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TDMS Study 05212-05 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                                          OXAZEPAM                                       DATE: 10/24/96       
EXPERIMENT: 05212 TEST: 05                                                                                     TIME: 12:01:17       
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        
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                     CONTROL VS 10,000 PPM STOP                                                     
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 001    0 PPM                                                                         
                                       INCLUDE 002    0 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: 10/24/96       
EXPERIMENT: 05212 TEST: 05                                                                                     TIME: 12:01:17       
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: 10/24/96       
EXPERIMENT: 05212 TEST: 05                                                                                     TIME: 12:01:17       
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
              Clitoral/Preputial Gland      Adenoma
                                            Carcinoma or Adenoma
              Pituitary Gland: Pars Distalis or Unspecified Site
                                            Adenoma
              Testes                        Adenoma
              Thyroid Gland: C-Cell         Adenoma
                                            Carcinoma or Adenoma
              All Organs                    Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
                                            Benign Tumors
                                            Malignant Tumors
                                            Malignant and Benign Tumors
              ====================================================================================================
                                                           FEMALE RATS
                                                          -------------
                  ORGAN                               MORPHOLOGY
                 -------                             ------------
              Clitoral/Preputial Gland      Adenoma
                                            Carcinoma or Adenoma
              All Organs                    Benign Tumors
                                            Malignant and Benign Tumors
              ====================================================================================================
         DATE: 10/24/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE   1
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXAZEPAM
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          0 PPM               10,000                |          0 PPM               10,000                |
|                       |                              PPM STOP              |                              PPM STOP              |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |        14/50 (28%)          0/1 (0%)               |         1/50 (2%)           0/0 (0%)               |
|ADJUSTED (b)           |         44.1%                0.0%                  |          3.1%                0.0%                  |
|TERMINAL (d)           |         3/17 (18%)          0/0                    |         1/32 (3%)           0/0                    |
|FIRST INCIDENCE (DAYS) |          571                 ---                   |          729 (T)             ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.045N*              |           (e)                 (e)                  |
|INCIDENTAL TUMOR       |                             P=0.521N               |           (e)                 (e)                  |
|LOGISTIC REGRESSION    |                             P=0.675N               |           (e)                 (e)                  |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.725N               |                             P=1.000N               |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |        14/50 (28%)          1/1 (100%)             |         3/50 (6%)           0/0 (0%)               |
|ADJUSTED (b)           |         44.1%               10.0%                  |          8.9%                0.0%                  |
|TERMINAL (d)           |         3/17 (18%)          0/0                    |         2/32 (6%)           0/0                    |
|FIRST INCIDENCE (DAYS) |          571                 690                   |          700                 ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.132N               |                             P=0.512N               |
|INCIDENTAL TUMOR       |                             P=0.521                |           (e)                 (e)                  |
|LOGISTIC REGRESSION    |                             P=0.345                |           (e)                 (e)                  |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.294                |                             P=1.000N               |
|=================================================================================================================================|
         DATE: 10/24/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE   2
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXAZEPAM
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          0 PPM               10,000                |          0 PPM               10,000                |
|                       |                              PPM STOP              |                              PPM STOP              |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         7/48 (15%)         10/14 (71%)             |         7/49 (14%)          7/11 (64%)             |
|ADJUSTED (b)           |         29.8%               73.6%                  |         19.4%               65.1%                  |
|TERMINAL (d)           |         3/17 (18%)          0/0                    |         4/31 (13%)          5/8 (63%)              |
|FIRST INCIDENCE (DAYS) |          601                 584                   |          550                 718                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.001 **             |                             P=0.077                |
|INCIDENTAL TUMOR       |                             P<0.001 **             |                             P=0.004 **             |
|LOGISTIC REGRESSION    |                             P<0.001 **             |                             P=0.002 **             |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P<0.001 **             |                             P=0.002 **             |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         8/48 (17%)         10/14 (71%)             |         8/49 (16%)          7/11 (64%)             |
|ADJUSTED (b)           |         31.5%               73.6%                  |         22.4%               65.1%                  |
|TERMINAL (d)           |         3/17 (18%)          0/0                    |         5/31 (16%)          5/8 (63%)              |
|FIRST INCIDENCE (DAYS) |          541                 584                   |          550                 718                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.004 **             |                             P=0.101                |
