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TDMS Study 05212-03 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                                          OXAZEPAM                                       DATE: 09/18/94       
EXPERIMENT: 05212 TEST: 03                                                                                     TIME: 10:10:04       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-85213          ROUTE: DOSED FEED                                                                  NTP C#: 62453        
PATHOLOGIST: R. PERSING                                                                                        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: 03                                                                                     TIME: 10:10:04      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01-ES-85213          ROUTE: DOSED FEED                                                                  NTP C#: 62453       
PATHOLOGIST: R. PERSING                                                                                        CAS: 604-75-1       
 
 
 
 
 
                                                    MICE(B6C3F1)
                                              ----------------------------
             FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
             IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
 
 
                                                    ----------------
 
                                                    Adrenal Cortex
                                                    Adrenal Medulla
                                                    Bone Marrow
                                                    Brain
                                                    Clitoral Gland
                                                    Epididymis
                                                    Gallbladder
                                                    Heart
                                                    Islets, Pancreatic
                                                    Kidney
                                                    Liver
                                                    Lung
                                                    Nose
                                                    Ovary
                                                    Pancreas
                                                    Parathyroid Gland
                                                    Pituitary Gland
                                                    Preputial Gland
                                                    Prostate
                                                    Salivary Glands
                                                    Spleen
                                                    Testes
                                                    Thymus
                                                    Thyroid Gland
                                                    Urinary Bladder
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                                          OXAZEPAM                                       DATE: 09/18/94       
EXPERIMENT: 05212 TEST: 03                                                                                     TIME: 10:10:04       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-85213          ROUTE: DOSED FEED                                                                  NTP C#: 62453        
PATHOLOGIST: R. PERSING                                                                                        CAS: 604-75-1        
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                            IN THE ANALYSIS OF THE STUDY OF OXAZEPAM
 
              ====================================================================================================
 
                                                           MALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Adrenal Cortex                Adenoma
                             Harderian Gland               Carcinoma or Adenoma
                             Liver                         Hepatoblastoma
                                                           Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma
                                                           Hepatocellular Carcinoma or Hepatoblastoma
                                                           Hepatocellular Carcinoma or Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
                             Lung                          Alveolar/Bronchiolar Adenoma
                                                           Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
                             Thyroid Gland: Follicular Cell
                                                           Adenoma
                             All Organs                    Hemangiosarcoma
                                                           Hemangiosarcoma or Hemangioma
                                                           Benign Tumors
                                                           Malignant Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
 
