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TDMS Study 05212-04 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                                          OXAZEPAM                                       DATE: 09/18/94       
EXPERIMENT: 05212 TEST: 04                                                                                     TIME: 12:07:43       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1ES85213            ROUTE: DOSED FEED                                                                  NTP C#: 062453       
PATHOLOGIST: M. RYAN                         HAILEY, JAMESR.                                                   CAS: 604-75-1        
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08    
LAB: Battelle Columbus                                          OXAZEPAM                                       DATE: 09/18/94      
EXPERIMENT: 05212 TEST: 04                                                                                     TIME: 12:07:43      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: NO1ES85213            ROUTE: DOSED FEED                                                                  NTP C#: 062453      
PATHOLOGIST: M. RYAN                         HAILEY, JAMESR.                                                   CAS: 604-75-1       
 
 
 
 
 
                                                    35(  )
                                              ----------------------------
             FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
             IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
 
 
                                                    ----------------
 
                                                    Adrenal Cortex
                                                    Adrenal Medulla
                                                    Bone Marrow
                                                    Brain
                                                    Clitoral Gland
                                                    Epididymis
                                                    Gallbladder
                                                    Heart
                                                    Islets, Pancreatic
                                                    Kidney
                                                    Liver
                                                    Lung
                                                    Nose
                                                    Ovary
                                                    Pancreas
                                                    Parathyroid Gland
                                                    Pituitary Gland
                                                    Preputial Gland
                                                    Prostate
                                                    Salivary Glands
                                                    Spleen
                                                    Testes
                                                    Thymus
                                                    Thyroid Gland
                                                    Urinary Bladder
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                                          OXAZEPAM                                       DATE: 09/18/94       
EXPERIMENT: 05212 TEST: 04                                                                                     TIME: 12:07:43       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1ES85213            ROUTE: DOSED FEED                                                                  NTP C#: 062453       
PATHOLOGIST: M. RYAN                         HAILEY, JAMESR.                                                   CAS: 604-75-1        
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                            IN THE ANALYSIS OF THE STUDY OF OXAZEPAM
 
              ====================================================================================================
 
                                                           MALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Liver                         Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma
                                                           Hepatocellular Carcinoma or Hepatoblastoma
                                                           Hepatocellular Carcinoma or Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
                             Lung                          Alveolar/Bronchiolar Carcinoma
                             All Organs                    Malignant Lymphoma And Histiocytic Sarcoma
                                                           Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,
                                                            NOS, or Undifferentiated Cell Type
                                                           Benign Tumors
                                                           Malignant Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
 
                                                           FEMALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Liver                         Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma
                                                           Hepatocellular Carcinoma or Hepatoblastoma
                                                           Hepatocellular Carcinoma or Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
                             All Organs                    Malignant Lymphoma And Histiocytic Sarcoma
                                                           Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,
                                                            NOS, or Undifferentiated Cell Type
                                                           Benign Tumors
                                                           Malignant Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
         DATE: 09/18/94                     EXPERIMENT: 05212 TEST: 04                                                 PAGE   1
                                       STATISTICAL ANALYSIS OF PRIMARY TUMORS IN 35(  ) -- OXAZEPAM
 