|INCIDENTAL TUMOR       |                             P<0.001 **             |                             P=0.008 **             |
|LOGISTIC REGRESSION    |                             P<0.001 **             |                             P=0.004 **             |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P<0.001 **             |                             P=0.003 **             |
|=================================================================================================================================|
         DATE: 10/24/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE   3
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXAZEPAM
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          0 PPM               10,000                |          0 PPM               10,000                |
|                       |                              PPM STOP              |                              PPM STOP              |
|=================================================================================================================================|
|                                                                                                                                 |
|Intestine Small: Jejunum                                                                                                         |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         2/50 (4%)           0/50 (0%)              |         0/50 (0%)           0/50 (0%)              |
|ADJUSTED (b)           |          9.1%                0.0%                  |          0.0%                0.0%                  |
|TERMINAL (d)           |         1/17 (6%)           0/0                    |         0/32 (0%)           0/25 (0%)              |
|FIRST INCIDENCE (DAYS) |          690                 ---                   |          ---                 ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.712N               |           (e)                 (e)                  |
|INCIDENTAL TUMOR       |                             P=0.511N               |           (e)                 (e)                  |
|LOGISTIC REGRESSION    |                             P=0.506N               |           (e)                 (e)                  |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.247N               |                               (e)                  |
|=================================================================================================================================|
|                                                                                                                                 |
|Intestine Small: Site Unspecified                                                                                                |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         2/50 (4%)           0/50 (0%)              |         0/50 (0%)           0/50 (0%)              |
|ADJUSTED (b)           |          9.1%                0.0%                  |          0.0%                0.0%                  |
|TERMINAL (d)           |         1/17 (6%)           0/0                    |         0/32 (0%)           0/25 (0%)              |
|FIRST INCIDENCE (DAYS) |          690                 ---                   |          ---                 ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.712N               |           (e)                 (e)                  |
|INCIDENTAL TUMOR       |                             P=0.511N               |           (e)                 (e)                  |
|LOGISTIC REGRESSION    |                             P=0.506N               |           (e)                 (e)                  |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.247N               |                               (e)                  |
|=================================================================================================================================|
         DATE: 10/24/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE   4
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXAZEPAM
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          0 PPM               10,000                |          0 PPM               10,000                |
|                       |                              PPM STOP              |                              PPM STOP              |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         2/50 (4%)           0/0 (0%)               |         0/50 (0%)           0/0 (0%)               |
|ADJUSTED (b)           |          6.7%                0.0%                  |          0.0%                0.0%                  |
|TERMINAL (d)           |         0/17 (0%)           0/0                    |         0/32 (0%)           0/0                    |
|FIRST INCIDENCE (DAYS) |          682                 ---                   |          ---                 ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.547N               |           (e)                 (e)                  |
|INCIDENTAL TUMOR       |           (e)                 (e)                  |           (e)                 (e)                  |
|LOGISTIC REGRESSION    |           (e)                 (e)                  |           (e)                 (e)                  |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=1.000N               |                               (e)                  |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         3/50 (6%)           0/0 (0%)               |         1/50 (2%)           0/0 (0%)               |
|ADJUSTED (b)           |          9.9%                0.0%                  |          3.1%                0.0%                  |
|TERMINAL (d)           |         0/17 (0%)           0/0                    |         1/32 (3%)           0/0                    |
|FIRST INCIDENCE (DAYS) |          682                 ---                   |          729 (T)             ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.407N               |           (e)                 (e)                  |
|INCIDENTAL TUMOR       |           (e)                 (e)                  |           (e)                 (e)                  |
|LOGISTIC REGRESSION    |           (e)                 (e)                  |           (e)                 (e)                  |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=1.000N               |                             P=1.000N               |
|=================================================================================================================================|
         DATE: 10/24/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE   5
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXAZEPAM
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          0 PPM               10,000                |          0 PPM               10,000                |
|                       |                              PPM STOP              |                              PPM STOP              |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         2/50 (4%)           1/50 (2%)              |         0/50 (0%)           0/49 (0%)              |
|ADJUSTED (b)           |          8.4%                2.6%                  |          0.0%                0.0%                  |