                                                           FEMALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Harderian Gland               Carcinoma or Adenoma
                             Liver                         Hepatoblastoma
                                                           Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma
                                                           Hepatocellular Carcinoma or Hepatoblastoma
                                                           Hepatocellular Carcinoma or Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
                             Lung                          Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
                             Ovary                         Adenoma
                             Pituitary Gland: Pars Distalis or Unspecified Site
                                                           Adenoma
                             Skin: Subcutaneous Tissue     Fibrosarcoma
                             Thyroid Gland: Follicular Cell
                                                           Adenoma
                             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
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                                          OXAZEPAM                                       DATE: 09/18/94       
EXPERIMENT: 05212 TEST: 03                                                                                     TIME: 10:10:04       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-85213          ROUTE: DOSED FEED                                                                  NTP C#: 62453        
PATHOLOGIST: R. PERSING                                                                                        CAS: 604-75-1        
 
 
              ====================================================================================================
         DATE: 09/18/94                     EXPERIMENT: 05212 TEST: 03                                                 PAGE   1
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- OXAZEPAM
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        125 PPM      2500 PPM     5000 PPM  |   0 PPM        125 PPM      2500 PPM     5000 PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Cortex                                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  6/59 (10%)   4/60 (7%)    1/59 (2%)    0/60 (0%)  |  0/60 (0%)    1/60 (2%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |  13.3%         9.1%         6.7%         0.0%      |   0.0%         2.4%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  6/45 (13%)   4/44 (9%)    1/15 (7%)    0/0        |  0/39 (0%)    1/41 (2%)    0/2 (0%)     0/0        |
|FIRST INCIDENCE (DAYS) |   729 (T)      729 (T)      729 (T)      ---       |   ---          735 (T)      ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.456N     P=0.384N     P=0.409N       (e)      |  P=0.999      P=0.510        (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.456N     P=0.384N     P=0.409N       (e)      |  P=0.999      P=0.510        (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.456N     P=0.384N     P=0.409N       (e)      |  P=0.999      P=0.510        (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.006N**                                        |  P=0.397N                                          |
|FISHER EXACT           |               P=0.361N     P=0.057N     P=0.013N*  |               P=0.500        (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/60 (3%)    1/60 (2%)    0/60 (0%)    1/60 (2%)  |  1/60 (2%)    3/60 (5%)    1/60 (2%)    1/60 (2%)  |
|ADJUSTED (b)           |   4.3%         2.3%         0.0%         5.0%      |   2.0%         7.1%         5.6%         2.8%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/45 (2%)    1/44 (2%)    0/15 (0%)    0/0        |  0/39 (0%)    2/41 (5%)    0/2 (0%)     0/0        |
|FIRST INCIDENCE (DAYS) |   707          729 (T)      ---          596       |   516          732          710          479       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.314      P=0.508N     P=0.448N     P=0.326    |  P=0.202      P=0.318      P=0.673      P=0.673    |
|INCIDENTAL TUMOR       |  P=0.367N     P=0.427N     P=0.070N     P=0.938    |  P=0.169N     P=0.479      P=0.373N     P=0.084N   |
|LOGISTIC REGRESSION    |  P=0.669N     P=0.504N     P=0.322N     P=0.748    |  P=0.450N     P=0.307      P=0.747N     P=0.666N   |
|COCHRAN-ARMITAGE       |  P=0.379N                                          |  P=0.320N                                          |
|FISHER EXACT           |               P=0.500N     P=0.248N     P=0.500N   |               P=0.309      P=0.752N     P=0.752N   |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05212 TEST: 03                                                 PAGE   2
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- OXAZEPAM
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        125 PPM      2500 PPM     5000 PPM  |   0 PPM        125 PPM      2500 PPM     5000 PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/60 (5%)    2/60 (3%)    0/60 (0%)    1/60 (2%)  |  2/60 (3%)    3/60 (5%)    1/60 (2%)    1/60 (2%)  |