                                                 TERMINAL SACRIFICE AT 57 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 PPM           2500 PPM        5000 PPM      |      0 PPM           2500 PPM        5000 PPM      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/60 (2%)      35/60 (58%)     50/60 (83%)     |     0/60 (0%)      22/59 (37%)     47/59 (80%)     |
|ADJUSTED (b)           |      2.2%           88.7%           98.0%          |      0.0%           52.6%           95.7%          |
|TERMINAL (d)           |     1/45 (2%)      15/19 (79%)      9/10 (90%)     |     0/47 (0%)      10/28 (36%)     15/17 (88%)     |
|FIRST INCIDENCE (DAYS) |      397 (T)         268             231           |      ---             291             284           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P<0.001 **      P<0.001 **      P<0.001 **     |     P<0.001 **      P<0.001 **      P<0.001 **     |
|INCIDENTAL TUMOR       |     P<0.001 **      P<0.001 **      P<0.001 **     |     P<0.001 **      P<0.001 **      P<0.001 **     |
|LOGISTIC REGRESSION    |     P<0.001 **      P<0.001 **      P<0.001 **     |     P<0.001 **      P<0.001 **      P<0.001 **     |
|COCHRAN-ARMITAGE       |     P<0.001 **                                     |     P<0.001 **                                     |
|FISHER EXACT           |                     P<0.001 **      P<0.001 **     |                     P<0.001 **      P<0.001 **     |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/60 (0%)       5/60 (8%)      19/60 (32%)     |     1/60 (2%)       1/59 (2%)      11/59 (19%)     |
|ADJUSTED (b)           |      0.0%           21.7%           72.0%          |      2.1%            3.6%           51.6%          |
|TERMINAL (d)           |     0/45 (0%)       3/19 (16%)      5/10 (50%)     |     1/47 (2%)       1/28 (4%)       8/17 (47%)     |
|FIRST INCIDENCE (DAYS) |      ---             356             302           |      397 (T)         397 (T)         337           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P<0.001 **      P=0.003 **      P<0.001 **     |     P<0.001 **      P=0.642         P<0.001 **     |
|INCIDENTAL TUMOR       |     P<0.001 **      P=0.017 *       P<0.001 **     |     P<0.001 **      P=0.642         P<0.001 **     |
|LOGISTIC REGRESSION    |     P<0.001 **      P=0.010 *       P<0.001 **     |     P<0.001 **      P=0.642         P<0.001 **     |
|COCHRAN-ARMITAGE       |     P<0.001 **                                     |     P<0.001 **                                     |
|FISHER EXACT           |                     P=0.029 *       P<0.001 **     |                     P=0.748         P=0.002 **     |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05212 TEST: 04                                                 PAGE   2
                                       STATISTICAL ANALYSIS OF PRIMARY TUMORS IN 35(  ) -- OXAZEPAM
 
                                                 TERMINAL SACRIFICE AT 57 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 PPM           2500 PPM        5000 PPM      |      0 PPM           2500 PPM        5000 PPM      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatoblastoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/60 (0%)       5/60 (8%)      19/60 (32%)     |     1/60 (2%)       1/59 (2%)      11/59 (19%)     |
|ADJUSTED (b)           |      0.0%           21.7%           72.0%          |      2.1%            3.6%           51.6%          |
|TERMINAL (d)           |     0/45 (0%)       3/19 (16%)      5/10 (50%)     |     1/47 (2%)       1/28 (4%)       8/17 (47%)     |
|FIRST INCIDENCE (DAYS) |      ---             356             302           |      397 (T)         397 (T)         337           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P<0.001 **      P=0.003 **      P<0.001 **     |     P<0.001 **      P=0.642         P<0.001 **     |
|INCIDENTAL TUMOR       |     P<0.001 **      P=0.017 *       P<0.001 **     |     P<0.001 **      P=0.642         P<0.001 **     |
|LOGISTIC REGRESSION    |     P<0.001 **      P=0.010 *       P<0.001 **     |     P<0.001 **      P=0.642         P<0.001 **     |
|COCHRAN-ARMITAGE       |     P<0.001 **                                     |     P<0.001 **                                     |
|FISHER EXACT           |                     P=0.029 *       P<0.001 **     |                     P=0.748         P=0.002 **     |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/60 (2%)      35/60 (58%)     52/60 (87%)     |     1/60 (2%)      23/59 (39%)     47/59 (80%)     |
|ADJUSTED (b)           |      2.2%           88.7%           98.1%          |      2.1%           55.2%           95.7%          |
|TERMINAL (d)           |     1/45 (2%)      15/19 (79%)      9/10 (90%)     |     1/47 (2%)      11/28 (39%)     15/17 (88%)     |
|FIRST INCIDENCE (DAYS) |      397 (T)         268             231           |      397 (T)         291             284           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P<0.001 **      P<0.001 **      P<0.001 **     |     P<0.001 **      P<0.001 **      P<0.001 **     |
|INCIDENTAL TUMOR       |     P<0.001 **      P<0.001 **      P<0.001 **     |     P<0.001 **      P<0.001 **      P<0.001 **     |
|LOGISTIC REGRESSION    |     P<0.001 **      P<0.001 **      P<0.001 **     |     P<0.001 **      P<0.001 **      P<0.001 **     |
|COCHRAN-ARMITAGE       |     P<0.001 **                                     |     P<0.001 **                                     |
|FISHER EXACT           |                     P<0.001 **      P<0.001 **     |                     P<0.001 **      P<0.001 **     |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05212 TEST: 04                                                 PAGE   3
                                       STATISTICAL ANALYSIS OF PRIMARY TUMORS IN 35(  ) -- OXAZEPAM
 