|TERMINAL (d)           |         1/17 (6%)           0/0                    |         0/32 (0%)           0/25 (0%)              |
|FIRST INCIDENCE (DAYS) |          608                 585                   |          ---                 ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.741                |           (e)                 (e)                  |
|INCIDENTAL TUMOR       |                             P=0.438N               |           (e)                 (e)                  |
|LOGISTIC REGRESSION    |                             P=0.504N               |           (e)                 (e)                  |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.500N               |                               (e)                  |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         2/50 (4%)           1/50 (2%)              |         0/50 (0%)           0/49 (0%)              |
|ADJUSTED (b)           |          8.4%                2.6%                  |          0.0%                0.0%                  |
|TERMINAL (d)           |         1/17 (6%)           0/0                    |         0/32 (0%)           0/25 (0%)              |
|FIRST INCIDENCE (DAYS) |          608                 585                   |          ---                 ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.741                |           (e)                 (e)                  |
|INCIDENTAL TUMOR       |                             P=0.438N               |           (e)                 (e)                  |
|LOGISTIC REGRESSION    |                             P=0.504N               |           (e)                 (e)                  |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.500N               |                               (e)                  |
|=================================================================================================================================|
         DATE: 10/24/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE   6
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXAZEPAM
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          0 PPM               10,000                |          0 PPM               10,000                |
|                       |                              PPM STOP              |                              PPM STOP              |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         0/50 (0%)           1/50 (2%)              |         2/50 (4%)           1/50 (2%)              |
|ADJUSTED (b)           |          0.0%                3.4%                  |          5.1%                2.1%                  |
|TERMINAL (d)           |         0/17 (0%)           0/0                    |         1/32 (3%)           0/25 (0%)              |
|FIRST INCIDENCE (DAYS) |          ---                 614                   |          228                 562                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.457                |                             P=0.519N               |
|INCIDENTAL TUMOR       |                             P=0.767                |                             P=0.761N               |
|LOGISTIC REGRESSION    |                             P=0.530                |                             P=0.713N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.500                |                             P=0.500N               |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         0/50 (0%)           2/50 (4%)              |         3/50 (6%)           1/50 (2%)              |
|ADJUSTED (b)           |          0.0%               13.1%                  |          7.4%                2.1%                  |
|TERMINAL (d)           |         0/17 (0%)           0/0                    |         1/32 (3%)           0/25 (0%)              |
|FIRST INCIDENCE (DAYS) |          ---                 614                   |          228                 562                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.114                |                             P=0.327N               |
|INCIDENTAL TUMOR       |                             P=0.366                |                             P=0.470N               |
|LOGISTIC REGRESSION    |                             P=0.204                |                             P=0.466N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.247                |                             P=0.309N               |
|=================================================================================================================================|
         DATE: 10/24/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE   7
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXAZEPAM
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          0 PPM               10,000                |          0 PPM               10,000                |
|                       |                              PPM STOP              |                              PPM STOP              |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroadenoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         4/50 (8%)           0/50 (0%)              |        25/50 (50%)         23/50 (46%)             |
|ADJUSTED (b)           |         18.2%                0.0%                  |         67.0%               66.7%                  |
|TERMINAL (d)           |         1/17 (6%)           0/0                    |        20/32 (63%)         14/25 (56%)             |
|FIRST INCIDENCE (DAYS) |          698                 ---                   |          529                 562                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.537N               |                             P=0.394                |
|INCIDENTAL TUMOR       |                             P=0.127N               |                             P=0.455N               |
|LOGISTIC REGRESSION    |                             P=0.214N               |                             P=0.428N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.059N               |                             P=0.421N               |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma or Adenoma                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         4/50 (8%)           1/50 (2%)              |        26/50 (52%)         23/50 (46%)             |
|ADJUSTED (b)           |         18.2%               10.0%                  |         67.8%               66.7%                  |
|TERMINAL (d)           |         1/17 (6%)           0/0                    |        20/32 (63%)         14/25 (56%)             |
|FIRST INCIDENCE (DAYS) |          698                 690                   |          529                 562                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.608                |                             P=0.468                |
|INCIDENTAL TUMOR       |                             P=0.321N               |                             P=0.364N               |
|LOGISTIC REGRESSION    |                             P=0.515N               |                             P=0.340N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.181N               |                             P=0.345N               |
|=================================================================================================================================|
         DATE: 10/24/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE   8
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXAZEPAM
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          0 PPM               10,000                |          0 PPM               10,000                |
|                       |                              PPM STOP              |                              PPM STOP              |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         4/50 (8%)           2/50 (4%)              |        27/50 (54%)         23/50 (46%)             |
|ADJUSTED (b)           |         18.2%               13.1%                  |         68.4%               66.7%                  |
|TERMINAL (d)           |         1/17 (6%)           0/0                    |        20/32 (63%)         14/25 (56%)             |
|FIRST INCIDENCE (DAYS) |          698                 614                   |          228                 562                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.345                |                             P=0.542                |
|INCIDENTAL TUMOR       |                             P=0.410N               |                             P=0.364N               |
|LOGISTIC REGRESSION    |                             P=0.614N               |                             P=0.346N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.339N               |                             P=0.274N               |
|=================================================================================================================================|
|                                                                                                                                 |
|Pancreas                                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         2/50 (4%)           0/0 (0%)               |         0/50 (0%)           0/0 (0%)               |
|ADJUSTED (b)           |         11.8%                0.0%                  |          0.0%                0.0%                  |
|TERMINAL (d)           |         2/17 (12%)          0/0                    |         0/32 (0%)           0/0                    |
|FIRST INCIDENCE (DAYS) |          730 (T)             ---                   |          ---                 ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |           (e)                 (e)                  |           (e)                 (e)                  |
|INCIDENTAL TUMOR       |           (e)                 (e)                  |           (e)                 (e)                  |
|LOGISTIC REGRESSION    |           (e)                 (e)                  |           (e)                 (e)                  |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=1.000N               |                               (e)                  |
|=================================================================================================================================|
         DATE: 10/24/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE   9
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXAZEPAM
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          0 PPM               10,000                |          0 PPM               10,000                |
|                       |                              PPM STOP              |                              PPM STOP              |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |        17/49 (35%)          5/5 (100%)             |        31/50 (62%)         23/35 (66%)             |
|ADJUSTED (b)           |         61.7%               49.7%                  |         73.6%               67.3%                  |
|TERMINAL (d)           |         8/17 (47%)          0/0                    |        21/32 (66%)          8/16 (50%)             |
|FIRST INCIDENCE (DAYS) |          471                 627                   |          529                 562                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.310                |                             P=0.438                |
|INCIDENTAL TUMOR       |                             P=0.009 **             |                             P=0.486N               |
|LOGISTIC REGRESSION    |                             P=0.010 **             |                             P=0.507                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.008 **             |                             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)            |         5/50 (10%)          2/50 (4%)              |         0/50 (0%)           1/50 (2%)              |
|ADJUSTED (b)           |         14.6%                4.8%                  |          0.0%                2.1%                  |
|TERMINAL (d)           |         0/17 (0%)           0/0                    |         0/32 (0%)           0/25 (0%)              |
|FIRST INCIDENCE (DAYS) |          517                 542                   |          ---                 562                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.458N               |                             P=0.513                |
|INCIDENTAL TUMOR       |                             P=0.138N               |                             P=0.550                |
|LOGISTIC REGRESSION    |                             P=0.157N               |                             P=0.424                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.218N               |                             P=0.500                |
|=================================================================================================================================|
         DATE: 10/24/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE  10
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXAZEPAM
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          0 PPM               10,000                |          0 PPM               10,000                |
|                       |                              PPM STOP              |                              PPM STOP              |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         3/50 (6%)           2/50 (4%)              |         0/50 (0%)           2/50 (4%)              |
|ADJUSTED (b)           |         16.2%               34.8%                  |          0.0%                6.1%                  |
|TERMINAL (d)           |         2/17 (12%)          0/0                    |         0/32 (0%)           0/25 (0%)              |
|FIRST INCIDENCE (DAYS) |          711                 558                   |          ---                 703                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.154                |                             P=0.240                |
|INCIDENTAL TUMOR       |                             P=0.629                |                             P=0.399                |
|LOGISTIC REGRESSION    |                             P=0.629                |                             P=0.235                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.500N               |                             P=0.247                |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         5/50 (10%)          3/50 (6%)              |         0/50 (0%)           2/50 (4%)              |
|ADJUSTED (b)           |         21.5%               47.9%                  |          0.0%                6.1%                  |
|TERMINAL (d)           |         2/17 (12%)          0/0                    |         0/32 (0%)           0/25 (0%)              |