|ADJUSTED (b)           |   6.3%         4.4%         0.0%         5.0%      |   4.2%         7.1%         5.6%         2.8%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/45 (2%)    1/44 (2%)    0/15 (0%)    0/0        |  0/39 (0%)    2/41 (5%)    0/2 (0%)     0/0        |
|FIRST INCIDENCE (DAYS) |   624          701          ---          596       |   516          732          710          479       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.540      P=0.508N     P=0.251N     P=0.432    |  P=0.304      P=0.512      P=0.599N     P=0.673    |
|INCIDENTAL TUMOR       |  P=0.006N**   P=0.470N     P=0.010N*    P=0.187N   |  P=0.031N*    P=0.479      P=0.116N     P=0.006N** |
|LOGISTIC REGRESSION    |  P=0.295N     P=0.470N     P=0.136N     P=0.618N   |  P=0.292N     P=0.500      P=0.476N     P=0.390N   |
|COCHRAN-ARMITAGE       |  P=0.159N                                          |  P=0.214N                                          |
|FISHER EXACT           |               P=0.500N     P=0.122N     P=0.309N   |               P=0.500      P=0.500N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatoblastoma                                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/59 (0%)    2/60 (3%)   21/60 (35%)  14/60 (23%) |  0/60 (0%)    1/60 (2%)    8/60 (13%)  10/60 (17%) |
|ADJUSTED (b)           |   0.0%         4.5%        58.3%        53.6%      |   0.0%         2.3%        31.7%        59.6%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    1/10 (10%) |  0/10 (0%)    0/10 (0%)    0/10 (0%)    2/10 (20%) |
|TERMINAL (d)           |  0/45 (0%)    2/44 (5%)    4/15 (27%)   0/0        |  0/39 (0%)    0/41 (0%)    0/2 (0%)     0/0        |
|FIRST INCIDENCE (DAYS) |   ---          729 (T)      598          434       |   ---          714          614          460 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.234      P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.519      P<0.001 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P=0.011 *    P=0.234      P<0.001 **   P=0.184    |  P=0.058      P=0.602      P=0.123      P=0.071    |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.234      P<0.001 **   P=0.001 ** |  P=0.028 *    P=0.506      P=0.004 **   P=0.001 ** |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P<0.001 **                                        |
|FISHER EXACT           |               P=0.252      P<0.001 **   P<0.001 ** |               P=0.500      P=0.003 **   P<0.001 ** |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05212 TEST: 03                                                 PAGE   3
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- OXAZEPAM
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        125 PPM      2500 PPM     5000 PPM  |   0 PPM        125 PPM      2500 PPM     5000 PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 17/59 (29%)  21/60 (35%)  43/60 (72%)  41/60 (68%) | 26/60 (43%)  36/60 (60%)  44/60 (73%)  46/60 (77%) |
|ADJUSTED (b)           |  37.8%        40.4%        89.2%        95.8%      |  60.0%        79.8%        97.2%       100.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    3/10 (30%)   9/10 (90%)   9/10 (90%) |  1/10 (10%)   1/10 (10%)   9/10 (90%)  10/10 (100%)|
|TERMINAL (d)           | 17/45 (38%)  14/44 (32%)  11/15 (73%)   0/0        | 22/39 (56%)  32/41 (78%)   1/2 (50%)    0/0        |
|FIRST INCIDENCE (DAYS) |   729 (T)      453          460 (I)      401       |   460 (I)      460 (I)      393          403       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.260      P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.070      P<0.001 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P<0.001 **   P=0.445      P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.039 *    P<0.001 **   P<0.001 ** |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.281      P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.044 *    P<0.001 **   P<0.001 ** |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P<0.001 **                                        |
|FISHER EXACT           |               P=0.299      P<0.001 **   P<0.001 ** |               P=0.050 *    P<0.001 **   P<0.001 ** |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  9/59 (15%)   6/60 (10%)  49/60 (82%)  59/60 (98%) | 10/60 (17%)   5/60 (8%)   51/60 (85%)  54/60 (90%) |
|ADJUSTED (b)           |  18.7%        11.9%        96.0%       100.0%      |  22.9%        11.9%       100.0%       100.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    1/10 (10%)   4/10 (40%)   9/10 (90%) |  1/10 (10%)   0/10 (0%)    2/10 (20%)  10/10 (100%)|
|TERMINAL (d)           |  6/45 (13%)   3/44 (7%)   13/15 (87%)   0/0        |  7/39 (18%)   4/41 (10%)   2/2 (100%)   0/0        |
|FIRST INCIDENCE (DAYS) |   586          453          460 (I)      401       |   460 (I)      714          393          410       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.310N     P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.119N     P<0.001 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P<0.001 **   P=0.220N     P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.140N     P<0.001 **   P<0.001 ** |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.305N     P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.125N     P<0.001 **   P<0.001 ** |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P<0.001 **                                        |
