0.487    |  P=0.088      P=0.067      P=0.224      P=0.395    |
|LOGISTIC REGRESSION    |  P=0.064      P=0.751      P=0.173      P=0.163    |  P=0.096      P=0.054      P=0.096      P=0.022 *  |
|COCHRAN-ARMITAGE       |  P=0.074                                           |  P=0.058                                           |
|FISHER EXACT           |               P=0.752N     P=0.182      P=0.177    |               P=0.057      P=0.103      P=0.031 *  |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 04                                                 PAGE   3
                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                                                 MALE TERMINAL SACRIFICE AT 106 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 107 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.0312%      0.0625%      0.125%    |   UNTREATD     0.0312%      0.0625%      0.125%    |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/60 (7%)    7/60 (12%)  17/60 (28%)  25/59 (42%) |  4/60 (7%)   13/60 (22%)  13/60 (22%)  23/60 (38%) |
|ADJUSTED (b)           |   9.3%        18.2%        40.4%        56.8%      |   8.1%        34.4%        37.5%        66.7%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     1/10 (10%)   3/10 (30%) |  1/8 (13%)    1/10 (10%)   0/9 (0%)     4/10 (40%) |
|TERMINAL (d)           |  3/42 (7%)    5/36 (14%)  11/35 (31%)  12/30 (40%) |  0/37 (0%)    7/30 (23%)   7/26 (27%)   3/11 (27%) |
|FIRST INCIDENCE (DAYS) |   674          656          456 (I)      456 (I)   |   447          456 (I)      557          456 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.194      P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.015 *    P=0.010 *    P<0.001 ** |
|INCIDENTAL TUMOR       |  P<0.001 **   P=0.354      P=0.007 **   P<0.001 ** |  P<0.001 **   P=0.037 *    P=0.035 *    P=0.004 ** |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.221      P=0.001 **   P<0.001 ** |  P<0.001 **   P=0.028 *    P=0.018 *    P=0.002 ** |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P<0.001 **                                        |
|FISHER EXACT           |               P=0.264      P=0.002 **   P<0.001 ** |               P=0.017 *    P=0.017 *    P<0.001 ** |
|=================================================================================================================================|
|                                                                                                                                 |
|Intestine Small: Jejunum                                                                                                         |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    0/60 (0%)    2/59 (3%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         5.9%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/10 (0%)  |  0/8 (0%)     0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  0/42 (0%)    0/36 (0%)    0/35 (0%)    1/30 (3%)  |  0/37 (0%)    0/30 (0%)    0/26 (0%)    0/11 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          669       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.035 *      (e)          (e)        P=0.188    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.056        (e)          (e)        P=0.336    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.040 *      (e)          (e)        P=0.214    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.045 *                                         |    (e)                                             |
|FISHER EXACT           |                 (e)          (e)        P=0.244    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 04                                                 PAGE   4
                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                                                 MALE TERMINAL SACRIFICE AT 106 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 107 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.0312%      0.0625%      0.125%    |   UNTREATD     0.0312%      0.0625%      0.125%    |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Intestine Small: Site Unspecified                                                                                                |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    1/60 (2%)    0/60 (0%)    2/59 (3%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         1.8%         0.0%         5.9%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    1/9 (11%)    0/10 (0%)    0/10 (0%)  |  0/8 (0%)     0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  0/42 (0%)    0/36 (0%)    0/35 (0%)    1/30 (3%)  |  0/37 (0%)    0/30 (0%)    0/26 (0%)    0/11 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          456 (I)      ---          669       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.122      P=0.479        (e)        P=0.188    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.170      P=0.479        (e)        P=0.336    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.139      P=0.592        (e)        P=0.214    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.137                                           |    (e)                                             |
|FISHER EXACT           |               P=0.500        (e)        P=0.244    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/59 (2%)    1/59 (2%)    1/59 (2%)    2/59 (3%)  |  1/59 (2%)    3/60 (5%)    2/58 (3%)    2/59 (3%)  |
|ADJUSTED (b)           |   2.4%         2.8%         2.9%         6.3%      |   2.1%        10.0%         6.4%        13.2%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/10 (0%)  |  0/8 (0%)     0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  1/42 (2%)    1/36 (3%)    1/35 (3%)    1/30 (3%)  |  0/37 (0%)    3/30 (10%)   0/26 (0%)    1/11 (9%)  |
|FIRST INCIDENCE (DAYS) |   736 (T)      736 (T)      736 (T)      705       |   569          743 (T)      707          669       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.260      P=0.727      P=0.721      P=0.392    |  P=0.164      P=0.252      P=0.456      P=0.274    |
|INCIDENTAL TUMOR       |  P=0.331      P=0.727      P=0.721      P=0.576    |  P=0.503      P=0.263      P=0.696N     P=0.585    |
|LOGISTIC REGRESSION    |  P=0.290      P=0.727      P=0.721      P=0.437    |  P=0.329      P=0.295      P=0.494      P=0.444    |
|COCHRAN-ARMITAGE       |  P=0.351                                           |  P=0.497                                           |
|FISHER EXACT           |               P=0.752N     P=0.752N     P=0.500    |               P=0.316      P=0.494      P=0.500    |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 04                                                 PAGE   5
                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                                                 MALE TERMINAL SACRIFICE AT 106 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 107 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.0312%      0.0625%      0.125%    |   UNTREATD     0.0312%      0.0625%      0.125%    |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney: Renal Tubule                                                                                                             |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/59 (0%)    0/60 (0%)    3/60 (5%)    2/59 (3%)  |  0/59 (0%)    0/60 (0%)    0/60 (0%)    0/59 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         8.0%         6.7%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/10 (0%)  |  0/8 (0%)     0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  0/42 (0%)    0/36 (0%)    2/35 (6%)    2/30 (7%)  |  0/37 (0%)    0/30 (0%)    0/26 (0%)    0/11 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          669          736 (T)   |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.060        (e)        P=0.100      P=0.168    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.082        (e)        P=0.170      P=0.168    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.073        (e)        P=0.113      P=0.168    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.096                                           |    (e)                                             |