                                                 TERMINAL SACRIFICE AT 57 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 PPM           2500 PPM        5000 PPM      |      0 PPM           2500 PPM        5000 PPM      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/60 (2%)      35/60 (58%)     52/60 (87%)     |     1/60 (2%)      23/59 (39%)     47/59 (80%)     |
|ADJUSTED (b)           |      2.2%           88.7%           98.1%          |      2.1%           55.2%           95.7%          |
|TERMINAL (d)           |     1/45 (2%)      15/19 (79%)      9/10 (90%)     |     1/47 (2%)      11/28 (39%)     15/17 (88%)     |
|FIRST INCIDENCE (DAYS) |      397 (T)         268             231           |      397 (T)         291             284           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P<0.001 **      P<0.001 **      P<0.001 **     |     P<0.001 **      P<0.001 **      P<0.001 **     |
|INCIDENTAL TUMOR       |     P<0.001 **      P<0.001 **      P<0.001 **     |     P<0.001 **      P<0.001 **      P<0.001 **     |
|LOGISTIC REGRESSION    |     P<0.001 **      P<0.001 **      P<0.001 **     |     P<0.001 **      P<0.001 **      P<0.001 **     |
|COCHRAN-ARMITAGE       |     P<0.001 **                                     |     P<0.001 **                                     |
|FISHER EXACT           |                     P<0.001 **      P<0.001 **     |                     P<0.001 **      P<0.001 **     |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    12/60 (20%)      6/60 (10%)      7/60 (12%)     |     6/60 (10%)      4/59 (7%)       6/59 (10%)     |
|ADJUSTED (b)           |     26.7%           28.9%           26.0%          |     12.8%           12.4%           24.2%          |
|TERMINAL (d)           |    12/45 (27%)      5/19 (26%)      0/10 (0%)      |     6/47 (13%)      3/28 (11%)      2/17 (12%)     |
|FIRST INCIDENCE (DAYS) |      397 (T)         369             272           |      397 (T)         294             325           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.123         P=0.482         P=0.164        |     P=0.103         P=0.593         P=0.105        |
|INCIDENTAL TUMOR       |     P=0.538N        P=0.606         P=0.406N       |     P=0.305         P=0.609N        P=0.389        |
|LOGISTIC REGRESSION    |     P=0.353N        P=0.570N        P=0.329N       |     P=0.385         P=0.515N        P=0.393        |
|COCHRAN-ARMITAGE       |     P=0.117N                                       |     P=0.552                                        |
|FISHER EXACT           |                     P=0.100N        P=0.159N       |                     P=0.382N        P=0.607        |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05212 TEST: 04                                                 PAGE   4
                                       STATISTICAL ANALYSIS OF PRIMARY TUMORS IN 35(  ) -- OXAZEPAM
 