|FISHER EXACT           |               P=0.279N     P<0.001 **   P<0.001 ** |               P=0.135N     P<0.001 **   P<0.001 ** |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05212 TEST: 03                                                 PAGE   4
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- OXAZEPAM
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        125 PPM      2500 PPM     5000 PPM  |   0 PPM        125 PPM      2500 PPM     5000 PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatoblastoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  9/59 (15%)   7/60 (12%)  51/60 (85%)  60/60 (100%)| 10/60 (17%)   5/60 (8%)   51/60 (85%)  54/60 (90%) |
|ADJUSTED (b)           |  18.7%        14.1%        98.1%       100.0%      |  22.9%        11.9%       100.0%       100.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    1/10 (10%)   4/10 (40%)  10/10 (100%)|  1/10 (10%)   0/10 (0%)    2/10 (20%)  10/10 (100%)|
|TERMINAL (d)           |  6/45 (13%)   4/44 (9%)   14/15 (93%)   0/0        |  7/39 (18%)   4/41 (10%)   2/2 (100%)   0/0        |
|FIRST INCIDENCE (DAYS) |   586          453          460 (I)      401       |   460 (I)      714          393          410       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.413N     P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.119N     P<0.001 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P<0.001 **   P=0.326N     P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.140N     P<0.001 **   P<0.001 ** |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.382N     P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.125N     P<0.001 **   P<0.001 ** |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P<0.001 **                                        |
|FISHER EXACT           |               P=0.381N     P<0.001 **   P<0.001 ** |               P=0.135N     P<0.001 **   P<0.001 ** |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 23/59 (39%)  22/60 (37%)  59/60 (98%)  60/60 (100%)| 30/60 (50%)  37/60 (62%)  59/60 (98%)  57/60 (95%) |
|ADJUSTED (b)           |  47.9%        42.4%       100.0%       100.0%      |  67.6%        82.1%       100.0%       100.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    3/10 (30%)   9/10 (90%)  10/10 (100%)|  2/10 (20%)   1/10 (10%)   9/10 (90%)  10/10 (100%)|
|TERMINAL (d)           | 20/45 (44%)  15/44 (34%)  15/15 (100%)  0/0        | 25/39 (64%)  33/41 (80%)   2/2 (100%)   0/0        |
|FIRST INCIDENCE (DAYS) |   586          453          460 (I)      401       |   460 (I)      460 (I)      393          403       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.531N     P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.189      P<0.001 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P<0.001 **   P=0.374N     P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.131      P<0.001 **   P<0.001 ** |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.493N     P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.131      P<0.001 **   P<0.001 ** |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P<0.001 **                                        |
|FISHER EXACT           |               P=0.471N     P<0.001 **   P<0.001 ** |               P=0.135      P<0.001 **   P<0.001 ** |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05212 TEST: 03                                                 PAGE   5
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- OXAZEPAM
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        125 PPM      2500 PPM     5000 PPM  |   0 PPM        125 PPM      2500 PPM     5000 PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 23/59 (39%)  22/60 (37%)  59/60 (98%)  60/60 (100%)| 30/60 (50%)  37/60 (62%)  59/60 (98%)  57/60 (95%) |
|ADJUSTED (b)           |  47.9%        42.4%       100.0%       100.0%      |  67.6%        82.1%       100.0%       100.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    3/10 (30%)   9/10 (90%)  10/10 (100%)|  2/10 (20%)   1/10 (10%)   9/10 (90%)  10/10 (100%)|
|TERMINAL (d)           | 20/45 (44%)  15/44 (34%)  15/15 (100%)  0/0        | 25/39 (64%)  33/41 (80%)   2/2 (100%)   0/0        |
|FIRST INCIDENCE (DAYS) |   586          453          460 (I)      401       |   460 (I)      460 (I)      393          403       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.531N     P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.189      P<0.001 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P<0.001 **   P=0.374N     P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.131      P<0.001 **   P<0.001 ** |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.493N     P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.131      P<0.001 **   P<0.001 ** |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P<0.001 **                                        |
|FISHER EXACT           |               P=0.471N     P<0.001 **   P<0.001 ** |               P=0.135      P<0.001 **   P<0.001 ** |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 13/60 (22%)  18/60 (30%)   5/60 (8%)    1/60 (2%)  |  4/60 (7%)    1/60 (2%)    0/60 (0%)    1/60 (2%)  |