|FISHER EXACT           |                 (e)        P=0.125      P=0.248    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/59 (2%)    2/60 (3%)    0/59 (0%)    2/59 (3%)  |  0/59 (0%)    0/60 (0%)    0/59 (0%)    0/59 (0%)  |
|ADJUSTED (b)           |   2.4%         5.6%         0.0%         6.7%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/10 (0%)  |  0/8 (0%)     0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  1/42 (2%)    2/36 (6%)    0/35 (0%)    2/30 (7%)  |  0/37 (0%)    0/30 (0%)    0/26 (0%)    0/11 (0%)  |
|FIRST INCIDENCE (DAYS) |   736 (T)      736 (T)      ---          736 (T)   |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.365      P=0.446      P=0.536N     P=0.383    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.365      P=0.446      P=0.536N     P=0.383    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.365      P=0.446      P=0.536N     P=0.383    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.468                                           |    (e)                                             |
|FISHER EXACT           |               P=0.506      P=0.500N     P=0.500    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 04                                                 PAGE   6
                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                                                 MALE TERMINAL SACRIFICE AT 106 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 107 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.0312%      0.0625%      0.125%    |   UNTREATD     0.0312%      0.0625%      0.125%    |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 22/59 (37%)  24/60 (40%)  20/59 (34%)  21/59 (36%) | 16/59 (27%)  12/60 (20%)   6/59 (10%)  17/59 (29%) |
|ADJUSTED (b)           |  44.8%        54.3%        48.9%        51.3%      |  39.4%        36.8%        19.4%        74.6%      |
|INTERIM SACRIFICE 1 (c)|  4/10 (40%)   4/9 (44%)    1/10 (10%)   2/10 (20%) |  0/8 (0%)     0/10 (0%)    1/9 (11%)    1/10 (10%) |
|TERMINAL (d)           | 16/42 (38%)  17/36 (47%)  15/35 (43%)  12/30 (40%) | 13/37 (35%)  10/30 (33%)   4/26 (15%)   7/11 (64%) |
|FIRST INCIDENCE (DAYS) |   456 (I)      456 (I)      456 (I)      447       |   569          627          456 (I)      456 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.301      P=0.221      P=0.499      P=0.273    |  P=0.002 **   P=0.458N     P=0.074N     P=0.002 ** |
|INCIDENTAL TUMOR       |  P=0.492N     P=0.310      P=0.445N     P=0.558    |  P=0.076      P=0.377N     P=0.053N     P=0.120    |
|LOGISTIC REGRESSION    |  P=0.442N     P=0.410      P=0.442N     P=0.542N   |  P=0.095      P=0.313N     P=0.010N*    P=0.124    |
|COCHRAN-ARMITAGE       |  P=0.393N                                          |  P=0.419                                           |
|FISHER EXACT           |               P=0.454      P=0.424N     P=0.500N   |               P=0.242N     P=0.016N*    P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 11/59 (19%)  17/60 (28%)  15/59 (25%)   9/59 (15%) |  5/59 (8%)    8/60 (13%)   5/59 (8%)    3/59 (5%)  |
|ADJUSTED (b)           |  22.7%        39.7%        34.3%        22.2%      |  13.5%        20.2%        17.2%        19.6%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/10 (0%)    2/10 (20%) |  0/8 (0%)     0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  5/42 (12%)  11/36 (31%)   7/35 (20%)   3/30 (10%) |  5/37 (14%)   2/30 (7%)    4/26 (15%)   1/11 (9%)  |
|FIRST INCIDENCE (DAYS) |   478          543          579          456 (I)   |   743 (T)      579          557          642       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.471N     P=0.094      P=0.183      P=0.582    |  P=0.411      P=0.211      P=0.423      P=0.345    |
|INCIDENTAL TUMOR       |  P=0.070N     P=0.157      P=0.555      P=0.170N   |  P=0.284N     P=0.426      P=0.412      P=0.605    |
|LOGISTIC REGRESSION    |  P=0.103N     P=0.211      P=0.536      P=0.210N   |  P=0.384N     P=0.259      P=0.579      P=0.515    |
|COCHRAN-ARMITAGE       |  P=0.234N                                          |  P=0.189N                                          |
|FISHER EXACT           |               P=0.152      P=0.253      P=0.403N   |               P=0.290      P=0.629N     P=0.358N   |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 04                                                 PAGE   7
                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                                                 MALE TERMINAL SACRIFICE AT 106 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 107 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.0312%      0.0625%      0.125%    |   UNTREATD     0.0312%      0.0625%      0.125%    |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatoblastoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 11/59 (19%)  17/60 (28%)  15/59 (25%)   9/59 (15%) |  5/59 (8%)    8/60 (13%)   5/59 (8%)    3/59 (5%)  |
|ADJUSTED (b)           |  22.7%        39.7%        34.3%        22.2%      |  13.5%        20.2%        17.2%        19.6%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/10 (0%)    2/10 (20%) |  0/8 (0%)     0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  5/42 (12%)  11/36 (31%)   7/35 (20%)   3/30 (10%) |  5/37 (14%)   2/30 (7%)    4/26 (15%)   1/11 (9%)  |
|FIRST INCIDENCE (DAYS) |   478          543          579          456 (I)   |   743 (T)      579          557          642       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.471N     P=0.094      P=0.183      P=0.582    |  P=0.411      P=0.211      P=0.423      P=0.345    |
|INCIDENTAL TUMOR       |  P=0.070N     P=0.157      P=0.555      P=0.170N   |  P=0.284N     P=0.426      P=0.412      P=0.605    |
|LOGISTIC REGRESSION    |  P=0.103N     P=0.211      P=0.536      P=0.210N   |  P=0.384N     P=0.259      P=0.579      P=0.515    |
|COCHRAN-ARMITAGE       |  P=0.234N                                          |  P=0.189N                                          |
|FISHER EXACT           |               P=0.152      P=0.253      P=0.403N   |               P=0.290      P=0.629N     P=0.358N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 31/59 (53%)  36/60 (60%)  28/59 (47%)  27/59 (46%) | 20/59 (34%)  19/60 (32%)  10/59 (17%)  19/59 (32%) |
|ADJUSTED (b)           |  58.1%        74.4%        61.6%        59.4%      |  49.5%        48.7%        31.8%        77.5%      |
|INTERIM SACRIFICE 1 (c)|  4/10 (40%)   4/9 (44%)    1/10 (10%)   4/10 (40%) |  0/8 (0%)     0/10 (0%)    1/9 (11%)    1/10 (10%) |
|TERMINAL (d)           | 20/42 (48%)  24/36 (67%)  18/35 (51%)  13/30 (43%) | 17/37 (46%)  11/30 (37%)   7/26 (27%)   7/11 (64%) |
|FIRST INCIDENCE (DAYS) |   456 (I)      456 (I)      456 (I)      447       |   569          579          456 (I)      456 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.482      P=0.093      P=0.508      P=0.389    |  P=0.006 **   P=0.415      P=0.146N     P=0.002 ** |
|INCIDENTAL TUMOR       |  P=0.085N     P=0.203      P=0.227N     P=0.197N   |  P=0.280      P=0.502N     P=0.117N     P=0.165    |
|LOGISTIC REGRESSION    |  P=0.115N     P=0.214      P=0.238N     P=0.298N   |  P=0.240      P=0.568N     P=0.021N*    P=0.149    |
|COCHRAN-ARMITAGE       |  P=0.143N                                          |  P=0.393N                                          |
|FISHER EXACT           |               P=0.263      P=0.356N     P=0.290N   |               P=0.474N     P=0.028N*    P=0.500N   |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 04                                                 PAGE   8
                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                                                 MALE TERMINAL SACRIFICE AT 106 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 107 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.0312%      0.0625%      0.125%    |   UNTREATD     0.0312%      0.0625%      0.125%    |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 31/59 (53%)  36/60 (60%)  28/59 (47%)  27/59 (46%) | 20/59 (34%)  19/60 (32%)  10/59 (17%)  19/59 (32%) |
