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TDMS Study 05121-07 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                             SCOPOLAMINE HYDROBROMIDE TRIHYDRATE                         DATE: 04/03/96       
EXPERIMENT: 05121 TEST: 07                                                                                     TIME: 22:23:41       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-85227                              ROUTE: GAVAGE                                                  NTP C#: 03098C       
PATHOLOGIST: A. SINGER                                                                                         CAS: 6533-68-2       
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               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                             SCOPOLAMINE HYDROBROMIDE TRIHYDRATE                         DATE: 04/03/96       
EXPERIMENT: 05121 TEST: 07                                                                                     TIME: 22:23:41       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-85227                              ROUTE: GAVAGE                                                  NTP C#: 03098C       
PATHOLOGIST: A. SINGER                                                                                         CAS: 6533-68-2       




                                                    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: Battelle Columbus                             SCOPOLAMINE HYDROBROMIDE TRIHYDRATE                         DATE: 04/03/96       
EXPERIMENT: 05121 TEST: 07                                                                                     TIME: 22:23:41       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-85227                              ROUTE: GAVAGE                                                  NTP C#: 03098C       
PATHOLOGIST: A. SINGER                                                                                         CAS: 6533-68-2       




                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                              IN THE ANALYSIS OF THE STUDY OF SCOPOLAMINE HYDROBROMIDE TRIHYDRATE

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

                                                           MALE MICE
                                                          -------------
                  ORGAN                               MORPHOLOGY
                 -------                             ------------

              Harderian Gland               Carcinoma
              Liver                         Hemangiosarcoma
                                            Hepatocellular Adenoma
                                            Hepatocellular Carcinoma
                                            Hepatocellular Carcinoma or Hepatoblastoma
                                            Hepatocellular Carcinoma or Hepatocellular Adenoma
                                            Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
              All Organs                    Benign Tumors
                                            Malignant Tumors
                                            Malignant and Benign Tumors

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

                                                           FEMALE MICE
                                                          -------------
                  ORGAN                               MORPHOLOGY
                 -------                             ------------

              Liver                         Hepatocellular Adenoma
                                            Hepatocellular Carcinoma or Hepatocellular Adenoma
                                            Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
              All Organs                    Malignant Tumors

              ====================================================================================================
         DATE: 04/03/96                     EXPERIMENT: 05121 TEST: 07                                                 PAGE   1
                     STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |   0 MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |
|                       |   FEED RTD                                         |   FEED RTD                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/119 (0%)   0/55 (0%)    0/60 (0%)    0/60 (0%)  |  0/119 (0%)   2/59 (3%)    0/59 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   0.0%         4.8%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/19 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/19 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/80 (0%)    0/34 (0%)    0/39 (0%)    0/39 (0%)  |  0/69 (0%)    0/35 (0%)    0/36 (0%)    0/37 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   ---          676          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.485N     P=0.109        (e)          (e)      |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.539N     P=0.087        (e)          (e)      |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.487N     P=0.103        (e)          (e)      |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.486N                                          |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.109        (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/119 (0%)   0/55 (0%)    0/60 (0%)    0/60 (0%)  |  1/119 (1%)   2/59 (3%)    0/59 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   1.1%         4.8%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/19 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/19 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/80 (0%)    0/34 (0%)    0/39 (0%)    0/39 (0%)  |  0/69 (0%)    0/35 (0%)    0/36 (0%)    0/37 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   610          676          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.345N     P=0.268      P=0.649N     P=0.645N   |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.421N     P=0.211      P=0.773N     P=0.773N   |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.275N     P=0.235      P=0.638N     P=0.639N   |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.342N                                          |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.255      P=0.669N     P=0.665N   |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05121 TEST: 07                                                 PAGE   2
                     STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |   0 MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |
|                       |   FEED RTD                                         |   FEED RTD                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/120 (3%)   1/60 (2%)    1/60 (2%)    2/60 (3%)  |  4/121 (3%)   3/60 (5%)    2/60 (3%)    1/61 (2%)  |
|ADJUSTED (b)           |   4.8%         2.6%         2.6%         4.2%      |   5.5%         7.5%         5.1%         2.6%      |
|INTERIM SACRIFICE 1 (c)|  0/19 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  3/81 (4%)    1/39 (3%)    1/39 (3%)    1/39 (3%)  |  2/69 (3%)    2/36 (6%)    1/37 (3%)    1/38 (3%)  |
