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TDMS Study 05121-05 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                             SCOPOLAMINE HYDROBROMIDE TRIHYDRATE                         DATE: 04/03/96       
EXPERIMENT: 05121 TEST: 05                                                                                     TIME: 21:36:18       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01 ES 85227                              ROUTE: GAVAGE                                                  NTP C#: 03098C       
PATHOLOGIST: M. RYAN                                                                                           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: 05                                                                                     TIME: 21:36:18       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01 ES 85227                              ROUTE: GAVAGE                                                  NTP C#: 03098C       
PATHOLOGIST: M. RYAN                                                                                           CAS: 6533-68-2       




                                                    RATS(FISCHER344)
                                              ----------------------------
             FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
             IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
                                                                    

                                                    ----------------

                                                    Adrenal Cortex
                                                    Adrenal Medulla
                                                    Bone Marrow
                                                    Brain
                                                    Clitoral Gland
                                                    Clitoral/Preputial Gland
                                                    Epididymis
                                                    Heart
                                                    Islets, Pancreatic
                                                    Kidney
                                                    Liver
                                                    Lung
                                                    Nose
                                                    Ovary
                                                    Pancreas
                                                    Parathyroid Gland
                                                    Pituitary Gland
                                                    Preputial Gland
                                                    Prostate
                                                    Salivary Glands
                                                    Spleen
                                                    Testes
                                                    Thymus
                                                    Thyroid Gland
                                                    Urinary Bladder
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                             SCOPOLAMINE HYDROBROMIDE TRIHYDRATE                         DATE: 04/03/96       
EXPERIMENT: 05121 TEST: 05                                                                                     TIME: 21:36:18       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01 ES 85227                              ROUTE: GAVAGE                                                  NTP C#: 03098C       
PATHOLOGIST: M. RYAN                                                                                           CAS: 6533-68-2       




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

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

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

              Islets, Pancreatic            Carcinoma or Adenoma
              Pituitary Gland: Pars Distalis or Unspecified Site
                                            Adenoma
              Testes                        Adenoma
              Thyroid Gland: Follicular Cell
                                            Carcinoma or Adenoma
              All Organs                    Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
                                            Benign Tumors
                                            Malignant Tumors
                                            Malignant and Benign Tumors

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

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

              Mammary Gland                 Fibroadenoma
                                            Fibroma, Fibroadenoma or Adenoma
                                            Fibroma, Fibroadenoma, Carcinoma, or Adenoma
              Pituitary Gland: Pars Distalis or Unspecified Site
                                            Adenoma
              Thyroid Gland: Follicular Cell
                                            Adenoma
                                            Carcinoma or Adenoma
              Uterus                        Polyp Stromal
              All Organs                    Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
                                            Benign Tumors
                                            Malignant Tumors
                                            Malignant and Benign Tumors

              ====================================================================================================
         DATE: 04/03/96                     EXPERIMENT: 05121 TEST: 05                                                 PAGE   1
                   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   O MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |   O MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Cortex                                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |  0/60 (0%)    0/60 (0%)    2/60 (3%)    1/60 (2%)  |
|ADJUSTED (b)           |   3.2%         0.0%         0.0%         0.0%      |   0.0%         0.0%         6.8%         4.5%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/0          0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/20 (0%)    0/14 (0%)    0/22 (0%)    0/28 (0%)  |  0/34 (0%)    0/17 (0%)    1/26 (4%)    1/22 (5%)  |
|FIRST INCIDENCE (DAYS) |   671          ---          ---          ---       |   ---          ---          680          726 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.547N     P=0.535N     P=0.507N     P=0.470N   |  P=0.402        (e)        P=0.201      P=0.413    |
|INCIDENTAL TUMOR       |  P=0.689N     P=0.500N     P=0.550N     P=0.617N   |  P=0.365        (e)        P=0.262      P=0.413    |
|LOGISTIC REGRESSION    |  P=0.581N     P=0.517N     P=0.496N     P=0.498N   |  P=0.396        (e)        P=0.216      P=0.413    |
|COCHRAN-ARMITAGE       |  P=0.588N                                          |  P=0.460                                           |
|FISHER EXACT           |               P=0.500N     P=0.500N     P=0.500N   |                 (e)        P=0.248      P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 11/60 (18%)  13/60 (22%)  12/60 (20%)  10/60 (17%) |  1/60 (2%)    0/60 (0%)    1/60 (2%)    1/60 (2%)  |