|ADJUSTED (b)           |  58.1%        74.4%        61.6%        59.4%      |  49.5%        48.7%        31.8%        77.5%      |
|INTERIM SACRIFICE 1 (c)|  4/10 (40%)   4/9 (44%)    1/10 (10%)   4/10 (40%) |  0/8 (0%)     0/10 (0%)    1/9 (11%)    1/10 (10%) |
|TERMINAL (d)           | 20/42 (48%)  24/36 (67%)  18/35 (51%)  13/30 (43%) | 17/37 (46%)  11/30 (37%)   7/26 (27%)   7/11 (64%) |
|FIRST INCIDENCE (DAYS) |   456 (I)      456 (I)      456 (I)      447       |   569          579          456 (I)      456 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.482      P=0.093      P=0.508      P=0.389    |  P=0.006 **   P=0.415      P=0.146N     P=0.002 ** |
|INCIDENTAL TUMOR       |  P=0.085N     P=0.203      P=0.227N     P=0.197N   |  P=0.280      P=0.502N     P=0.117N     P=0.165    |
|LOGISTIC REGRESSION    |  P=0.115N     P=0.214      P=0.238N     P=0.298N   |  P=0.240      P=0.568N     P=0.021N*    P=0.149    |
|COCHRAN-ARMITAGE       |  P=0.143N                                          |  P=0.393N                                          |
|FISHER EXACT           |               P=0.263      P=0.356N     P=0.290N   |               P=0.474N     P=0.028N*    P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 14/60 (23%)   5/60 (8%)   16/60 (27%)  21/59 (36%) |  4/60 (7%)    3/60 (5%)    9/60 (15%)  19/60 (32%) |
|ADJUSTED (b)           |  29.6%        11.9%        35.3%        57.6%      |   9.3%         8.8%        29.1%        65.5%      |
|INTERIM SACRIFICE 1 (c)|  2/10 (20%)   1/9 (11%)    4/10 (40%)   0/10 (0%)  |  1/8 (13%)    0/10 (0%)    0/9 (0%)     2/10 (20%) |
|TERMINAL (d)           | 10/42 (24%)   3/36 (8%)    9/35 (26%)  15/30 (50%) |  2/37 (5%)    2/30 (7%)    5/26 (19%)   4/11 (36%) |
|FIRST INCIDENCE (DAYS) |   456 (I)      456 (I)      456 (I)      593       |   456 (I)      619          669          456 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.002 **   P=0.049N*    P=0.278      P=0.017 *  |  P<0.001 **   P=0.553N     P=0.056      P<0.001 ** |
|INCIDENTAL TUMOR       |  P=0.009 **   P=0.028N*    P=0.368      P=0.111    |  P<0.001 **   P=0.527N     P=0.208      P=0.005 ** |
|LOGISTIC REGRESSION    |  P=0.007 **   P=0.025N*    P=0.422      P=0.057    |  P<0.001 **   P=0.506N     P=0.106      P<0.001 ** |
|COCHRAN-ARMITAGE       |  P=0.010 **                                        |  P<0.001 **                                        |
|FISHER EXACT           |               P=0.022N*    P=0.417      P=0.103    |               P=0.500N     P=0.120      P<0.001 ** |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 04                                                 PAGE   9
                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                                                 MALE TERMINAL SACRIFICE AT 106 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 107 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.0312%      0.0625%      0.125%    |   UNTREATD     0.0312%      0.0625%      0.125%    |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/60 (5%)    7/60 (12%)   8/60 (13%)  12/59 (20%) |  3/60 (5%)    2/60 (3%)    6/60 (10%)   5/60 (8%)  |
|ADJUSTED (b)           |   7.1%        18.7%        19.9%        34.7%      |   6.9%         6.7%        17.4%        33.9%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/10 (0%)    1/10 (10%) |  1/8 (13%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  3/42 (7%)    6/36 (17%)   5/35 (14%)   9/30 (30%) |  1/37 (3%)    2/30 (7%)    3/26 (12%)   2/11 (18%) |
|FIRST INCIDENCE (DAYS) |   736 (T)      646          572          456 (I)   |   456 (I)      743 (T)      428          669       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.002 **   P=0.108      P=0.068      P=0.002 ** |  P=0.012 *    P=0.555N     P=0.177      P=0.044 *  |
|INCIDENTAL TUMOR       |  P=0.005 **   P=0.140      P=0.122      P=0.005 ** |  P=0.176      P=0.445N     P=0.315      P=0.541    |
|LOGISTIC REGRESSION    |  P=0.005 **   P=0.125      P=0.090      P=0.006 ** |  P=0.100      P=0.508N     P=0.245      P=0.176    |
|COCHRAN-ARMITAGE       |  P=0.009 **                                        |  P=0.191                                           |
|FISHER EXACT           |               P=0.161      P=0.102      P=0.011 *  |               P=0.500N     P=0.245      P=0.359    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 17/60 (28%)  12/60 (20%)  20/60 (33%)  26/59 (44%) |  7/60 (12%)   5/60 (8%)   15/60 (25%)  21/60 (35%) |
|ADJUSTED (b)           |  36.2%        29.6%        43.0%        67.5%      |  15.8%        15.3%        43.2%        72.9%      |
|INTERIM SACRIFICE 1 (c)|  2/10 (20%)   1/9 (11%)    4/10 (40%)   1/10 (10%) |  2/8 (25%)    0/10 (0%)    0/9 (0%)     2/10 (20%) |
|TERMINAL (d)           | 13/42 (31%)   9/36 (25%)  11/35 (31%)  18/30 (60%) |  3/37 (8%)    4/30 (13%)   8/26 (31%)   5/11 (45%) |
|FIRST INCIDENCE (DAYS) |   456 (I)      456 (I)      456 (I)      456 (I)   |   456 (I)      619          428          456 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.001 **   P=0.334N     P=0.206      P=0.005 ** |  P<0.001 **   P=0.458N     P=0.019 *    P<0.001 ** |
|INCIDENTAL TUMOR       |  P=0.009 **   P=0.228N     P=0.366      P=0.043 *  |  P<0.001 **   P=0.366N     P=0.110      P=0.021 *  |
|LOGISTIC REGRESSION    |  P=0.006 **   P=0.228N     P=0.342      P=0.025 *  |  P<0.001 **   P=0.390N     P=0.046 *    P<0.001 ** |
|COCHRAN-ARMITAGE       |  P=0.010 *                                         |  P<0.001 **                                        |
|FISHER EXACT           |               P=0.197N     P=0.346      P=0.055    |               P=0.381N     P=0.049 *    P=0.002 ** |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 04                                                 PAGE  10
                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                                                 MALE TERMINAL SACRIFICE AT 106 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 107 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.0312%      0.0625%      0.125%    |   UNTREATD     0.0312%      0.0625%      0.125%    |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/59 (0%)  |  0/60 (0%)    0/60 (0%)    1/60 (2%)    3/60 (5%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   0.0%         0.0%         3.8%         8.7%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/10 (0%)  |  0/8 (0%)     0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  0/42 (0%)    0/36 (0%)    0/35 (0%)    0/30 (0%)  |  0/37 (0%)    0/30 (0%)    1/26 (4%)    0/11 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   ---          ---          743 (T)      520       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.006 **     (e)        P=0.430      P=0.083    |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.038 *      (e)        P=0.430      P=0.241    |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.023 *      (e)        P=0.430      P=0.149    |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.020 *                                         |
|FISHER EXACT           |                 (e)          (e)          (e)      |                 (e)        P=0.500      P=0.122    |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  2/59 (3%)    0/59 (0%)    1/60 (2%)    0/57 (0%)  |
|ADJUSTED (b)           |                                                    |   5.6%         0.0%         3.8%         0.0%      |
|INTERIM SACRIFICE 1 (c)|                                                    |  0/8 (0%)     0/10 (0%)    0/9 (0%)     0/9 (0%)   |
|TERMINAL (d)           |                                                    |  2/36 (6%)    0/29 (0%)    1/26 (4%)    0/11 (0%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   743 (T)      ---          743 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.375N     P=0.287N     P=0.613N     P=0.521N   |
|INCIDENTAL TUMOR       |                                                    |  P=0.375N     P=0.287N     P=0.613N     P=0.521N   |
|LOGISTIC REGRESSION    |                                                    |  P=0.375N     P=0.287N     P=0.613N     P=0.521N   |