|FIRST INCIDENCE (DAYS) |          491                 558                   |          ---                 703                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.187                |                             P=0.240                |
|INCIDENTAL TUMOR       |                             P=0.629N               |                             P=0.399                |
|LOGISTIC REGRESSION    |                             P=0.492N               |                             P=0.235                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.357N               |                             P=0.247                |
|=================================================================================================================================|
         DATE: 10/24/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE  11
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXAZEPAM
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          0 PPM               10,000                |          0 PPM               10,000                |
|                       |                              PPM STOP              |                              PPM STOP              |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibrosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         2/50 (4%)           1/50 (2%)              |         0/50 (0%)           0/50 (0%)              |
|ADJUSTED (b)           |          6.3%               20.0%                  |          0.0%                0.0%                  |
|TERMINAL (d)           |         0/17 (0%)           0/0                    |         0/32 (0%)           0/25 (0%)              |
|FIRST INCIDENCE (DAYS) |          491                 697                   |          ---                 ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.669                |           (e)                 (e)                  |
|INCIDENTAL TUMOR       |                             P=0.567N               |           (e)                 (e)                  |
|LOGISTIC REGRESSION    |                             P=0.476N               |           (e)                 (e)                  |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.500N               |                               (e)                  |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         3/50 (6%)           1/50 (2%)              |         0/50 (0%)           0/50 (0%)              |
|ADJUSTED (b)           |         11.0%               20.0%                  |          0.0%                0.0%                  |
|TERMINAL (d)           |         0/17 (0%)           0/0                    |         0/32 (0%)           0/25 (0%)              |
|FIRST INCIDENCE (DAYS) |          491                 697                   |          ---                 ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.712                |           (e)                 (e)                  |
|INCIDENTAL TUMOR       |                             P=0.362N               |           (e)                 (e)                  |
|LOGISTIC REGRESSION    |                             P=0.323N               |           (e)                 (e)                  |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.309N               |                               (e)                  |
|=================================================================================================================================|
         DATE: 10/24/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE  12
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXAZEPAM
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          0 PPM               10,000                |          0 PPM               10,000                |
|                       |                              PPM STOP              |                              PPM STOP              |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Keratoacanthoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         3/50 (6%)           2/50 (4%)              |         0/50 (0%)           0/50 (0%)              |
|ADJUSTED (b)           |         10.1%                4.8%                  |          0.0%                0.0%                  |
|TERMINAL (d)           |         0/17 (0%)           0/0                    |         0/32 (0%)           0/25 (0%)              |
|FIRST INCIDENCE (DAYS) |          585                 542                   |          ---                 ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.645                |           (e)                 (e)                  |
|INCIDENTAL TUMOR       |                             P=0.331N               |           (e)                 (e)                  |
|LOGISTIC REGRESSION    |                             P=0.449N               |           (e)                 (e)                  |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.500N               |                               (e)                  |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Schwannoma Malignant                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         3/50 (6%)           0/50 (0%)              |         0/50 (0%)           0/50 (0%)              |
|ADJUSTED (b)           |         11.6%                0.0%                  |          0.0%                0.0%                  |
|TERMINAL (d)           |         1/17 (6%)           0/0                    |         0/32 (0%)           0/25 (0%)              |
|FIRST INCIDENCE (DAYS) |          480                 ---                   |          ---                 ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.377N               |           (e)                 (e)                  |
|INCIDENTAL TUMOR       |                             P=0.298N               |           (e)                 (e)                  |
|LOGISTIC REGRESSION    |                             P=0.107N               |           (e)                 (e)                  |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.121N               |                               (e)                  |
|=================================================================================================================================|
         DATE: 10/24/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE  13
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXAZEPAM
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          0 PPM               10,000                |          0 PPM               10,000                |
|                       |                              PPM STOP              |                              PPM STOP              |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         2/50 (4%)           0/50 (0%)              |         0/50 (0%)           0/50 (0%)              |
|ADJUSTED (b)           |          5.0%                0.0%                  |          0.0%                0.0%                  |
|TERMINAL (d)           |         0/17 (0%)           0/0                    |         0/32 (0%)           0/25 (0%)              |
|FIRST INCIDENCE (DAYS) |          517                 ---                   |          ---                 ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.353N               |           (e)                 (e)                  |