|ADJUSTED (b)           |  41.4%        57.0%        37.7%        30.3%      |   2.4%         0.0%         3.8%         3.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    1/10 (10%) |  0/10 (0%)    0/0          0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  5/20 (25%)   6/14 (43%)   4/22 (18%)   7/28 (25%) |  0/34 (0%)    0/17 (0%)    1/26 (4%)    0/22 (0%)  |
|FIRST INCIDENCE (DAYS) |   673          585          589          456 (I)   |   627          ---          726 (T)      499       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.096N     P=0.156      P=0.532      P=0.268N   |  P=0.517      P=0.633N     P=0.722      P=0.666    |
|INCIDENTAL TUMOR       |  P=0.344N     P=0.308      P=0.476      P=0.529N   |  P=0.570      P=0.398N     P=0.760N     P=0.664N   |
|LOGISTIC REGRESSION    |  P=0.246N     P=0.233      P=0.522      P=0.451N   |  P=0.558      P=0.565N     P=0.750      P=0.752N   |
|COCHRAN-ARMITAGE       |  P=0.352N                                          |  P=0.574                                           |
|FISHER EXACT           |               P=0.410      P=0.500      P=0.500N   |               P=0.500N     P=0.752N     P=0.752N   |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05121 TEST: 05                                                 PAGE   2
                   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   O MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |   O MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 11/60 (18%)  13/60 (22%)  12/60 (20%)  10/60 (17%) |  1/60 (2%)    0/60 (0%)    1/60 (2%)    2/60 (3%)  |
|ADJUSTED (b)           |  41.4%        57.0%        37.7%        30.3%      |   2.4%         0.0%         3.8%         7.4%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    1/10 (10%) |  0/10 (0%)    0/0          0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  5/20 (25%)   6/14 (43%)   4/22 (18%)   7/28 (25%) |  0/34 (0%)    0/17 (0%)    1/26 (4%)    1/22 (5%)  |
|FIRST INCIDENCE (DAYS) |   673          585          589          456 (I)   |   627          ---          726 (T)      499       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.096N     P=0.156      P=0.532      P=0.268N   |  P=0.185      P=0.633N     P=0.722      P=0.357    |
|INCIDENTAL TUMOR       |  P=0.344N     P=0.308      P=0.476      P=0.529N   |  P=0.229      P=0.398N     P=0.760N     P=0.551    |
|LOGISTIC REGRESSION    |  P=0.246N     P=0.233      P=0.522      P=0.451N   |  P=0.210      P=0.565N     P=0.750      P=0.462    |
|COCHRAN-ARMITAGE       |  P=0.352N                                          |  P=0.243                                           |
|FISHER EXACT           |               P=0.410      P=0.500      P=0.500N   |               P=0.500N     P=0.752N     P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/60 (5%)    1/60 (2%)    4/58 (7%)    2/60 (3%)  |  3/59 (5%)    2/60 (3%)    3/58 (5%)    1/60 (2%)  |
|ADJUSTED (b)           |  11.1%         7.1%        11.1%         7.1%      |   9.1%        11.8%        10.4%         4.5%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    1/9 (11%)    0/10 (0%)  |  0/10 (0%)    0/0          0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/20 (5%)    1/14 (7%)    0/21 (0%)    2/28 (7%)  |  3/33 (9%)    2/17 (12%)   2/24 (8%)    1/22 (5%)  |
|FIRST INCIDENCE (DAYS) |   471          726 (T)      456 (I)      726 (T)   |   726 (T)      726 (T)      547          726 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.395N     P=0.406N     P=0.492      P=0.391N   |  P=0.337N     P=0.578      P=0.532      P=0.458N   |
|INCIDENTAL TUMOR       |  P=0.567N     P=0.344N     P=0.307      P=0.497N   |  P=0.338N     P=0.578      P=0.560      P=0.458N   |
|LOGISTIC REGRESSION    |  P=0.532N     P=0.326N     P=0.480      P=0.495N   |  P=0.347N     P=0.578      P=0.609      P=0.458N   |
|COCHRAN-ARMITAGE       |  P=0.541N                                          |  P=0.271N                                          |
|FISHER EXACT           |               P=0.309N     P=0.481      P=0.500N   |               P=0.492N     P=0.652      P=0.303N   |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05121 TEST: 05                                                 PAGE   3
                   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   O MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |   O MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/60 (5%)    2/60 (3%)    4/58 (7%)    2/60 (3%)  |  3/59 (5%)    2/60 (3%)    3/58 (5%)    1/60 (2%)  |
|ADJUSTED (b)           |  11.1%         9.1%        11.1%         7.1%      |   9.1%        11.8%        10.4%         4.5%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    1/9 (11%)    0/10 (0%)  |  0/10 (0%)    0/0          0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/20 (5%)    1/14 (7%)    0/21 (0%)    2/28 (7%)  |  3/33 (9%)    2/17 (12%)   2/24 (8%)    1/22 (5%)  |
|FIRST INCIDENCE (DAYS) |   471          492          456 (I)      726 (T)   |   726 (T)      726 (T)      547          726 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.328N     P=0.594N     P=0.492      P=0.391N   |  P=0.337N     P=0.578      P=0.532      P=0.458N   |
|INCIDENTAL TUMOR       |  P=0.503N     P=0.512N     P=0.307      P=0.497N   |  P=0.338N     P=0.578      P=0.560      P=0.458N   |
|LOGISTIC REGRESSION    |  P=0.455N     P=0.504N     P=0.480      P=0.495N   |  P=0.347N     P=0.578      P=0.609      P=0.458N   |
|COCHRAN-ARMITAGE       |  P=0.458N                                          |  P=0.271N                                          |
|FISHER EXACT           |               P=0.500N     P=0.481      P=0.500N   |               P=0.492N     P=0.652      P=0.303N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/60 (5%)    2/60 (3%)    1/60 (2%)    0/60 (0%)  |  0/60 (0%)    0/60 (0%)    0/59 (0%)    1/60 (2%)  |
|ADJUSTED (b)           |  15.0%        10.9%         4.5%         0.0%      |   0.0%         0.0%         0.0%         4.2%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/0          0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  3/20 (15%)   1/14 (7%)    1/22 (5%)    0/28 (0%)  |  0/34 (0%)    0/17 (0%)    0/26 (0%)    0/22 (0%)  |
|FIRST INCIDENCE (DAYS) |   726 (T)      678          726 (T)      ---       |   ---          ---          ---          647       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.059N     P=0.643N     P=0.268N     P=0.067N   |  P=0.195        (e)          (e)        P=0.398    |
|INCIDENTAL TUMOR       |  P=0.069N     P=0.630N     P=0.268N     P=0.067N   |  P=0.096        (e)          (e)        P=0.282    |
|LOGISTIC REGRESSION    |  P=0.076N     P=0.622N     P=0.268N     P=0.067N   |  P=0.217        (e)          (e)        P=0.455    |
|COCHRAN-ARMITAGE       |  P=0.114N                                          |  P=0.237                                           |
|FISHER EXACT           |               P=0.500N     P=0.309N     P=0.122N   |                 (e)          (e)        P=0.500    |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05121 TEST: 05                                                 PAGE   4
                   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   O MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |   O MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/60 (5%)    3/60 (5%)    1/60 (2%)    0/60 (0%)  |  0/60 (0%)    0/60 (0%)    0/59 (0%)    1/60 (2%)  |