|COCHRAN-ARMITAGE       |                                                    |  P=0.192N                                          |
|FISHER EXACT           |                                                    |               P=0.248N     P=0.494N     P=0.257N   |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 04                                                 PAGE  11
                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                                                 MALE TERMINAL SACRIFICE AT 106 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 107 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.0312%      0.0625%      0.125%    |   UNTREATD     0.0312%      0.0625%      0.125%    |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Luteoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  0/59 (0%)    0/59 (0%)    2/60 (3%)    0/57 (0%)  |
|ADJUSTED (b)           |                                                    |   0.0%         0.0%         7.7%         0.0%      |
|INTERIM SACRIFICE 1 (c)|                                                    |  0/8 (0%)     0/10 (0%)    0/9 (0%)     0/9 (0%)   |
|TERMINAL (d)           |                                                    |  0/36 (0%)    0/29 (0%)    2/26 (8%)    0/11 (0%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   ---          ---          743 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.376        (e)        P=0.170        (e)      |
|INCIDENTAL TUMOR       |                                                    |  P=0.376        (e)        P=0.170        (e)      |
|LOGISTIC REGRESSION    |                                                    |  P=0.376        (e)        P=0.170        (e)      |
|COCHRAN-ARMITAGE       |                                                    |  P=0.589                                           |
|FISHER EXACT           |                                                    |                 (e)        P=0.252        (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/57 (0%)    0/54 (0%)    0/59 (0%)    0/54 (0%)  |  4/58 (7%)    8/58 (14%)   3/57 (5%)    5/56 (9%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |  10.8%        24.0%         9.6%        21.9%      |
|INTERIM SACRIFICE 1 (c)|  0/9 (0%)     0/8 (0%)     0/9 (0%)     0/8 (0%)   |  0/8 (0%)     0/10 (0%)    1/9 (11%)    0/10 (0%)  |
|TERMINAL (d)           |  0/42 (0%)    0/34 (0%)    0/35 (0%)    0/30 (0%)  |  4/37 (11%)   5/29 (17%)   2/25 (8%)    1/11 (9%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   743 (T)      619          456 (I)      537       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.129      P=0.098      P=0.640      P=0.093    |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.423      P=0.165      P=0.640      P=0.314    |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.414      P=0.128      P=0.640      P=0.346    |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.526N                                          |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.181      P=0.510N     P=0.478    |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 04                                                 PAGE  12
                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                                                 MALE TERMINAL SACRIFICE AT 106 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 107 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.0312%      0.0625%      0.125%    |   UNTREATD     0.0312%      0.0625%      0.125%    |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/57 (0%)    0/54 (0%)    0/59 (0%)    1/54 (2%)  |  4/58 (7%)    8/58 (14%)   4/57 (7%)    5/56 (9%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         1.8%      |  10.8%        24.0%        13.5%        21.9%      |
|INTERIM SACRIFICE 1 (c)|  0/9 (0%)     0/8 (0%)     0/9 (0%)     0/8 (0%)   |  0/8 (0%)     0/10 (0%)    1/9 (11%)    0/10 (0%)  |
|TERMINAL (d)           |  0/42 (0%)    0/34 (0%)    0/35 (0%)    0/30 (0%)  |  4/37 (11%)   5/29 (17%)   3/25 (12%)   1/11 (9%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          447       |   743 (T)      619          456 (I)      537       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.196        (e)          (e)        P=0.493    |  P=0.105      P=0.098      P=0.456      P=0.093    |
|INCIDENTAL TUMOR       |  P=0.325        (e)          (e)        P=0.718    |  P=0.371      P=0.165      P=0.456      P=0.314    |
|LOGISTIC REGRESSION    |  P=0.154        (e)          (e)        P=0.993    |  P=0.375      P=0.128      P=0.456      P=0.346    |
|COCHRAN-ARMITAGE       |  P=0.193                                           |  P=0.542N                                          |
|FISHER EXACT           |                 (e)          (e)        P=0.486    |               P=0.181      P=0.632      P=0.478    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    2/60 (3%)    0/59 (0%)  |  0/60 (0%)    2/60 (3%)    4/60 (7%)   12/60 (20%) |
|ADJUSTED (b)           |   0.0%         0.0%         5.7%         0.0%      |   0.0%         5.9%        11.1%        42.8%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/10 (0%)  |  0/8 (0%)     0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  0/42 (0%)    0/36 (0%)    2/35 (6%)    0/30 (0%)  |  0/37 (0%)    0/30 (0%)    1/26 (4%)    1/11 (9%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          736 (T)      ---       |   ---          677          536          480       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.531        (e)        P=0.199        (e)      |  P<0.001 **   P=0.212      P=0.053      P<0.001 ** |
|INCIDENTAL TUMOR       |  P=0.531        (e)        P=0.199        (e)      |  P=0.002 **   P=0.500      P=0.141      P=0.017 *  |
|LOGISTIC REGRESSION    |  P=0.531        (e)        P=0.199        (e)      |  P<0.001 **   P=0.232      P=0.063      P<0.001 ** |
|COCHRAN-ARMITAGE       |  P=0.591                                           |  P<0.001 **                                        |
|FISHER EXACT           |                 (e)        P=0.248        (e)      |               P=0.248      P=0.059      P<0.001 ** |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 04                                                 PAGE  13
                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                                                 MALE TERMINAL SACRIFICE AT 106 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 107 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.0312%      0.0625%      0.125%    |   UNTREATD     0.0312%      0.0625%      0.125%    |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    2/60 (3%)    0/59 (0%)  |  0/60 (0%)    2/60 (3%)    4/60 (7%)   12/60 (20%) |
|ADJUSTED (b)           |   0.0%         0.0%         5.7%         0.0%      |   0.0%         5.9%        11.1%        42.8%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/10 (0%)  |  0/8 (0%)     0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  0/42 (0%)    0/36 (0%)    2/35 (6%)    0/30 (0%)  |  0/37 (0%)    0/30 (0%)    1/26 (4%)    1/11 (9%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          736 (T)      ---       |   ---          677          536          480       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.531        (e)        P=0.199        (e)      |  P<0.001 **   P=0.212      P=0.053      P<0.001 ** |
|INCIDENTAL TUMOR       |  P=0.531        (e)        P=0.199        (e)      |  P=0.002 **   P=0.500      P=0.141      P=0.017 *  |
|LOGISTIC REGRESSION    |  P=0.531        (e)        P=0.199        (e)      |  P<0.001 **   P=0.232      P=0.063      P<0.001 ** |
|COCHRAN-ARMITAGE       |  P=0.591                                           |  P<0.001 **                                        |
|FISHER EXACT           |                 (e)        P=0.248        (e)      |               P=0.248      P=0.059      P<0.001 ** |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    1/60 (2%)    0/60 (0%)    0/59 (0%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    2/60 (3%)  |
