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TDMS Study 05212-05 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                                          OXAZEPAM                                       DATE: 07/19/96       
EXPERIMENT: 05212 TEST: 05                                                                                     TIME: 16:29:30       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-15322                              ROUTE: DOSED FEED                                              NTP C#: 62453B       
PATHOLOGIST: RYAN, M.                                                                                          CAS: 604-75-1        
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                             CORE STUDY                                                             
                                                                                                                                    
               REASONS FOR REMOVAL:    25022 Accidently Killed                                                                      
                                       25019 Moribund Sacrifice                                                                     
                                       25020 Natural Death                                                                          
                                       25021 Terminal Sacrifice                                                                     
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 001    0 PPM                                                                         
                                       INCLUDE 002    0 PPM                                                                         
                                       INCLUDE 003    625 PPM                                                                       
                                       INCLUDE 004    625 PPM                                                                       
                                       INCLUDE 007    2500 PPM                                                                      
                                       INCLUDE 008    2500 PPM                                                                      
                                       INCLUDE 009    5000 PPM                                                                      
                                       INCLUDE 010    5000 PPM                                                                      
                                       INCLUDE 011    10,000  PPM STOP                                                              
                                       INCLUDE 012    10,000  PPM STOP                                                              
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                                          OXAZEPAM                                       DATE: 07/19/96       
EXPERIMENT: 05212 TEST: 05                                                                                     TIME: 16:29:30       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-15322                              ROUTE: DOSED FEED                                              NTP C#: 62453B       
PATHOLOGIST: RYAN, M.                                                                                          CAS: 604-75-1        


                                                    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                                          OXAZEPAM                                       DATE: 07/19/96       
EXPERIMENT: 05212 TEST: 05                                                                                     TIME: 16:29:30       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-15322                              ROUTE: DOSED FEED                                              NTP C#: 62453B       
PATHOLOGIST: RYAN, M.                                                                                          CAS: 604-75-1        


                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                            IN THE ANALYSIS OF THE STUDY OF OXAZEPAM
              ====================================================================================================
                                                           MALE RATS
                                                          -------------
                  ORGAN                               MORPHOLOGY
                 -------                             ------------
              Adrenal Medulla               Pheochromocytoma Benign
                                            Pheochromocytoma: Benign, Complex, Malignant, NOS
              Clitoral/Preputial Gland      Adenoma
                                            Carcinoma or Adenoma
              Mammary Gland                 Carcinoma or Adenoma
                                            Fibroadenoma
              Pituitary Gland: Pars Distalis or Unspecified Site
                                            Adenoma
                                            Carcinoma or Adenoma
              Skin                          Fibroma
              Skin: Sebaceous Gland         Adenoma
              Testes                        Adenoma
              Thyroid Gland: C-Cell         Adenoma
                                            Carcinoma or Adenoma
              Thyroid Gland: Follicular Cell
                                            Carcinoma or Adenoma
              All Organs                    Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
                                            Benign Tumors
                                            Malignant Tumors
                                            Malignant and Benign Tumors
              ====================================================================================================
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                                          OXAZEPAM                                       DATE: 07/19/96       
EXPERIMENT: 05212 TEST: 05                                                                                     TIME: 16:29:30       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-15322                              ROUTE: DOSED FEED                                              NTP C#: 62453B       
PATHOLOGIST: RYAN, M.                                                                                          CAS: 604-75-1        


                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                            IN THE ANALYSIS OF THE STUDY OF OXAZEPAM
              ====================================================================================================
                                                           FEMALE RATS
                                                          -------------
                  ORGAN                               MORPHOLOGY
                 -------                             ------------
              Clitoral/Preputial Gland      Adenoma
                                            Carcinoma or Adenoma
              Mammary Gland                 Fibroadenoma
                                            Fibroma, Fibroadenoma or Adenoma
                                            Fibroma, Fibroadenoma, Carcinoma, or Adenoma
              Pituitary Gland: Pars Distalis or Unspecified Site
                                            Adenoma
                                            Carcinoma or Adenoma
              Skin                          Fibroma
              All Organs                    Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
                                            Benign Tumors
                                            Malignant Tumors
                                            Malignant and Benign Tumors
              ====================================================================================================
         DATE: 07/19/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE   1
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- OXAZEPAM
                       TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE                   |         0 PPM              625 PPM            2500 PPM           5000 PPM           10,000              |
|                       |                                                                                     PPM STOP            |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |       14/50 (28%)         9/50 (18%)         6/50 (12%)         3/50 (6%)          0/1 (0%)             |
|ADJUSTED (b)           |        44.1%              42.4%              38.8%               8.8%               0.0%                |
|TERMINAL (d)           |        3/17 (18%)         2/11 (18%)         1/6 (17%)          0/0                0/0                  |
|FIRST INCIDENCE (DAYS) |         571                557                655                452                ---                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.040N*          P=0.562N           P=0.529N           P=0.543            P=0.045N*            |
|INCIDENTAL TUMOR       |        P=0.030N*          P=0.300N           P=0.041N*          P=0.059N           P=0.521N             |
|LOGISTIC REGRESSION    |        P=0.049N*          P=0.259N           P=0.022N*          P=0.049N*          P=0.675N             |
|COCHRAN-ARMITAGE       |        P=0.004N**                                                                                       |
|FISHER EXACT           |                           P=0.171N           P=0.039N*          P=0.003N**         P=0.725N             |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |       14/50 (28%)         9/50 (18%)         6/50 (12%)         3/50 (6%)          1/1 (100%)           |
|ADJUSTED (b)           |        44.1%              42.4%              38.8%               8.8%              10.0%                |
|TERMINAL (d)           |        3/17 (18%)         2/11 (18%)         1/6 (17%)          0/0                0/0                  |
|FIRST INCIDENCE (DAYS) |         571                557                655                452                690                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.101N           P=0.562N           P=0.529N           P=0.543            P=0.132N             |
|INCIDENTAL TUMOR       |        P=0.170N           P=0.300N           P=0.041N*          P=0.059N           P=0.521              |
|LOGISTIC REGRESSION    |        P=0.246N           P=0.259N           P=0.022N*          P=0.049N*          P=0.345              |
|COCHRAN-ARMITAGE       |        P=0.028N*                                                                                        |
|FISHER EXACT           |                           P=0.171N           P=0.039N*          P=0.003N**         P=0.294              |
|=================================================================================================================================|
         DATE: 07/19/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE   2
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- OXAZEPAM
                       TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE                   |         0 PPM              625 PPM            2500 PPM           5000 PPM           10,000              |
|                       |                                                                                     PPM STOP            |
|=================================================================================================================================|
|                                                                                                                                 |
|Brain                                                                                                                            |
|     Oligodendroglioma, Glioma, or Astrocytoma                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/50 (0%)          0/50 (0%)          2/50 (4%)          0/50 (0%)          0/2 (0%)             |
|ADJUSTED (b)           |         0.0%               0.0%              15.3%               0.0%               0.0%                |
|TERMINAL (d)           |        0/17 (0%)          0/11 (0%)          0/6 (0%)           0/0                0/0                  |
|FIRST INCIDENCE (DAYS) |         ---                ---                662                ---                ---                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.626              (e)              P=0.112              (e)                (e)                |
|INCIDENTAL TUMOR       |        P=0.595              (e)              P=0.249              (e)                (e)                |
|LOGISTIC REGRESSION    |        P=0.560              (e)              P=0.174              (e)                (e)                |
|COCHRAN-ARMITAGE       |        P=0.721                                                                                          |
|FISHER EXACT           |                             (e)              P=0.247              (e)                (e)                |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |        7/48 (15%)         9/50 (18%)         5/50 (10%)         4/49 (8%)         10/14 (71%)           |
|ADJUSTED (b)           |        29.8%              38.8%              30.2%              17.7%              73.6%                |
|TERMINAL (d)           |        3/17 (18%)         3/11 (27%)         1/6 (17%)          0/0                0/0                  |
|FIRST INCIDENCE (DAYS) |         601                523                613                529                584                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.004 **         P=0.178            P=0.371            P=0.069            P=0.001 **           |
|INCIDENTAL TUMOR       |        P<0.001 **         P=0.432            P=0.420N           P=0.592N           P<0.001 **           |
|LOGISTIC REGRESSION    |        P<0.001 **         P=0.362            P=0.558N           P=0.656N           P<0.001 **           |
|COCHRAN-ARMITAGE       |        P<0.001 **                                                                                       |
|FISHER EXACT           |                           P=0.428            P=0.351N           P=0.250N           P<0.001 **           |
|=================================================================================================================================|
         DATE: 07/19/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE   3
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- OXAZEPAM
                       TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE                   |         0 PPM              625 PPM            2500 PPM           5000 PPM           10,000              |
|                       |                                                                                     PPM STOP            |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |        8/48 (17%)         9/50 (18%)         5/50 (10%)         4/49 (8%)         10/14 (71%)           |
|ADJUSTED (b)           |        31.5%              38.8%              30.2%              17.7%              73.6%                |
|TERMINAL (d)           |        3/17 (18%)         3/11 (27%)         1/6 (17%)          0/0                0/0                  |
|FIRST INCIDENCE (DAYS) |         541                523                613                529                584                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.008 **         P=0.257            P=0.494            P=0.143            P=0.004 **           |
|INCIDENTAL TUMOR       |        P<0.001 **         P=0.572            P=0.301N           P=0.333N           P<0.001 **           |
|LOGISTIC REGRESSION    |        P<0.001 **         P=0.507            P=0.377N           P=0.432N           P<0.001 **           |
|COCHRAN-ARMITAGE       |        P=0.002 **                                                                                       |
|FISHER EXACT           |                           P=0.537            P=0.250N           P=0.168N           P<0.001 **           |
|=================================================================================================================================|
|                                                                                                                                 |
|Intestine Large: Colon/Rectum                                                                                                    |
|     Polyp Adenomatous                                                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/50 (0%)          2/50 (4%)          0/50 (0%)          0/50 (0%)          0/50 (0%)            |
|ADJUSTED (b)           |         0.0%              11.6%               0.0%               0.0%               0.0%                |
|TERMINAL (d)           |        0/17 (0%)          1/11 (9%)          0/6 (0%)           0/0                0/0                  |
|FIRST INCIDENCE (DAYS) |         ---                571                ---                ---                ---                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.457N           P=0.180              (e)                (e)                (e)                |
|INCIDENTAL TUMOR       |        P=0.336N           P=0.275              (e)                (e)                (e)                |
|LOGISTIC REGRESSION    |        P=0.286N           P=0.218              (e)                (e)                (e)                |
|COCHRAN-ARMITAGE       |        P=0.247N                                                                                         |
|FISHER EXACT           |                           P=0.247              (e)                (e)                (e)                |
|=================================================================================================================================|
         DATE: 07/19/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE   4
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- OXAZEPAM
                       TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE                   |         0 PPM              625 PPM            2500 PPM           5000 PPM           10,000              |
|                       |                                                                                     PPM STOP            |
|=================================================================================================================================|
|                                                                                                                                 |
|Intestine Small: Jejunum                                                                                                         |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        2/50 (4%)          0/50 (0%)          0/50 (0%)          0/50 (0%)          0/50 (0%)            |
|ADJUSTED (b)           |         9.1%               0.0%               0.0%               0.0%               0.0%                |
|TERMINAL (d)           |        1/17 (6%)          0/11 (0%)          0/6 (0%)           0/0                0/0                  |
|FIRST INCIDENCE (DAYS) |         690                ---                ---                ---                ---                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.463N           P=0.351N           P=0.477N           P=0.918N           P=0.712N             |
|INCIDENTAL TUMOR       |        P=0.331N           P=0.357N           P=0.340N           P=0.753N           P=0.511N             |
|LOGISTIC REGRESSION    |        P=0.345N           P=0.328N           P=0.374N           P=0.729N           P=0.506N             |
|COCHRAN-ARMITAGE       |        P=0.177N                                                                                         |
|FISHER EXACT           |                           P=0.247N           P=0.247N           P=0.247N           P=0.247N             |
|=================================================================================================================================|
|                                                                                                                                 |
|Intestine Small: Site Unspecified                                                                                                |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        2/50 (4%)          0/50 (0%)          0/50 (0%)          0/50 (0%)          0/50 (0%)            |
|ADJUSTED (b)           |         9.1%               0.0%               0.0%               0.0%               0.0%                |
|TERMINAL (d)           |        1/17 (6%)          0/11 (0%)          0/6 (0%)           0/0                0/0                  |