|FIRST INCIDENCE (DAYS) |   540          726 (T)      726 (T)      405       |   707          482          676          726 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.546      P=0.443N     P=0.448N     P=0.663    |  P=0.300N     P=0.456      P=0.654N     P=0.411N   |
|INCIDENTAL TUMOR       |  P=0.616      P=0.424N     P=0.424N     P=0.571N   |  P=0.311N     P=0.491      P=0.621      P=0.464N   |
|LOGISTIC REGRESSION    |  P=0.555      P=0.421N     P=0.438N     P=0.670N   |  P=0.316N     P=0.442      P=0.661      P=0.432N   |
|COCHRAN-ARMITAGE       |  P=0.554                                           |  P=0.315N                                          |
|FISHER EXACT           |               P=0.459N     P=0.459N     P=0.682N   |               P=0.425      P=0.649      P=0.455N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/120 (0%)   4/60 (7%)    1/60 (2%)    1/60 (2%)  |  2/121 (2%)   1/60 (2%)    1/60 (2%)    0/61 (0%)  |
|ADJUSTED (b)           |   0.0%         9.7%         2.6%         2.6%      |   2.1%         2.8%         2.6%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/19 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/81 (0%)    2/39 (5%)    1/39 (3%)    1/39 (3%)  |  0/69 (0%)    1/36 (3%)    0/37 (0%)    0/38 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          705          726 (T)      726 (T)   |   511          726 (T)      685          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.626N     P=0.010 **   P=0.354      P=0.354    |  P=0.320N     P=0.727      P=0.717      P=0.408N   |
|INCIDENTAL TUMOR       |  P=0.668      P=0.022 *    P=0.354      P=0.354    |  P=0.335N     P=0.691N     P=0.652      P=0.377N   |
|LOGISTIC REGRESSION    |  P=0.628N     P=0.011 *    P=0.354      P=0.354    |  P=0.363N     P=0.725      P=0.668      P=0.412N   |
|COCHRAN-ARMITAGE       |  P=0.615N                                          |  P=0.319N                                          |
|FISHER EXACT           |               P=0.012 *    P=0.333      P=0.333    |               P=0.704      P=0.704      P=0.441N   |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05121 TEST: 07                                                 PAGE   3
                     STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |   0 MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |
|                       |   FEED RTD                                         |   FEED RTD                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/120 (3%)   5/60 (8%)    2/60 (3%)    3/60 (5%)  |  6/121 (5%)   4/60 (7%)    3/60 (5%)    1/61 (2%)  |
|ADJUSTED (b)           |   4.8%        12.1%         5.1%         6.7%      |   7.5%        10.2%         7.5%         2.6%      |
|INTERIM SACRIFICE 1 (c)|  0/19 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  3/81 (4%)    3/39 (8%)    2/39 (5%)    2/39 (5%)  |  2/69 (3%)    3/36 (8%)    1/37 (3%)    1/38 (3%)  |
|FIRST INCIDENCE (DAYS) |   540          705          726 (T)      405       |   511          482          676          726 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.564      P=0.135      P=0.658      P=0.437    |  P=0.165N     P=0.461      P=0.637N     P=0.237N   |
|INCIDENTAL TUMOR       |  P=0.587      P=0.193      P=0.662N     P=0.541    |  P=0.173N     P=0.518      P=0.541      P=0.255N   |
|LOGISTIC REGRESSION    |  P=0.575      P=0.152      P=0.668      P=0.450    |  P=0.172N     P=0.451      P=0.583      P=0.245N   |
|COCHRAN-ARMITAGE       |  P=0.577                                           |  P=0.171N                                          |
|FISHER EXACT           |               P=0.139      P=0.682N     P=0.429    |               P=0.436      P=0.623      P=0.255N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/120 (3%)   0/60 (0%)    1/60 (2%)    1/60 (2%)  |  0/121 (0%)   1/60 (2%)    1/60 (2%)    0/61 (0%)  |
|ADJUSTED (b)           |   3.6%         0.0%         2.3%         2.6%      |   0.0%         2.3%         2.7%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/19 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  2/81 (2%)    0/39 (0%)    0/39 (0%)    1/39 (3%)  |  0/69 (0%)    0/36 (0%)    1/37 (3%)    0/38 (0%)  |
|FIRST INCIDENCE (DAYS) |   647          ---          606          726 (T)   |   ---          594          726 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.675N     P=0.273N     P=0.587N     P=0.587N   |  P=0.597N     P=0.351      P=0.376        (e)      |
|INCIDENTAL TUMOR       |  P=0.610N     P=0.228N     P=0.401N     P=0.608N   |  P=0.658N     P=0.282      P=0.376        (e)      |
|LOGISTIC REGRESSION    |  P=0.666N     P=0.259N     P=0.571N     P=0.574N   |  P=0.602N     P=0.351      P=0.376        (e)      |
|COCHRAN-ARMITAGE       |  P=0.664N                                          |  P=0.602N                                          |
|FISHER EXACT           |               P=0.294N     P=0.593N     P=0.593N   |               P=0.331      P=0.331        (e)      |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05121 TEST: 07                                                 PAGE   4
                     STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |   0 MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |
|                       |   FEED RTD                                         |   FEED RTD                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney: Renal Tubule                                                                                                             |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/120 (2%)   0/60 (0%)    0/60 (0%)    0/60 (0%)  |  0/121 (0%)   0/60 (0%)    0/60 (0%)    0/61 (0%)  |
|ADJUSTED (b)           |   2.5%         0.0%         0.0%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/19 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  2/81 (2%)    0/39 (0%)    0/39 (0%)    0/39 (0%)  |  0/69 (0%)    0/36 (0%)    0/37 (0%)    0/38 (0%)  |
|FIRST INCIDENCE (DAYS) |   726 (T)      ---          ---          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.435N     P=0.410N     P=0.410N     P=0.410N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.435N     P=0.410N     P=0.410N     P=0.410N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.435N     P=0.410N     P=0.410N     P=0.410N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.429N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.443N     P=0.443N     P=0.443N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney: Renal Tubule                                                                                                             |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/120 (2%)   0/60 (0%)    1/60 (2%)    0/60 (0%)  |  0/121 (0%)   0/60 (0%)    0/60 (0%)    0/61 (0%)  |
|ADJUSTED (b)           |   2.5%         0.0%         2.6%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/19 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  2/81 (2%)    0/39 (0%)    1/39 (3%)    0/39 (0%)  |  0/69 (0%)    0/36 (0%)    0/37 (0%)    0/38 (0%)  |