|ADJUSTED (b)           |   0.0%         2.8%         0.0%         0.0%      |   0.0%         0.0%         0.0%        15.6%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/10 (0%)  |  0/8 (0%)     0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  0/42 (0%)    1/36 (3%)    0/35 (0%)    0/30 (0%)  |  0/37 (0%)    0/30 (0%)    0/26 (0%)    1/11 (9%)  |
|FIRST INCIDENCE (DAYS) |   ---          736 (T)      ---          ---       |   ---          ---          ---          677       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.614N     P=0.469        (e)          (e)      |  P=0.005 **     (e)          (e)        P=0.051    |
|INCIDENTAL TUMOR       |  P=0.614N     P=0.469        (e)          (e)      |  P=0.033 *      (e)          (e)        P=0.221    |
|LOGISTIC REGRESSION    |  P=0.614N     P=0.469        (e)          (e)      |  P=0.017 *      (e)          (e)        P=0.118    |
|COCHRAN-ARMITAGE       |  P=0.570N                                          |  P=0.046 *                                         |
|FISHER EXACT           |               P=0.500        (e)          (e)      |                 (e)          (e)        P=0.248    |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 04                                                 PAGE  14
                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                                                 MALE TERMINAL SACRIFICE AT 106 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 107 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.0312%      0.0625%      0.125%    |   UNTREATD     0.0312%      0.0625%      0.125%    |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Sarcoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    2/60 (3%)    0/59 (0%)  |  0/60 (0%)    1/60 (2%)    4/60 (7%)   11/60 (18%) |
|ADJUSTED (b)           |   0.0%         0.0%         5.7%         0.0%      |   0.0%         3.1%        11.1%        38.1%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/10 (0%)  |  0/8 (0%)     0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  0/42 (0%)    0/36 (0%)    2/35 (6%)    0/30 (0%)  |  0/37 (0%)    0/30 (0%)    1/26 (4%)    1/11 (9%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          736 (T)      ---       |   ---          696          536          480       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.531        (e)        P=0.199        (e)      |  P<0.001 **   P=0.466      P=0.053      P<0.001 ** |
|INCIDENTAL TUMOR       |  P=0.531        (e)        P=0.199        (e)      |  P=0.002 **   P=0.718      P=0.141      P=0.021 *  |
|LOGISTIC REGRESSION    |  P=0.531        (e)        P=0.199        (e)      |  P<0.001 **   P=0.494      P=0.063      P<0.001 ** |
|COCHRAN-ARMITAGE       |  P=0.591                                           |  P<0.001 **                                        |
|FISHER EXACT           |                 (e)        P=0.248        (e)      |               P=0.500      P=0.059      P<0.001 ** |
|=================================================================================================================================|
|                                                                                                                                 |
|Spleen                                                                                                                           |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/59 (0%)    3/60 (5%)    0/59 (0%)    0/59 (0%)  |  0/59 (0%)    0/60 (0%)    0/59 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         8.3%         0.0%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/10 (0%)  |  0/8 (0%)     0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  0/42 (0%)    3/36 (8%)    0/35 (0%)    0/30 (0%)  |  0/37 (0%)    0/30 (0%)    0/26 (0%)    0/11 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          736 (T)      ---          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.382N     P=0.095        (e)          (e)      |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.382N     P=0.095        (e)          (e)      |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.382N     P=0.095        (e)          (e)      |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.312N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.125        (e)          (e)      |                 (e)          (e)          (e)      |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 04                                                 PAGE  15
                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                                                 MALE TERMINAL SACRIFICE AT 106 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 107 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.0312%      0.0625%      0.125%    |   UNTREATD     0.0312%      0.0625%      0.125%    |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Squamous Cell Carcinoma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    1/60 (2%)    2/59 (3%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         2.9%         5.9%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/10 (0%)  |  0/8 (0%)     0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  0/42 (0%)    0/36 (0%)    1/35 (3%)    1/30 (3%)  |  0/37 (0%)    0/30 (0%)    0/26 (0%)    0/11 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          736 (T)      669       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.049 *      (e)        P=0.464      P=0.188    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.073        (e)        P=0.464      P=0.336    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.058        (e)        P=0.464      P=0.214    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.068                                           |    (e)                                             |
|FISHER EXACT           |                 (e)        P=0.500      P=0.244    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Squamous Cell Carcinoma or Papilloma Squamous                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    3/60 (5%)    3/60 (5%)    5/59 (8%)  |  0/60 (0%)    1/60 (2%)    5/60 (8%)    4/60 (7%)  |
|ADJUSTED (b)           |   0.0%         8.0%         8.6%        13.9%      |   0.0%         2.4%        16.6%        25.4%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/10 (0%)    1/10 (10%) |  0/8 (0%)     0/10 (0%)    0/9 (0%)     1/10 (10%) |
|TERMINAL (d)           |  0/42 (0%)    2/36 (6%)    3/35 (9%)    3/30 (10%) |  0/37 (0%)    0/30 (0%)    3/26 (12%)   2/11 (18%) |
|FIRST INCIDENCE (DAYS) |   ---          683          736 (T)      456 (I)   |   ---          625          639          456 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.015 *    P=0.100      P=0.091      P=0.019 *  |  P=0.001 **   P=0.495      P=0.017 *    P=0.006 ** |
|INCIDENTAL TUMOR       |  P=0.026 *    P=0.158      P=0.091      P=0.033 *  |  P=0.013 *    P=0.527      P=0.032 *    P=0.027 *  |
|LOGISTIC REGRESSION    |  P=0.025 *    P=0.108      P=0.091      P=0.030 *  |  P=0.012 *    P=0.505      P=0.028 *    P=0.041 *  |
|COCHRAN-ARMITAGE       |  P=0.032 *                                         |  P=0.032 *                                         |
|FISHER EXACT           |               P=0.122      P=0.122      P=0.027 *  |               P=0.500      P=0.029 *    P=0.059    |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 04                                                 PAGE  16
                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                                                 MALE TERMINAL SACRIFICE AT 106 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 107 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.0312%      0.0625%      0.125%    |   UNTREATD     0.0312%      0.0625%      0.125%    |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    3/60 (5%)    2/60 (3%)    3/59 (5%)  |  0/60 (0%)    1/60 (2%)    5/60 (8%)    4/60 (7%)  |
|ADJUSTED (b)           |   0.0%         8.0%         5.7%         8.3%      |   0.0%         2.4%        16.6%        25.4%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/10 (0%)    1/10 (10%) |  0/8 (0%)     0/10 (0%)    0/9 (0%)     1/10 (10%) |