|FIRST INCIDENCE (DAYS) |         690                ---                ---                ---                ---                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.463N           P=0.351N           P=0.477N           P=0.918N           P=0.712N             |
|INCIDENTAL TUMOR       |        P=0.331N           P=0.357N           P=0.340N           P=0.753N           P=0.511N             |
|LOGISTIC REGRESSION    |        P=0.345N           P=0.328N           P=0.374N           P=0.729N           P=0.506N             |
|COCHRAN-ARMITAGE       |        P=0.177N                                                                                         |
|FISHER EXACT           |                           P=0.247N           P=0.247N           P=0.247N           P=0.247N             |
|=================================================================================================================================|
         DATE: 07/19/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE   5
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- OXAZEPAM
                       TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE                   |         0 PPM              625 PPM            2500 PPM           5000 PPM           10,000              |
|                       |                                                                                     PPM STOP            |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |        2/50 (4%)          0/48 (0%)          0/49 (0%)          0/50 (0%)          0/0 (0%)             |
|ADJUSTED (b)           |         6.7%               0.0%               0.0%               0.0%               0.0%                |
|TERMINAL (d)           |        0/17 (0%)          0/11 (0%)          0/6 (0%)           0/0                0/0                  |
|FIRST INCIDENCE (DAYS) |         682                ---                ---                ---                ---                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.371N           P=0.362N           P=0.445N           P=0.750N           P=0.547N             |
|INCIDENTAL TUMOR       |        P=0.405N           P=0.374N           P=0.225N           P=0.546N             (e)                |
|LOGISTIC REGRESSION    |        P=0.405N           P=0.374N           P=0.225N           P=0.546N             (e)                |
|COCHRAN-ARMITAGE       |        P=0.282N                                                                                         |
|FISHER EXACT           |                           P=0.258N           P=0.253N           P=0.247N           P=1.000N             |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |        3/50 (6%)          0/48 (0%)          0/49 (0%)          0/50 (0%)          0/0 (0%)             |
|ADJUSTED (b)           |         9.9%               0.0%               0.0%               0.0%               0.0%                |
|TERMINAL (d)           |        0/17 (0%)          0/11 (0%)          0/6 (0%)           0/0                0/0                  |
|FIRST INCIDENCE (DAYS) |         682                ---                ---                ---                ---                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.262N           P=0.232N           P=0.321N           P=0.648N           P=0.407N             |
|INCIDENTAL TUMOR       |        P=0.222N           P=0.237N           P=0.108N           P=0.412N             (e)                |
|LOGISTIC REGRESSION    |        P=0.222N           P=0.237N           P=0.108N           P=0.412N             (e)                |
|COCHRAN-ARMITAGE       |        P=0.140N                                                                                         |
|FISHER EXACT           |                           P=0.129N           P=0.125N           P=0.121N           P=1.000N             |
|=================================================================================================================================|
         DATE: 07/19/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE   6
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- OXAZEPAM
                       TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE                   |         0 PPM              625 PPM            2500 PPM           5000 PPM           10,000              |
|                       |                                                                                     PPM STOP            |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney: Renal Tubule                                                                                                             |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |        1/50 (2%)          0/50 (0%)          3/50 (6%)          1/50 (2%)          0/42 (0%)            |
|ADJUSTED (b)           |         5.6%               0.0%              23.8%              16.7%               0.0%                |
|TERMINAL (d)           |        0/17 (0%)          0/11 (0%)          1/6 (17%)          0/0                0/0                  |
|FIRST INCIDENCE (DAYS) |         723                ---                641                634                ---                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.454            P=0.598N           P=0.099            P=0.159              (e)                |
|INCIDENTAL TUMOR       |        P=0.410N           P=0.617N           P=0.296            P=0.748            P=0.523N             |
|LOGISTIC REGRESSION    |        P=0.559N           P=0.588N           P=0.188            P=0.503            P=0.918N             |
|COCHRAN-ARMITAGE       |        P=0.395N                                                                                         |
|FISHER EXACT           |                           P=0.500N           P=0.309            P=0.753N           P=0.543N             |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |        1/50 (2%)          0/50 (0%)          0/49 (0%)          3/50 (6%)          1/50 (2%)            |
|ADJUSTED (b)           |         5.9%               0.0%               0.0%               8.9%               2.6%                |
|TERMINAL (d)           |        1/17 (6%)          0/11 (0%)          0/6 (0%)           0/0                0/0                  |
|FIRST INCIDENCE (DAYS) |         730 (T)            ---                ---                451                585                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.165            P=0.587N           P=0.707N           P=0.073            P=0.495              |
|INCIDENTAL TUMOR       |        P=0.153            P=0.587N           P=0.707N           P=0.386            P=0.767              |
|LOGISTIC REGRESSION    |        P=0.333            P=0.587N           P=0.707N           P=0.419            P=0.742              |
|COCHRAN-ARMITAGE       |        P=0.294                                                                                          |
|FISHER EXACT           |                           P=0.500N           P=0.505N           P=0.309            P=0.753N             |
|=================================================================================================================================|
         DATE: 07/19/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE   7
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- OXAZEPAM
                       TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE                   |         0 PPM              625 PPM            2500 PPM           5000 PPM           10,000              |
|                       |                                                                                     PPM STOP            |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |        2/50 (4%)          0/50 (0%)          0/49 (0%)          3/50 (6%)          1/50 (2%)            |
|ADJUSTED (b)           |         8.4%               0.0%               0.0%               8.9%               2.6%                |
|TERMINAL (d)           |        1/17 (6%)          0/11 (0%)          0/6 (0%)           0/0                0/0                  |
|FIRST INCIDENCE (DAYS) |         608                ---                ---                451                585                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.318            P=0.325N           P=0.368N           P=0.144            P=0.741              |
|INCIDENTAL TUMOR       |        P=0.411            P=0.184N           P=0.229N           P=0.718            P=0.438N             |
|LOGISTIC REGRESSION    |        P=0.517            P=0.269N           P=0.268N           P=0.637            P=0.504N             |
|COCHRAN-ARMITAGE       |        P=0.467                                                                                          |
|FISHER EXACT           |                           P=0.247N           P=0.253N           P=0.500            P=0.500N             |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |        2/50 (4%)          0/50 (0%)          0/49 (0%)          3/50 (6%)          1/50 (2%)            |
|ADJUSTED (b)           |         8.4%               0.0%               0.0%               8.9%               2.6%                |
|TERMINAL (d)           |        1/17 (6%)          0/11 (0%)          0/6 (0%)           0/0                0/0                  |
|FIRST INCIDENCE (DAYS) |         608                ---                ---                451                585                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.318            P=0.325N           P=0.368N           P=0.144            P=0.741              |
|INCIDENTAL TUMOR       |        P=0.411            P=0.184N           P=0.229N           P=0.718            P=0.438N             |
|LOGISTIC REGRESSION    |        P=0.517            P=0.269N           P=0.268N           P=0.637            P=0.504N             |
|COCHRAN-ARMITAGE       |        P=0.467                                                                                          |
|FISHER EXACT           |                           P=0.247N           P=0.253N           P=0.500            P=0.500N             |
|=================================================================================================================================|
         DATE: 07/19/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE   8
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- OXAZEPAM
                       TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE                   |         0 PPM              625 PPM            2500 PPM           5000 PPM           10,000              |
|                       |                                                                                     PPM STOP            |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |        1/50 (2%)          0/50 (0%)          1/50 (2%)          0/50 (0%)          0/3 (0%)             |
|ADJUSTED (b)           |         2.2%               0.0%              16.7%               0.0%               0.0%                |
|TERMINAL (d)           |        0/17 (0%)          0/11 (0%)          1/6 (17%)          0/0                0/0                  |
|FIRST INCIDENCE (DAYS) |         517                ---                730 (T)            ---                ---                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.580N           P=0.518N           P=0.643            P=0.566N           P=0.504N             |
|INCIDENTAL TUMOR       |        P=0.733N           P=0.419N           P=0.652            P=0.266N             (e)                |
|LOGISTIC REGRESSION    |        P=0.629N           P=0.353N           P=0.749N           P=0.341N           P=0.999N             |
|COCHRAN-ARMITAGE       |        P=0.591N                                                                                         |
|FISHER EXACT           |                           P=0.500N           P=0.753N           P=0.500N           P=0.943N             |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |        1/50 (2%)          1/50 (2%)          2/50 (4%)          0/50 (0%)          0/3 (0%)             |
|ADJUSTED (b)           |         2.2%               9.1%              23.6%               0.0%               0.0%                |
|TERMINAL (d)           |        0/17 (0%)          1/11 (9%)          1/6 (17%)          0/0                0/0                  |
|FIRST INCIDENCE (DAYS) |         517                730 (T)            689                ---                ---                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.581N           P=0.702            P=0.283            P=0.566N           P=0.504N             |
|INCIDENTAL TUMOR       |        P=0.735N           P=0.762            P=0.393            P=0.266N             (e)                |
|LOGISTIC REGRESSION    |        P=0.647N           P=0.751N           P=0.493            P=0.341N           P=0.999N             |
|COCHRAN-ARMITAGE       |        P=0.456N                                                                                         |
|FISHER EXACT           |                           P=0.753N           P=0.500            P=0.500N           P=0.943N             |
|=================================================================================================================================|
         DATE: 07/19/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE   9
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- OXAZEPAM
                       TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE                   |         0 PPM              625 PPM            2500 PPM           5000 PPM           10,000              |
|                       |                                                                                     PPM STOP            |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/50 (0%)          0/50 (0%)          0/50 (0%)          0/50 (0%)          1/50 (2%)            |
|ADJUSTED (b)           |         0.0%               0.0%               0.0%               0.0%              10.0%                |
|TERMINAL (d)           |        0/17 (0%)          0/11 (0%)          0/6 (0%)           0/0                0/0                  |
|FIRST INCIDENCE (DAYS) |         ---                ---                ---                ---                690                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.060              (e)                (e)                (e)              P=0.288              |
|INCIDENTAL TUMOR       |        P=0.159              (e)                (e)                (e)              P=0.489              |
|LOGISTIC REGRESSION    |        P=0.073              (e)                (e)                (e)              P=0.368              |
|COCHRAN-ARMITAGE       |        P=0.142                                                                                          |
|FISHER EXACT           |                             (e)                (e)                (e)              P=0.500              |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/50 (0%)          0/50 (0%)          0/50 (0%)          1/50 (2%)          1/50 (2%)            |
|ADJUSTED (b)           |         0.0%               0.0%               0.0%               2.5%               3.4%                |
|TERMINAL (d)           |        0/17 (0%)          0/11 (0%)          0/6 (0%)           0/0                0/0                  |
|FIRST INCIDENCE (DAYS) |         ---                ---                ---                452                614                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.146              (e)                (e)              P=0.455            P=0.457              |
|INCIDENTAL TUMOR       |        P=0.193              (e)                (e)              P=0.734            P=0.767              |
|LOGISTIC REGRESSION    |        P=0.162              (e)                (e)              P=0.766            P=0.530              |
|COCHRAN-ARMITAGE       |        P=0.152                                                                                          |
|FISHER EXACT           |                             (e)                (e)              P=0.500            P=0.500              |
|=================================================================================================================================|
         DATE: 07/19/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE  10
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- OXAZEPAM
                       TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE                   |         0 PPM              625 PPM            2500 PPM           5000 PPM           10,000              |
|                       |                                                                                     PPM STOP            |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/50 (0%)          0/50 (0%)          0/50 (0%)          1/50 (2%)          2/50 (4%)            |
|ADJUSTED (b)           |         0.0%               0.0%               0.0%               2.5%              13.1%                |
|TERMINAL (d)           |        0/17 (0%)          0/11 (0%)          0/6 (0%)           0/0                0/0                  |
|FIRST INCIDENCE (DAYS) |         ---                ---                ---                452                614                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.017 *            (e)                (e)              P=0.455            P=0.114              |
|INCIDENTAL TUMOR       |        P=0.044 *            (e)                (e)              P=0.734            P=0.366              |
|LOGISTIC REGRESSION    |        P=0.032 *            (e)                (e)              P=0.766            P=0.204              |
|COCHRAN-ARMITAGE       |        P=0.031 *                                                                                        |
|FISHER EXACT           |                             (e)                (e)              P=0.500            P=0.247              |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroadenoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        4/50 (8%)          5/50 (10%)         4/50 (8%)          2/50 (4%)          0/50 (0%)            |
|ADJUSTED (b)           |        18.2%              32.9%              38.9%               7.4%               0.0%                |
|TERMINAL (d)           |        1/17 (6%)          3/11 (27%)         2/6 (33%)          0/0                0/0                  |
|FIRST INCIDENCE (DAYS) |         698                481                655                452                ---                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.465N           P=0.280            P=0.213            P=0.330            P=0.537N             |
|INCIDENTAL TUMOR       |        P=0.143N           P=0.257            P=0.453            P=0.662N           P=0.127N             |
|LOGISTIC REGRESSION    |        P=0.052N           P=0.336            P=0.384            P=0.592N           P=0.214N             |
|COCHRAN-ARMITAGE       |        P=0.017N*                                                                                        |
|FISHER EXACT           |                           P=0.500            P=0.643N           P=0.339N           P=0.059N             |
|=================================================================================================================================|
         DATE: 07/19/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE  11
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- OXAZEPAM
                       TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE                   |         0 PPM              625 PPM            2500 PPM           5000 PPM           10,000              |
|                       |                                                                                     PPM STOP            |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma or Adenoma                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        4/50 (8%)          5/50 (10%)         4/50 (8%)          2/50 (4%)          1/50 (2%)            |
|ADJUSTED (b)           |        18.2%              32.9%              38.9%               7.4%              10.0%                |
|TERMINAL (d)           |        1/17 (6%)          3/11 (27%)         2/6 (33%)          0/0                0/0                  |
|FIRST INCIDENCE (DAYS) |         698                481                655                452                690                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.428            P=0.280            P=0.213            P=0.330            P=0.608              |
|INCIDENTAL TUMOR       |        P=0.322N           P=0.257            P=0.453            P=0.662N           P=0.321N             |
|LOGISTIC REGRESSION    |        P=0.148N           P=0.336            P=0.384            P=0.592N           P=0.515N             |
|COCHRAN-ARMITAGE       |        P=0.056N                                                                                         |