                                                 TERMINAL SACRIFICE AT 57 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 PPM           2500 PPM        5000 PPM      |      0 PPM           2500 PPM        5000 PPM      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     5/60 (8%)       4/60 (7%)       0/60 (0%)      |     5/60 (8%)       3/59 (5%)       1/59 (2%)      |
|ADJUSTED (b)           |     10.5%           14.2%            0.0%          |     10.6%            8.9%            2.6%          |
|TERMINAL (d)           |     4/45 (9%)       1/19 (5%)       0/10 (0%)      |     5/47 (11%)      2/28 (7%)       0/17 (0%)      |
|FIRST INCIDENCE (DAYS) |      281             268             ---           |      397 (T)         294             342           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.266N        P=0.407         P=0.217N       |     P=0.317N        P=0.620N        P=0.413N       |
|INCIDENTAL TUMOR       |     P=0.033N*       P=0.444N        P=0.139N       |     P=0.186N        P=0.544N        P=0.274N       |
|LOGISTIC REGRESSION    |     P=0.043N*       P=0.551N        P=0.051N       |     P=0.111N        P=0.458N        P=0.213N       |
|COCHRAN-ARMITAGE       |     P=0.030N*                                      |     P=0.074N                                       |
|FISHER EXACT           |                     P=0.500N        P=0.029N*      |                     P=0.368N        P=0.107N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    14/60 (23%)      9/60 (15%)      7/60 (12%)     |    11/60 (18%)      6/59 (10%)      7/59 (12%)     |
|ADJUSTED (b)           |     30.2%           35.7%           26.0%          |     23.4%           19.4%           26.2%          |
|TERMINAL (d)           |    13/45 (29%)      5/19 (26%)      0/10 (0%)      |    11/47 (23%)      5/28 (18%)      2/17 (12%)     |
|FIRST INCIDENCE (DAYS) |      281             268             272           |      397 (T)         294             325           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.200         P=0.291         P=0.286        |     P=0.266         P=0.510N        P=0.259        |
|INCIDENTAL TUMOR       |     P=0.203N        P=0.514N        P=0.216N       |     P=0.545N        P=0.452N        P=0.567N       |
|LOGISTIC REGRESSION    |     P=0.158N        P=0.415N        P=0.155N       |     P=0.407N        P=0.346N        P=0.506N       |
|COCHRAN-ARMITAGE       |     P=0.056N                                       |     P=0.183N                                       |
|FISHER EXACT           |                     P=0.177N        P=0.074N       |                     P=0.156N        P=0.234N       |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05212 TEST: 04                                                 PAGE   5
                                       STATISTICAL ANALYSIS OF PRIMARY TUMORS IN 35(  ) -- OXAZEPAM
 
                                                 TERMINAL SACRIFICE AT 57 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 PPM           2500 PPM        5000 PPM      |      0 PPM           2500 PPM        5000 PPM      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal or Polyp Stromal                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |     2/60 (3%)       0/59 (0%)       1/59 (2%)      |
|ADJUSTED (b)           |                                                    |      3.7%            0.0%            5.9%          |
|TERMINAL (d)           |                                                    |     0/47 (0%)       0/28 (0%)       1/17 (6%)      |
|FIRST INCIDENCE (DAYS) |                                                    |      322             ---             397 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.527N        P=0.309N        P=0.699N       |
|INCIDENTAL TUMOR       |                                                    |     P=0.270N        P=0.095N        P=0.372N       |
|LOGISTIC REGRESSION    |                                                    |     P=0.361N        P=0.200N        P=0.485N       |
|COCHRAN-ARMITAGE       |                                                    |     P=0.365N                                       |
|FISHER EXACT           |                                                    |                     P=0.252N        P=0.506N       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma And Histiocytic Sarcoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    10/60 (17%)      7/60 (12%)      6/60 (10%)     |     9/60 (15%)     13/59 (22%)      7/59 (12%)     |
|ADJUSTED (b)           |     17.6%           13.9%           28.3%          |     15.4%           26.2%           17.9%          |
|TERMINAL (d)           |     0/45 (0%)       0/19 (0%)       2/10 (20%)     |     0/47 (0%)       2/28 (7%)       1/17 (6%)      |
|FIRST INCIDENCE (DAYS) |      244             145             272           |      184             106             197           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.415N        P=0.435N        P=0.519N       |     P=0.447         P=0.117         P=0.516        |
|INCIDENTAL TUMOR       |     P=0.002N**      P=0.002N**      P=0.002N**     |     P=0.002N**      P=0.144N        P=0.002N**     |
|LOGISTIC REGRESSION    |     P=0.005N**      P=0.036N*       P=0.007N**     |     P=0.017N*       P=0.260N        P=0.056N       |
|COCHRAN-ARMITAGE       |     P=0.169N                                       |     P=0.370N                                       |
|FISHER EXACT           |                     P=0.301N        P=0.211N       |                     P=0.226         P=0.409N       |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05212 TEST: 04                                                 PAGE   6
                                       STATISTICAL ANALYSIS OF PRIMARY TUMORS IN 35(  ) -- OXAZEPAM
 