|TERMINAL (d)           |  0/42 (0%)    2/36 (6%)    2/35 (6%)    2/30 (7%)  |  0/37 (0%)    0/30 (0%)    3/26 (12%)   2/11 (18%) |
|FIRST INCIDENCE (DAYS) |   ---          683          736 (T)      456 (I)   |   ---          625          639          456 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.103      P=0.100      P=0.199      P=0.086    |  P=0.001 **   P=0.495      P=0.017 *    P=0.006 ** |
|INCIDENTAL TUMOR       |  P=0.134      P=0.158      P=0.199      P=0.086    |  P=0.013 *    P=0.527      P=0.032 *    P=0.027 *  |
|LOGISTIC REGRESSION    |  P=0.145      P=0.108      P=0.199      P=0.121    |  P=0.012 *    P=0.505      P=0.028 *    P=0.041 *  |
|COCHRAN-ARMITAGE       |  P=0.160                                           |  P=0.032 *                                         |
|FISHER EXACT           |               P=0.122      P=0.248      P=0.119    |               P=0.500      P=0.029 *    P=0.059    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/59 (0%)    3/60 (5%)    0/59 (0%)    4/59 (7%)  |  3/59 (5%)    1/60 (2%)    3/60 (5%)    0/59 (0%)  |
|ADJUSTED (b)           |   0.0%         8.3%         0.0%        12.4%      |   8.1%         3.3%        10.6%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/10 (0%)  |  0/8 (0%)     0/10 (0%)    0/9 (0%)     0/9 (0%)   |
|TERMINAL (d)           |  0/42 (0%)    3/36 (8%)    0/35 (0%)    3/30 (10%) |  3/37 (8%)    1/30 (3%)    2/26 (8%)    0/11 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          736 (T)      ---          669       |   743 (T)      743 (T)      709          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.035 *    P=0.095        (e)        P=0.034 *  |  P=0.429N     P=0.382N     P=0.509      P=0.396N   |
|INCIDENTAL TUMOR       |  P=0.047 *    P=0.095        (e)        P=0.061    |  P=0.303N     P=0.382N     P=0.634      P=0.396N   |
|LOGISTIC REGRESSION    |  P=0.045 *    P=0.095        (e)        P=0.044 *  |  P=0.355N     P=0.382N     P=0.588      P=0.396N   |
|COCHRAN-ARMITAGE       |  P=0.067                                           |  P=0.135N                                          |
|FISHER EXACT           |               P=0.125        (e)        P=0.059    |               P=0.303N     P=0.652N     P=0.122N   |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 04                                                 PAGE  17
                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                                                 MALE TERMINAL SACRIFICE AT 106 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 107 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.0312%      0.0625%      0.125%    |   UNTREATD     0.0312%      0.0625%      0.125%    |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/59 (2%)    3/60 (5%)    0/59 (0%)    4/59 (7%)  |  3/59 (5%)    1/60 (2%)    3/60 (5%)    0/59 (0%)  |
|ADJUSTED (b)           |   2.4%         8.3%         0.0%        12.4%      |   8.1%         3.3%        10.6%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/10 (0%)  |  0/8 (0%)     0/10 (0%)    0/9 (0%)     0/9 (0%)   |
|TERMINAL (d)           |  1/42 (2%)    3/36 (8%)    0/35 (0%)    3/30 (10%) |  3/37 (8%)    1/30 (3%)    2/26 (8%)    0/11 (0%)  |
|FIRST INCIDENCE (DAYS) |   736 (T)      736 (T)      ---          669       |   743 (T)      743 (T)      709          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.096      P=0.252      P=0.536N     P=0.104    |  P=0.429N     P=0.382N     P=0.509      P=0.396N   |
|INCIDENTAL TUMOR       |  P=0.121      P=0.252      P=0.536N     P=0.164    |  P=0.303N     P=0.382N     P=0.634      P=0.396N   |
|LOGISTIC REGRESSION    |  P=0.118      P=0.252      P=0.536N     P=0.131    |  P=0.355N     P=0.382N     P=0.588      P=0.396N   |
|COCHRAN-ARMITAGE       |  P=0.164                                           |  P=0.135N                                          |
|FISHER EXACT           |               P=0.316      P=0.500N     P=0.182    |               P=0.303N     P=0.652N     P=0.122N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  0/60 (0%)    1/60 (2%)    2/60 (3%)    2/60 (3%)  |
|ADJUSTED (b)           |                                                    |   0.0%         3.3%         7.7%         7.5%      |
|INTERIM SACRIFICE 1 (c)|                                                    |  0/8 (0%)     0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |                                                    |  0/37 (0%)    1/30 (3%)    2/26 (8%)    0/11 (0%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   ---          743 (T)      743 (T)      615       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.032 *    P=0.458      P=0.164      P=0.148    |
|INCIDENTAL TUMOR       |                                                    |  P=0.086      P=0.458      P=0.164      P=0.455    |
|LOGISTIC REGRESSION    |                                                    |  P=0.078      P=0.458      P=0.164      P=0.216    |
|COCHRAN-ARMITAGE       |                                                    |  P=0.160                                           |
|FISHER EXACT           |                                                    |               P=0.500      P=0.248      P=0.248    |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 04                                                 PAGE  18
                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                                                 MALE TERMINAL SACRIFICE AT 106 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 107 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.0312%      0.0625%      0.125%    |   UNTREATD     0.0312%      0.0625%      0.125%    |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  3/60 (5%)    1/60 (2%)    0/60 (0%)    1/60 (2%)  |
|ADJUSTED (b)           |                                                    |   8.1%         3.3%         0.0%         8.3%      |
|INTERIM SACRIFICE 1 (c)|                                                    |  0/8 (0%)     0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |                                                    |  3/37 (8%)    1/30 (3%)    0/26 (0%)    0/11 (0%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   743 (T)      743 (T)      ---          733       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.487N     P=0.382N     P=0.189N     P=0.698    |
|INCIDENTAL TUMOR       |                                                    |  P=0.327N     P=0.382N     P=0.189N     P=0.485N   |
|LOGISTIC REGRESSION    |                                                    |  P=0.448N     P=0.382N     P=0.189N     P=0.711N   |
|COCHRAN-ARMITAGE       |                                                    |  P=0.200N                                          |
|FISHER EXACT           |                                                    |               P=0.309N     P=0.122N     P=0.309N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  0/60 (0%)    1/60 (2%)    0/60 (0%)    2/60 (3%)  |
|ADJUSTED (b)           |                                                    |   0.0%         3.3%         0.0%        10.9%      |
|INTERIM SACRIFICE 1 (c)|                                                    |  0/8 (0%)     0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |                                                    |  0/37 (0%)    1/30 (3%)    0/26 (0%)    0/11 (0%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   ---          743 (T)      ---          615       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.038 *    P=0.458        (e)        P=0.098    |
|INCIDENTAL TUMOR       |                                                    |  P=0.154      P=0.458        (e)        P=0.455    |
|LOGISTIC REGRESSION    |                                                    |  P=0.087      P=0.458        (e)        P=0.183    |
|COCHRAN-ARMITAGE       |                                                    |  P=0.140                                           |
|FISHER EXACT           |                                                    |               P=0.500        (e)        P=0.248    |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 04                                                 PAGE  19