|FIRST INCIDENCE (DAYS) |   726 (T)      ---          726 (T)      ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.420N     P=0.410N     P=0.723      P=0.410N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.420N     P=0.410N     P=0.723      P=0.410N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.420N     P=0.410N     P=0.723      P=0.410N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.414N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.443N     P=0.742N     P=0.443N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05121 TEST: 07                                                 PAGE   5
                     STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |   0 MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |
|                       |   FEED RTD                                         |   FEED RTD                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/120 (0%)   0/60 (0%)    4/60 (7%)    0/60 (0%)  |  1/121 (1%)   1/60 (2%)    0/60 (0%)    0/61 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         9.0%         0.0%      |   1.3%         2.2%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/19 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/81 (0%)    0/39 (0%)    1/39 (3%)    0/39 (0%)  |  0/69 (0%)    0/36 (0%)    0/37 (0%)    0/38 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          560          ---       |   709          562          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.613N       (e)        P=0.010 *      (e)      |  P=0.463N     P=0.587      P=0.646N     P=0.641N   |
|INCIDENTAL TUMOR       |  P=0.311N       (e)        P=0.126        (e)      |  P=0.549N     P=0.532      P=0.705N     P=0.705N   |
|LOGISTIC REGRESSION    |  P=0.463N       (e)        P=0.010 **     (e)      |  P=0.457N     P=0.596      P=0.644N     P=0.638N   |
|COCHRAN-ARMITAGE       |  P=0.608N                                          |  P=0.456N                                          |
|FISHER EXACT           |                 (e)        P=0.012 *      (e)      |               P=0.554      P=0.669N     P=0.665N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 34/120 (28%) 26/60 (43%)  10/60 (17%)   8/60 (13%) | 23/121 (19%) 18/60 (30%)   9/60 (15%)   6/61 (10%) |
|ADJUSTED (b)           |  37.7%        56.7%        22.7%        19.1%      |  30.8%        47.1%        22.8%        15.4%      |
|INTERIM SACRIFICE 1 (c)|  3/19 (16%)   4/10 (40%)   1/10 (10%)   0/10 (0%)  |  1/20 (5%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           | 26/81 (32%)  20/39 (51%)   6/39 (15%)   6/39 (15%) | 19/69 (28%)  16/36 (44%)   7/37 (19%)   5/38 (13%) |
|FIRST INCIDENCE (DAYS) |   456 (I)      456 (I)      456 (I)      587       |   457 (I)      676          578          694       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.005N**   P=0.027 *    P=0.082N     P=0.027N*  |  P=0.016N*    P=0.086      P=0.261N     P=0.056N   |
|INCIDENTAL TUMOR       |  P=0.003N**   P=0.048 *    P=0.062N     P=0.011N*  |  P=0.020N*    P=0.071      P=0.320N     P=0.071N   |
|LOGISTIC REGRESSION    |  P=0.003N**   P=0.046 *    P=0.061N     P=0.018N*  |  P=0.022N*    P=0.060      P=0.341N     P=0.080N   |
|COCHRAN-ARMITAGE       |  P=0.003N**                                        |  P=0.026N*                                         |
|FISHER EXACT           |               P=0.033 *    P=0.060N     P=0.018N*  |               P=0.072      P=0.328N     P=0.081N   |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05121 TEST: 07                                                 PAGE   6
                     STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |   0 MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |
|                       |   FEED RTD                                         |   FEED RTD                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 11/120 (9%)  15/60 (25%)   6/60 (10%)   8/60 (13%) | 10/121 (8%)   6/60 (10%)   8/60 (13%)   4/61 (7%)  |
|ADJUSTED (b)           |  13.0%        30.7%        14.9%        18.8%      |  12.8%        16.0%        19.1%        10.3%      |
|INTERIM SACRIFICE 1 (c)|  0/19 (0%)    0/10 (0%)    0/10 (0%)    1/10 (10%) |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  8/81 (10%)   6/39 (15%)   5/39 (13%)   6/39 (15%) |  6/69 (9%)    5/36 (14%)   4/37 (11%)   3/38 (8%)  |
|FIRST INCIDENCE (DAYS) |   532          405          693          456 (I)   |   594          680          617          694       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.563      P=0.006 **   P=0.505      P=0.255    |  P=0.319N     P=0.483      P=0.240      P=0.419N   |
|INCIDENTAL TUMOR       |  P=0.545N     P=0.018 *    P=0.487      P=0.347    |  P=0.413N     P=0.427      P=0.122      P=0.528N   |
|LOGISTIC REGRESSION    |  P=0.527N     P=0.014 *    P=0.520      P=0.275    |  P=0.346N     P=0.456      P=0.167      P=0.459N   |
|COCHRAN-ARMITAGE       |  P=0.549N                                          |  P=0.349N                                          |
|FISHER EXACT           |               P=0.005 **   P=0.526      P=0.270    |               P=0.446      P=0.207      P=0.466N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatoblastoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 11/120 (9%)  16/60 (27%)   6/60 (10%)   8/60 (13%) | 10/121 (8%)   6/60 (10%)   8/60 (13%)   4/61 (7%)  |
|ADJUSTED (b)           |  13.0%        32.8%        14.9%        18.8%      |  12.8%        16.0%        19.1%        10.3%      |
|INTERIM SACRIFICE 1 (c)|  0/19 (0%)    0/10 (0%)    0/10 (0%)    1/10 (10%) |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  8/81 (10%)   7/39 (18%)   5/39 (13%)   6/39 (15%) |  6/69 (9%)    5/36 (14%)   4/37 (11%)   3/38 (8%)  |
|FIRST INCIDENCE (DAYS) |   532          405          693          456 (I)   |   594          680          617          694       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.539N     P=0.003 **   P=0.505      P=0.255    |  P=0.319N     P=0.483      P=0.240      P=0.419N   |
|INCIDENTAL TUMOR       |  P=0.508N     P=0.009 **   P=0.487      P=0.347    |  P=0.413N     P=0.427      P=0.122      P=0.528N   |
|LOGISTIC REGRESSION    |  P=0.490N     P=0.007 **   P=0.520      P=0.275    |  P=0.346N     P=0.456      P=0.167      P=0.459N   |
|COCHRAN-ARMITAGE       |  P=0.513N                                          |  P=0.349N                                          |
|FISHER EXACT           |               P=0.003 **   P=0.526      P=0.270    |               P=0.446      P=0.207      P=0.466N   |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05121 TEST: 07                                                 PAGE   7
                     STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |   0 MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |
|                       |   FEED RTD                                         |   FEED RTD                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 43/120 (36%) 37/60 (62%)  15/60 (25%)  16/60 (27%) | 32/121 (26%) 21/60 (35%)  16/60 (27%)   9/61 (15%) |
|ADJUSTED (b)           |  46.4%        69.4%        33.7%        36.4%      |  40.6%        55.0%        37.0%        23.1%      |