|ADJUSTED (b)           |  26.5%        37.2%        28.1%        25.0%      |  10.3%         2.4%         0.0%        10.0%      |
|INTERIM SACRIFICE 1 (c)|  2/10 (20%)   1/10 (10%)   0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           | 10/45 (22%)  14/44 (32%)   4/15 (27%)   0/0        |  4/39 (10%)   1/41 (2%)    0/2 (0%)     0/0        |
|FIRST INCIDENCE (DAYS) |   460 (I)      460 (I)      486          625       |   735 (T)      735 (T)      ---          596       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.314N     P=0.193      P=0.507N     P=0.691N   |  P=0.111      P=0.165N     P=0.769N     P=0.197    |
|INCIDENTAL TUMOR       |  P=0.002N**   P=0.202      P=0.320N     P=0.044N*  |  P=0.582      P=0.165N     P=0.769N     P=0.795    |
|LOGISTIC REGRESSION    |  P<0.001N**   P=0.201      P=0.050N*    P=0.008N** |  P=0.675N     P=0.165N     P=0.769N     P=0.598    |
|COCHRAN-ARMITAGE       |  P<0.001N**                                        |  P=0.153N                                          |
|FISHER EXACT           |               P=0.202      P=0.036N*    P<0.001N** |               P=0.182N     P=0.059N     P=0.182N   |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05212 TEST: 03                                                 PAGE   6
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- OXAZEPAM
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        125 PPM      2500 PPM     5000 PPM  |   0 PPM        125 PPM      2500 PPM     5000 PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/60 (3%)    2/60 (3%)    0/60 (0%)    0/60 (0%)  |  1/60 (2%)    3/60 (5%)    1/60 (2%)    0/60 (0%)  |
|ADJUSTED (b)           |   4.4%         4.5%         0.0%         0.0%      |   2.6%         7.3%         2.9%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  2/45 (4%)    2/44 (5%)    0/15 (0%)    0/0        |  1/39 (3%)    3/41 (7%)    0/2 (0%)     0/0        |
|FIRST INCIDENCE (DAYS) |   729 (T)      729 (T)      ---          ---       |   735 (T)      735 (T)      645          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.464N     P=0.686      P=0.500N       (e)      |  P=0.390      P=0.323      P=0.502        (e)      |
|INCIDENTAL TUMOR       |  P=0.464N     P=0.686      P=0.500N       (e)      |  P=0.769      P=0.323      P=0.908        (e)      |
|LOGISTIC REGRESSION    |  P=0.464N     P=0.686      P=0.500N       (e)      |  P=0.547N     P=0.323      P=0.727        (e)      |
|COCHRAN-ARMITAGE       |  P=0.066N                                          |  P=0.116N                                          |
|FISHER EXACT           |               P=0.691N     P=0.248N     P=0.248N   |               P=0.309      P=0.752N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 15/60 (25%)  19/60 (32%)   5/60 (8%)    1/60 (2%)  |  5/60 (8%)    4/60 (7%)    1/60 (2%)    1/60 (2%)  |
|ADJUSTED (b)           |  30.7%        39.3%        28.1%        25.0%      |  12.8%         9.8%         2.9%        10.0%      |
|INTERIM SACRIFICE 1 (c)|  2/10 (20%)   1/10 (10%)   0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           | 12/45 (27%)  15/44 (34%)   4/15 (27%)   0/0        |  5/39 (13%)   4/41 (10%)   0/2 (0%)     0/0        |
|FIRST INCIDENCE (DAYS) |   460 (I)      460 (I)      486          625       |   735 (T)      735 (T)      645          596       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.257N     P=0.256      P=0.396N     P=0.691N   |  P=0.042 *    P=0.468N     P=0.615      P=0.197    |
|INCIDENTAL TUMOR       |  P=0.001N**   P=0.270      P=0.228N     P=0.044N*  |  P=0.510      P=0.468N     P=0.737N     P=0.795    |
|LOGISTIC REGRESSION    |  P<0.001N**   P=0.270      P=0.022N*    P=0.006N** |  P=0.516N     P=0.468N     P=0.261N     P=0.603    |
|COCHRAN-ARMITAGE       |  P<0.001N**                                        |  P=0.038N*                                         |
|FISHER EXACT           |               P=0.272      P=0.013N*    P<0.001N** |               P=0.500N     P=0.103N     P=0.103N   |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05212 TEST: 03                                                 PAGE   7
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- OXAZEPAM
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        125 PPM      2500 PPM     5000 PPM  |   0 PPM        125 PPM      2500 PPM     5000 PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  1/60 (2%)    0/60 (0%)    2/58 (3%)    0/60 (0%)  |
|ADJUSTED (b)           |                                                    |   2.6%         0.0%        20.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|                                                    |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |                                                    |  1/39 (3%)    0/41 (0%)    0/2 (0%)     0/0        |
|FIRST INCIDENCE (DAYS) |                                                    |   735 (T)      ---          719          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.005 **   P=0.490N     P=0.042 *      (e)      |
|INCIDENTAL TUMOR       |                                                    |  P=0.606      P=0.490N     P=0.796        (e)      |