                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                                                 MALE TERMINAL SACRIFICE AT 106 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 107 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.0312%      0.0625%      0.125%    |   UNTREATD     0.0312%      0.0625%      0.125%    |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal or Polyp Stromal                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  3/60 (5%)    2/60 (3%)    0/60 (0%)    3/60 (5%)  |
|ADJUSTED (b)           |                                                    |   8.1%         6.7%         0.0%        18.3%      |
|INTERIM SACRIFICE 1 (c)|                                                    |  0/8 (0%)     0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |                                                    |  3/37 (8%)    2/30 (7%)    0/26 (0%)    0/11 (0%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   743 (T)      743 (T)      ---          615       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.206      P=0.596N     P=0.189N     P=0.194    |
|INCIDENTAL TUMOR       |                                                    |  P=0.479      P=0.596N     P=0.189N     P=0.677    |
|LOGISTIC REGRESSION    |                                                    |  P=0.346      P=0.596N     P=0.189N     P=0.370    |
|COCHRAN-ARMITAGE       |                                                    |  P=0.596                                           |
|FISHER EXACT           |                                                    |               P=0.500N     P=0.122N     P=0.660N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangioma                                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    1/60 (2%)    0/60 (0%)    2/59 (3%)  |  1/60 (2%)    2/60 (3%)    1/60 (2%)    2/60 (3%)  |
|ADJUSTED (b)           |   0.0%         2.8%         0.0%         6.7%      |   2.7%         5.6%         1.7%         7.7%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/10 (0%)  |  0/8 (0%)     0/10 (0%)    1/9 (11%)    0/10 (0%)  |
|TERMINAL (d)           |  0/42 (0%)    1/36 (3%)    0/35 (0%)    2/30 (7%)  |  1/37 (3%)    0/30 (0%)    0/26 (0%)    0/11 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          736 (T)      ---          736 (T)   |   743 (T)      635          456 (I)      649       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.095      P=0.469        (e)        P=0.168    |  P=0.268      P=0.453      P=0.736      P=0.282    |
|INCIDENTAL TUMOR       |  P=0.095      P=0.469        (e)        P=0.168    |  P=0.593N     P=0.610      P=0.736      P=0.736    |
|LOGISTIC REGRESSION    |  P=0.095      P=0.469        (e)        P=0.168    |  P=0.386      P=0.486      P=0.736      P=0.381    |
|COCHRAN-ARMITAGE       |  P=0.137                                           |  P=0.445                                           |
|FISHER EXACT           |               P=0.500        (e)        P=0.244    |               P=0.500      P=0.752N     P=0.500    |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 04                                                 PAGE  20
                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                                                 MALE TERMINAL SACRIFICE AT 106 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 107 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.0312%      0.0625%      0.125%    |   UNTREATD     0.0312%      0.0625%      0.125%    |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/60 (3%)    5/60 (8%)    0/60 (0%)    4/59 (7%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    3/60 (5%)  |
|ADJUSTED (b)           |   4.8%        13.3%         0.0%        13.3%      |   0.0%         0.0%         0.0%        20.9%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/10 (0%)  |  0/8 (0%)     0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  2/42 (5%)    4/36 (11%)   0/35 (0%)    4/30 (13%) |  0/37 (0%)    0/30 (0%)    0/26 (0%)    1/11 (9%)  |
|FIRST INCIDENCE (DAYS) |   736 (T)      656          ---          736 (T)   |   ---          ---          ---          672       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.296      P=0.165      P=0.279N     P=0.195    |  P<0.001 **     (e)          (e)        P=0.013 *  |
|INCIDENTAL TUMOR       |  P=0.341      P=0.218      P=0.279N     P=0.195    |  P=0.014 *      (e)          (e)        P=0.185    |
|LOGISTIC REGRESSION    |  P=0.346      P=0.185      P=0.279N     P=0.195    |  P=0.004 **     (e)          (e)        P=0.049 *  |
|COCHRAN-ARMITAGE       |  P=0.429                                           |  P=0.012 *                                         |
|FISHER EXACT           |               P=0.219      P=0.248N     P=0.332    |                 (e)          (e)        P=0.122    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma or Hemangioma                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/60 (3%)    6/60 (10%)   0/60 (0%)    5/59 (8%)  |  1/60 (2%)    2/60 (3%)    1/60 (2%)    5/60 (8%)  |
|ADJUSTED (b)           |   4.8%        16.0%         0.0%        16.7%      |   2.7%         5.6%         1.7%        27.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/10 (0%)  |  0/8 (0%)     0/10 (0%)    1/9 (11%)    0/10 (0%)  |
|TERMINAL (d)           |  2/42 (5%)    5/36 (14%)   0/35 (0%)    5/30 (17%) |  1/37 (3%)    0/30 (0%)    0/26 (0%)    1/11 (9%)  |
|FIRST INCIDENCE (DAYS) |   736 (T)      656          ---          736 (T)   |   743 (T)      635          456 (I)      649       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.194      P=0.095      P=0.279N     P=0.102    |  P=0.005 **   P=0.453      P=0.736      P=0.008 ** |
|INCIDENTAL TUMOR       |  P=0.227      P=0.128      P=0.279N     P=0.102    |  P=0.116      P=0.610      P=0.736      P=0.224    |
|LOGISTIC REGRESSION    |  P=0.237      P=0.109      P=0.279N     P=0.102    |  P=0.017 *    P=0.486      P=0.736      P=0.032 *  |
|COCHRAN-ARMITAGE       |  P=0.324                                           |  P=0.048 *                                         |
|FISHER EXACT           |               P=0.136      P=0.248N     P=0.213    |               P=0.500      P=0.752N     P=0.103    |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 04                                                 PAGE  21
                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                                                 MALE TERMINAL SACRIFICE AT 106 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 107 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.0312%      0.0625%      0.125%    |   UNTREATD     0.0312%      0.0625%      0.125%    |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Histiocytic Sarcoma                                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    2/60 (3%)    0/60 (0%)    0/59 (0%)  |  1/60 (2%)    4/60 (7%)    2/60 (3%)    1/60 (2%)  |
|ADJUSTED (b)           |   0.0%         4.8%         0.0%         0.0%      |   2.7%        11.6%         7.3%         3.3%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/10 (0%)  |  0/8 (0%)     0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  0/42 (0%)    0/36 (0%)    0/35 (0%)    0/30 (0%)  |  1/37 (3%)    2/30 (7%)    1/26 (4%)    0/11 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          586          ---          ---       |   743 (T)      579          726          610       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.442N     P=0.224        (e)          (e)      |  P=0.440      P=0.140      P=0.387      P=0.579    |
|INCIDENTAL TUMOR       |  P=0.267N     P=0.353        (e)          (e)      |  P=0.443N     P=0.208      P=0.575      P=0.688    |
|LOGISTIC REGRESSION    |  P=0.409N     P=0.236        (e)          (e)      |  P=0.559N     P=0.166      P=0.442      P=0.714    |
|COCHRAN-ARMITAGE       |  P=0.408N                                          |  P=0.404N                                          |