|ADJUSTED (b)           |  15.0%        17.7%         4.5%         0.0%      |   0.0%         0.0%         0.0%         4.2%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/0          0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  3/20 (15%)   2/14 (14%)   1/22 (5%)    0/28 (0%)  |  0/34 (0%)    0/17 (0%)    0/26 (0%)    0/22 (0%)  |
|FIRST INCIDENCE (DAYS) |   726 (T)      678          726 (T)      ---       |   ---          ---          ---          647       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.038N*    P=0.508      P=0.268N     P=0.067N   |  P=0.195        (e)          (e)        P=0.398    |
|INCIDENTAL TUMOR       |  P=0.045N*    P=0.520      P=0.268N     P=0.067N   |  P=0.096        (e)          (e)        P=0.282    |
|LOGISTIC REGRESSION    |  P=0.051N     P=0.530      P=0.268N     P=0.067N   |  P=0.217        (e)          (e)        P=0.455    |
|COCHRAN-ARMITAGE       |  P=0.085N                                          |  P=0.237                                           |
|FISHER EXACT           |               P=0.660N     P=0.309N     P=0.122N   |                 (e)          (e)        P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney: Renal Tubule                                                                                                             |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/60 (3%)    0/60 (0%)    1/60 (2%)    0/60 (0%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |  10.0%         0.0%         2.1%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/0          0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  2/20 (10%)   0/14 (0%)    0/22 (0%)    0/28 (0%)  |  0/34 (0%)    0/17 (0%)    0/26 (0%)    0/22 (0%)  |
|FIRST INCIDENCE (DAYS) |   726 (T)      ---          576          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.251N     P=0.318N     P=0.465N     P=0.167N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.267N     P=0.318N     P=0.380N     P=0.167N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.306N     P=0.318N     P=0.492N     P=0.167N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.318N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.248N     P=0.500N     P=0.248N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05121 TEST: 05                                                 PAGE   5
                   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   O MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |   O MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    2/60 (3%)    2/60 (3%)    2/60 (3%)  |  1/60 (2%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   4.5%         7.7%         6.7%         6.7%      |   2.9%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/0          0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/20 (0%)    0/14 (0%)    1/22 (5%)    1/28 (4%)  |  1/34 (3%)    0/17 (0%)    0/26 (0%)    0/22 (0%)  |
|FIRST INCIDENCE (DAYS) |   720          660          596          686       |   726 (T)      ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.634N     P=0.414      P=0.519      P=0.574    |  P=0.619N     P=0.638N     P=0.553N     P=0.587N   |
|INCIDENTAL TUMOR       |  P=0.442      P=0.500      P=0.579      P=0.403    |  P=0.619N     P=0.638N     P=0.554N     P=0.587N   |
|LOGISTIC REGRESSION    |  P=0.566      P=0.453      P=0.508      P=0.530    |  P=0.619N     P=0.638N     P=0.554N     P=0.587N   |
|COCHRAN-ARMITAGE       |  P=0.534                                           |  P=0.588N                                          |
|FISHER EXACT           |               P=0.500      P=0.500      P=0.500    |               P=0.500N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/60 (3%)    3/60 (5%)    2/60 (3%)    2/60 (3%)  |  1/60 (2%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   9.3%        14.3%         6.7%         6.7%      |   2.9%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/0          0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/20 (5%)    1/14 (7%)    1/22 (5%)    1/28 (4%)  |  1/34 (3%)    0/17 (0%)    0/26 (0%)    0/22 (0%)  |
|FIRST INCIDENCE (DAYS) |   720          660          596          686       |   726 (T)      ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.388N     P=0.371      P=0.669N     P=0.603N   |  P=0.619N     P=0.638N     P=0.553N     P=0.587N   |
|INCIDENTAL TUMOR       |  P=0.569N     P=0.435      P=0.625N     P=0.655    |  P=0.619N     P=0.638N     P=0.554N     P=0.587N   |
|LOGISTIC REGRESSION    |  P=0.492N     P=0.414      P=0.688N     P=0.659N   |  P=0.619N     P=0.638N     P=0.554N     P=0.587N   |
|COCHRAN-ARMITAGE       |  P=0.543N                                          |  P=0.588N                                          |
|FISHER EXACT           |               P=0.500      P=0.691N     P=0.691N   |               P=0.500N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05121 TEST: 05                                                 PAGE   6
                   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   O MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |   O MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/60 (3%)    3/60 (5%)    2/60 (3%)    2/60 (3%)  |  1/60 (2%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   9.3%        14.3%         6.7%         6.7%      |   2.9%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/0          0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/20 (5%)    1/14 (7%)    1/22 (5%)    1/28 (4%)  |  1/34 (3%)    0/17 (0%)    0/26 (0%)    0/22 (0%)  |
|FIRST INCIDENCE (DAYS) |   720          660          596          686       |   726 (T)      ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.388N     P=0.371      P=0.669N     P=0.603N   |  P=0.619N     P=0.638N     P=0.553N     P=0.587N   |
|INCIDENTAL TUMOR       |  P=0.569N     P=0.435      P=0.625N     P=0.655    |  P=0.619N     P=0.638N     P=0.554N     P=0.587N   |
|LOGISTIC REGRESSION    |  P=0.492N     P=0.414      P=0.688N     P=0.659N   |  P=0.619N     P=0.638N     P=0.554N     P=0.587N   |
|COCHRAN-ARMITAGE       |  P=0.543N                                          |  P=0.588N                                          |
|FISHER EXACT           |               P=0.500      P=0.691N     P=0.691N   |               P=0.500N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |  1/60 (2%)    1/60 (2%)    2/60 (3%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   2.9%         5.9%         7.7%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/0          0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/20 (0%)    0/14 (0%)    0/22 (0%)    0/28 (0%)  |  1/34 (3%)    1/17 (6%)    2/26 (8%)    0/22 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   726 (T)      726 (T)      726 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.355N     P=0.600      P=0.406      P=0.587N   |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.355N     P=0.600      P=0.406      P=0.587N   |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.355N     P=0.600      P=0.406      P=0.587N   |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.309N                                          |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.752N     P=0.500      P=0.500N   |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05121 TEST: 05                                                 PAGE   7