|FISHER EXACT           |                           P=0.500            P=0.643N           P=0.339N           P=0.181N             |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        4/50 (8%)          5/50 (10%)         4/50 (8%)          2/50 (4%)          2/50 (4%)            |
|ADJUSTED (b)           |        18.2%              32.9%              38.9%               7.4%              13.1%                |
|TERMINAL (d)           |        1/17 (6%)          3/11 (27%)         2/6 (33%)          0/0                0/0                  |
|FIRST INCIDENCE (DAYS) |         698                481                655                452                614                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.222            P=0.280            P=0.213            P=0.330            P=0.345              |
|INCIDENTAL TUMOR       |        P=0.497N           P=0.257            P=0.453            P=0.662N           P=0.410N             |
|LOGISTIC REGRESSION    |        P=0.283N           P=0.336            P=0.384            P=0.592N           P=0.614N             |
|COCHRAN-ARMITAGE       |        P=0.134N                                                                                         |
|FISHER EXACT           |                           P=0.500            P=0.643N           P=0.339N           P=0.339N             |
|=================================================================================================================================|
         DATE: 07/19/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE  12
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- OXAZEPAM
                       TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE                   |         0 PPM              625 PPM            2500 PPM           5000 PPM           10,000              |
|                       |                                                                                     PPM STOP            |
|=================================================================================================================================|
|                                                                                                                                 |
|Pancreas                                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |        2/50 (4%)          1/48 (2%)          1/49 (2%)          0/50 (0%)          0/0 (0%)             |
|ADJUSTED (b)           |        11.8%               4.5%               3.7%               0.0%               0.0%                |
|TERMINAL (d)           |        2/17 (12%)         0/11 (0%)          0/6 (0%)           0/0                0/0                  |
|FIRST INCIDENCE (DAYS) |         730 (T)            642                641                ---                ---                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.432N           P=0.653N           P=0.720              (e)                (e)                |
|INCIDENTAL TUMOR       |        P=0.455N           P=0.503N           P=0.639N             (e)                (e)                |
|LOGISTIC REGRESSION    |        P=0.455N           P=0.503N           P=0.639N             (e)                (e)                |
|COCHRAN-ARMITAGE       |        P=0.255N                                                                                         |
|FISHER EXACT           |                           P=0.515N           P=0.508N           P=0.247N           P=1.000N             |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |       17/49 (35%)        12/50 (24%)        10/50 (20%)         2/48 (4%)          5/5 (100%)           |
|ADJUSTED (b)           |        61.7%              41.5%              56.7%              10.9%              49.7%                |
|TERMINAL (d)           |        8/17 (47%)         1/11 (9%)          1/6 (17%)          0/0                0/0                  |
|FIRST INCIDENCE (DAYS) |         471                481                600                529                627                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.444N           P=0.577N           P=0.330            P=0.573N           P=0.310              |
|INCIDENTAL TUMOR       |        P=0.490            P=0.254N           P=0.261N           P=0.055N           P=0.009 **           |
|LOGISTIC REGRESSION    |        P=0.377            P=0.246N           P=0.246N           P=0.030N*          P=0.010 **           |
|COCHRAN-ARMITAGE       |        P=0.313N                                                                                         |
|FISHER EXACT           |                           P=0.172N           P=0.078N           P<0.001N**         P=0.008 **           |
|=================================================================================================================================|
         DATE: 07/19/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE  13
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- OXAZEPAM
                       TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE                   |         0 PPM              625 PPM            2500 PPM           5000 PPM           10,000              |
|                       |                                                                                     PPM STOP            |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |       17/49 (35%)        12/50 (24%)        10/50 (20%)         2/48 (4%)          5/5 (100%)           |
|ADJUSTED (b)           |        61.7%              41.5%              56.7%              10.9%              49.7%                |
|TERMINAL (d)           |        8/17 (47%)         1/11 (9%)          1/6 (17%)          0/0                0/0                  |
|FIRST INCIDENCE (DAYS) |         471                481                600                529                627                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.444N           P=0.577N           P=0.330            P=0.573N           P=0.310              |
|INCIDENTAL TUMOR       |        P=0.490            P=0.254N           P=0.261N           P=0.055N           P=0.009 **           |
|LOGISTIC REGRESSION    |        P=0.377            P=0.246N           P=0.246N           P=0.030N*          P=0.010 **           |
|COCHRAN-ARMITAGE       |        P=0.313N                                                                                         |
|FISHER EXACT           |                           P=0.172N           P=0.078N           P<0.001N**         P=0.008 **           |
|=================================================================================================================================|
|                                                                                                                                 |
|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)            |        5/50 (10%)         5/50 (10%)         2/50 (4%)          3/50 (6%)          2/50 (4%)            |
|ADJUSTED (b)           |        14.6%              23.5%              12.9%              17.5%               4.8%                |
|TERMINAL (d)           |        0/17 (0%)          1/11 (9%)          0/6 (0%)           0/0                0/0                  |
|FIRST INCIDENCE (DAYS) |         517                524                663                507                542                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.450N           P=0.422            P=0.512N           P=0.292            P=0.458N             |
|INCIDENTAL TUMOR       |        P=0.085N           P=0.597N           P=0.154N           P=0.257N           P=0.138N             |
|LOGISTIC REGRESSION    |        P=0.146N           P=0.616N           P=0.222N           P=0.411N           P=0.157N             |
|COCHRAN-ARMITAGE       |        P=0.134N                                                                                         |
|FISHER EXACT           |                           P=0.630N           P=0.218N           P=0.357N           P=0.218N             |
|=================================================================================================================================|
         DATE: 07/19/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE  14
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- OXAZEPAM
                       TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE                   |         0 PPM              625 PPM            2500 PPM           5000 PPM           10,000              |
|                       |                                                                                     PPM STOP            |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        3/50 (6%)          1/50 (2%)          1/50 (2%)          2/50 (4%)          2/50 (4%)            |
|ADJUSTED (b)           |        16.2%               2.9%               3.1%             100.0%              34.8%                |
|TERMINAL (d)           |        2/17 (12%)         0/11 (0%)          0/6 (0%)           0/0                0/0                  |
|FIRST INCIDENCE (DAYS) |         711                572                613                585                558                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.111            P=0.433N           P=0.609N           P=0.016 *          P=0.154              |
|INCIDENTAL TUMOR       |        P=0.526            P=0.355N           P=0.394N           P=0.307            P=0.629              |
|LOGISTIC REGRESSION    |        P=0.432            P=0.398N           P=0.452N           P=0.230            P=0.629              |
|COCHRAN-ARMITAGE       |        P=0.574                                                                                          |
|FISHER EXACT           |                           P=0.309N           P=0.309N           P=0.500N           P=0.500N             |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        5/50 (10%)         4/50 (8%)          1/50 (2%)          2/50 (4%)          3/50 (6%)            |
|ADJUSTED (b)           |        21.5%              12.9%               3.1%             100.0%              47.9%                |
|TERMINAL (d)           |        2/17 (12%)         0/11 (0%)          0/6 (0%)           0/0                0/0                  |
|FIRST INCIDENCE (DAYS) |         491                536                613                585                558                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.298            P=0.594            P=0.318N           P=0.231            P=0.187              |
|INCIDENTAL TUMOR       |        P=0.282N           P=0.407N           P=0.136N           P=0.662N           P=0.629N             |
|LOGISTIC REGRESSION    |        P=0.397N           P=0.489N           P=0.124N           P=0.670N           P=0.492N             |
|COCHRAN-ARMITAGE       |        P=0.307N                                                                                         |
|FISHER EXACT           |                           P=0.500N           P=0.102N           P=0.218N           P=0.357N             |
|=================================================================================================================================|
         DATE: 07/19/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE  15
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- OXAZEPAM
                       TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE                   |         0 PPM              625 PPM            2500 PPM           5000 PPM           10,000              |
|                       |                                                                                     PPM STOP            |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibrosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        2/50 (4%)          3/50 (6%)          0/50 (0%)          0/50 (0%)          1/50 (2%)            |
|ADJUSTED (b)           |         6.3%              10.4%               0.0%               0.0%              20.0%                |
|TERMINAL (d)           |        0/17 (0%)          0/11 (0%)          0/6 (0%)           0/0                0/0                  |
|FIRST INCIDENCE (DAYS) |         491                536                ---                ---                697                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.405N           P=0.389            P=0.339N           P=0.461N           P=0.669              |
|INCIDENTAL TUMOR       |        P=0.139N           P=0.676            P=0.234N           P=0.208N           P=0.567N             |
|LOGISTIC REGRESSION    |        P=0.202N           P=0.607            P=0.182N           P=0.188N           P=0.476N             |
|COCHRAN-ARMITAGE       |        P=0.201N                                                                                         |
|FISHER EXACT           |                           P=0.500            P=0.247N           P=0.247N           P=0.500N             |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        3/50 (6%)          3/50 (6%)          0/50 (0%)          0/50 (0%)          1/50 (2%)            |
|ADJUSTED (b)           |        11.0%              10.4%               0.0%               0.0%              20.0%                |
|TERMINAL (d)           |        0/17 (0%)          0/11 (0%)          0/6 (0%)           0/0                0/0                  |
|FIRST INCIDENCE (DAYS) |         491                536                ---                ---                697                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.350N           P=0.533            P=0.252N           P=0.434N           P=0.712              |
|INCIDENTAL TUMOR       |        P=0.084N           P=0.559N           P=0.116N           P=0.162N           P=0.362N             |
|LOGISTIC REGRESSION    |        P=0.139N           P=0.608N           P=0.107N           P=0.149N           P=0.323N             |
|COCHRAN-ARMITAGE       |        P=0.123N                                                                                         |
|FISHER EXACT           |                           P=0.661N           P=0.121N           P=0.121N           P=0.309N             |
|=================================================================================================================================|
         DATE: 07/19/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE  16
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- OXAZEPAM
                       TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE                   |         0 PPM              625 PPM            2500 PPM           5000 PPM           10,000              |
|                       |                                                                                     PPM STOP            |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Keratoacanthoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        3/50 (6%)          5/50 (10%)         1/50 (2%)          3/50 (6%)          2/50 (4%)            |
|ADJUSTED (b)           |        10.1%              23.5%               5.0%              17.5%               4.8%                |
|TERMINAL (d)           |        0/17 (0%)          1/11 (9%)          0/6 (0%)           0/0                0/0                  |
|FIRST INCIDENCE (DAYS) |         585                524                663                507                542                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.539            P=0.210            P=0.547N           P=0.121            P=0.645              |
|INCIDENTAL TUMOR       |        P=0.192N           P=0.405            P=0.217N           P=0.581N           P=0.331N             |
|LOGISTIC REGRESSION    |        P=0.294N           P=0.343            P=0.338N           P=0.606            P=0.449N             |
|COCHRAN-ARMITAGE       |        P=0.282N                                                                                         |
|FISHER EXACT           |                           P=0.357            P=0.309N           P=0.661N           P=0.500N             |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Schwannoma Malignant                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        3/50 (6%)          0/50 (0%)          0/50 (0%)          0/50 (0%)          0/50 (0%)            |
|ADJUSTED (b)           |        11.6%               0.0%               0.0%               0.0%               0.0%                |
|TERMINAL (d)           |        1/17 (6%)          0/11 (0%)          0/6 (0%)           0/0                0/0                  |
|FIRST INCIDENCE (DAYS) |         480                ---                ---                ---                ---                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.229N           P=0.181N           P=0.256N           P=0.467N           P=0.377N             |
|INCIDENTAL TUMOR       |        P=0.142N           P=0.156N           P=0.176N           P=0.208N           P=0.298N             |
|LOGISTIC REGRESSION    |        P=0.103N           P=0.110N           P=0.109N           P=0.155N           P=0.107N             |
|COCHRAN-ARMITAGE       |        P=0.090N                                                                                         |
|FISHER EXACT           |                           P=0.121N           P=0.121N           P=0.121N           P=0.121N             |
|=================================================================================================================================|
         DATE: 07/19/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE  17
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- OXAZEPAM
                       TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE                   |         0 PPM              625 PPM            2500 PPM           5000 PPM           10,000              |
|                       |                                                                                     PPM STOP            |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        2/50 (4%)          0/50 (0%)          1/50 (2%)          0/50 (0%)          0/50 (0%)            |
|ADJUSTED (b)           |         5.0%               0.0%               8.3%               0.0%               0.0%                |
|TERMINAL (d)           |        0/17 (0%)          0/11 (0%)          0/6 (0%)           0/0                0/0                  |
|FIRST INCIDENCE (DAYS) |         517                ---                689                ---                ---                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.310N           P=0.323N           P=0.698N           P=0.486N           P=0.353N             |
|INCIDENTAL TUMOR       |        P=0.177N           P=0.252N           P=0.487N           P=0.208N           P=0.298N             |
|LOGISTIC REGRESSION    |        P=0.188N           P=0.183N           P=0.478N           P=0.198N           P=0.186N             |
|COCHRAN-ARMITAGE       |        P=0.174N                                                                                         |
|FISHER EXACT           |                           P=0.247N           P=0.500N           P=0.247N           P=0.247N             |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        5/50 (10%)         5/50 (10%)         2/50 (4%)          3/50 (6%)          2/50 (4%)            |
|ADJUSTED (b)           |        14.6%              23.5%              12.9%              17.5%               4.8%                |
|TERMINAL (d)           |        0/17 (0%)          1/11 (9%)          0/6 (0%)           0/0                0/0                  |
|FIRST INCIDENCE (DAYS) |         517                524                663                507                542                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.450N           P=0.422            P=0.512N           P=0.292            P=0.458N             |
|INCIDENTAL TUMOR       |        P=0.085N           P=0.597N           P=0.154N           P=0.257N           P=0.138N             |
|LOGISTIC REGRESSION    |        P=0.146N           P=0.616N           P=0.222N           P=0.411N           P=0.157N             |
|COCHRAN-ARMITAGE       |        P=0.134N                                                                                         |
|FISHER EXACT           |                           P=0.630N           P=0.218N           P=0.357N           P=0.218N             |
|=================================================================================================================================|
         DATE: 07/19/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE  18
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- OXAZEPAM
                       TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE                   |         0 PPM              625 PPM            2500 PPM           5000 PPM           10,000              |