|FISHER EXACT           |               P=0.248        (e)          (e)      |               P=0.182      P=0.500      P=0.752N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma And Histiocytic Sarcoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/60 (3%)    5/60 (8%)    6/60 (10%)   4/59 (7%)  |  6/60 (10%)  14/60 (23%)  11/60 (18%)   5/60 (8%)  |
|ADJUSTED (b)           |   4.8%        12.7%        15.0%        12.1%      |  15.0%        34.9%        33.5%        38.5%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/10 (0%)  |  0/8 (0%)     0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  2/42 (5%)    3/36 (8%)    3/35 (9%)    3/30 (10%) |  5/37 (14%)   7/30 (23%)   6/26 (23%)   4/11 (36%) |
|FIRST INCIDENCE (DAYS) |   736 (T)      586          662          592       |   285          386          543          610       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.215      P=0.171      P=0.102      P=0.213    |  P=0.163      P=0.024 *    P=0.054      P=0.126    |
|INCIDENTAL TUMOR       |  P=0.401      P=0.229      P=0.277      P=0.244    |  P=0.528N     P=0.021 *    P=0.079      P=0.069    |
|LOGISTIC REGRESSION    |  P=0.291      P=0.192      P=0.122      P=0.278    |  P=0.416N     P=0.041 *    P=0.068      P=0.112    |
|COCHRAN-ARMITAGE       |  P=0.341                                           |  P=0.231N                                          |
|FISHER EXACT           |               P=0.219      P=0.136      P=0.332    |               P=0.042 *    P=0.148      P=0.500N   |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 04                                                 PAGE  22
                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                                                 MALE TERMINAL SACRIFICE AT 106 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 107 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.0312%      0.0625%      0.125%    |   UNTREATD     0.0312%      0.0625%      0.125%    |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated                                               |
|     Cell Type                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/60 (3%)    3/60 (5%)    6/60 (10%)   4/59 (7%)  |  5/60 (8%)   10/60 (17%)   9/60 (15%)   4/60 (7%)  |
|ADJUSTED (b)           |   4.8%         8.3%        15.0%        12.1%      |  12.3%        25.3%        27.6%        36.4%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/10 (0%)  |  0/8 (0%)     0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  2/42 (5%)    3/36 (8%)    3/35 (9%)    3/30 (10%) |  4/37 (11%)   5/30 (17%)   5/26 (19%)   4/11 (36%) |
|FIRST INCIDENCE (DAYS) |   736 (T)      736 (T)      662          592       |   285          386          543          743 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.140      P=0.430      P=0.102      P=0.213    |  P=0.194      P=0.091      P=0.092      P=0.167    |
|INCIDENTAL TUMOR       |  P=0.244      P=0.430      P=0.277      P=0.244    |  P=0.497      P=0.065      P=0.095      P=0.064    |
|LOGISTIC REGRESSION    |  P=0.192      P=0.430      P=0.122      P=0.278    |  P=0.439N     P=0.136      P=0.105      P=0.556    |
|COCHRAN-ARMITAGE       |  P=0.241                                           |  P=0.293N                                          |
|FISHER EXACT           |               P=0.500      P=0.136      P=0.332    |               P=0.135      P=0.197      P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 36/60 (60%)  33/60 (55%)  44/60 (73%)  49/59 (83%) | 28/60 (47%)  30/60 (50%)  31/60 (52%)  41/60 (68%) |
|ADJUSTED (b)           |  70.0%        70.9%        85.9%        97.9%      |  61.2%        76.3%        76.1%        94.7%      |
|INTERIM SACRIFICE 1 (c)|  6/10 (60%)   4/9 (44%)    6/10 (60%)   6/10 (60%) |  2/8 (25%)    1/10 (10%)   3/9 (33%)    7/10 (70%) |
|TERMINAL (d)           | 27/42 (64%)  23/36 (64%)  28/35 (80%)  29/30 (97%) | 20/37 (54%)  21/30 (70%)  17/26 (65%)   9/11 (82%) |
|FIRST INCIDENCE (DAYS) |   456 (I)      456 (I)      456 (I)      447       |   447          456 (I)      456 (I)      456 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.452      P=0.017 *    P<0.001 ** |  P<0.001 **   P=0.174      P=0.072      P<0.001 ** |
|INCIDENTAL TUMOR       |  P<0.001 **   P=0.478N     P=0.076      P=0.002 ** |  P<0.001 **   P=0.298      P=0.237      P=0.004 ** |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.424N     P=0.074      P=0.002 ** |  P<0.001 **   P=0.429      P=0.534      P=0.002 ** |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P=0.008 **                                        |
|FISHER EXACT           |               P=0.356N     P=0.087      P=0.005 ** |               P=0.428      P=0.358      P=0.013 *  |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 04                                                 PAGE  23
                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                                                 MALE TERMINAL SACRIFICE AT 106 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 107 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.0312%      0.0625%      0.125%    |   UNTREATD     0.0312%      0.0625%      0.125%    |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 17/60 (28%)  32/60 (53%)  24/60 (40%)  33/59 (56%) | 17/60 (28%)  32/60 (53%)  31/60 (52%)  36/60 (60%) |
|ADJUSTED (b)           |  35.2%        67.8%        52.9%        72.3%      |  39.3%        66.2%        73.8%        91.7%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    1/9 (11%)    0/10 (0%)    3/10 (30%) |  1/8 (13%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           | 11/42 (26%)  21/36 (58%)  14/35 (40%)  18/30 (60%) | 12/37 (32%)  14/30 (47%)  16/26 (62%)   8/11 (73%) |
|FIRST INCIDENCE (DAYS) |   478          456 (I)      572          447       |   285          386          397          456 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.001 **   P=0.002 **   P=0.066      P<0.001 ** |  P<0.001 **   P=0.003 **   P=0.001 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P=0.027 *    P=0.003 **   P=0.244      P=0.006 ** |  P=0.004 **   P=0.008 **   P=0.005 **   P<0.001 ** |
|LOGISTIC REGRESSION    |  P=0.016 *    P=0.004 **   P=0.274      P=0.004 ** |  P<0.001 **   P=0.003 **   P=0.007 **   P<0.001 ** |
|COCHRAN-ARMITAGE       |  P=0.010 **                                        |  P=0.001 **                                        |
|FISHER EXACT           |               P=0.004 **   P=0.124      P=0.002 ** |               P=0.004 **   P=0.008 **   P<0.001 ** |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 43/60 (72%)  47/60 (78%)  51/60 (85%)  53/59 (90%) | 38/60 (63%)  43/60 (72%)  46/60 (77%)  49/60 (82%) |
|ADJUSTED (b)           |  78.0%        88.6%        92.7%        98.1%      |  75.4%        87.6%        93.6%        97.9%      |
|INTERIM SACRIFICE 1 (c)|  6/10 (60%)   5/9 (56%)    6/10 (60%)   8/10 (80%) |  3/8 (38%)    1/10 (10%)   3/9 (33%)    7/10 (70%) |
|TERMINAL (d)           | 30/42 (71%)  30/36 (83%)  31/35 (89%)  29/30 (97%) | 25/37 (68%)  24/30 (80%)  23/26 (88%)  10/11 (91%) |
|FIRST INCIDENCE (DAYS) |   456 (I)      456 (I)      456 (I)      447       |   285          386          397          456 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.077      P=0.018 *    P<0.001 ** |  P<0.001 **   P=0.083      P=0.009 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P=0.012 *    P=0.231      P=0.094      P=0.018 *  |  P=0.005 **   P=0.189      P=0.052      P=0.014 *  |
|LOGISTIC REGRESSION    |  P=0.006 **   P=0.172      P=0.045 *    P=0.006 ** |  P=0.001 **   P=0.226      P=0.196      P=0.006 ** |
|COCHRAN-ARMITAGE       |  P=0.006 **                                        |  P=0.015 *                                         |
|FISHER EXACT           |               P=0.264      P=0.060      P=0.011 *  |               P=0.218      P=0.081      P=0.020 *  |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05103 TEST: 04                                                 PAGE  24
                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                                                 MALE TERMINAL SACRIFICE AT 106 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 107 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):   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).