|INCIDENTAL TUMOR       |                             P=0.298N               |           (e)                 (e)                  |
|LOGISTIC REGRESSION    |                             P=0.186N               |           (e)                 (e)                  |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.247N               |                               (e)                  |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         5/50 (10%)          2/50 (4%)              |         0/50 (0%)           1/50 (2%)              |
|ADJUSTED (b)           |         14.6%                4.8%                  |          0.0%                2.1%                  |
|TERMINAL (d)           |         0/17 (0%)           0/0                    |         0/32 (0%)           0/25 (0%)              |
|FIRST INCIDENCE (DAYS) |          517                 542                   |          ---                 562                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.458N               |                             P=0.513                |
|INCIDENTAL TUMOR       |                             P=0.138N               |                             P=0.550                |
|LOGISTIC REGRESSION    |                             P=0.157N               |                             P=0.424                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.218N               |                             P=0.500                |
|=================================================================================================================================|
         DATE: 10/24/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE  14
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXAZEPAM
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          0 PPM               10,000                |          0 PPM               10,000                |
|                       |                              PPM STOP              |                              PPM STOP              |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma, Papilloma, or Keratoacanthoma                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         5/50 (10%)          2/50 (4%)              |         0/50 (0%)           0/50 (0%)              |
|ADJUSTED (b)           |         14.6%                4.8%                  |          0.0%                0.0%                  |
|TERMINAL (d)           |         0/17 (0%)           0/0                    |         0/32 (0%)           0/25 (0%)              |
|FIRST INCIDENCE (DAYS) |          517                 542                   |          ---                 ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.458N               |           (e)                 (e)                  |
|INCIDENTAL TUMOR       |                             P=0.138N               |           (e)                 (e)                  |
|LOGISTIC REGRESSION    |                             P=0.157N               |           (e)                 (e)                  |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.218N               |                               (e)                  |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Sebaceous Gland                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         1/50 (2%)           2/50 (4%)              |         0/50 (0%)           0/50 (0%)              |
|ADJUSTED (b)           |          2.9%               19.5%                  |          0.0%                0.0%                  |
|TERMINAL (d)           |         0/17 (0%)           0/0                    |         0/32 (0%)           0/25 (0%)              |
|FIRST INCIDENCE (DAYS) |          682                 614                   |          ---                 ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.214                |           (e)                 (e)                  |
|INCIDENTAL TUMOR       |                             P=0.629                |           (e)                 (e)                  |
|LOGISTIC REGRESSION    |                             P=0.421                |           (e)                 (e)                  |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.500                |                               (e)                  |
|=================================================================================================================================|
         DATE: 10/24/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE  15
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXAZEPAM
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          0 PPM               10,000                |          0 PPM               10,000                |
|                       |                              PPM STOP              |                              PPM STOP              |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |        45/50 (90%)         48/48 (100%)            |                                                    |
|ADJUSTED (b)           |        100.0%              100.0%                  |                                                    |
|TERMINAL (d)           |        17/17 (100%)         0/0                    |                                                    |
|FIRST INCIDENCE (DAYS) |          517                 480                   |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P<0.001 **             |                                                    |
|INCIDENTAL TUMOR       |                             P=0.055                |                                                    |
|LOGISTIC REGRESSION    |                             P=0.014 *              |                                                    |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.031 *              |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |        10/50 (20%)          1/50 (2%)              |         6/50 (12%)          4/50 (8%)              |
|ADJUSTED (b)           |         35.5%                9.1%                  |         16.5%               13.8%                  |
|TERMINAL (d)           |         3/17 (18%)          0/0                    |         3/32 (9%)           3/25 (12%)             |
|FIRST INCIDENCE (DAYS) |          571                 687                   |          647                 562                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.320N               |                             P=0.472N               |
|INCIDENTAL TUMOR       |                             P=0.017N*              |                             P=0.320N               |
|LOGISTIC REGRESSION    |                             P=0.030N*              |                             P=0.365N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.004N**             |                             P=0.370N               |
|=================================================================================================================================|
         DATE: 10/24/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE  16
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXAZEPAM
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          0 PPM               10,000                |          0 PPM               10,000                |
|                       |                              PPM STOP              |                              PPM STOP              |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |        10/50 (20%)          2/50 (4%)              |         7/50 (14%)          4/50 (8%)              |