|                       |                                                                                     PPM STOP            |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma, Papilloma, or Keratoacanthoma                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        5/50 (10%)         5/50 (10%)         2/50 (4%)          3/50 (6%)          2/50 (4%)            |
|ADJUSTED (b)           |        14.6%              23.5%              12.9%              17.5%               4.8%                |
|TERMINAL (d)           |        0/17 (0%)          1/11 (9%)          0/6 (0%)           0/0                0/0                  |
|FIRST INCIDENCE (DAYS) |         517                524                663                507                542                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.450N           P=0.422            P=0.512N           P=0.292            P=0.458N             |
|INCIDENTAL TUMOR       |        P=0.085N           P=0.597N           P=0.154N           P=0.257N           P=0.138N             |
|LOGISTIC REGRESSION    |        P=0.146N           P=0.616N           P=0.222N           P=0.411N           P=0.157N             |
|COCHRAN-ARMITAGE       |        P=0.134N                                                                                         |
|FISHER EXACT           |                           P=0.630N           P=0.218N           P=0.357N           P=0.218N             |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Sebaceous Gland                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        1/50 (2%)          0/50 (0%)          0/50 (0%)          0/50 (0%)          2/50 (4%)            |
|ADJUSTED (b)           |         2.9%               0.0%               0.0%               0.0%              19.5%                |
|TERMINAL (d)           |        0/17 (0%)          0/11 (0%)          0/6 (0%)           0/0                0/0                  |
|FIRST INCIDENCE (DAYS) |         682                ---                ---                ---                614                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.042 *          P=0.627N           P=0.677N           P=0.901N           P=0.214              |
|INCIDENTAL TUMOR       |        P=0.207            P=0.617N           P=0.489N           P=0.753N           P=0.629              |
|LOGISTIC REGRESSION    |        P=0.091            P=0.548N           P=0.554N           P=0.776N           P=0.421              |
|COCHRAN-ARMITAGE       |        P=0.145                                                                                          |
|FISHER EXACT           |                           P=0.500N           P=0.500N           P=0.500N           P=0.500              |
|=================================================================================================================================|
         DATE: 07/19/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE  19
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- OXAZEPAM
                       TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE                   |         0 PPM              625 PPM            2500 PPM           5000 PPM           10,000              |
|                       |                                                                                     PPM STOP            |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |       45/50 (90%)        48/50 (96%)        49/50 (98%)        47/50 (94%)        48/48 (100%)          |
|ADJUSTED (b)           |       100.0%             100.0%             100.0%             100.0%             100.0%                |
|TERMINAL (d)           |       17/17 (100%)       11/11 (100%)        6/6 (100%)         0/0                0/0                  |
|FIRST INCIDENCE (DAYS) |         517                386                381                422                480                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P<0.001 **         P=0.014 *          P<0.001 **         P<0.001 **         P<0.001 **           |
|INCIDENTAL TUMOR       |        P=0.004 **         P=0.092            P=0.053            P<0.001 **         P=0.055              |
|LOGISTIC REGRESSION    |        P=0.011 *          P=0.054            P=0.012 *          P<0.001 **         P=0.014 *            |
|COCHRAN-ARMITAGE       |        P=0.061                                                                                          |
|FISHER EXACT           |                           P=0.218            P=0.102            P=0.357            P=0.031 *            |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |       10/50 (20%)         5/49 (10%)         6/50 (12%)         2/50 (4%)          1/50 (2%)            |
|ADJUSTED (b)           |        35.5%              34.6%              31.7%               8.6%               9.1%                |
|TERMINAL (d)           |        3/17 (18%)         3/11 (27%)         0/6 (0%)           0/0                0/0                  |
|FIRST INCIDENCE (DAYS) |         571                614                558                452                687                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.298N           P=0.400N           P=0.444            P=0.564            P=0.320N             |
|INCIDENTAL TUMOR       |        P=0.013N*          P=0.328N           P=0.185N           P=0.206N           P=0.017N*            |
|LOGISTIC REGRESSION    |        P=0.019N*          P=0.312N           P=0.351N           P=0.145N           P=0.030N*            |
|COCHRAN-ARMITAGE       |        P=0.003N**                                                                                       |
|FISHER EXACT           |                           P=0.140N           P=0.207N           P=0.014N*          P=0.004N**           |
|=================================================================================================================================|
         DATE: 07/19/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE  20
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- OXAZEPAM
                       TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE                   |         0 PPM              625 PPM            2500 PPM           5000 PPM           10,000              |
|                       |                                                                                     PPM STOP            |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |       10/50 (20%)         5/49 (10%)         6/50 (12%)         2/50 (4%)          2/50 (4%)            |
|ADJUSTED (b)           |        35.5%              34.6%              31.7%               8.6%              13.2%                |
|TERMINAL (d)           |        3/17 (18%)         3/11 (27%)         0/6 (0%)           0/0                0/0                  |
|FIRST INCIDENCE (DAYS) |         571                614                558                452                634                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.484N           P=0.400N           P=0.444            P=0.564            P=0.516N             |
|INCIDENTAL TUMOR       |        P=0.033N*          P=0.328N           P=0.185N           P=0.206N           P=0.030N*            |
|LOGISTIC REGRESSION    |        P=0.051N           P=0.312N           P=0.351N           P=0.145N           P=0.068N             |
|COCHRAN-ARMITAGE       |        P=0.010N**                                                                                       |
|FISHER EXACT           |                           P=0.140N           P=0.207N           P=0.014N*          P=0.014N*            |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |        1/50 (2%)          0/49 (0%)          1/50 (2%)          2/50 (4%)          2/50 (4%)            |
|ADJUSTED (b)           |         2.4%               0.0%               3.1%              52.9%               9.5%                |
|TERMINAL (d)           |        0/17 (0%)          0/11 (0%)          0/6 (0%)           0/0                0/0                  |
|FIRST INCIDENCE (DAYS) |         554                ---                613                575                638                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.083            P=0.525N           P=0.747            P=0.135            P=0.384              |
|INCIDENTAL TUMOR       |        P=0.409            P=0.335N           P=0.553N           P=0.557            P=0.569N             |
|LOGISTIC REGRESSION    |        P=0.161            P=0.408N           P=0.707N           P=0.426            P=0.557              |
|COCHRAN-ARMITAGE       |        P=0.176                                                                                          |
|FISHER EXACT           |                           P=0.505N           P=0.753N           P=0.500            P=0.500              |
|=================================================================================================================================|
         DATE: 07/19/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE  21
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- OXAZEPAM
                       TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE                   |         0 PPM              625 PPM            2500 PPM           5000 PPM           10,000              |
|                       |                                                                                     PPM STOP            |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |        3/50 (6%)          3/49 (6%)          3/50 (6%)          4/50 (8%)          1/50 (2%)            |
|ADJUSTED (b)           |        12.5%              16.3%              12.6%              13.4%               4.8%                |
|TERMINAL (d)           |        1/17 (6%)          1/11 (9%)          0/6 (0%)           0/0                0/0                  |
|FIRST INCIDENCE (DAYS) |         688                614                424                442                638                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.506            P=0.456            P=0.339            P=0.057            P=0.660              |
|INCIDENTAL TUMOR       |        P=0.275N           P=0.634            P=0.606            P=0.471            P=0.371N             |
|LOGISTIC REGRESSION    |        P=0.245N           P=0.546            P=0.656            P=0.516            P=0.513N             |
|COCHRAN-ARMITAGE       |        P=0.247N                                                                                         |
|FISHER EXACT           |                           P=0.651            P=0.661N           P=0.500            P=0.309N             |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |        4/50 (8%)          3/49 (6%)          4/50 (8%)          6/50 (12%)         2/50 (4%)            |
|ADJUSTED (b)           |        14.6%              16.3%              15.4%              59.2%               9.5%                |
|TERMINAL (d)           |        1/17 (6%)          1/11 (9%)          0/6 (0%)           0/0                0/0                  |
|FIRST INCIDENCE (DAYS) |         554                614                424                442                638                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.308            P=0.603            P=0.354            P=0.010 *          P=0.573              |
|INCIDENTAL TUMOR       |        P=0.297N           P=0.471N           P=0.580N           P=0.354            P=0.190N             |
|LOGISTIC REGRESSION    |        P=0.384N           P=0.582N           P=0.617N           P=0.318            P=0.400N             |
|COCHRAN-ARMITAGE       |        P=0.378N                                                                                         |
|FISHER EXACT           |                           P=0.511N           P=0.643N           P=0.370            P=0.339N             |
|=================================================================================================================================|
         DATE: 07/19/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE  22
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- OXAZEPAM
                       TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE                   |         0 PPM              625 PPM            2500 PPM           5000 PPM           10,000              |
|                       |                                                                                     PPM STOP            |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |                                                                                                         |
|ADJUSTED (b)           |                                                                                                         |
|TERMINAL (d)           |                                                                                                         |
|FIRST INCIDENCE (DAYS) |                                                                                                         |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |                                                                                                         |
|INCIDENTAL TUMOR       |                                                                                                         |
|LOGISTIC REGRESSION    |                                                                                                         |
|COCHRAN-ARMITAGE       |                                                                                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal or Polyp Stromal                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |                                                                                                         |
|ADJUSTED (b)           |                                                                                                         |
|TERMINAL (d)           |                                                                                                         |
|FIRST INCIDENCE (DAYS) |                                                                                                         |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |                                                                                                         |
|INCIDENTAL TUMOR       |                                                                                                         |
|LOGISTIC REGRESSION    |                                                                                                         |
|COCHRAN-ARMITAGE       |                                                                                                         |
|=================================================================================================================================|
         DATE: 07/19/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE  23
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- OXAZEPAM
                       TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE                   |         0 PPM              625 PPM            2500 PPM           5000 PPM           10,000              |
|                       |                                                                                     PPM STOP            |
|=================================================================================================================================|
|                                                                                                                                 |
|Zymbal's Gland                                                                                                                   |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/50 (0%)          1/50 (2%)          0/50 (0%)          1/50 (2%)          1/50 (2%)            |
|ADJUSTED (b)           |         0.0%               2.7%               0.0%               5.0%               7.7%                |
|TERMINAL (d)           |        0/17 (0%)          0/11 (0%)          0/6 (0%)           0/0                0/0                  |
|FIRST INCIDENCE (DAYS) |         ---                557                ---                562                670                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.293            P=0.480              (e)              P=0.357            P=0.303              |
|INCIDENTAL TUMOR       |        P=0.505            P=0.677              (e)              P=0.665            P=0.489              |
|LOGISTIC REGRESSION    |        P=0.369            P=0.592              (e)              P=0.575            P=0.439              |
|COCHRAN-ARMITAGE       |        P=0.359                                                                                          |
|FISHER EXACT           |                           P=0.500              (e)              P=0.500            P=0.500              |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |       27/50 (54%)        36/50 (72%)        33/50 (66%)        19/50 (38%)        33/50 (66%)           |
|ADJUSTED (b)           |        72.4%              91.4%              86.0%             100.0%             100.0%                |
|TERMINAL (d)           |        8/17 (47%)         8/11 (73%)         3/6 (50%)          0/0                0/0                  |
|FIRST INCIDENCE (DAYS) |         498                426                381                442                480                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P<0.001 **         P=0.005 **         P=0.002 **         P<0.001 **         P<0.001 **           |
|INCIDENTAL TUMOR       |        P=0.397N           P=0.033 *          P=0.294            P=0.379N           P=0.188              |
|LOGISTIC REGRESSION    |        P=0.502            P=0.020 *          P=0.187            P=0.459N           P=0.110              |
|COCHRAN-ARMITAGE       |        P=0.444N                                                                                         |
|FISHER EXACT           |                           P=0.048 *          P=0.154            P=0.080N           P=0.154              |
|=================================================================================================================================|
         DATE: 07/19/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE  24
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- OXAZEPAM
                       TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE                   |         0 PPM              625 PPM            2500 PPM           5000 PPM           10,000              |
|                       |                                                                                     PPM STOP            |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Mesothelioma: Benign, Malignant, NOS                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        2/50 (4%)          2/50 (4%)          1/50 (2%)          1/50 (2%)          1/50 (2%)            |
|ADJUSTED (b)           |         5.4%               8.6%               3.7%               2.1%               3.1%                |
|TERMINAL (d)           |        0/17 (0%)          0/11 (0%)          0/6 (0%)           0/0                0/0                  |
|FIRST INCIDENCE (DAYS) |         592                586                641                237                613                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.503N           P=0.522            P=0.637N           P=0.682            P=0.647N             |
|INCIDENTAL TUMOR       |        P=0.119N           P=0.657N           P=0.296N           P=0.252N           P=0.223N             |
|LOGISTIC REGRESSION    |        P=0.285N           P=0.694N           P=0.494N           P=0.203N           P=0.476N             |
|COCHRAN-ARMITAGE       |        P=0.332N                                                                                         |
|FISHER EXACT           |                           P=0.691N           P=0.500N           P=0.500N           P=0.500N             |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |       47/50 (94%)        50/50 (100%)       50/50 (100%)       47/50 (94%)        48/50 (96%)           |
|ADJUSTED (b)           |       100.0%             100.0%             100.0%             100.0%             100.0%                |
|TERMINAL (d)           |       17/17 (100%)       11/11 (100%)        6/6 (100%)         0/0                0/0                  |
|FIRST INCIDENCE (DAYS) |         471                386                381                422                480                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P<0.001 **         P=0.014 *          P<0.001 **         P<0.001 **         P<0.001 **           |
|INCIDENTAL TUMOR       |        P=0.323            P=0.053            P=0.107            P=0.006 **         P=0.303              |
|LOGISTIC REGRESSION    |        P=0.643            P=0.011 *          P=0.014 *          P=0.001 **         P=0.331              |
|COCHRAN-ARMITAGE       |        P=0.365N                                                                                         |