|INTERIM SACRIFICE 1 (c)|  3/19 (16%)   4/10 (40%)   1/10 (10%)   1/10 (10%) |  1/20 (5%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           | 32/81 (40%)  23/39 (59%)  10/39 (26%)  12/39 (31%) | 24/69 (35%)  19/36 (53%)  10/37 (27%)   8/38 (21%) |
|FIRST INCIDENCE (DAYS) |   456 (I)      405          456 (I)      456 (I)   |   457 (I)      676          578          694       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.032N*    P=0.002 **   P=0.134N     P=0.182N   |  P=0.012N*    P=0.192      P=0.505N     P=0.035N*  |
|INCIDENTAL TUMOR       |  P=0.015N*    P=0.004 **   P=0.103N     P=0.079N   |  P=0.018N*    P=0.146      P=0.471      P=0.054N   |
|LOGISTIC REGRESSION    |  P=0.015N*    P=0.002 **   P=0.094N     P=0.100N   |  P=0.018N*    P=0.138      P=0.478      P=0.052N   |
|COCHRAN-ARMITAGE       |  P=0.019N*                                         |  P=0.020N*                                         |
|FISHER EXACT           |               P<0.001 **   P=0.096N     P=0.143N   |               P=0.155      P=0.555      P=0.053N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 43/120 (36%) 37/60 (62%)  15/60 (25%)  16/60 (27%) | 32/121 (26%) 21/60 (35%)  16/60 (27%)   9/61 (15%) |
|ADJUSTED (b)           |  46.4%        69.4%        33.7%        36.4%      |  40.6%        55.0%        37.0%        23.1%      |
|INTERIM SACRIFICE 1 (c)|  3/19 (16%)   4/10 (40%)   1/10 (10%)   1/10 (10%) |  1/20 (5%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           | 32/81 (40%)  23/39 (59%)  10/39 (26%)  12/39 (31%) | 24/69 (35%)  19/36 (53%)  10/37 (27%)   8/38 (21%) |
|FIRST INCIDENCE (DAYS) |   456 (I)      405          456 (I)      456 (I)   |   457 (I)      676          578          694       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.032N*    P=0.002 **   P=0.134N     P=0.182N   |  P=0.012N*    P=0.192      P=0.505N     P=0.035N*  |
|INCIDENTAL TUMOR       |  P=0.015N*    P=0.004 **   P=0.103N     P=0.079N   |  P=0.018N*    P=0.146      P=0.471      P=0.054N   |
|LOGISTIC REGRESSION    |  P=0.015N*    P=0.002 **   P=0.094N     P=0.100N   |  P=0.018N*    P=0.138      P=0.478      P=0.052N   |
|COCHRAN-ARMITAGE       |  P=0.019N*                                         |  P=0.020N*                                         |
|FISHER EXACT           |               P<0.001 **   P=0.096N     P=0.143N   |               P=0.155      P=0.555      P=0.053N   |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05121 TEST: 07                                                 PAGE   8
                     STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |   0 MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |
|                       |   FEED RTD                                         |   FEED RTD                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 25/120 (21%)  7/60 (12%)   9/60 (15%)   7/60 (12%) |  5/121 (4%)   4/60 (7%)    1/60 (2%)    2/61 (3%)  |
|ADJUSTED (b)           |  28.4%        17.9%        21.7%        16.9%      |   6.5%        11.1%         2.7%         5.3%      |
|INTERIM SACRIFICE 1 (c)|  2/19 (11%)   0/10 (0%)    0/10 (0%)    1/10 (10%) |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           | 20/81 (25%)   7/39 (18%)   7/39 (18%)   6/39 (15%) |  2/69 (3%)    4/36 (11%)   1/37 (3%)    2/38 (5%)  |
|FIRST INCIDENCE (DAYS) |   449 (I)      726 (T)      594          456 (I)   |   618          726 (T)      726 (T)      726 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.198N     P=0.131N     P=0.302N     P=0.132N   |  P=0.403N     P=0.368      P=0.327N     P=0.528N   |
|INCIDENTAL TUMOR       |  P=0.193N     P=0.109N     P=0.254N     P=0.140N   |  P=0.448N     P=0.332      P=0.401N     P=0.617N   |
|LOGISTIC REGRESSION    |  P=0.164N     P=0.075N     P=0.232N     P=0.090N   |  P=0.429N     P=0.352      P=0.341N     P=0.553N   |
|COCHRAN-ARMITAGE       |  P=0.160N                                          |  P=0.428N                                          |
|FISHER EXACT           |               P=0.093N     P=0.232N     P=0.093N   |               P=0.343      P=0.351N     P=0.566N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/120 (3%)   4/60 (7%)    1/60 (2%)    2/60 (3%)  |  2/121 (2%)   3/60 (5%)    1/60 (2%)    1/61 (2%)  |
|ADJUSTED (b)           |   4.7%         9.7%         2.6%         5.1%      |   2.9%         7.3%         2.6%         2.2%      |
|INTERIM SACRIFICE 1 (c)|  0/19 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  2/81 (2%)    3/39 (8%)    1/39 (3%)    2/39 (5%)  |  2/69 (3%)    1/36 (3%)    0/37 (0%)    0/38 (0%)  |
|FIRST INCIDENCE (DAYS) |   680          618          726 (T)      726 (T)   |   726 (T)      590          706          604       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.525N     P=0.257      P=0.455N     P=0.653    |  P=0.484N     P=0.220      P=0.721N     P=0.713N   |
|INCIDENTAL TUMOR       |  P=0.498N     P=0.418      P=0.492N     P=0.623    |  P=0.575N     P=0.185      P=0.717      P=0.700    |
|LOGISTIC REGRESSION    |  P=0.522N     P=0.279      P=0.446N     P=0.664    |  P=0.490N     P=0.208      P=0.727      P=0.730N   |
|COCHRAN-ARMITAGE       |  P=0.510N                                          |  P=0.489N                                          |
|FISHER EXACT           |               P=0.255      P=0.459N     P=0.682N   |               P=0.204      P=0.704      P=0.740N   |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05121 TEST: 07                                                 PAGE   9
                     STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |   0 MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |
|                       |   FEED RTD                                         |   FEED RTD                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 29/120 (24%) 11/60 (18%)  10/60 (17%)   9/60 (15%) |  7/121 (6%)   7/60 (12%)   2/60 (3%)    3/61 (5%)  |
|ADJUSTED (b)           |  32.3%        27.2%        24.2%        21.9%      |   9.3%        17.9%         5.3%         7.4%      |
|INTERIM SACRIFICE 1 (c)|  2/19 (11%)   0/10 (0%)    0/10 (0%)    1/10 (10%) |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           | 22/81 (27%)  10/39 (26%)   8/39 (21%)   8/39 (21%) |  4/69 (6%)    5/36 (14%)   1/37 (3%)    2/38 (5%)  |
|FIRST INCIDENCE (DAYS) |   449 (I)      618          594          456 (I)   |   618          590          706          604       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.183N     P=0.312N     P=0.234N     P=0.155N   |  P=0.322N     P=0.151      P=0.351N     P=0.513N   |
|INCIDENTAL TUMOR       |  P=0.168N     P=0.205N     P=0.199N     P=0.169N   |  P=0.403N     P=0.114      P=0.430N     P=0.624N   |
|LOGISTIC REGRESSION    |  P=0.150N     P=0.198N     P=0.170N     P=0.104N   |  P=0.343N     P=0.133      P=0.372N     P=0.545N   |
|COCHRAN-ARMITAGE       |  P=0.145N                                          |  P=0.341N                                          |
|FISHER EXACT           |               P=0.245N     P=0.169N     P=0.108N   |               P=0.137      P=0.377N     P=0.554N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Nose                                                                                                                             |