|ADJUSTED (b)           |         35.5%               13.2%                  |         19.4%               13.8%                  |
|TERMINAL (d)           |         3/17 (18%)          0/0                    |         4/32 (13%)          3/25 (12%)             |
|FIRST INCIDENCE (DAYS) |          571                 634                   |          647                 562                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.516N               |                             P=0.366N               |
|INCIDENTAL TUMOR       |                             P=0.030N*              |                             P=0.232N               |
|LOGISTIC REGRESSION    |                             P=0.068N               |                             P=0.258N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.014N*              |                             P=0.262N               |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         1/50 (2%)           2/50 (4%)              |         1/50 (2%)           0/50 (0%)              |
|ADJUSTED (b)           |          2.4%                9.5%                  |          3.1%                0.0%                  |
|TERMINAL (d)           |         0/17 (0%)           0/0                    |         1/32 (3%)           0/25 (0%)              |
|FIRST INCIDENCE (DAYS) |          554                 638                   |          729 (T)             ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.384                |                             P=0.549N               |
|INCIDENTAL TUMOR       |                             P=0.569N               |                             P=0.549N               |
|LOGISTIC REGRESSION    |                             P=0.557                |                             P=0.549N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.500                |                             P=0.500N               |
|=================================================================================================================================|
         DATE: 10/24/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE  17
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXAZEPAM
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          0 PPM               10,000                |          0 PPM               10,000                |
|                       |                              PPM STOP              |                              PPM STOP              |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         3/50 (6%)           1/50 (2%)              |         1/50 (2%)           0/50 (0%)              |
|ADJUSTED (b)           |         12.5%                4.8%                  |          2.5%                0.0%                  |
|TERMINAL (d)           |         1/17 (6%)           0/0                    |         0/32 (0%)           0/25 (0%)              |
|FIRST INCIDENCE (DAYS) |          688                 638                   |          641                 ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.660                |                             P=0.505N               |
|INCIDENTAL TUMOR       |                             P=0.371N               |                             P=0.450N               |
|LOGISTIC REGRESSION    |                             P=0.513N               |                             P=0.517N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.309N               |                             P=0.500N               |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         4/50 (8%)           2/50 (4%)              |         2/50 (4%)           0/50 (0%)              |
|ADJUSTED (b)           |         14.6%                9.5%                  |          5.5%                0.0%                  |
|TERMINAL (d)           |         1/17 (6%)           0/0                    |         1/32 (3%)           0/25 (0%)              |
|FIRST INCIDENCE (DAYS) |          554                 638                   |          641                 ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.573                |                             P=0.270N               |
|INCIDENTAL TUMOR       |                             P=0.190N               |                             P=0.238N               |
|LOGISTIC REGRESSION    |                             P=0.400N               |                             P=0.237N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.339N               |                             P=0.247N               |
|=================================================================================================================================|
         DATE: 10/24/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE  18
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXAZEPAM
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          0 PPM               10,000                |          0 PPM               10,000                |
|                       |                              PPM STOP              |                              PPM STOP              |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |         2/50 (4%)           0/50 (0%)              |
|ADJUSTED (b)           |                                                    |          6.3%                0.0%                  |
|TERMINAL (d)           |                                                    |         2/32 (6%)           0/25 (0%)              |
|FIRST INCIDENCE (DAYS) |                                                    |          729 (T)             ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |                             P=0.294N               |
|INCIDENTAL TUMOR       |                                                    |                             P=0.294N               |
|LOGISTIC REGRESSION    |                                                    |                             P=0.294N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                                                    |                             P=0.247N               |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal or Polyp Stromal                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |         3/50 (6%)           1/50 (2%)              |
|ADJUSTED (b)           |                                                    |          9.4%                4.0%                  |
|TERMINAL (d)           |                                                    |         3/32 (9%)           1/25 (4%)              |
|FIRST INCIDENCE (DAYS) |                                                    |          729 (T)             729 (T)               |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |                             P=0.396N               |
|INCIDENTAL TUMOR       |                                                    |                             P=0.396N               |
|LOGISTIC REGRESSION    |                                                    |                             P=0.396N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                                                    |                             P=0.309N               |
|=================================================================================================================================|
         DATE: 10/24/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE  19