|FISHER EXACT           |                           P=0.121            P=0.121            P=0.661N           P=0.500              |
|=================================================================================================================================|
         DATE: 07/19/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE  25
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- OXAZEPAM
                       TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE                   |         0 PPM              625 PPM            2500 PPM           5000 PPM           10,000              |
|                       |                                                                                     PPM STOP            |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |       38/50 (76%)        43/50 (86%)        40/50 (80%)        25/50 (50%)        35/50 (70%)           |
|ADJUSTED (b)           |        85.6%              93.5%              96.5%             100.0%             100.0%                |
|TERMINAL (d)           |       11/17 (65%)         8/11 (73%)         5/6 (83%)          0/0                0/0                  |
|FIRST INCIDENCE (DAYS) |         480                426                381                237                480                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.003 **         P=0.016 *          P=0.003 **         P<0.001 **         P<0.001 **           |
|INCIDENTAL TUMOR       |        P=0.014N*          P=0.181            P=0.549            P=0.024N*          P=0.288N             |
|LOGISTIC REGRESSION    |        P=0.035N*          P=0.083            P=0.477            P=0.025N*          P=0.363N             |
|COCHRAN-ARMITAGE       |        P=0.022N*                                                                                        |
|FISHER EXACT           |                           P=0.154            P=0.405            P=0.006N**         P=0.326N             |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |       50/50 (100%)       50/50 (100%)       50/50 (100%)       48/50 (96%)        48/50 (96%)           |
|ADJUSTED (b)           |       100.0%             100.0%             100.0%             100.0%             100.0%                |
|TERMINAL (d)           |       17/17 (100%)       11/11 (100%)        6/6 (100%)         0/0                0/0                  |
|FIRST INCIDENCE (DAYS) |         471                386                381                237                480                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P<0.001 **         P=0.035 *          P=0.001 **         P<0.001 **         P<0.001 **           |
|INCIDENTAL TUMOR       |        P=0.188N             (e)                (e)                (e)              P=0.767N             |
|LOGISTIC REGRESSION    |        P=0.022N*            (e)                (e)                (e)              P=0.423N             |
|COCHRAN-ARMITAGE       |        P=0.036N*                                                                                        |
|FISHER EXACT           |                           P=1.000N           P=1.000N           P=0.247N           P=0.247N             |
|=================================================================================================================================|
         DATE: 07/19/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE  26
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- OXAZEPAM
                       TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE                   |         0 PPM              625 PPM            2500 PPM           5000 PPM           10,000              |
|                       |                                                                                     PPM STOP            |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |        1/50 (2%)          3/50 (6%)          0/50 (0%)          1/50 (2%)          0/0 (0%)             |
|ADJUSTED (b)           |         3.1%               9.4%               0.0%               3.2%               0.0%                |
|TERMINAL (d)           |        1/32 (3%)          1/26 (4%)          0/20 (0%)          1/31 (3%)          0/0                  |
|FIRST INCIDENCE (DAYS) |         729 (T)            550                ---                729 (T)            ---                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.265N           P=0.258            P=0.594N           P=0.755              (e)                |
|INCIDENTAL TUMOR       |        P=0.417N           P=0.322            P=0.594N           P=0.755              (e)                |
|LOGISTIC REGRESSION    |        P=0.417N           P=0.322            P=0.594N           P=0.755              (e)                |
|COCHRAN-ARMITAGE       |        P=0.428N                                                                                         |
|FISHER EXACT           |                           P=0.309            P=0.500N           P=0.753N           P=1.000N             |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |        3/50 (6%)          3/50 (6%)          0/50 (0%)          1/50 (2%)          0/0 (0%)             |
|ADJUSTED (b)           |         8.9%               9.4%               0.0%               3.2%               0.0%                |
|TERMINAL (d)           |        2/32 (6%)          1/26 (4%)          0/20 (0%)          1/31 (3%)          0/0                  |
|FIRST INCIDENCE (DAYS) |         700                550                ---                729 (T)            ---                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.101N           P=0.596            P=0.204N           P=0.312N           P=0.512N             |
|INCIDENTAL TUMOR       |        P=0.164N           P=0.618N           P=0.147N           P=0.283N             (e)                |
|LOGISTIC REGRESSION    |        P=0.164N           P=0.618N           P=0.147N           P=0.283N             (e)                |
|COCHRAN-ARMITAGE       |        P=0.169N                                                                                         |
|FISHER EXACT           |                           P=0.661N           P=0.121N           P=0.309N           P=1.000N             |
|=================================================================================================================================|
         DATE: 07/19/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE  27
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- OXAZEPAM
                       TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE                   |         0 PPM              625 PPM            2500 PPM           5000 PPM           10,000              |
|                       |                                                                                     PPM STOP            |
|=================================================================================================================================|
|                                                                                                                                 |
|Brain                                                                                                                            |
|     Oligodendroglioma, Glioma, or Astrocytoma                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |        1/50 (2%)          1/50 (2%)          0/50 (0%)          0/50 (0%)          0/0 (0%)             |
|ADJUSTED (b)           |         2.0%               3.8%               0.0%               0.0%               0.0%                |
|TERMINAL (d)           |        0/32 (0%)          1/26 (4%)          0/20 (0%)          0/31 (0%)          0/0                  |
|FIRST INCIDENCE (DAYS) |         223                729 (T)            ---                ---                ---                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.273N           P=0.738            P=0.500N           P=0.504N           P=0.500N             |
|INCIDENTAL TUMOR       |        P=0.458N           P=0.659              (e)              P=0.638N             (e)                |
|LOGISTIC REGRESSION    |        P=0.458N           P=0.659              (e)              P=0.638N             (e)                |
|COCHRAN-ARMITAGE       |        P=0.366N                                                                                         |
|FISHER EXACT           |                           P=0.753N           P=0.500N           P=0.500N           P=1.000N             |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |        7/49 (14%)         3/50 (6%)          3/50 (6%)          4/50 (8%)          7/11 (64%)           |
|ADJUSTED (b)           |        19.4%              10.1%               9.6%              11.5%              65.1%                |
|TERMINAL (d)           |        4/31 (13%)         2/26 (8%)          1/20 (5%)          2/31 (6%)          5/8 (63%)            |
|FIRST INCIDENCE (DAYS) |         550                654                565                679                718                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.059            P=0.210N           P=0.309N           P=0.259N           P=0.077              |
|INCIDENTAL TUMOR       |        P=0.002 **         P=0.129N           P=0.133N           P=0.192N           P=0.004 **           |
|LOGISTIC REGRESSION    |        P=0.001 **         P=0.149N           P=0.153N           P=0.239N           P=0.002 **           |
|COCHRAN-ARMITAGE       |        P<0.001 **                                                                                       |
|FISHER EXACT           |                           P=0.151N           P=0.151N           P=0.251N           P=0.002 **           |
|=================================================================================================================================|
         DATE: 07/19/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE  28
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- OXAZEPAM
                       TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE                   |         0 PPM              625 PPM            2500 PPM           5000 PPM           10,000              |
|                       |                                                                                     PPM STOP            |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |        8/49 (16%)         3/50 (6%)          4/50 (8%)          4/50 (8%)          7/11 (64%)           |
|ADJUSTED (b)           |        22.4%              10.1%              12.5%              11.5%              65.1%                |
|TERMINAL (d)           |        5/31 (16%)         2/26 (8%)          1/20 (5%)          2/31 (6%)          5/8 (63%)            |
|FIRST INCIDENCE (DAYS) |         550                654                565                679                718                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.103            P=0.145N           P=0.360N           P=0.179N           P=0.101              |
|INCIDENTAL TUMOR       |        P=0.005 **         P=0.084N           P=0.152N           P=0.126N           P=0.008 **           |
|LOGISTIC REGRESSION    |        P=0.004 **         P=0.093N           P=0.174N           P=0.157N           P=0.004 **           |
|COCHRAN-ARMITAGE       |        P=0.002 **                                                                                       |
|FISHER EXACT           |                           P=0.094N           P=0.168N           P=0.168N           P=0.003 **           |
|=================================================================================================================================|
|                                                                                                                                 |
|Intestine Large: Colon/Rectum                                                                                                    |
|     Polyp Adenomatous                                                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        1/50 (2%)          0/50 (0%)          0/50 (0%)          0/50 (0%)          0/50 (0%)            |
|ADJUSTED (b)           |         2.6%               0.0%               0.0%               0.0%               0.0%                |
|TERMINAL (d)           |        0/32 (0%)          0/26 (0%)          0/20 (0%)          0/31 (0%)          0/25 (0%)            |
|FIRST INCIDENCE (DAYS) |         647                ---                ---                ---                ---                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.377N           P=0.500N           P=0.552N           P=0.495N           P=0.505N             |
|INCIDENTAL TUMOR       |        P=0.337N           P=0.377N           P=0.410N           P=0.429N           P=0.362N             |
|LOGISTIC REGRESSION    |        P=0.383N           P=0.503N           P=0.495N           P=0.503N           P=0.513N             |
|COCHRAN-ARMITAGE       |        P=0.378N                                                                                         |
|FISHER EXACT           |                           P=0.500N           P=0.500N           P=0.500N           P=0.500N             |
|=================================================================================================================================|
         DATE: 07/19/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE  29
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- OXAZEPAM
                       TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE                   |         0 PPM              625 PPM            2500 PPM           5000 PPM           10,000              |
|                       |                                                                                     PPM STOP            |
|=================================================================================================================================|
|                                                                                                                                 |
|Intestine Small: Jejunum                                                                                                         |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/50 (0%)          0/50 (0%)          0/50 (0%)          0/50 (0%)          0/50 (0%)            |
|ADJUSTED (b)           |         0.0%               0.0%               0.0%               0.0%               0.0%                |
|TERMINAL (d)           |        0/32 (0%)          0/26 (0%)          0/20 (0%)          0/31 (0%)          0/25 (0%)            |
|FIRST INCIDENCE (DAYS) |         ---                ---                ---                ---                ---                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |          (e)                (e)                (e)                (e)                (e)                |
|INCIDENTAL TUMOR       |          (e)                (e)                (e)                (e)                (e)                |
|LOGISTIC REGRESSION    |          (e)                (e)                (e)                (e)                (e)                |
|COCHRAN-ARMITAGE       |          (e)                                                                                            |
|FISHER EXACT           |                             (e)                (e)                (e)                (e)                |
|=================================================================================================================================|
|                                                                                                                                 |
|Intestine Small: Site Unspecified                                                                                                |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/50 (0%)          0/50 (0%)          0/50 (0%)          0/50 (0%)          0/50 (0%)            |
|ADJUSTED (b)           |         0.0%               0.0%               0.0%               0.0%               0.0%                |
|TERMINAL (d)           |        0/32 (0%)          0/26 (0%)          0/20 (0%)          0/31 (0%)          0/25 (0%)            |
|FIRST INCIDENCE (DAYS) |         ---                ---                ---                ---                ---                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |          (e)                (e)                (e)                (e)                (e)                |
|INCIDENTAL TUMOR       |          (e)                (e)                (e)                (e)                (e)                |
|LOGISTIC REGRESSION    |          (e)                (e)                (e)                (e)                (e)                |
|COCHRAN-ARMITAGE       |          (e)                                                                                            |
|FISHER EXACT           |                             (e)                (e)                (e)                (e)                |
|=================================================================================================================================|
         DATE: 07/19/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE  30
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- OXAZEPAM
                       TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE                   |         0 PPM              625 PPM            2500 PPM           5000 PPM           10,000              |
|                       |                                                                                     PPM STOP            |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/50 (0%)          0/50 (0%)          0/49 (0%)          0/49 (0%)          0/0 (0%)             |
|ADJUSTED (b)           |         0.0%               0.0%               0.0%               0.0%               0.0%                |
|TERMINAL (d)           |        0/32 (0%)          0/26 (0%)          0/20 (0%)          0/31 (0%)          0/0                  |
|FIRST INCIDENCE (DAYS) |         ---                ---                ---                ---                ---                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |          (e)                (e)                (e)                (e)                (e)                |
|INCIDENTAL TUMOR       |          (e)                (e)                (e)                (e)                (e)                |
|LOGISTIC REGRESSION    |          (e)                (e)                (e)                (e)                (e)                |
|COCHRAN-ARMITAGE       |          (e)                                                                                            |
|FISHER EXACT           |                             (e)                (e)                (e)                (e)                |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |        1/50 (2%)          0/50 (0%)          0/49 (0%)          0/49 (0%)          0/0 (0%)             |
|ADJUSTED (b)           |         3.1%               0.0%               0.0%               0.0%               0.0%                |
|TERMINAL (d)           |        1/32 (3%)          0/26 (0%)          0/20 (0%)          0/31 (0%)          0/0                  |
|FIRST INCIDENCE (DAYS) |         729 (T)            ---                ---                ---                ---                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.590N           P=0.541N           P=0.594N           P=0.506N             (e)                |
|INCIDENTAL TUMOR       |        P=0.590N           P=0.541N           P=0.594N           P=0.506N             (e)                |
|LOGISTIC REGRESSION    |        P=0.590N           P=0.541N           P=0.594N           P=0.506N             (e)                |
|COCHRAN-ARMITAGE       |        P=0.599N                                                                                         |
|FISHER EXACT           |                           P=0.500N           P=0.505N           P=0.505N           P=1.000N             |
|=================================================================================================================================|
         DATE: 07/19/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE  31
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- OXAZEPAM
                       TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE                   |         0 PPM              625 PPM            2500 PPM           5000 PPM           10,000              |
|                       |                                                                                     PPM STOP            |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney: Renal Tubule                                                                                                             |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/50 (0%)          0/50 (0%)          0/50 (0%)          0/50 (0%)          0/1 (0%)             |