|     Mast Cell Tumor Malignant                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/120 (0%)   2/60 (3%)    0/60 (0%)    1/60 (2%)  |  0/121 (0%)   0/60 (0%)    0/60 (0%)    0/61 (0%)  |
|ADJUSTED (b)           |   0.0%         4.9%         0.0%         2.3%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/19 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/81 (0%)    1/39 (3%)    0/39 (0%)    0/39 (0%)  |  0/69 (0%)    0/36 (0%)    0/37 (0%)    0/38 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          707          ---          622       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.531      P=0.103        (e)        P=0.360    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.614      P=0.150        (e)        P=0.773    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.538      P=0.108        (e)        P=0.359    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.539                                           |    (e)                                             |
|FISHER EXACT           |               P=0.110        (e)        P=0.333    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05121 TEST: 07                                                 PAGE  10
                     STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |   0 MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |
|                       |   FEED RTD                                         |   FEED RTD                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Cystadenoma                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  4/120 (3%)   0/59 (0%)    3/59 (5%)    1/61 (2%)  |
|ADJUSTED (b)           |                                                    |   4.3%         0.0%         8.3%         2.6%      |
|INTERIM SACRIFICE 1 (c)|                                                    |  1/20 (5%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |                                                    |  0/69 (0%)    0/35 (0%)    3/36 (8%)    1/38 (3%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   457 (I)      ---          726 (T)      726 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.484N     P=0.192N     P=0.448      P=0.429N   |
|INCIDENTAL TUMOR       |                                                    |  P=0.486N     P=0.159N     P=0.409      P=0.418N   |
|LOGISTIC REGRESSION    |                                                    |  P=0.496N     P=0.198N     P=0.437      P=0.434N   |
|COCHRAN-ARMITAGE       |                                                    |  P=0.496N                                          |
|FISHER EXACT           |                                                    |               P=0.199N     P=0.421      P=0.452N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/116 (0%)   0/56 (0%)    0/55 (0%)    1/53 (2%)  |  5/118 (4%)   3/57 (5%)    3/57 (5%)    3/56 (5%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         2.2%      |   6.9%         8.8%         7.5%         8.2%      |
|INTERIM SACRIFICE 1 (c)|  0/19 (0%)    0/9 (0%)     0/9 (0%)     0/9 (0%)   |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/79 (0%)    0/37 (0%)    0/36 (0%)    0/33 (0%)  |  3/67 (4%)    3/34 (9%)    1/35 (3%)    2/33 (6%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          594       |   617          726 (T)      604          670       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.177        (e)          (e)        P=0.362    |  P=0.539      P=0.555      P=0.556      P=0.552    |
|INCIDENTAL TUMOR       |  P=0.357        (e)          (e)        P=0.773    |  P=0.466      P=0.515      P=0.418      P=0.465    |
|LOGISTIC REGRESSION    |  P=0.164        (e)          (e)        P=0.337    |  P=0.502      P=0.527      P=0.518      P=0.504    |
|COCHRAN-ARMITAGE       |  P=0.167                                           |  P=0.519                                           |
|FISHER EXACT           |                 (e)          (e)        P=0.314    |               P=0.515      P=0.515      P=0.505    |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05121 TEST: 07                                                 PAGE  11
                     STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |   0 MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |
|                       |   FEED RTD                                         |   FEED RTD                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Intermedia                                                                                                 |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/116 (2%)   0/56 (0%)    1/55 (2%)    0/53 (0%)  |  0/118 (0%)   1/57 (2%)    0/57 (0%)    1/56 (2%)  |
|ADJUSTED (b)           |   2.4%         0.0%         2.1%         0.0%      |   0.0%         2.9%         0.0%         3.0%      |
|INTERIM SACRIFICE 1 (c)|  0/19 (0%)    0/9 (0%)     0/9 (0%)     0/9 (0%)   |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/79 (1%)    0/37 (0%)    0/36 (0%)    0/33 (0%)  |  0/67 (0%)    1/34 (3%)    0/35 (0%)    1/33 (3%)  |
|FIRST INCIDENCE (DAYS) |   647          ---          520          ---       |   ---          726 (T)      ---          726 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.434N     P=0.405N     P=0.720      P=0.430N   |  P=0.389      P=0.365        (e)        P=0.359    |
|INCIDENTAL TUMOR       |  P=0.397N     P=0.341N     P=0.725N     P=0.442N   |  P=0.389      P=0.365        (e)        P=0.359    |
|LOGISTIC REGRESSION    |  P=0.346N     P=0.400N     P=0.546N     P=0.425N   |  P=0.389      P=0.365        (e)        P=0.359    |
|COCHRAN-ARMITAGE       |  P=0.433N                                          |  P=0.385                                           |
|FISHER EXACT           |               P=0.454N     P=0.690      P=0.470N   |               P=0.326        (e)        P=0.322    |
|=================================================================================================================================|
|                                                                                                                                 |
|Spleen                                                                                                                           |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/120 (1%)   1/60 (2%)    1/60 (2%)    0/60 (0%)  |  2/121 (2%)   0/60 (0%)    0/60 (0%)    0/61 (0%)  |
|ADJUSTED (b)           |   1.2%         2.3%         2.4%         0.0%      |   2.8%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/19 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/81 (1%)    0/39 (0%)    0/39 (0%)    0/39 (0%)  |  1/69 (1%)    0/36 (0%)    0/37 (0%)    0/38 (0%)  |
|FIRST INCIDENCE (DAYS) |   726 (T)      705          693          ---       |   721          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.444N     P=0.597      P=0.588      P=0.646N   |  P=0.415N     P=0.394N     P=0.388N     P=0.381N   |
|INCIDENTAL TUMOR       |  P=0.517N     P=0.665      P=0.560      P=0.646N   |  P=0.449N     P=0.414N     P=0.431N     P=0.428N   |