                   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   O MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |   O MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroadenoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/60 (5%)    8/60 (13%)   3/60 (5%)    3/60 (5%)  | 29/60 (48%)  10/60 (17%)  19/60 (32%)  16/60 (27%) |
|ADJUSTED (b)           |  11.7%        31.5%        11.6%        10.7%      |  70.4%        46.1%        59.8%        58.1%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/0          0/10 (0%)    1/10 (10%) |
|TERMINAL (d)           |  1/20 (5%)    3/14 (21%)   2/22 (9%)    3/28 (11%) | 22/34 (65%)   6/17 (35%)  14/26 (54%)  11/22 (50%) |
|FIRST INCIDENCE (DAYS) |   673          404          646          726 (T)   |   562          562          404          457 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.142N     P=0.059      P=0.644N     P=0.532N   |  P=0.476N     P=0.134N     P=0.242N     P=0.322N   |
|INCIDENTAL TUMOR       |  P=0.252N     P=0.088      P=0.627      P=0.651N   |  P=0.517N     P=0.026N*    P=0.092N     P=0.251N   |
|LOGISTIC REGRESSION    |  P=0.264N     P=0.097      P=0.656N     P=0.620N   |  P=0.484N     P=0.052N     P=0.071N     P=0.235N   |
|COCHRAN-ARMITAGE       |  P=0.278N                                          |  P=0.210N                                          |
|FISHER EXACT           |               P=0.102      P=0.660N     P=0.660N   |               P<0.001N**   P=0.047N*    P=0.012N*  |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma or Adenoma                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/60 (5%)    8/60 (13%)   3/60 (5%)    3/60 (5%)  | 29/60 (48%)  10/60 (17%)  20/60 (33%)  16/60 (27%) |
|ADJUSTED (b)           |  11.7%        31.5%        11.6%        10.7%      |  70.4%        46.1%        63.1%        58.1%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/0          0/10 (0%)    1/10 (10%) |
|TERMINAL (d)           |  1/20 (5%)    3/14 (21%)   2/22 (9%)    3/28 (11%) | 22/34 (65%)   6/17 (35%)  15/26 (58%)  11/22 (50%) |
|FIRST INCIDENCE (DAYS) |   673          404          646          726 (T)   |   562          562          404          457 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.142N     P=0.059      P=0.644N     P=0.532N   |  P=0.463N     P=0.134N     P=0.315N     P=0.322N   |
|INCIDENTAL TUMOR       |  P=0.252N     P=0.088      P=0.627      P=0.651N   |  P=0.503N     P=0.026N*    P=0.136N     P=0.251N   |
|LOGISTIC REGRESSION    |  P=0.264N     P=0.097      P=0.656N     P=0.620N   |  P=0.473N     P=0.052N     P=0.105N     P=0.235N   |
|COCHRAN-ARMITAGE       |  P=0.278N                                          |  P=0.200N                                          |
|FISHER EXACT           |               P=0.102      P=0.660N     P=0.660N   |               P<0.001N**   P=0.068N     P=0.012N*  |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05121 TEST: 05                                                 PAGE   8
                   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   O MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |   O MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/60 (5%)    8/60 (13%)   3/60 (5%)    3/60 (5%)  | 29/60 (48%)  10/60 (17%)  21/60 (35%)  16/60 (27%) |
|ADJUSTED (b)           |  11.7%        31.5%        11.6%        10.7%      |  70.4%        46.1%        66.5%        58.1%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/0          0/10 (0%)    1/10 (10%) |
|TERMINAL (d)           |  1/20 (5%)    3/14 (21%)   2/22 (9%)    3/28 (11%) | 22/34 (65%)   6/17 (35%)  16/26 (62%)  11/22 (50%) |
|FIRST INCIDENCE (DAYS) |   673          404          646          726 (T)   |   562          562          404          457 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.142N     P=0.059      P=0.644N     P=0.532N   |  P=0.451N     P=0.134N     P=0.398N     P=0.322N   |
|INCIDENTAL TUMOR       |  P=0.252N     P=0.088      P=0.627      P=0.651N   |  P=0.489N     P=0.026N*    P=0.194N     P=0.251N   |
|LOGISTIC REGRESSION    |  P=0.264N     P=0.097      P=0.656N     P=0.620N   |  P=0.462N     P=0.052N     P=0.149N     P=0.235N   |
|COCHRAN-ARMITAGE       |  P=0.278N                                          |  P=0.190N                                          |
|FISHER EXACT           |               P=0.102      P=0.660N     P=0.660N   |               P<0.001N**   P=0.097N     P=0.012N*  |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva)                                                                       |
|     Squamous Cell Carcinoma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    1/60 (2%)    1/60 (2%)  |  0/60 (0%)    0/60 (0%)    2/60 (3%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         4.5%         3.6%      |   0.0%         0.0%         6.4%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/0          0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/20 (0%)    0/14 (0%)    1/22 (5%)    1/28 (4%)  |  0/34 (0%)    0/17 (0%)    1/26 (4%)    0/22 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          726 (T)      726 (T)   |   ---          ---          631          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.490        (e)        P=0.519      P=0.567    |  P=0.678N       (e)        P=0.205        (e)      |
|INCIDENTAL TUMOR       |  P=0.490        (e)        P=0.519      P=0.567    |  P=0.679N       (e)        P=0.240        (e)      |
|LOGISTIC REGRESSION    |  P=0.490        (e)        P=0.519      P=0.567    |  P=0.665N       (e)        P=0.224        (e)      |
|COCHRAN-ARMITAGE       |  P=0.376                                           |  P=0.624N                                          |
|FISHER EXACT           |                 (e)        P=0.500      P=0.500    |                 (e)        P=0.248        (e)      |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05121 TEST: 05                                                 PAGE   9
                   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   O MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |   O MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva)                                                                       |
|     Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    1/60 (2%)    1/60 (2%)    1/60 (2%)  |  0/60 (0%)    0/60 (0%)    2/60 (3%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         4.0%         4.5%         3.6%      |   0.0%         0.0%         6.4%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/0          0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/20 (0%)    0/14 (0%)    1/22 (5%)    1/28 (4%)  |  0/34 (0%)    0/17 (0%)    1/26 (4%)    0/22 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          678          726 (T)      726 (T)   |   ---          ---          631          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.653      P=0.470      P=0.519      P=0.567    |  P=0.678N       (e)        P=0.205        (e)      |
|INCIDENTAL TUMOR       |  P=0.595      P=0.500      P=0.519      P=0.567    |  P=0.679N       (e)        P=0.240        (e)      |
|LOGISTIC REGRESSION    |  P=0.600      P=0.480      P=0.519      P=0.567    |  P=0.665N       (e)        P=0.224        (e)      |
|COCHRAN-ARMITAGE       |  P=0.551                                           |  P=0.624N                                          |