|ADJUSTED (b)           |         0.0%               0.0%               0.0%               0.0%               0.0%                |
|TERMINAL (d)           |        0/32 (0%)          0/26 (0%)          0/20 (0%)          0/31 (0%)          0/0                  |
|FIRST INCIDENCE (DAYS) |         ---                ---                ---                ---                ---                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |          (e)                (e)                (e)                (e)                (e)                |
|INCIDENTAL TUMOR       |          (e)                (e)                (e)                (e)                (e)                |
|LOGISTIC REGRESSION    |          (e)                (e)                (e)                (e)                (e)                |
|COCHRAN-ARMITAGE       |          (e)                                                                                            |
|FISHER EXACT           |                             (e)                (e)                (e)                (e)                |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/50 (0%)          0/50 (0%)          0/50 (0%)          0/50 (0%)          0/49 (0%)            |
|ADJUSTED (b)           |         0.0%               0.0%               0.0%               0.0%               0.0%                |
|TERMINAL (d)           |        0/32 (0%)          0/26 (0%)          0/20 (0%)          0/31 (0%)          0/25 (0%)            |
|FIRST INCIDENCE (DAYS) |         ---                ---                ---                ---                ---                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |          (e)                (e)                (e)                (e)                (e)                |
|INCIDENTAL TUMOR       |          (e)                (e)                (e)                (e)                (e)                |
|LOGISTIC REGRESSION    |          (e)                (e)                (e)                (e)                (e)                |
|COCHRAN-ARMITAGE       |          (e)                                                                                            |
|FISHER EXACT           |                             (e)                (e)                (e)                (e)                |
|=================================================================================================================================|
         DATE: 07/19/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE  32
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- OXAZEPAM
                       TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE                   |         0 PPM              625 PPM            2500 PPM           5000 PPM           10,000              |
|                       |                                                                                     PPM STOP            |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/50 (0%)          0/50 (0%)          0/50 (0%)          0/50 (0%)          0/49 (0%)            |
|ADJUSTED (b)           |         0.0%               0.0%               0.0%               0.0%               0.0%                |
|TERMINAL (d)           |        0/32 (0%)          0/26 (0%)          0/20 (0%)          0/31 (0%)          0/25 (0%)            |
|FIRST INCIDENCE (DAYS) |         ---                ---                ---                ---                ---                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |          (e)                (e)                (e)                (e)                (e)                |
|INCIDENTAL TUMOR       |          (e)                (e)                (e)                (e)                (e)                |
|LOGISTIC REGRESSION    |          (e)                (e)                (e)                (e)                (e)                |
|COCHRAN-ARMITAGE       |          (e)                                                                                            |
|FISHER EXACT           |                             (e)                (e)                (e)                (e)                |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/50 (0%)          0/50 (0%)          0/50 (0%)          0/50 (0%)          0/49 (0%)            |
|ADJUSTED (b)           |         0.0%               0.0%               0.0%               0.0%               0.0%                |
|TERMINAL (d)           |        0/32 (0%)          0/26 (0%)          0/20 (0%)          0/31 (0%)          0/25 (0%)            |
|FIRST INCIDENCE (DAYS) |         ---                ---                ---                ---                ---                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |          (e)                (e)                (e)                (e)                (e)                |
|INCIDENTAL TUMOR       |          (e)                (e)                (e)                (e)                (e)                |
|LOGISTIC REGRESSION    |          (e)                (e)                (e)                (e)                (e)                |
|COCHRAN-ARMITAGE       |          (e)                                                                                            |
|FISHER EXACT           |                             (e)                (e)                (e)                (e)                |
|=================================================================================================================================|
         DATE: 07/19/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE  33
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- OXAZEPAM
                       TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE                   |         0 PPM              625 PPM            2500 PPM           5000 PPM           10,000              |
|                       |                                                                                     PPM STOP            |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/50 (0%)          0/50 (0%)          0/49 (0%)          2/49 (4%)          0/0 (0%)             |
|ADJUSTED (b)           |         0.0%               0.0%               0.0%               6.5%               0.0%                |
|TERMINAL (d)           |        0/32 (0%)          0/26 (0%)          0/20 (0%)          2/31 (6%)          0/0                  |
|FIRST INCIDENCE (DAYS) |         ---                ---                ---                729 (T)            ---                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.117              (e)                (e)              P=0.231              (e)                |
|INCIDENTAL TUMOR       |        P=0.117              (e)                (e)              P=0.231              (e)                |
|LOGISTIC REGRESSION    |        P=0.117              (e)                (e)              P=0.231              (e)                |
|COCHRAN-ARMITAGE       |        P=0.102                                                                                          |
|FISHER EXACT           |                             (e)                (e)              P=0.242              (e)                |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/50 (0%)          1/50 (2%)          0/49 (0%)          2/49 (4%)          0/0 (0%)             |
|ADJUSTED (b)           |         0.0%               3.2%               0.0%               6.5%               0.0%                |
|TERMINAL (d)           |        0/32 (0%)          0/26 (0%)          0/20 (0%)          2/31 (6%)          0/0                  |
|FIRST INCIDENCE (DAYS) |         ---                718                ---                729 (T)            ---                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.456            P=0.494              (e)              P=0.231              (e)                |
|INCIDENTAL TUMOR       |        P=0.283            P=0.623              (e)              P=0.231              (e)                |
|LOGISTIC REGRESSION    |        P=0.283            P=0.623              (e)              P=0.231              (e)                |
|COCHRAN-ARMITAGE       |        P=0.266                                                                                          |
|FISHER EXACT           |                           P=0.500              (e)              P=0.242              (e)                |
|=================================================================================================================================|
         DATE: 07/19/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE  34
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- OXAZEPAM
                       TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE                   |         0 PPM              625 PPM            2500 PPM           5000 PPM           10,000              |
|                       |                                                                                     PPM STOP            |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        1/50 (2%)          2/50 (4%)          0/50 (0%)          0/50 (0%)          0/50 (0%)            |
|ADJUSTED (b)           |         2.4%               6.9%               0.0%               0.0%               0.0%                |
|TERMINAL (d)           |        0/32 (0%)          1/26 (4%)          0/20 (0%)          0/31 (0%)          0/25 (0%)            |
|FIRST INCIDENCE (DAYS) |         613                718                ---                ---                ---                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.133N           P=0.475            P=0.537N           P=0.473N           P=0.510N             |
|INCIDENTAL TUMOR       |        P=0.115N           P=0.546            P=0.377N           P=0.500N           P=0.450N             |
|LOGISTIC REGRESSION    |        P=0.126N           P=0.500            P=0.497N           P=0.502N           P=0.535N             |
|COCHRAN-ARMITAGE       |        P=0.127N                                                                                         |
|FISHER EXACT           |                           P=0.500            P=0.500N           P=0.500N           P=0.500N             |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        2/50 (4%)          3/50 (6%)          0/50 (0%)          0/50 (0%)          1/50 (2%)            |
|ADJUSTED (b)           |         5.1%              10.3%               0.0%               0.0%               2.1%                |
|TERMINAL (d)           |        1/32 (3%)          2/26 (8%)          0/20 (0%)          0/31 (0%)          0/25 (0%)            |
|FIRST INCIDENCE (DAYS) |         228                697                ---                ---                562                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.209N           P=0.443            P=0.288N           P=0.243N           P=0.519N             |
|INCIDENTAL TUMOR       |        P=0.258N           P=0.437            P=0.594N           P=0.318N           P=0.761N             |
|LOGISTIC REGRESSION    |        P=0.218N           P=0.483            P=0.288N           P=0.213N           P=0.713N             |
|COCHRAN-ARMITAGE       |        P=0.201N                                                                                         |
|FISHER EXACT           |                           P=0.500            P=0.247N           P=0.247N           P=0.500N             |
|=================================================================================================================================|
         DATE: 07/19/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE  35
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- OXAZEPAM
                       TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE                   |         0 PPM              625 PPM            2500 PPM           5000 PPM           10,000              |
|                       |                                                                                     PPM STOP            |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        3/50 (6%)          5/50 (10%)         0/50 (0%)          0/50 (0%)          1/50 (2%)            |
|ADJUSTED (b)           |         7.4%              16.8%               0.0%               0.0%               2.1%                |
|TERMINAL (d)           |        1/32 (3%)          3/26 (12%)         0/20 (0%)          0/31 (0%)          0/25 (0%)            |
|FIRST INCIDENCE (DAYS) |         228                697                ---                ---                562                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.062N           P=0.305            P=0.163N           P=0.118N           P=0.327N             |
|INCIDENTAL TUMOR       |        P=0.068N           P=0.336            P=0.216N           P=0.166N           P=0.470N             |
|LOGISTIC REGRESSION    |        P=0.060N           P=0.347            P=0.130N           P=0.109N           P=0.466N             |
|COCHRAN-ARMITAGE       |        P=0.056N                                                                                         |
|FISHER EXACT           |                           P=0.357            P=0.121N           P=0.121N           P=0.309N             |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroadenoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |       25/50 (50%)        19/50 (38%)         9/50 (18%)        13/50 (26%)        23/50 (46%)           |
|ADJUSTED (b)           |        67.0%              52.8%              33.2%              35.1%              66.7%                |
|TERMINAL (d)           |       20/32 (63%)        10/26 (38%)         4/20 (20%)         8/31 (26%)        14/25 (56%)           |
|FIRST INCIDENCE (DAYS) |         529                612                589                550                562                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.375            P=0.363N           P=0.039N*          P=0.017N*          P=0.394              |
|INCIDENTAL TUMOR       |        P=0.524            P=0.143N           P=0.003N**         P=0.010N**         P=0.455N             |
|LOGISTIC REGRESSION    |        P=0.489            P=0.152N           P=0.003N**         P=0.007N**         P=0.428N             |
|COCHRAN-ARMITAGE       |        P=0.439                                                                                          |
|FISHER EXACT           |                           P=0.157N           P<0.001N**         P=0.011N*          P=0.421N             |
|=================================================================================================================================|
         DATE: 07/19/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE  36
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- OXAZEPAM
                       TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE                   |         0 PPM              625 PPM            2500 PPM           5000 PPM           10,000              |
|                       |                                                                                     PPM STOP            |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma or Adenoma                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |       26/50 (52%)        20/50 (40%)         9/50 (18%)        13/50 (26%)        23/50 (46%)           |
|ADJUSTED (b)           |        67.8%              55.7%              33.2%              35.1%              66.7%                |
|TERMINAL (d)           |       20/32 (63%)        11/26 (42%)         4/20 (20%)         8/31 (26%)        14/25 (56%)           |
|FIRST INCIDENCE (DAYS) |         529                612                589                550                562                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.461            P=0.372N           P=0.028N*          P=0.011N*          P=0.468              |
|INCIDENTAL TUMOR       |        P=0.452N           P=0.151N           P=0.001N**         P=0.006N**         P=0.364N             |
|LOGISTIC REGRESSION    |        P=0.486N           P=0.153N           P=0.001N**         P=0.004N**         P=0.340N             |
|COCHRAN-ARMITAGE       |        P=0.534                                                                                          |
|FISHER EXACT           |                           P=0.158N           P<0.001N**         P=0.007N**         P=0.345N             |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |       27/50 (54%)        23/50 (46%)         9/50 (18%)        13/50 (26%)        23/50 (46%)           |
|ADJUSTED (b)           |        68.4%              62.7%              33.2%              35.1%              66.7%                |
|TERMINAL (d)           |       20/32 (63%)        13/26 (50%)         4/20 (20%)         8/31 (26%)        14/25 (56%)           |
|FIRST INCIDENCE (DAYS) |         228                612                589                550                562                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.440N           P=0.531N           P=0.019N*          P=0.007N**         P=0.542              |
|INCIDENTAL TUMOR       |        P=0.305N           P=0.287N           P=0.001N**         P=0.005N**         P=0.364N             |
|LOGISTIC REGRESSION    |        P=0.310N           P=0.268N           P<0.001N**         P=0.003N**         P=0.346N             |
|COCHRAN-ARMITAGE       |        P=0.360N                                                                                         |
|FISHER EXACT           |                           P=0.274N           P<0.001N**         P=0.004N**         P=0.274N             |
|=================================================================================================================================|
         DATE: 07/19/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE  37
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- OXAZEPAM
                       TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE                   |         0 PPM              625 PPM            2500 PPM           5000 PPM           10,000              |
|                       |                                                                                     PPM STOP            |
|=================================================================================================================================|
|                                                                                                                                 |
|Pancreas                                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/50 (0%)          0/50 (0%)          0/49 (0%)          1/49 (2%)          0/0 (0%)             |
|ADJUSTED (b)           |         0.0%               0.0%               0.0%               3.2%               0.0%                |
|TERMINAL (d)           |        0/32 (0%)          0/26 (0%)          0/20 (0%)          1/31 (3%)          0/0                  |
|FIRST INCIDENCE (DAYS) |         ---                ---                ---                729 (T)            ---                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.410              (e)                (e)              P=0.494              (e)                |
|INCIDENTAL TUMOR       |        P=0.410              (e)                (e)              P=0.494              (e)                |
|LOGISTIC REGRESSION    |        P=0.410              (e)                (e)              P=0.494              (e)                |
|COCHRAN-ARMITAGE       |        P=0.401                                                                                          |
|FISHER EXACT           |                             (e)                (e)              P=0.495              (e)                |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |       31/50 (62%)        28/50 (56%)        21/50 (42%)        12/50 (24%)        23/35 (66%)           |
|ADJUSTED (b)           |        73.6%              79.6%              62.0%              31.8%              67.3%                |
|TERMINAL (d)           |       21/32 (66%)        19/26 (73%)         9/20 (45%)         6/31 (19%)         8/16 (50%)           |
|FIRST INCIDENCE (DAYS) |         529                475                506                646                562                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.268N           P=0.479            P=0.504N           P<0.001N**         P=0.438              |
|INCIDENTAL TUMOR       |        P=0.218N           P=0.320N           P=0.040N*          P<0.001N**         P=0.486N             |
|LOGISTIC REGRESSION    |        P=0.302N           P=0.338N           P=0.058N           P<0.001N**         P=0.507              |
|COCHRAN-ARMITAGE       |        P=0.384N                                                                                         |