|LOGISTIC REGRESSION    |  P=0.442N     P=0.606      P=0.595      P=0.646N   |  P=0.426N     P=0.402N     P=0.404N     P=0.397N   |
|COCHRAN-ARMITAGE       |  P=0.437N                                          |  P=0.427N                                          |
|FISHER EXACT           |               P=0.557      P=0.557      P=0.667N   |               P=0.446N     P=0.446N     P=0.441N   |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05121 TEST: 07                                                 PAGE  12
                     STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |   0 MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |
|                       |   FEED RTD                                         |   FEED RTD                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/120 (2%)   0/60 (0%)    1/60 (2%)    0/60 (0%)  |  1/121 (1%)   0/60 (0%)    1/60 (2%)    2/61 (3%)  |
|ADJUSTED (b)           |   2.5%         0.0%         2.4%         0.0%      |   1.4%         0.0%         2.7%         5.3%      |
|INTERIM SACRIFICE 1 (c)|  0/19 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  2/81 (2%)    0/39 (0%)    0/39 (0%)    0/39 (0%)  |  1/69 (1%)    0/36 (0%)    1/37 (3%)    2/38 (5%)  |
|FIRST INCIDENCE (DAYS) |   726 (T)      ---          693          ---       |   726 (T)      ---          726 (T)      726 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.420N     P=0.410N     P=0.721      P=0.410N   |  P=0.163      P=0.630N     P=0.616      P=0.298    |
|INCIDENTAL TUMOR       |  P=0.454N     P=0.410N     P=0.702      P=0.410N   |  P=0.163      P=0.630N     P=0.616      P=0.298    |
|LOGISTIC REGRESSION    |  P=0.420N     P=0.410N     P=0.726      P=0.410N   |  P=0.163      P=0.630N     P=0.616      P=0.298    |
|COCHRAN-ARMITAGE       |  P=0.414N                                          |  P=0.147                                           |
|FISHER EXACT           |               P=0.443N     P=0.742N     P=0.443N   |               P=0.669N     P=0.554      P=0.260    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/120 (1%)   1/60 (2%)    0/60 (0%)    1/60 (2%)  |  4/121 (3%)   0/59 (0%)    0/60 (0%)    3/61 (5%)  |
|ADJUSTED (b)           |   1.2%         2.6%         0.0%         2.6%      |   5.8%         0.0%         0.0%         6.6%      |
|INTERIM SACRIFICE 1 (c)|  0/19 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/20 (0%)    0/9 (0%)     0/10 (0%)    1/10 (10%) |
|TERMINAL (d)           |  1/81 (1%)    1/39 (3%)    0/39 (0%)    1/39 (3%)  |  4/69 (6%)    0/36 (0%)    0/37 (0%)    1/38 (3%)  |
|FIRST INCIDENCE (DAYS) |   726 (T)      726 (T)      ---          726 (T)   |   726 (T)      ---          ---          457 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.556      P=0.590      P=0.646N     P=0.590    |  P=0.218      P=0.176N     P=0.170N     P=0.483    |
|INCIDENTAL TUMOR       |  P=0.556      P=0.590      P=0.646N     P=0.590    |  P=0.203      P=0.176N     P=0.170N     P=0.459    |
|LOGISTIC REGRESSION    |  P=0.556      P=0.590      P=0.646N     P=0.590    |  P=0.198      P=0.176N     P=0.170N     P=0.449    |
|COCHRAN-ARMITAGE       |  P=0.563                                           |  P=0.200                                           |
|FISHER EXACT           |               P=0.557      P=0.667N     P=0.557    |               P=0.201N     P=0.196N     P=0.434    |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05121 TEST: 07                                                 PAGE  13
                     STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |   0 MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |
|                       |   FEED RTD                                         |   FEED RTD                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Tooth                                                                                                                            |
|     Odontoma                                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/120 (1%)   1/60 (2%)    2/60 (3%)    1/60 (2%)  |  0/121 (0%)   0/60 (0%)    0/60 (0%)    0/61 (0%)  |
|ADJUSTED (b)           |   1.2%         2.6%         5.1%         2.6%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/19 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/81 (1%)    1/39 (3%)    2/39 (5%)    1/39 (3%)  |  0/69 (0%)    0/36 (0%)    0/37 (0%)    0/38 (0%)  |
|FIRST INCIDENCE (DAYS) |   726 (T)      726 (T)      726 (T)      726 (T)   |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.585      P=0.590      P=0.257      P=0.590    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.585      P=0.590      P=0.257      P=0.590    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.585      P=0.590      P=0.257      P=0.590    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.593                                           |    (e)                                             |
|FISHER EXACT           |               P=0.557      P=0.258      P=0.557    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  2/121 (2%)   0/60 (0%)    0/60 (0%)    0/61 (0%)  |
|ADJUSTED (b)           |                                                    |   2.9%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|                                                    |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |                                                    |  2/69 (3%)    0/36 (0%)    0/37 (0%)    0/38 (0%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   726 (T)      ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.413N     P=0.391N     P=0.384N     P=0.377N   |
|INCIDENTAL TUMOR       |                                                    |  P=0.413N     P=0.391N     P=0.384N     P=0.377N   |
|LOGISTIC REGRESSION    |                                                    |  P=0.413N     P=0.391N     P=0.384N     P=0.377N   |
|COCHRAN-ARMITAGE       |                                                    |  P=0.427N                                          |
|FISHER EXACT           |                                                    |               P=0.446N     P=0.446N     P=0.441N   |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05121 TEST: 07                                                 PAGE  14
                     STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |   0 MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |
|                       |   FEED RTD                                         |   FEED RTD                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  2/121 (2%)   0/60 (0%)    0/60 (0%)    0/61 (0%)  |
|ADJUSTED (b)           |                                                    |   2.9%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|                                                    |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |                                                    |  2/69 (3%)    0/36 (0%)    0/37 (0%)    0/38 (0%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   726 (T)      ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.413N     P=0.391N     P=0.384N     P=0.377N   |
|INCIDENTAL TUMOR       |                                                    |  P=0.413N     P=0.391N     P=0.384N     P=0.377N   |