|LOGISTIC REGRESSION    |                                                    |  P=0.091      P=0.490N     P=0.193        (e)      |
|COCHRAN-ARMITAGE       |                                                    |  P=0.561N                                          |
|FISHER EXACT           |                                                    |               P=0.500N     P=0.487      P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Cystadenoma                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  1/60 (2%)    3/60 (5%)    1/58 (2%)    0/60 (0%)  |
|ADJUSTED (b)           |                                                    |   2.6%         7.0%        50.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|                                                    |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |                                                    |  1/39 (3%)    2/41 (5%)    1/2 (50%)    0/0        |
|FIRST INCIDENCE (DAYS) |                                                    |   735 (T)      701          735 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.328      P=0.331      P=0.090        (e)      |
|INCIDENTAL TUMOR       |                                                    |  P=0.761      P=0.366      P=0.090        (e)      |
|LOGISTIC REGRESSION    |                                                    |  P=0.704      P=0.324      P=0.090        (e)      |
|COCHRAN-ARMITAGE       |                                                    |  P=0.118N                                          |
|FISHER EXACT           |                                                    |               P=0.309      P=0.744      P=0.500N   |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05212 TEST: 03                                                 PAGE   8
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- OXAZEPAM
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        125 PPM      2500 PPM     5000 PPM  |   0 PPM        125 PPM      2500 PPM     5000 PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Luteoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  2/60 (3%)    0/60 (0%)    0/58 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |                                                    |   5.1%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|                                                    |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |                                                    |  2/39 (5%)    0/41 (0%)    0/2 (0%)     0/0        |
|FIRST INCIDENCE (DAYS) |                                                    |   735 (T)      ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.970N     P=0.227N     P=0.910N       (e)      |
|INCIDENTAL TUMOR       |                                                    |  P=0.970N     P=0.227N     P=0.910N       (e)      |
|LOGISTIC REGRESSION    |                                                    |  P=0.970N     P=0.227N     P=0.910N       (e)      |
|COCHRAN-ARMITAGE       |                                                    |  P=0.189N                                          |
|FISHER EXACT           |                                                    |               P=0.248N     P=0.256N     P=0.248N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/58 (2%)    0/60 (0%)    0/52 (0%)    0/47 (0%)  |  3/60 (5%)    9/59 (15%)   0/53 (0%)    0/59 (0%)  |
|ADJUSTED (b)           |   2.3%         0.0%         0.0%         0.0%      |   6.7%        21.4%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  1/10 (10%)   1/10 (10%)   0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/44 (2%)    0/44 (0%)    0/15 (0%)    0/0        |  2/39 (5%)    8/40 (20%)   0/2 (0%)     0/0        |
|FIRST INCIDENCE (DAYS) |   729 (T)      ---          ---          ---       |   460 (I)      460 (I)      ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.833N     P=0.500N     P=0.714N       (e)      |  P=0.192N     P=0.068      P=0.434N     P=0.500N   |
|INCIDENTAL TUMOR       |  P=0.833N     P=0.500N     P=0.714N       (e)      |  P=0.192N     P=0.068      P=0.434N     P=0.500N   |
|LOGISTIC REGRESSION    |  P=0.833N     P=0.500N     P=0.714N       (e)      |  P=0.006N**   P=0.061      P=0.139N     P=0.182N   |
|COCHRAN-ARMITAGE       |  P=0.407N                                          |  P=0.002N**                                        |
|FISHER EXACT           |               P=0.492N     P=0.527N     P=0.552N   |               P=0.059      P=0.146N     P=0.125N   |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05212 TEST: 03                                                 PAGE   9
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- OXAZEPAM