|FISHER EXACT           |                           P=0.342N           P=0.036N*          P<0.001N**         P=0.453              |
|=================================================================================================================================|
         DATE: 07/19/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE  38
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- OXAZEPAM
                       TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE                   |         0 PPM              625 PPM            2500 PPM           5000 PPM           10,000              |
|                       |                                                                                     PPM STOP            |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |       31/50 (62%)        28/50 (56%)        22/50 (44%)        12/50 (24%)        23/35 (66%)           |
|ADJUSTED (b)           |        73.6%              79.6%              65.4%              31.8%              67.3%                |
|TERMINAL (d)           |       21/32 (66%)        19/26 (73%)        10/20 (50%)         6/31 (19%)         8/16 (50%)           |
|FIRST INCIDENCE (DAYS) |         529                475                506                646                562                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.263N           P=0.479            P=0.548            P<0.001N**         P=0.438              |
|INCIDENTAL TUMOR       |        P=0.211N           P=0.320N           P=0.067N           P<0.001N**         P=0.486N             |
|LOGISTIC REGRESSION    |        P=0.290N           P=0.338N           P=0.089N           P<0.001N**         P=0.507              |
|COCHRAN-ARMITAGE       |        P=0.374N                                                                                         |
|FISHER EXACT           |                           P=0.342N           P=0.054N           P<0.001N**         P=0.453              |
|=================================================================================================================================|
|                                                                                                                                 |
|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)            |        0/50 (0%)          1/50 (2%)          1/50 (2%)          1/50 (2%)          1/50 (2%)            |
|ADJUSTED (b)           |         0.0%               3.8%               5.0%               2.9%               2.1%                |
|TERMINAL (d)           |        0/32 (0%)          1/26 (4%)          1/20 (5%)          0/31 (0%)          0/25 (0%)            |
|FIRST INCIDENCE (DAYS) |         ---                729 (T)            729 (T)            715                562                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.435            P=0.459            P=0.406            P=0.512            P=0.513              |
|INCIDENTAL TUMOR       |        P=0.460            P=0.459            P=0.406            P=0.571            P=0.550              |
|LOGISTIC REGRESSION    |        P=0.441            P=0.459            P=0.406            P=0.508            P=0.424              |
|COCHRAN-ARMITAGE       |        P=0.438                                                                                          |
|FISHER EXACT           |                           P=0.500            P=0.500            P=0.500            P=0.500              |
|=================================================================================================================================|
         DATE: 07/19/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE  39
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- OXAZEPAM
                       TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE                   |         0 PPM              625 PPM            2500 PPM           5000 PPM           10,000              |
|                       |                                                                                     PPM STOP            |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/50 (0%)          0/50 (0%)          0/50 (0%)          1/50 (2%)          2/50 (4%)            |
|ADJUSTED (b)           |         0.0%               0.0%               0.0%               3.2%               6.1%                |
|TERMINAL (d)           |        0/32 (0%)          0/26 (0%)          0/20 (0%)          1/31 (3%)          0/25 (0%)            |
|FIRST INCIDENCE (DAYS) |         ---                ---                ---                729 (T)            703                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.035 *            (e)                (e)              P=0.494            P=0.240              |
|INCIDENTAL TUMOR       |        P=0.047 *            (e)                (e)              P=0.494            P=0.399              |
|LOGISTIC REGRESSION    |        P=0.034 *            (e)                (e)              P=0.494            P=0.235              |
|COCHRAN-ARMITAGE       |        P=0.031 *                                                                                        |
|FISHER EXACT           |                             (e)                (e)              P=0.500            P=0.247              |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/50 (0%)          2/50 (4%)          0/50 (0%)          1/50 (2%)          2/50 (4%)            |
|ADJUSTED (b)           |         0.0%               6.9%               0.0%               3.2%               6.1%                |
|TERMINAL (d)           |        0/32 (0%)          1/26 (4%)          0/20 (0%)          1/31 (3%)          0/25 (0%)            |
|FIRST INCIDENCE (DAYS) |         ---                717                ---                729 (T)            703                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.242            P=0.217              (e)              P=0.494            P=0.240              |
|INCIDENTAL TUMOR       |        P=0.296            P=0.280              (e)              P=0.494            P=0.399              |
|LOGISTIC REGRESSION    |        P=0.249            P=0.228              (e)              P=0.494            P=0.235              |
|COCHRAN-ARMITAGE       |        P=0.242                                                                                          |
|FISHER EXACT           |                           P=0.247              (e)              P=0.500            P=0.247              |
|=================================================================================================================================|
         DATE: 07/19/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE  40
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- OXAZEPAM
                       TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE                   |         0 PPM              625 PPM            2500 PPM           5000 PPM           10,000              |
|                       |                                                                                     PPM STOP            |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibrosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/50 (0%)          2/50 (4%)          0/50 (0%)          0/50 (0%)          0/50 (0%)            |
|ADJUSTED (b)           |         0.0%               6.9%               0.0%               0.0%               0.0%                |
|TERMINAL (d)           |        0/32 (0%)          1/26 (4%)          0/20 (0%)          0/31 (0%)          0/25 (0%)            |
|FIRST INCIDENCE (DAYS) |         ---                717                ---                ---                ---                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.258N           P=0.217              (e)                (e)                (e)                |
|INCIDENTAL TUMOR       |        P=0.231N           P=0.280              (e)                (e)                (e)                |
|LOGISTIC REGRESSION    |        P=0.247N           P=0.228              (e)                (e)                (e)                |
|COCHRAN-ARMITAGE       |        P=0.247N                                                                                         |
|FISHER EXACT           |                           P=0.247              (e)                (e)                (e)                |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/50 (0%)          2/50 (4%)          0/50 (0%)          0/50 (0%)          0/50 (0%)            |
|ADJUSTED (b)           |         0.0%               6.9%               0.0%               0.0%               0.0%                |
|TERMINAL (d)           |        0/32 (0%)          1/26 (4%)          0/20 (0%)          0/31 (0%)          0/25 (0%)            |
|FIRST INCIDENCE (DAYS) |         ---                717                ---                ---                ---                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.258N           P=0.217              (e)                (e)                (e)                |
|INCIDENTAL TUMOR       |        P=0.231N           P=0.280              (e)                (e)                (e)                |
|LOGISTIC REGRESSION    |        P=0.247N           P=0.228              (e)                (e)                (e)                |
|COCHRAN-ARMITAGE       |        P=0.247N                                                                                         |
|FISHER EXACT           |                           P=0.247              (e)                (e)                (e)                |
|=================================================================================================================================|
         DATE: 07/19/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE  41
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- OXAZEPAM
                       TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE                   |         0 PPM              625 PPM            2500 PPM           5000 PPM           10,000              |
|                       |                                                                                     PPM STOP            |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Keratoacanthoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/50 (0%)          0/50 (0%)          0/50 (0%)          1/50 (2%)          0/50 (0%)            |
|ADJUSTED (b)           |         0.0%               0.0%               0.0%               2.9%               0.0%                |
|TERMINAL (d)           |        0/32 (0%)          0/26 (0%)          0/20 (0%)          0/31 (0%)          0/25 (0%)            |
|FIRST INCIDENCE (DAYS) |         ---                ---                ---                715                ---                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.623              (e)                (e)              P=0.512              (e)                |
|INCIDENTAL TUMOR       |        P=0.663              (e)                (e)              P=0.571              (e)                |
|LOGISTIC REGRESSION    |        P=0.624              (e)                (e)              P=0.508              (e)                |
|COCHRAN-ARMITAGE       |        P=0.622                                                                                          |
|FISHER EXACT           |                             (e)                (e)              P=0.500              (e)                |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Schwannoma Malignant                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/50 (0%)          0/50 (0%)          0/50 (0%)          0/50 (0%)          0/50 (0%)            |
|ADJUSTED (b)           |         0.0%               0.0%               0.0%               0.0%               0.0%                |
|TERMINAL (d)           |        0/32 (0%)          0/26 (0%)          0/20 (0%)          0/31 (0%)          0/25 (0%)            |
|FIRST INCIDENCE (DAYS) |         ---                ---                ---                ---                ---                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |          (e)                (e)                (e)                (e)                (e)                |
|INCIDENTAL TUMOR       |          (e)                (e)                (e)                (e)                (e)                |
|LOGISTIC REGRESSION    |          (e)                (e)                (e)                (e)                (e)                |
|COCHRAN-ARMITAGE       |          (e)                                                                                            |
|FISHER EXACT           |                             (e)                (e)                (e)                (e)                |
|=================================================================================================================================|
         DATE: 07/19/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE  42
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- OXAZEPAM
                       TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE                   |         0 PPM              625 PPM            2500 PPM           5000 PPM           10,000              |
|                       |                                                                                     PPM STOP            |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/50 (0%)          0/50 (0%)          0/50 (0%)          0/50 (0%)          0/50 (0%)            |
|ADJUSTED (b)           |         0.0%               0.0%               0.0%               0.0%               0.0%                |
|TERMINAL (d)           |        0/32 (0%)          0/26 (0%)          0/20 (0%)          0/31 (0%)          0/25 (0%)            |
|FIRST INCIDENCE (DAYS) |         ---                ---                ---                ---                ---                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |          (e)                (e)                (e)                (e)                (e)                |
|INCIDENTAL TUMOR       |          (e)                (e)                (e)                (e)                (e)                |
|LOGISTIC REGRESSION    |          (e)                (e)                (e)                (e)                (e)                |
|COCHRAN-ARMITAGE       |          (e)                                                                                            |
|FISHER EXACT           |                             (e)                (e)                (e)                (e)                |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/50 (0%)          0/50 (0%)          0/50 (0%)          1/50 (2%)          1/50 (2%)            |
|ADJUSTED (b)           |         0.0%               0.0%               0.0%               2.9%               2.1%                |
|TERMINAL (d)           |        0/32 (0%)          0/26 (0%)          0/20 (0%)          0/31 (0%)          0/25 (0%)            |
|FIRST INCIDENCE (DAYS) |         ---                ---                ---                715                562                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.164              (e)                (e)              P=0.512            P=0.513              |
|INCIDENTAL TUMOR       |        P=0.188              (e)                (e)              P=0.571            P=0.550              |
|LOGISTIC REGRESSION    |        P=0.142              (e)                (e)              P=0.508            P=0.424              |
|COCHRAN-ARMITAGE       |        P=0.152                                                                                          |
|FISHER EXACT           |                             (e)                (e)              P=0.500            P=0.500              |
|=================================================================================================================================|
         DATE: 07/19/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE  43
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- OXAZEPAM
                       TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE                   |         0 PPM              625 PPM            2500 PPM           5000 PPM           10,000              |
|                       |                                                                                     PPM STOP            |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma, Papilloma, or Keratoacanthoma                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/50 (0%)          0/50 (0%)          0/50 (0%)          1/50 (2%)          0/50 (0%)            |
|ADJUSTED (b)           |         0.0%               0.0%               0.0%               2.9%               0.0%                |
|TERMINAL (d)           |        0/32 (0%)          0/26 (0%)          0/20 (0%)          0/31 (0%)          0/25 (0%)            |
|FIRST INCIDENCE (DAYS) |         ---                ---                ---                715                ---                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.623              (e)                (e)              P=0.512              (e)                |
|INCIDENTAL TUMOR       |        P=0.663              (e)                (e)              P=0.571              (e)                |
|LOGISTIC REGRESSION    |        P=0.624              (e)                (e)              P=0.508              (e)                |
|COCHRAN-ARMITAGE       |        P=0.622                                                                                          |
|FISHER EXACT           |                             (e)                (e)              P=0.500              (e)                |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Sebaceous Gland                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/50 (0%)          1/50 (2%)          0/50 (0%)          0/50 (0%)          0/50 (0%)            |
|ADJUSTED (b)           |         0.0%               2.7%               0.0%               0.0%               0.0%                |
|TERMINAL (d)           |        0/32 (0%)          0/26 (0%)          0/20 (0%)          0/31 (0%)          0/25 (0%)            |
|FIRST INCIDENCE (DAYS) |         ---                666                ---                ---                ---                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.440N           P=0.495              (e)                (e)                (e)                |
|INCIDENTAL TUMOR       |        P=0.399N           P=0.623              (e)                (e)                (e)                |
|LOGISTIC REGRESSION    |        P=0.447N           P=0.499              (e)                (e)                (e)                |
|COCHRAN-ARMITAGE       |        P=0.445N                                                                                         |
|FISHER EXACT           |                           P=0.500              (e)                (e)                (e)                |
|=================================================================================================================================|
         DATE: 07/19/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE  44
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- OXAZEPAM
                       TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE                   |         0 PPM              625 PPM            2500 PPM           5000 PPM           10,000              |
|                       |                                                                                     PPM STOP            |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |                                                                                                         |
|ADJUSTED (b)           |                                                                                                         |
|TERMINAL (d)           |                                                                                                         |
|FIRST INCIDENCE (DAYS) |                                                                                                         |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |                                                                                                         |
|INCIDENTAL TUMOR       |                                                                                                         |
|LOGISTIC REGRESSION    |                                                                                                         |
|COCHRAN-ARMITAGE       |                                                                                                         |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |        6/50 (12%)         3/50 (6%)          6/48 (13%)         2/49 (4%)          4/50 (8%)            |
|ADJUSTED (b)           |        16.5%              11.5%              23.4%               5.8%              13.8%                |
|TERMINAL (d)           |        3/32 (9%)          3/26 (12%)         3/20 (15%)         1/31 (3%)          3/25 (12%)           |