|FISHER EXACT           |               P=0.500      P=0.500      P=0.500    |                 (e)        P=0.248        (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 19/59 (32%)  17/58 (29%)  14/60 (23%)  11/60 (18%) | 21/60 (35%)  13/60 (22%)  15/60 (25%)  10/60 (17%) |
|ADJUSTED (b)           |  57.6%        51.9%        43.7%        27.9%      |  51.4%        51.0%        39.2%        38.6%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     1/10 (10%)   1/10 (10%) |  1/10 (10%)   0/0          1/10 (10%)   0/10 (0%)  |
|TERMINAL (d)           |  7/19 (37%)   2/14 (14%)   6/22 (27%)   5/28 (18%) | 15/34 (44%)   6/17 (35%)   5/26 (19%)   7/22 (32%) |
|FIRST INCIDENCE (DAYS) |   471          446          456 (I)      351       |   457 (I)      408          457 (I)      520       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.016N*    P=0.445      P=0.181N     P=0.029N*  |  P=0.153N     P=0.314      P=0.385N     P=0.217N   |
|INCIDENTAL TUMOR       |  P=0.112N     P=0.405N     P=0.256N     P=0.075N   |  P=0.123N     P=0.548N     P=0.158N     P=0.125N   |
|LOGISTIC REGRESSION    |  P=0.051N     P=0.415N     P=0.155N     P=0.061N   |  P=0.105N     P=0.558N     P=0.201N     P=0.137N   |
|COCHRAN-ARMITAGE       |  P=0.060N                                          |  P=0.053N                                          |
|FISHER EXACT           |               P=0.445N     P=0.191N     P=0.063N   |               P=0.078N     P=0.160N     P=0.018N*  |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05121 TEST: 05                                                 PAGE  10
                   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   O MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |   O MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal                                                       |
|     Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepithelioma                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/60 (7%)    5/60 (8%)    3/60 (5%)    5/60 (8%)  |  1/60 (2%)    1/60 (2%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |  18.7%        27.4%        12.0%        15.2%      |   2.9%         3.3%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    1/10 (10%) |  0/10 (0%)    0/0          0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  3/20 (15%)   3/14 (21%)   2/22 (9%)    3/28 (11%) |  1/34 (3%)    0/17 (0%)    0/26 (0%)    0/22 (0%)  |
|FIRST INCIDENCE (DAYS) |   713          589          666          456 (I)   |   726 (T)      519          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.463N     P=0.306      P=0.459N     P=0.614N   |  P=0.418N     P=0.632      P=0.553N     P=0.587N   |
|INCIDENTAL TUMOR       |  P=0.593      P=0.391      P=0.502N     P=0.560    |  P=0.357N     P=0.742N     P=0.554N     P=0.587N   |
|LOGISTIC REGRESSION    |  P=0.537      P=0.374      P=0.499N     P=0.521    |  P=0.389N     P=0.708      P=0.554N     P=0.587N   |
|COCHRAN-ARMITAGE       |  P=0.468                                           |  P=0.376N                                          |
|FISHER EXACT           |               P=0.500      P=0.500N     P=0.500    |               P=0.752N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/60 (8%)    3/60 (5%)    3/60 (5%)    3/60 (5%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |  15.7%        13.0%        11.8%        10.0%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/0          0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/20 (5%)    1/14 (7%)    2/22 (9%)    2/28 (7%)  |  0/34 (0%)    0/17 (0%)    0/26 (0%)    0/22 (0%)  |
|FIRST INCIDENCE (DAYS) |   649          656          656          685       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.278N     P=0.454N     P=0.359N     P=0.267N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.489N     P=0.404N     P=0.423N     P=0.489N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.390N     P=0.407N     P=0.344N     P=0.341N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.441N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.359N     P=0.359N     P=0.359N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05121 TEST: 05                                                 PAGE  11
                   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   O MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |   O MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  6/60 (10%)   3/60 (5%)    4/60 (7%)    3/60 (5%)  |  1/60 (2%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |  17.8%        13.0%        14.3%        10.0%      |   2.9%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/0          0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/20 (5%)    1/14 (7%)    2/22 (9%)    2/28 (7%)  |  1/34 (3%)    0/17 (0%)    0/26 (0%)    0/22 (0%)  |
|FIRST INCIDENCE (DAYS) |   642          656          646          685       |   726 (T)      ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.206N     P=0.340N     P=0.378N     P=0.179N   |  P=0.619N     P=0.638N     P=0.553N     P=0.587N   |
|INCIDENTAL TUMOR       |  P=0.416N     P=0.246N     P=0.392N     P=0.350N   |  P=0.619N     P=0.638N     P=0.554N     P=0.587N   |
|LOGISTIC REGRESSION    |  P=0.507N     P=0.226N     P=0.356N     P=0.232N   |  P=0.619N     P=0.638N     P=0.554N     P=0.587N   |
|COCHRAN-ARMITAGE       |  P=0.341N                                          |  P=0.588N                                          |
|FISHER EXACT           |               P=0.245N     P=0.372N     P=0.245N   |               P=0.500N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Keratoacanthoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/60 (7%)    3/60 (5%)    3/60 (5%)    2/60 (3%)  |  1/60 (2%)    1/60 (2%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |  18.7%        18.6%        12.0%         6.8%      |   2.9%         3.3%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/0          0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  3/20 (15%)   2/14 (14%)   2/22 (9%)    1/28 (4%)  |  1/34 (3%)    0/17 (0%)    0/26 (0%)    0/22 (0%)  |
|FIRST INCIDENCE (DAYS) |   713          702          666          692       |   726 (T)      519          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.161N     P=0.627      P=0.459N     P=0.220N   |  P=0.418N     P=0.632      P=0.553N     P=0.587N   |
|INCIDENTAL TUMOR       |  P=0.250N     P=0.638N     P=0.502N     P=0.319N   |  P=0.357N     P=0.742N     P=0.554N     P=0.587N   |
|LOGISTIC REGRESSION    |  P=0.223N     P=0.651      P=0.499N     P=0.274N   |  P=0.389N     P=0.708      P=0.554N     P=0.587N   |
|COCHRAN-ARMITAGE       |  P=0.331N                                          |  P=0.376N                                          |
|FISHER EXACT           |               P=0.500N     P=0.500N     P=0.340N   |               P=0.752N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05121 TEST: 05                                                 PAGE  12