|LOGISTIC REGRESSION    |                                                    |  P=0.413N     P=0.391N     P=0.384N     P=0.377N   |
|COCHRAN-ARMITAGE       |                                                    |  P=0.427N                                          |
|FISHER EXACT           |                                                    |               P=0.446N     P=0.446N     P=0.441N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal or Polyp Stromal                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  3/121 (2%)   1/60 (2%)    0/60 (0%)    0/61 (0%)  |
|ADJUSTED (b)           |                                                    |   4.3%         2.2%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|                                                    |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |                                                    |  3/69 (4%)    0/36 (0%)    0/37 (0%)    0/38 (0%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   726 (T)      562          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.225N     P=0.561N     P=0.252N     P=0.246N   |
|INCIDENTAL TUMOR       |                                                    |  P=0.248N     P=0.595N     P=0.252N     P=0.246N   |
|LOGISTIC REGRESSION    |                                                    |  P=0.233N     P=0.573N     P=0.252N     P=0.246N   |
|COCHRAN-ARMITAGE       |                                                    |  P=0.232N                                          |
|FISHER EXACT           |                                                    |               P=0.596N     P=0.296N     P=0.291N   |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05121 TEST: 07                                                 PAGE  15
                     STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |   0 MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |
|                       |   FEED RTD                                         |   FEED RTD                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangioma                                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/120 (2%)   0/60 (0%)    0/60 (0%)    0/60 (0%)  |  0/121 (0%)   0/60 (0%)    1/60 (2%)    0/61 (0%)  |
|ADJUSTED (b)           |   2.4%         0.0%         0.0%         0.0%      |   0.0%         0.0%         2.5%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/19 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/81 (1%)    0/39 (0%)    0/39 (0%)    0/39 (0%)  |  0/69 (0%)    0/36 (0%)    0/37 (0%)    0/38 (0%)  |
|FIRST INCIDENCE (DAYS) |   680          ---          ---          ---       |   ---          ---          678          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.437N     P=0.406N     P=0.411N     P=0.411N   |  P=0.820N       (e)        P=0.357        (e)      |
|INCIDENTAL TUMOR       |  P=0.477N     P=0.335N     P=0.440N     P=0.440N   |  P=0.861N       (e)        P=0.295        (e)      |
|LOGISTIC REGRESSION    |  P=0.433N     P=0.391N     P=0.404N     P=0.402N   |  P=0.819N       (e)        P=0.357        (e)      |
|COCHRAN-ARMITAGE       |  P=0.429N                                          |  P=0.819N                                          |
|FISHER EXACT           |               P=0.443N     P=0.443N     P=0.443N   |                 (e)        P=0.331        (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/120 (3%)   2/60 (3%)    5/60 (8%)    0/60 (0%)  |  7/121 (6%)   2/60 (3%)    1/60 (2%)    1/61 (2%)  |
|ADJUSTED (b)           |   3.7%         4.0%        11.2%         0.0%      |   9.6%         4.5%         2.7%         2.6%      |
|INTERIM SACRIFICE 1 (c)|  0/19 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  2/81 (2%)    0/39 (0%)    1/39 (3%)    0/39 (0%)  |  4/69 (6%)    0/36 (0%)    1/37 (3%)    1/38 (3%)  |
|FIRST INCIDENCE (DAYS) |   725          405          560          ---       |   709          562          726 (T)      726 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.210N     P=0.560      P=0.077      P=0.280N   |  P=0.187N     P=0.355N     P=0.173N     P=0.165N   |
|INCIDENTAL TUMOR       |  P=0.102N     P=0.675      P=0.302      P=0.298N   |  P=0.233N     P=0.405N     P=0.207N     P=0.201N   |
|LOGISTIC REGRESSION    |  P=0.167N     P=0.570      P=0.183      P=0.279N   |  P=0.198N     P=0.362N     P=0.188N     P=0.179N   |
|COCHRAN-ARMITAGE       |  P=0.201N                                          |  P=0.197N                                          |
|FISHER EXACT           |               P=0.541      P=0.083      P=0.294N   |               P=0.377N     P=0.192N     P=0.186N   |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05121 TEST: 07                                                 PAGE  16
                     STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |   0 MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |
|                       |   FEED RTD                                         |   FEED RTD                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma or Hemangioma                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/120 (4%)   2/60 (3%)    5/60 (8%)    0/60 (0%)  |  7/121 (6%)   2/60 (3%)    2/60 (3%)    1/61 (2%)  |
|ADJUSTED (b)           |   6.0%         4.0%        11.2%         0.0%      |   9.6%         4.5%         5.1%         2.6%      |
|INTERIM SACRIFICE 1 (c)|  0/19 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  3/81 (4%)    0/39 (0%)    1/39 (3%)    0/39 (0%)  |  4/69 (6%)    0/36 (0%)    1/37 (3%)    1/38 (3%)  |
|FIRST INCIDENCE (DAYS) |   680          405          560          ---       |   709          562          678          726 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.134N     P=0.559N     P=0.201      P=0.141N   |  P=0.187N     P=0.355N     P=0.341N     P=0.165N   |
|INCIDENTAL TUMOR       |  P=0.064N     P=0.412N     P=0.506      P=0.154N   |  P=0.238N     P=0.405N     P=0.411N     P=0.201N   |
|LOGISTIC REGRESSION    |  P=0.098N     P=0.540N     P=0.396      P=0.134N   |  P=0.197N     P=0.362N     P=0.369N     P=0.179N   |
|COCHRAN-ARMITAGE       |  P=0.125N                                          |  P=0.196N                                          |
|FISHER EXACT           |               P=0.571N     P=0.207      P=0.128N   |               P=0.377N     P=0.377N     P=0.186N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Histiocytic Sarcoma                                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/120 (3%)   0/60 (0%)    0/60 (0%)    1/60 (2%)  |  5/121 (4%)   2/60 (3%)    0/60 (0%)    1/61 (2%)  |
|ADJUSTED (b)           |   3.3%         0.0%         0.0%         2.5%      |   5.6%         4.4%         0.0%         2.5%      |
|INTERIM SACRIFICE 1 (c)|  0/19 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  2/81 (2%)    0/39 (0%)    0/39 (0%)    0/39 (0%)  |  0/69 (0%)    0/36 (0%)    0/37 (0%)    0/38 (0%)  |
|FIRST INCIDENCE (DAYS) |   447          ---          ---          707       |   492          532          ---          691       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.689      P=0.272N     P=0.275N     P=0.583N   |  P=0.324N     P=0.565N     P=0.145N     P=0.342N   |