|FIRST INCIDENCE (DAYS) |         647                729 (T)            578                679                562                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.363N           P=0.324N           P=0.364            P=0.147N           P=0.472N             |
|INCIDENTAL TUMOR       |        P=0.295N           P=0.208N           P=0.601            P=0.084N           P=0.320N             |
|LOGISTIC REGRESSION    |        P=0.317N           P=0.247N           P=0.519            P=0.126N           P=0.365N             |
|COCHRAN-ARMITAGE       |        P=0.335N                                                                                         |
|FISHER EXACT           |                           P=0.243N           P=0.591            P=0.141N           P=0.370N             |
|=================================================================================================================================|
         DATE: 07/19/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE  45
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- OXAZEPAM
                       TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE                   |         0 PPM              625 PPM            2500 PPM           5000 PPM           10,000              |
|                       |                                                                                     PPM STOP            |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |        7/50 (14%)         3/50 (6%)          7/48 (15%)         3/49 (6%)          4/50 (8%)            |
|ADJUSTED (b)           |        19.4%              11.5%              27.9%               8.5%              13.8%                |
|TERMINAL (d)           |        4/32 (13%)         3/26 (12%)         4/20 (20%)         1/31 (3%)          3/25 (12%)           |
|FIRST INCIDENCE (DAYS) |         647                729 (T)            578                679                562                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.304N           P=0.232N           P=0.324            P=0.171N           P=0.366N             |
|INCIDENTAL TUMOR       |        P=0.235N           P=0.140N           P=0.540            P=0.094N           P=0.232N             |
|LOGISTIC REGRESSION    |        P=0.256N           P=0.162N           P=0.480            P=0.096N           P=0.258N             |
|COCHRAN-ARMITAGE       |        P=0.274N                                                                                         |
|FISHER EXACT           |                           P=0.159N           P=0.581            P=0.167N           P=0.262N             |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |        1/50 (2%)          0/50 (0%)          0/48 (0%)          2/49 (4%)          0/50 (0%)            |
|ADJUSTED (b)           |         3.1%               0.0%               0.0%               6.5%               0.0%                |
|TERMINAL (d)           |        1/32 (3%)          0/26 (0%)          0/20 (0%)          2/31 (6%)          0/25 (0%)            |
|FIRST INCIDENCE (DAYS) |         729 (T)            ---                ---                729 (T)            ---                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.623N           P=0.541N           P=0.594N           P=0.489            P=0.549N             |
|INCIDENTAL TUMOR       |        P=0.623N           P=0.541N           P=0.594N           P=0.489            P=0.549N             |
|LOGISTIC REGRESSION    |        P=0.623N           P=0.541N           P=0.594N           P=0.489            P=0.549N             |
|COCHRAN-ARMITAGE       |        P=0.601N                                                                                         |
|FISHER EXACT           |                           P=0.500N           P=0.510N           P=0.492            P=0.500N             |
|=================================================================================================================================|
         DATE: 07/19/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE  46
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- OXAZEPAM
                       TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE                   |         0 PPM              625 PPM            2500 PPM           5000 PPM           10,000              |
|                       |                                                                                     PPM STOP            |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |        1/50 (2%)          0/50 (0%)          3/48 (6%)          1/49 (2%)          0/50 (0%)            |
|ADJUSTED (b)           |         2.5%               0.0%              12.4%               3.2%               0.0%                |
|TERMINAL (d)           |        0/32 (0%)          0/26 (0%)          2/20 (10%)         1/31 (3%)          0/25 (0%)            |
|FIRST INCIDENCE (DAYS) |         641                ---                589                729 (T)            ---                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.360N           P=0.505N           P=0.201            P=0.758N           P=0.505N             |
|INCIDENTAL TUMOR       |        P=0.350N           P=0.500N           P=0.324            P=0.757            P=0.450N             |
|LOGISTIC REGRESSION    |        P=0.346N           P=0.504N           P=0.285            P=0.759            P=0.517N             |
|COCHRAN-ARMITAGE       |        P=0.349N                                                                                         |
|FISHER EXACT           |                           P=0.500N           P=0.293            P=0.747            P=0.500N             |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                                                                         |
|-----------            |                                                                                                         |
|OVERALL (a)            |        2/50 (4%)          0/50 (0%)          3/48 (6%)          3/49 (6%)          0/50 (0%)            |
|ADJUSTED (b)           |         5.5%               0.0%              12.4%               9.7%               0.0%                |
|TERMINAL (d)           |        1/32 (3%)          0/26 (0%)          2/20 (10%)         3/31 (10%)         0/25 (0%)            |
|FIRST INCIDENCE (DAYS) |         641                ---                589                729 (T)            ---                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.367N           P=0.265N           P=0.344            P=0.493            P=0.270N             |
|INCIDENTAL TUMOR       |        P=0.359N           P=0.262N           P=0.483            P=0.488            P=0.238N             |
|LOGISTIC REGRESSION    |        P=0.335N           P=0.237N           P=0.461            P=0.517            P=0.237N             |
|COCHRAN-ARMITAGE       |        P=0.346N                                                                                         |
|FISHER EXACT           |                           P=0.247N           P=0.480            P=0.490            P=0.247N             |
|=================================================================================================================================|
         DATE: 07/19/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE  47
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- OXAZEPAM
                       TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE                   |         0 PPM              625 PPM            2500 PPM           5000 PPM           10,000              |
|                       |                                                                                     PPM STOP            |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        2/50 (4%)          4/50 (8%)          3/50 (6%)          4/50 (8%)          0/50 (0%)            |
|ADJUSTED (b)           |         6.3%              13.6%              13.9%              10.9%               0.0%                |
|TERMINAL (d)           |        2/32 (6%)          2/26 (8%)          2/20 (10%)         2/31 (6%)          0/25 (0%)            |
|FIRST INCIDENCE (DAYS) |         729 (T)            718                703                631                ---                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.142N           P=0.273            P=0.302            P=0.340            P=0.294N             |
|INCIDENTAL TUMOR       |        P=0.110N           P=0.364            P=0.371            P=0.356            P=0.294N             |
|LOGISTIC REGRESSION    |        P=0.120N           P=0.311            P=0.349            P=0.349            P=0.294N             |
|COCHRAN-ARMITAGE       |        P=0.126N                                                                                         |
|FISHER EXACT           |                           P=0.339            P=0.500            P=0.339            P=0.247N             |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal or Polyp Stromal                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        3/50 (6%)          4/50 (8%)          3/50 (6%)          5/50 (10%)         1/50 (2%)            |
|ADJUSTED (b)           |         9.4%              13.6%              13.9%              12.9%               4.0%                |
|TERMINAL (d)           |        3/32 (9%)          2/26 (8%)          2/20 (10%)         2/31 (6%)          1/25 (4%)            |
|FIRST INCIDENCE (DAYS) |         729 (T)            718                703                631                729 (T)             |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.252N           P=0.415            P=0.443            P=0.364            P=0.396N             |
|INCIDENTAL TUMOR       |        P=0.207N           P=0.513            P=0.512            P=0.371            P=0.396N             |
|LOGISTIC REGRESSION    |        P=0.216N           P=0.469            P=0.497            P=0.366            P=0.396N             |
|COCHRAN-ARMITAGE       |        P=0.227N                                                                                         |
|FISHER EXACT           |                           P=0.500            P=0.661N           P=0.357            P=0.309N             |
|=================================================================================================================================|
         DATE: 07/19/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE  48
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- OXAZEPAM
                       TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE                   |         0 PPM              625 PPM            2500 PPM           5000 PPM           10,000              |
|                       |                                                                                     PPM STOP            |
|=================================================================================================================================|
|                                                                                                                                 |
|Zymbal's Gland                                                                                                                   |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/50 (0%)          0/50 (0%)          0/50 (0%)          2/50 (4%)          0/50 (0%)            |
|ADJUSTED (b)           |         0.0%               0.0%               0.0%               6.1%               0.0%                |
|TERMINAL (d)           |        0/32 (0%)          0/26 (0%)          0/20 (0%)          1/31 (3%)          0/25 (0%)            |
|FIRST INCIDENCE (DAYS) |         ---                ---                ---                715                ---                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.475              (e)                (e)              P=0.243              (e)                |
|INCIDENTAL TUMOR       |        P=0.509              (e)                (e)              P=0.275              (e)                |
|LOGISTIC REGRESSION    |        P=0.484              (e)                (e)              P=0.244              (e)                |
|COCHRAN-ARMITAGE       |        P=0.481                                                                                          |
|FISHER EXACT           |                             (e)                (e)              P=0.247              (e)                |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |       14/50 (28%)        19/50 (38%)        29/50 (58%)        18/50 (36%)        15/50 (30%)           |
|ADJUSTED (b)           |        37.7%              46.9%              67.4%              43.8%              40.5%                |
|TERMINAL (d)           |       10/32 (31%)         7/26 (27%)         7/20 (35%)         9/31 (29%)         6/25 (24%)           |
|FIRST INCIDENCE (DAYS) |         522                400                414                613                506                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.325N           P=0.136            P<0.001 **         P=0.277            P=0.336              |
|INCIDENTAL TUMOR       |        P=0.197N           P=0.255            P=0.017 *          P=0.317            P=0.576              |
|LOGISTIC REGRESSION    |        P=0.221N           P=0.198            P=0.003 **         P=0.279            P=0.507              |
|COCHRAN-ARMITAGE       |        P=0.265N                                                                                         |
|FISHER EXACT           |                           P=0.198            P=0.002 **         P=0.260            P=0.500              |
|=================================================================================================================================|
         DATE: 07/19/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE  49
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- OXAZEPAM
                       TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE                   |         0 PPM              625 PPM            2500 PPM           5000 PPM           10,000              |
|                       |                                                                                     PPM STOP            |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Mesothelioma: Benign, Malignant, NOS                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |        0/50 (0%)          0/50 (0%)          0/50 (0%)          0/50 (0%)          0/50 (0%)            |
|ADJUSTED (b)           |         0.0%               0.0%               0.0%               0.0%               0.0%                |
|TERMINAL (d)           |        0/32 (0%)          0/26 (0%)          0/20 (0%)          0/31 (0%)          0/25 (0%)            |
|FIRST INCIDENCE (DAYS) |         ---                ---                ---                ---                ---                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |          (e)                (e)                (e)                (e)                (e)                |
|INCIDENTAL TUMOR       |          (e)                (e)                (e)                (e)                (e)                |
|LOGISTIC REGRESSION    |          (e)                (e)                (e)                (e)                (e)                |
|COCHRAN-ARMITAGE       |          (e)                                                                                            |
|FISHER EXACT           |                             (e)                (e)                (e)                (e)                |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |       43/50 (86%)        39/50 (78%)        30/50 (60%)        26/50 (52%)        38/50 (76%)           |
|ADJUSTED (b)           |        95.5%              95.0%              81.9%              66.1%              84.3%                |
|TERMINAL (d)           |       30/32 (94%)        24/26 (92%)        14/20 (70%)        18/31 (58%)        18/25 (72%)           |
|FIRST INCIDENCE (DAYS) |         529                475                506                550                562                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.312N           P=0.446            P=0.563            P=0.003N**         P=0.482              |
|INCIDENTAL TUMOR       |        P=0.063N           P=0.162N           P=0.006N**         P<0.001N**         P=0.039N*            |
|LOGISTIC REGRESSION    |        P=0.090N           P=0.174N           P=0.007N**         P<0.001N**         P=0.092N             |
|COCHRAN-ARMITAGE       |        P=0.159N                                                                                         |
|FISHER EXACT           |                           P=0.218N           P=0.003N**         P<0.001N**         P=0.154N             |
|=================================================================================================================================|
         DATE: 07/19/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE  50
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- OXAZEPAM
                       TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE                   |         0 PPM              625 PPM            2500 PPM           5000 PPM           10,000              |
|                       |                                                                                     PPM STOP            |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |       21/50 (42%)        26/50 (52%)        34/50 (68%)        22/50 (44%)        17/50 (34%)           |
|ADJUSTED (b)           |        51.1%              60.1%              76.4%              51.6%              43.0%                |
|TERMINAL (d)           |       13/32 (41%)        10/26 (38%)        10/20 (50%)        11/31 (35%)         6/25 (24%)           |
|FIRST INCIDENCE (DAYS) |         223                288                414                613                506                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.095N           P=0.146            P=0.001 **         P=0.498            P=0.460N             |
|INCIDENTAL TUMOR       |        P=0.030N*          P=0.238            P=0.016 *          P=0.531            P=0.322N             |
|LOGISTIC REGRESSION    |        P=0.045N*          P=0.205            P=0.013 *          P=0.496            P=0.293N             |
|COCHRAN-ARMITAGE       |        P=0.037N*                                                                                        |
|FISHER EXACT           |                           P=0.212            P=0.008 **         P=0.500            P=0.268N             |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |          #                  #                  #                  #                  #                  |
|-----------            |                                                                                                         |
|OVERALL (a)            |       49/50 (98%)        49/50 (98%)        45/50 (90%)        38/50 (76%)        43/50 (86%)           |
|ADJUSTED (b)           |       100.0%              98.0%              90.0%              82.5%              89.5%                |
|TERMINAL (d)           |       32/32 (100%)       25/26 (96%)        15/20 (75%)        23/31 (74%)        20/25 (80%)           |
|FIRST INCIDENCE (DAYS) |         223                288                414                550                506                 |
|-----------------------|                                                                                                         |
|STATISTICAL TESTS (f)  |                                                                                                         |
|-----------------------|                                                                                                         |
|LIFE TABLE             |        P=0.178N           P=0.220            P=0.085            P=0.058N           P=0.515              |
|INCIDENTAL TUMOR       |        P=0.001N**         P=0.738N           P=0.047N*          P<0.001N**         P=0.024N*            |
|LOGISTIC REGRESSION    |        P=0.004N**         P=0.761N           P=0.063N           P=0.001N**         P=0.030N*            |
|COCHRAN-ARMITAGE       |        P=0.004N**                                                                                       |
|FISHER EXACT           |                           P=0.753N           P=0.102N           P<0.001N**         P=0.030N*            |
|=================================================================================================================================|
         DATE: 07/19/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE  51
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- OXAZEPAM
                       TERMINAL SACRIFICE AT 105 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.
 (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).