                                                 TERMINAL SACRIFICE AT 57 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 PPM           2500 PPM        5000 PPM      |      0 PPM           2500 PPM        5000 PPM      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,                                                                        |
|     NOS, or Undifferentiated Cell Type                                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     9/60 (15%)      7/60 (12%)      6/60 (10%)     |     9/60 (15%)     13/59 (22%)      6/59 (10%)     |
|ADJUSTED (b)           |     16.0%           13.9%           28.3%          |     15.4%           26.2%           16.1%          |
|TERMINAL (d)           |     0/45 (0%)       0/19 (0%)       2/10 (20%)     |     0/47 (0%)       2/28 (7%)       1/17 (6%)      |
|FIRST INCIDENCE (DAYS) |      244             145             272           |      184             106             197           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.508N        P=0.526N        P=0.603        |     P=0.543         P=0.117         P=0.581N       |
|INCIDENTAL TUMOR       |     P=0.007N**      P=0.006N**      P=0.007N**     |     P<0.001N**      P=0.144N        P=0.001N**     |
|LOGISTIC REGRESSION    |     P=0.014N*       P=0.080N        P=0.021N*      |     P=0.010N**      P=0.260N        P=0.036N*      |
|COCHRAN-ARMITAGE       |     P=0.243N                                       |     P=0.278N                                       |
|FISHER EXACT           |                     P=0.395N        P=0.291N       |                     P=0.226         P=0.303N       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    14/60 (23%)     36/60 (60%)     51/60 (85%)     |     9/60 (15%)     26/59 (44%)     47/59 (80%)     |
|ADJUSTED (b)           |     30.4%           91.5%           98.0%          |     18.5%           61.2%           95.7%          |
|TERMINAL (d)           |    13/45 (29%)     16/19 (84%)      9/10 (90%)     |     8/47 (17%)     13/28 (46%)     15/17 (88%)     |
|FIRST INCIDENCE (DAYS) |      344             268             231           |      322             291             284           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P<0.001 **      P<0.001 **      P<0.001 **     |     P<0.001 **      P<0.001 **      P<0.001 **     |
|INCIDENTAL TUMOR       |     P<0.001 **      P<0.001 **      P<0.001 **     |     P<0.001 **      P<0.001 **      P<0.001 **     |
|LOGISTIC REGRESSION    |     P<0.001 **      P<0.001 **      P<0.001 **     |     P<0.001 **      P<0.001 **      P<0.001 **     |
|COCHRAN-ARMITAGE       |     P<0.001 **                                     |     P<0.001 **                                     |
|FISHER EXACT           |                     P<0.001 **      P<0.001 **     |                     P<0.001 **      P<0.001 **     |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05212 TEST: 04                                                 PAGE   7
                                       STATISTICAL ANALYSIS OF PRIMARY TUMORS IN 35(  ) -- OXAZEPAM
 