                   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   O MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |   O MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    3/60 (5%)    0/60 (0%)    2/60 (3%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%        16.6%         0.0%         5.3%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    1/10 (10%) |  0/10 (0%)    0/0          0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/20 (0%)    2/14 (14%)   0/22 (0%)    1/28 (4%)  |  0/34 (0%)    0/17 (0%)    0/26 (0%)    0/22 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          589          ---          456 (I)   |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.533      P=0.078        (e)        P=0.276    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.508      P=0.108        (e)        P=0.276    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.428      P=0.101        (e)        P=0.242    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.425                                           |    (e)                                             |
|FISHER EXACT           |               P=0.122        (e)        P=0.248    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/60 (7%)    5/60 (8%)    3/60 (5%)    4/60 (7%)  |  1/60 (2%)    1/60 (2%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |  18.7%        27.4%        12.0%        11.8%      |   2.9%         3.3%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    1/10 (10%) |  0/10 (0%)    0/0          0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  3/20 (15%)   3/14 (21%)   2/22 (9%)    2/28 (7%)  |  1/34 (3%)    0/17 (0%)    0/26 (0%)    0/22 (0%)  |
|FIRST INCIDENCE (DAYS) |   713          589          666          456 (I)   |   726 (T)      519          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.322N     P=0.306      P=0.459N     P=0.500N   |  P=0.418N     P=0.632      P=0.553N     P=0.587N   |
|INCIDENTAL TUMOR       |  P=0.453N     P=0.391      P=0.502N     P=0.608N   |  P=0.357N     P=0.742N     P=0.554N     P=0.587N   |
|LOGISTIC REGRESSION    |  P=0.498N     P=0.374      P=0.499N     P=0.630N   |  P=0.389N     P=0.708      P=0.554N     P=0.587N   |
|COCHRAN-ARMITAGE       |  P=0.561N                                          |  P=0.376N                                          |
|FISHER EXACT           |               P=0.500      P=0.500N     P=0.641N   |               P=0.752N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05121 TEST: 05                                                 PAGE  13
                   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   O MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |   O MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma, Papilloma, or Keratoacanthoma                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/60 (7%)    5/60 (8%)    3/60 (5%)    4/60 (7%)  |  1/60 (2%)    1/60 (2%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |  18.7%        27.4%        12.0%        11.8%      |   2.9%         3.3%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    1/10 (10%) |  0/10 (0%)    0/0          0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  3/20 (15%)   3/14 (21%)   2/22 (9%)    2/28 (7%)  |  1/34 (3%)    0/17 (0%)    0/26 (0%)    0/22 (0%)  |
|FIRST INCIDENCE (DAYS) |   713          589          666          456 (I)   |   726 (T)      519          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.322N     P=0.306      P=0.459N     P=0.500N   |  P=0.418N     P=0.632      P=0.553N     P=0.587N   |
|INCIDENTAL TUMOR       |  P=0.453N     P=0.391      P=0.502N     P=0.608N   |  P=0.357N     P=0.742N     P=0.554N     P=0.587N   |
|LOGISTIC REGRESSION    |  P=0.498N     P=0.374      P=0.499N     P=0.630N   |  P=0.389N     P=0.708      P=0.554N     P=0.587N   |
|COCHRAN-ARMITAGE       |  P=0.561N                                          |  P=0.376N                                          |
|FISHER EXACT           |               P=0.500      P=0.500N     P=0.641N   |               P=0.752N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 52/60 (87%)  50/60 (83%)  55/60 (92%)  53/60 (88%) |                                                    |
|ADJUSTED (b)           | 100.0%       100.0%       100.0%       100.0%      |                                                    |
|INTERIM SACRIFICE 1 (c)|  9/10 (90%)   8/10 (80%)   9/10 (90%)   9/10 (90%) |                                                    |
|TERMINAL (d)           | 20/20 (100%) 14/14 (100%) 22/22 (100%) 28/28 (100%)|                                                    |
|FIRST INCIDENCE (DAYS) |   443          404          456 (I)      456 (I)   |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.028N*    P=0.167      P=0.499      P=0.115N   |                                                    |
|INCIDENTAL TUMOR       |  P=0.385      P=0.563N     P=0.561      P=0.374    |                                                    |
|LOGISTIC REGRESSION    |  P=0.278      P=0.460N     P=0.321      P=0.362    |                                                    |
|COCHRAN-ARMITAGE       |  P=0.405                                           |                                                    |
|FISHER EXACT           |               P=0.399N     P=0.279      P=0.500    |                                                    |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05121 TEST: 05                                                 PAGE  14
                   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   O MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |   O MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    4/60 (7%)    3/60 (5%)    2/60 (3%)  |  3/60 (5%)    1/60 (2%)    2/60 (3%)    1/60 (2%)  |
|ADJUSTED (b)           |   3.1%        16.1%         9.9%         5.3%      |   8.8%         5.9%         7.7%         4.5%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    1/10 (10%) |  0/10 (0%)    0/0          0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/20 (0%)    1/14 (7%)    0/22 (0%)    1/28 (4%)  |  3/34 (9%)    1/17 (6%)    2/26 (8%)    1/22 (5%)  |
|FIRST INCIDENCE (DAYS) |   663          504          646          456 (I)   |   726 (T)      726 (T)      726 (T)      726 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.398N     P=0.141      P=0.307      P=0.555    |  P=0.448N     P=0.572N     P=0.622N     P=0.470N   |
|INCIDENTAL TUMOR       |  P=0.609      P=0.176      P=0.213      P=0.472    |  P=0.448N     P=0.572N     P=0.622N     P=0.470N   |
|LOGISTIC REGRESSION    |  P=0.515N     P=0.167      P=0.313      P=0.501    |  P=0.448N     P=0.572N     P=0.622N     P=0.470N   |
|COCHRAN-ARMITAGE       |  P=0.519N                                          |  P=0.377N                                          |
|FISHER EXACT           |               P=0.182      P=0.309      P=0.500    |               P=0.309N     P=0.500N     P=0.309N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    0/60 (0%)    3/60 (5%)    0/60 (0%)  |  2/60 (3%)    1/60 (2%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   5.0%         0.0%        13.6%         0.0%      |   5.9%         5.9%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/0          0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/20 (5%)    0/14 (0%)    3/22 (14%)   0/28 (0%)  |  2/34 (6%)    1/17 (6%)    0/26 (0%)    0/22 (0%)  |
|FIRST INCIDENCE (DAYS) |   726 (T)      ---          726 (T)      ---       |   726 (T)      726 (T)      ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.253N     P=0.571N     P=0.337      P=0.433N   |  P=0.273N     P=0.734      P=0.299N     P=0.338N   |
|INCIDENTAL TUMOR       |  P=0.253N     P=0.571N     P=0.337      P=0.433N   |  P=0.273N     P=0.734      P=0.299N     P=0.338N   |
|LOGISTIC REGRESSION    |  P=0.253N     P=0.571N     P=0.337      P=0.433N   |  P=0.273N     P=0.734      P=0.299N     P=0.338N   |