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXAZEPAM
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          0 PPM               10,000                |          0 PPM               10,000                |
|                       |                              PPM STOP              |                              PPM STOP              |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |        27/50 (54%)         34/50 (68%)             |        14/50 (28%)         15/50 (30%)             |
|ADJUSTED (b)           |         72.4%              100.0%                  |         37.7%               40.5%                  |
|TERMINAL (d)           |         8/17 (47%)          0/0                    |        10/32 (31%)          6/25 (24%)             |
|FIRST INCIDENCE (DAYS) |          498                 480                   |          522                 506                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P<0.001 **             |                             P=0.336                |
|INCIDENTAL TUMOR       |                             P=0.161                |                             P=0.576                |
|LOGISTIC REGRESSION    |                             P=0.075                |                             P=0.507                |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.109                |                             P=0.500                |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Mesothelioma: Benign, Malignant, NOS                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |         2/50 (4%)           1/50 (2%)              |         0/50 (0%)           0/50 (0%)              |
|ADJUSTED (b)           |          5.4%                3.1%                  |          0.0%                0.0%                  |
|TERMINAL (d)           |         0/17 (0%)           0/0                    |         0/32 (0%)           0/25 (0%)              |
|FIRST INCIDENCE (DAYS) |          592                 613                   |          ---                 ---                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P=0.647N               |           (e)                 (e)                  |
|INCIDENTAL TUMOR       |                             P=0.223N               |           (e)                 (e)                  |
|LOGISTIC REGRESSION    |                             P=0.476N               |           (e)                 (e)                  |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.500N               |                               (e)                  |
|=================================================================================================================================|
         DATE: 10/24/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE  20
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXAZEPAM
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          0 PPM               10,000                |          0 PPM               10,000                |
|                       |                              PPM STOP              |                              PPM STOP              |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |        47/50 (94%)         48/50 (96%)             |        43/50 (86%)         38/50 (76%)             |
|ADJUSTED (b)           |        100.0%              100.0%                  |         95.5%               84.3%                  |
|TERMINAL (d)           |        17/17 (100%)         0/0                    |        30/32 (94%)         18/25 (72%)             |
|FIRST INCIDENCE (DAYS) |          471                 480                   |          529                 562                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P<0.001 **             |                             P=0.482                |
|INCIDENTAL TUMOR       |                             P=0.303                |                             P=0.039N*              |
|LOGISTIC REGRESSION    |                             P=0.331                |                             P=0.092N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.500                |                             P=0.154N               |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |        38/50 (76%)         35/50 (70%)             |        21/50 (42%)         17/50 (34%)             |
|ADJUSTED (b)           |         85.6%              100.0%                  |         51.1%               43.0%                  |
|TERMINAL (d)           |        11/17 (65%)          0/0                    |        13/32 (41%)          6/25 (24%)             |
|FIRST INCIDENCE (DAYS) |          480                 480                   |          223                 506                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P<0.001 **             |                             P=0.460N               |
|INCIDENTAL TUMOR       |                             P=0.288N               |                             P=0.322N               |
|LOGISTIC REGRESSION    |                             P=0.363N               |                             P=0.293N               |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.326N               |                             P=0.268N               |
|=================================================================================================================================|
         DATE: 10/24/96                     EXPERIMENT: 05212 TEST: 05                                                 PAGE  21
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXAZEPAM
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |          0 PPM               10,000                |          0 PPM               10,000                |
|                       |                              PPM STOP              |                              PPM STOP              |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                    |           #                   #                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |        50/50 (100%)        48/50 (96%)             |        49/50 (98%)         43/50 (86%)             |
|ADJUSTED (b)           |        100.0%              100.0%                  |        100.0%               89.5%                  |
|TERMINAL (d)           |        17/17 (100%)         0/0                    |        32/32 (100%)        20/25 (80%)             |
|FIRST INCIDENCE (DAYS) |          471                 480                   |          223                 506                   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                             P<0.001 **             |                             P=0.515                |
|INCIDENTAL TUMOR       |                             P=0.767N               |                             P=0.024N*              |
|LOGISTIC REGRESSION    |                             P=0.423N               |                             P=0.030N*              |
|COCHRAN-ARMITAGE       |                                                    |                                                    |
|FISHER EXACT           |                             P=0.247N               |                             P=0.030N*              |
|=================================================================================================================================|
 (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).