                                                 TERMINAL SACRIFICE AT 57 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 PPM           2500 PPM        5000 PPM      |      0 PPM           2500 PPM        5000 PPM      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    17/60 (28%)     17/60 (28%)     25/60 (42%)     |    16/60 (27%)     16/59 (27%)     17/59 (29%)     |
|ADJUSTED (b)           |     29.6%           44.1%           80.3%          |     27.7%           34.7%           61.0%          |
|TERMINAL (d)           |     5/45 (11%)      4/19 (21%)      6/10 (60%)     |     6/47 (13%)      5/28 (18%)      9/17 (53%)     |
|FIRST INCIDENCE (DAYS) |      244             145             271           |      184             106             197           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P<0.001 **      P=0.170         P<0.001 **     |     P=0.037 *       P=0.230         P=0.025 *      |
|INCIDENTAL TUMOR       |     P=0.495         P=0.053N        P=0.439N       |     P=0.313N        P=0.102N        P=0.452N       |
|LOGISTIC REGRESSION    |     P=0.321         P=0.203N        P=0.555        |     P=0.390N        P=0.236N        P=0.427N       |
|COCHRAN-ARMITAGE       |     P=0.072                                        |     P=0.437                                        |
|FISHER EXACT           |                     P=0.580N        P=0.090        |                     P=0.560         P=0.477        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    26/60 (43%)     42/60 (70%)     54/60 (90%)     |    24/60 (40%)     37/59 (63%)     49/59 (83%)     |
|ADJUSTED (b)           |     45.4%           92.6%          100.0%          |     41.8%           73.8%           95.8%          |
|TERMINAL (d)           |    14/45 (31%)     16/19 (84%)     10/10 (100%)    |    14/47 (30%)     16/28 (57%)     15/17 (88%)     |
|FIRST INCIDENCE (DAYS) |      244             145             231           |      184             106             197           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P<0.001 **      P<0.001 **      P<0.001 **     |     P<0.001 **      P<0.001 **      P<0.001 **     |
|INCIDENTAL TUMOR       |     P<0.001 **      P=0.025 *       P=0.001 **     |     P<0.001 **      P=0.092         P<0.001 **     |
|LOGISTIC REGRESSION    |     P<0.001 **      P=0.005 **      P<0.001 **     |     P<0.001 **      P=0.037 *       P<0.001 **     |
|COCHRAN-ARMITAGE       |     P<0.001 **                                     |     P<0.001 **                                     |
|FISHER EXACT           |                     P=0.003 **      P<0.001 **     |                     P=0.011 *       P<0.001 **     |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05212 TEST: 04                                                 PAGE   8
                                       STATISTICAL ANALYSIS OF PRIMARY TUMORS IN 35(  ) -- OXAZEPAM
 
                                                 TERMINAL SACRIFICE AT 57 WEEKS
 
 
 (a)  Number of tumor-bearing animals / number of animals examined at site.
 (b)  Kaplan-Meier estimated lifetime tumor incidence after adjustment for 
      intercurrent mortality.
 (d)  Observed incidence at terminal kill.
 (f)  Beneath the control incidence are the P-values associated with the trend 
      test.  Beneath the dosed group incidence are the P-values corresponding to 
      pairwise comparisons between the controls and that dosed group.  The life
      table analysis regards tumors in animals dying  prior to terminal kill as
      being (directly or indirectly) the cause of death.  The incidental tumor 
      test regards these lesions as non-fatal.  Logistic regression is an alternative
      method for analyzing the incidence of non-fatal tumors.  The Cochran-Armitage
      and Fisher's exact tests compare directly the overall incidence rates.  
      For all tests, a negative trend is indicated by "N".
 (e)  Value of Statistic cannot be computed. 
 (I)  Interim sacrifice
 (T)  Terminal sacrifice
  #   Tumor rates based on number of animals necropsied.
 
  *   To the right of any statistical result, indicates significance at (P<=0.05).
  **  To the right of any statistical result, indicates significance at (P<=0.01).