|COCHRAN-ARMITAGE       |  P=0.383N                                          |  P=0.241N                                          |
|FISHER EXACT           |               P=0.500N     P=0.309      P=0.500N   |               P=0.500N     P=0.248N     P=0.248N   |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05121 TEST: 05                                                 PAGE  15
                   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   O MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |   O MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/60 (3%)    4/60 (7%)    6/60 (10%)   2/60 (3%)  |  5/60 (8%)    2/60 (3%)    2/60 (3%)    1/60 (2%)  |
|ADJUSTED (b)           |   8.0%        16.1%        22.2%         5.3%      |  14.7%        11.8%         7.7%         4.5%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    1/10 (10%) |  0/10 (0%)    0/0          0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/20 (5%)    1/14 (7%)    3/22 (14%)   1/28 (4%)  |  5/34 (15%)   2/17 (12%)   2/26 (8%)    1/22 (5%)  |
|FIRST INCIDENCE (DAYS) |   663          504          646          456 (I)   |   726 (T)      726 (T)      726 (T)      726 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.202N     P=0.258      P=0.155      P=0.618N   |  P=0.214N     P=0.557N     P=0.334N     P=0.226N   |
|INCIDENTAL TUMOR       |  P=0.366N     P=0.306      P=0.110      P=0.687N   |  P=0.214N     P=0.557N     P=0.334N     P=0.226N   |
|LOGISTIC REGRESSION    |  P=0.326N     P=0.307      P=0.138      P=0.694    |  P=0.214N     P=0.557N     P=0.334N     P=0.226N   |
|COCHRAN-ARMITAGE       |  P=0.347N                                          |  P=0.165N                                          |
|FISHER EXACT           |               P=0.340      P=0.136      P=0.691N   |               P=0.219N     P=0.219N     P=0.103N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/60 (5%)    2/60 (3%)    1/60 (2%)    0/60 (0%)  |  1/60 (2%)    0/60 (0%)    0/60 (0%)    3/60 (5%)  |
|ADJUSTED (b)           |   8.9%        10.9%         4.2%         0.0%      |   2.9%         0.0%         0.0%        13.6%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/0          0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/20 (5%)    1/14 (7%)    0/22 (0%)    0/28 (0%)  |  1/34 (3%)    0/17 (0%)    0/26 (0%)    3/22 (14%) |
|FIRST INCIDENCE (DAYS) |   430          678          713          ---       |   726 (T)      ---          ---          726 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.081N     P=0.598N     P=0.303N     P=0.110N   |  P=0.028 *    P=0.638N     P=0.553N     P=0.164    |
|INCIDENTAL TUMOR       |  P=0.135N     P=0.486N     P=0.366N     P=0.125N   |  P=0.028 *    P=0.638N     P=0.554N     P=0.164    |
|LOGISTIC REGRESSION    |  P=0.112N     P=0.513N     P=0.306N     P=0.118N   |  P=0.028 *    P=0.638N     P=0.554N     P=0.164    |
|COCHRAN-ARMITAGE       |  P=0.114N                                          |  P=0.045 *                                         |
|FISHER EXACT           |               P=0.500N     P=0.309N     P=0.122N   |               P=0.500N     P=0.500N     P=0.309    |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05121 TEST: 05                                                 PAGE  16
                   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   O MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |   O MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/60 (7%)    2/60 (3%)    1/60 (2%)    0/60 (0%)  |  1/60 (2%)    0/60 (0%)    0/60 (0%)    3/60 (5%)  |
|ADJUSTED (b)           |  13.7%        10.9%         4.2%         0.0%      |   2.9%         0.0%         0.0%        13.6%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/0          0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  2/20 (10%)   1/14 (7%)    0/22 (0%)    0/28 (0%)  |  1/34 (3%)    0/17 (0%)    0/26 (0%)    3/22 (14%) |
|FIRST INCIDENCE (DAYS) |   430          678          713          ---       |   726 (T)      ---          ---          726 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.050N*    P=0.454N     P=0.175N     P=0.048N*  |  P=0.028 *    P=0.638N     P=0.553N     P=0.164    |
|INCIDENTAL TUMOR       |  P=0.083N     P=0.352N     P=0.209N     P=0.055N   |  P=0.028 *    P=0.638N     P=0.554N     P=0.164    |
|LOGISTIC REGRESSION    |  P=0.075N     P=0.361N     P=0.177N     P=0.064N   |  P=0.028 *    P=0.638N     P=0.554N     P=0.164    |
|COCHRAN-ARMITAGE       |  P=0.079N                                          |  P=0.045 *                                         |
|FISHER EXACT           |               P=0.340N     P=0.182N     P=0.059N   |               P=0.500N     P=0.500N     P=0.309    |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  7/60 (12%)   1/60 (2%)    4/60 (7%)    4/60 (7%)  |
|ADJUSTED (b)           |                                                    |  19.1%         2.6%        13.5%        12.8%      |
|INTERIM SACRIFICE 1 (c)|                                                    |  1/10 (10%)   0/0          0/10 (0%)    1/10 (10%) |
|TERMINAL (d)           |                                                    |  6/34 (18%)   0/17 (0%)    3/26 (12%)   1/22 (5%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   457 (I)      379          471          457 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.583      P=0.229N     P=0.400N     P=0.486N   |
|INCIDENTAL TUMOR       |                                                    |  P=0.558N     P=0.144N     P=0.398N     P=0.383N   |
|LOGISTIC REGRESSION    |                                                    |  P=0.580      P=0.091N     P=0.297N     P=0.389N   |
|COCHRAN-ARMITAGE       |                                                    |  P=0.571N                                          |
|FISHER EXACT           |                                                    |               P=0.031N*    P=0.264N     P=0.264N   |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05121 TEST: 05                                                 PAGE  17
                   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   O MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |   O MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Zymbal's Gland                                                                                                                   |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    2/60 (3%)    2/60 (3%)    2/60 (3%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         5.3%         7.5%         4.9%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/0          0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/20 (0%)    0/14 (0%)    1/22 (5%)    0/28 (0%)  |  0/34 (0%)    0/17 (0%)    0/26 (0%)    0/22 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          583          660          516       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.473      P=0.220      P=0.247      P=0.262    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.291      P=0.371      P=0.222      P=0.139    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.290      P=0.244      P=0.242      P=0.241    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.411                                           |    (e)                                             |