|INCIDENTAL TUMOR       |  P=0.689N     P=0.252N     P=0.252N     P=0.533N   |  P=0.380N     P=0.552N     P=0.210N     P=0.427N   |
|LOGISTIC REGRESSION    |  P=0.697      P=0.271N     P=0.269N     P=0.569N   |  P=0.398N     P=0.632N     P=0.131N     P=0.415N   |
|COCHRAN-ARMITAGE       |  P=0.697                                           |  P=0.315N                                          |
|FISHER EXACT           |               P=0.294N     P=0.294N     P=0.593N   |               P=0.575N     P=0.130N     P=0.344N   |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05121 TEST: 07                                                 PAGE  17
                     STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |   0 MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |
|                       |   FEED RTD                                         |   FEED RTD                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated                                               |
|     Cell Type                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  7/120 (6%)   2/60 (3%)    2/60 (3%)    3/60 (5%)  | 15/121 (12%)  8/60 (13%)   9/60 (15%)   7/61 (11%) |
|ADJUSTED (b)           |   8.5%         5.1%         5.0%         7.4%      |  19.2%        21.6%        22.6%        16.2%      |
|INTERIM SACRIFICE 1 (c)|  0/19 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  6/81 (7%)    2/39 (5%)    1/39 (3%)    2/39 (5%)  | 10/69 (14%)   7/36 (19%)   7/37 (19%)   3/38 (8%)  |
|FIRST INCIDENCE (DAYS) |   680          726 (T)      707          705       |   464          708          510          551       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.594      P=0.376N     P=0.380N     P=0.568N   |  P=0.416N     P=0.552      P=0.448      P=0.480N   |
|INCIDENTAL TUMOR       |  P=0.547      P=0.341N     P=0.406N     P=0.599N   |  P=0.491N     P=0.534      P=0.356      P=0.581    |
|LOGISTIC REGRESSION    |  P=0.593      P=0.348N     P=0.375N     P=0.563N   |  P=0.502N     P=0.524      P=0.382      P=0.597N   |
|COCHRAN-ARMITAGE       |  P=0.610                                           |  P=0.461N                                          |
|FISHER EXACT           |               P=0.372N     P=0.372N     P=0.559N   |               P=0.515      P=0.393      P=0.532N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 60/120 (50%) 32/60 (53%)  22/60 (37%)  19/60 (32%) | 39/121 (32%) 25/60 (42%)  21/60 (35%)  19/61 (31%) |
|ADJUSTED (b)           |  63.4%        70.4%        47.6%        43.2%      |  48.0%        62.0%        48.7%        44.7%      |
|INTERIM SACRIFICE 1 (c)|  5/19 (26%)   4/10 (40%)   1/10 (10%)   1/10 (10%) |  1/20 (5%)    0/10 (0%)    0/10 (0%)    1/10 (10%) |
|TERMINAL (d)           | 47/81 (58%)  26/39 (67%)  15/39 (38%)  15/39 (38%) | 28/69 (41%)  21/36 (58%)  15/37 (41%)  15/38 (39%) |
|FIRST INCIDENCE (DAYS) |   449 (I)      456 (I)      456 (I)      405       |   457 (I)      482          578          457 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.015N*    P=0.297      P=0.113N     P=0.028N*  |  P=0.250N     P=0.184      P=0.512      P=0.394N   |
|INCIDENTAL TUMOR       |  P=0.008N**   P=0.429      P=0.060N     P=0.010N*  |  P=0.338N     P=0.151      P=0.335      P=0.513N   |
|LOGISTIC REGRESSION    |  P=0.007N**   P=0.511      P=0.055N     P=0.010N*  |  P=0.335N     P=0.122      P=0.372      P=0.523N   |
|COCHRAN-ARMITAGE       |  P=0.008N**                                        |  P=0.334N                                          |
|FISHER EXACT           |               P=0.396      P=0.062N     P=0.014N*  |               P=0.139      P=0.417      P=0.511N   |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05121 TEST: 07                                                 PAGE  18
                     STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |   0 MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |
|                       |   FEED RTD                                         |   FEED RTD                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 28/120 (23%) 25/60 (42%)  16/60 (27%)  16/60 (27%) | 42/121 (35%) 22/60 (37%)  21/60 (35%)  14/61 (23%) |
|ADJUSTED (b)           |  31.5%        49.8%        35.5%        35.6%      |  45.7%        49.5%        47.7%        31.6%      |
|INTERIM SACRIFICE 1 (c)|  0/19 (0%)    0/10 (0%)    0/10 (0%)    1/10 (10%) |  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           | 21/81 (26%)  14/39 (36%)  10/39 (26%)  11/39 (28%) | 21/69 (30%)  14/36 (39%)  14/37 (38%)   8/38 (21%) |
|FIRST INCIDENCE (DAYS) |   447          405          560          405       |   464          532          510          551       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.480N     P=0.011 *    P=0.338      P=0.341    |  P=0.049N*    P=0.500      P=0.522N     P=0.075N   |
|INCIDENTAL TUMOR       |  P=0.375N     P=0.037 *    P=0.493      P=0.416    |  P=0.074N     P=0.413      P=0.317      P=0.136N   |
|LOGISTIC REGRESSION    |  P=0.417N     P=0.027 *    P=0.504      P=0.381    |  P=0.056N     P=0.398      P=0.400      P=0.097N   |
|COCHRAN-ARMITAGE       |  P=0.436N                                          |  P=0.048N*                                         |
|FISHER EXACT           |               P=0.009 **   P=0.376      P=0.376    |               P=0.460      P=0.548      P=0.072N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 73/120 (61%) 45/60 (75%)  32/60 (53%)  31/60 (52%) | 69/121 (57%) 36/60 (60%)  35/60 (58%)  30/61 (49%) |
|ADJUSTED (b)           |  74.2%        83.2%        66.6%        63.9%      |  72.3%        78.0%        76.1%        65.0%      |
|INTERIM SACRIFICE 1 (c)|  5/19 (26%)   4/10 (40%)   1/10 (10%)   2/10 (20%) |  1/20 (5%)    0/10 (0%)    0/10 (0%)    1/10 (10%) |
|TERMINAL (d)           | 56/81 (69%)  30/39 (77%)  23/39 (59%)  22/39 (56%) | 43/69 (62%)  26/36 (72%)  26/37 (70%)  22/38 (58%) |
|FIRST INCIDENCE (DAYS) |   447          405          456 (I)      405       |   457 (I)      482          510          457 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.110N     P=0.040 *    P=0.332N     P=0.257N   |  P=0.102N     P=0.498      P=0.500N     P=0.143N   |
|INCIDENTAL TUMOR       |  P=0.022N*    P=0.121      P=0.133N     P=0.084N   |  P=0.175N     P=0.388      P=0.252      P=0.294N   |
|LOGISTIC REGRESSION    |  P=0.041N*    P=0.080      P=0.107N     P=0.119N   |  P=0.166N     P=0.347      P=0.299      P=0.265N   |
|COCHRAN-ARMITAGE       |  P=0.052N                                          |  P=0.139N                                          |
|FISHER EXACT           |               P=0.041 *    P=0.211N     P=0.155N   |               P=0.413      P=0.498      P=0.199N   |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05121 TEST: 07                                                 PAGE  19
                     STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE

                                                 TERMINAL SACRIFICE AT 104 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): 457
 (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).