|FISHER EXACT           |               P=0.248      P=0.248      P=0.248    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 34/60 (57%)  21/60 (35%)  26/60 (43%)  24/60 (40%) | 20/60 (33%)   6/60 (10%)  13/60 (22%)   4/60 (7%)  |
|ADJUSTED (b)           |  86.2%        73.3%        66.5%        59.3%      |  47.3%        26.9%        38.8%        13.5%      |
|INTERIM SACRIFICE 1 (c)|  1/10 (10%)   0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/0          0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           | 15/20 (75%)   8/14 (57%)  10/22 (45%)  12/28 (43%) | 13/34 (38%)   2/17 (12%)   7/26 (27%)   2/22 (9%)  |
|FIRST INCIDENCE (DAYS) |   443          533          463          504       |   374          519          555          392       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.029N*    P=0.195N     P=0.111N     P=0.013N*  |  P=0.021N*    P=0.147N     P=0.306N     P=0.010N*  |
|INCIDENTAL TUMOR       |  P=0.313N     P=0.014N*    P=0.092N     P=0.067N   |  P=0.014N*    P=0.023N*    P=0.114N     P=0.002N** |
|LOGISTIC REGRESSION    |  P=0.290N     P=0.021N*    P=0.061N     P=0.049N*  |  P=0.011N*    P=0.040N*    P=0.144N     P=0.002N** |
|COCHRAN-ARMITAGE       |  P=0.249N                                          |  P=0.006N**                                        |
|FISHER EXACT           |               P=0.014N*    P=0.101N     P=0.050N*  |               P=0.002N**   P=0.110N     P<0.001N** |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05121 TEST: 05                                                 PAGE  18
                   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   O MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |   O MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Mesothelioma: Benign, Malignant, NOS                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    1/60 (2%)    4/60 (7%)    3/60 (5%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   3.7%         3.6%        10.9%        10.7%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/0          0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/20 (0%)    0/14 (0%)    1/22 (5%)    3/28 (11%) |  0/34 (0%)    0/17 (0%)    0/26 (0%)    0/22 (0%)  |
|FIRST INCIDENCE (DAYS) |   698          666          565          726 (T)   |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.422      P=0.715      P=0.201      P=0.406    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.279      P=0.763      P=0.340      P=0.342    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.313      P=0.739      P=0.183      P=0.354    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.293                                           |    (e)                                             |
|FISHER EXACT           |               P=0.752N     P=0.182      P=0.309    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 57/60 (95%)  57/60 (95%)  58/60 (97%)  57/60 (95%) | 39/60 (65%)  19/60 (32%)  33/60 (55%)  30/60 (50%) |
|ADJUSTED (b)           | 100.0%       100.0%       100.0%       100.0%      |  84.4%        65.7%        83.8%        87.9%      |
|INTERIM SACRIFICE 1 (c)|  9/10 (90%)   8/10 (80%)  10/10 (100%)  9/10 (90%) |  2/10 (20%)   0/0          1/10 (10%)   2/10 (20%) |
|TERMINAL (d)           | 20/20 (100%) 14/14 (100%) 22/22 (100%) 28/28 (100%)| 27/34 (79%)   8/17 (47%)  20/26 (77%)  18/22 (82%) |
|FIRST INCIDENCE (DAYS) |   430          404          456 (I)      351       |   457 (I)      379          404          457 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.020N*    P=0.115      P=0.498N     P=0.110N   |  P=0.207      P=0.547N     P=0.479      P=0.235    |
|INCIDENTAL TUMOR       |  P=0.313      P=0.647      P=0.579      P=0.397    |  P=0.206      P=0.037N*    P=0.316N     P=0.454    |
|LOGISTIC REGRESSION    |  P=0.311      P=0.666      P=0.545      P=0.408    |  P=0.218      P=0.088N     P=0.264N     P=0.442    |
|COCHRAN-ARMITAGE       |  P=0.587N                                          |  P=0.532N                                          |
|FISHER EXACT           |               P=0.660N     P=0.500      P=0.660N   |               P<0.001N**   P=0.176N     P=0.070N   |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05121 TEST: 05                                                 PAGE  19
                   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   O MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |   O MG/KG      1 MG/KG      5 MG/KG      25 MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 39/60 (65%)  27/60 (45%)  31/60 (52%)  29/60 (48%) | 23/60 (38%)   9/60 (15%)  16/60 (27%)   6/60 (10%) |
|ADJUSTED (b)           |  92.4%        84.1%        76.1%        65.2%      |  54.8%        41.5%        45.7%        19.5%      |
|INTERIM SACRIFICE 1 (c)|  1/10 (10%)   0/10 (0%)    0/10 (0%)    1/10 (10%) |  0/10 (0%)    0/0          0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           | 17/20 (85%)  10/14 (71%)  13/22 (59%)  13/28 (46%) | 16/34 (47%)   5/17 (29%)   8/26 (31%)   3/22 (14%) |
|FIRST INCIDENCE (DAYS) |   443          492          463          456 (I)   |   374          519          555          391       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.020N*    P=0.310N     P=0.113N     P=0.014N*  |  P=0.022N*    P=0.283N     P=0.361N     P=0.014N*  |
|INCIDENTAL TUMOR       |  P=0.303N     P=0.014N*    P=0.057N     P=0.082N   |  P=0.014N*    P=0.079N     P=0.128N     P=0.002N** |
|LOGISTIC REGRESSION    |  P=0.299N     P=0.013N*    P=0.027N*    P=0.050N*  |  P=0.010N*    P=0.118N     P=0.166N     P=0.003N** |
|COCHRAN-ARMITAGE       |  P=0.224N                                          |  P=0.005N**                                        |
|FISHER EXACT           |               P=0.022N*    P=0.097N     P=0.048N*  |               P=0.003N**   P=0.121N     P<0.001N** |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 58/60 (97%)  57/60 (95%)  59/60 (98%)  57/60 (95%) | 50/60 (83%)  23/60 (38%)  40/60 (67%)  33/60 (55%) |
|ADJUSTED (b)           | 100.0%       100.0%       100.0%       100.0%      |  96.1%        78.4%        92.8%        88.7%      |
|INTERIM SACRIFICE 1 (c)|  9/10 (90%)   8/10 (80%)  10/10 (100%)  9/10 (90%) |  2/10 (20%)   0/0          1/10 (10%)   2/10 (20%) |
|TERMINAL (d)           | 20/20 (100%) 14/14 (100%) 22/22 (100%) 28/28 (100%)| 32/34 (94%)  11/17 (65%)  23/26 (88%)  18/22 (82%) |
|FIRST INCIDENCE (DAYS) |   430          404          456 (I)      351       |   374          379          404          391       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.017N*    P=0.142      P=0.495N     P=0.088N   |  P=0.488      P=0.391N     P=0.490N     P=0.537N   |
|INCIDENTAL TUMOR       |  P=0.404      P=0.500N     P=0.500      P=0.621    |  P=0.556N     P<0.001N**   P=0.026N*    P=0.054N   |
|LOGISTIC REGRESSION    |  P=0.433      P=0.530N     P=0.570      P=0.630    |  P=0.476N     P=0.006N**   P=0.040N*    P=0.093N   |
|COCHRAN-ARMITAGE       |  P=0.457N                                          |  P=0.169N                                          |
|FISHER EXACT           |               P=0.500N     P=0.500      P=0.500N   |               P<0.001N**   P=0.028N*    P<0.001N** |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05121 TEST: 05                                                 PAGE  20
                   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 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).