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        125 PPM      2500 PPM     5000 PPM  |   0 PPM        125 PPM      2500 PPM     5000 PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibrosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |  2/60 (3%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   4.4%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/45 (0%)    0/44 (0%)    0/15 (0%)    0/0        |  0/39 (0%)    0/41 (0%)    0/2 (0%)     0/0        |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   516          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.309N     P=0.239N     P=0.271N     P=0.591N   |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.015N*    P=0.070N     P=0.012N*    P=0.017N*  |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.127N     P=0.238N     P=0.211N     P=0.199N   |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.187N                                          |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.248N     P=0.248N     P=0.248N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Squamous Cell Carcinoma or Papilloma Squamous                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/60 (3%)    0/60 (0%)    1/60 (2%)    0/60 (0%)  |  1/60 (2%)    0/60 (0%)    1/60 (2%)    0/60 (0%)  |
|ADJUSTED (b)           |   4.4%         0.0%         6.7%         0.0%      |   2.6%         0.0%        10.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  2/45 (4%)    0/44 (0%)    1/15 (7%)    0/0        |  1/39 (3%)    0/41 (0%)    0/2 (0%)     0/0        |
|FIRST INCIDENCE (DAYS) |   729 (T)      ---          729 (T)      ---       |   735 (T)      ---          719          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.497      P=0.243N     P=0.633        (e)      |  P=0.176      P=0.490N     P=0.294        (e)      |
|INCIDENTAL TUMOR       |  P=0.497      P=0.243N     P=0.633        (e)      |  P=0.808      P=0.490N     P=0.908        (e)      |
|LOGISTIC REGRESSION    |  P=0.497      P=0.243N     P=0.633        (e)      |  P=0.442      P=0.490N     P=0.548        (e)      |
|COCHRAN-ARMITAGE       |  P=0.288N                                          |  P=0.491N                                          |
|FISHER EXACT           |               P=0.248N     P=0.500N     P=0.248N   |               P=0.500N     P=0.752N     P=0.500N   |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05212 TEST: 03                                                 PAGE  10
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- OXAZEPAM
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        125 PPM      2500 PPM     5000 PPM  |   0 PPM        125 PPM      2500 PPM     5000 PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/59 (0%)    1/60 (2%)    1/60 (2%)    1/60 (2%)  |  0/60 (0%)    4/60 (7%)    5/60 (8%)    6/60 (10%) |
|ADJUSTED (b)           |   0.0%         2.3%         4.8%        50.0%      |   0.0%         9.8%        34.3%        46.1%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/45 (0%)    1/44 (2%)    0/15 (0%)    0/0        |  0/39 (0%)    4/41 (10%)   0/2 (0%)     0/0        |
|FIRST INCIDENCE (DAYS) |   ---          729 (T)      720          628       |   ---          735 (T)      663          470       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.005 **   P=0.496      P=0.348      P=0.011 *  |  P<0.001 **   P=0.070      P=0.001 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P=0.564      P=0.496      P=0.987      P=0.938    |  P=0.036 *    P=0.070      P=0.557      P=0.342    |
|LOGISTIC REGRESSION    |  P=0.139      P=0.496      P=0.406      P=0.449    |  P=0.002 **   P=0.070      P=0.014 *    P=0.012 *  |
|COCHRAN-ARMITAGE       |  P=0.429                                           |  P=0.043 *                                         |
|FISHER EXACT           |               P=0.504      P=0.504      P=0.504    |               P=0.059      P=0.029 *    P=0.014 *  |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    5/60 (8%)    1/60 (2%)    0/60 (0%)  |  1/60 (2%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   2.2%        10.7%         2.6%         0.0%      |   2.6%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/45 (2%)    3/44 (7%)    0/15 (0%)    0/0        |  1/39 (3%)    0/41 (0%)    0/2 (0%)     0/0        |
|FIRST INCIDENCE (DAYS) |   729 (T)      508          642          ---       |   735 (T)      ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.407N     P=0.104      P=0.620        (e)      |  P=0.998N     P=0.490N     P=0.982N       (e)      |
|INCIDENTAL TUMOR       |  P=0.002N**   P=0.118      P=0.787N       (e)      |  P=0.998N     P=0.490N     P=0.982N       (e)      |
|LOGISTIC REGRESSION    |  P=0.004N**   P=0.073      P=0.743        (e)      |  P=0.998N     P=0.490N     P=0.982N       (e)      |
|COCHRAN-ARMITAGE       |  P=0.046N*                                         |  P=0.374N                                          |
|FISHER EXACT           |               P=0.103      P=0.752N     P=0.500N   |               P=0.500N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05212 TEST: 03                                                 PAGE  11
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- OXAZEPAM
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        125 PPM      2500 PPM     5000 PPM  |   0 PPM        125 PPM      2500 PPM     5000 PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma or Hemangioma                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    5/60 (8%)    1/60 (2%)    0/60 (0%)  |  1/60 (2%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   2.2%        10.7%         2.6%         0.0%      |   2.6%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/45 (2%)    3/44 (7%)    0/15 (0%)    0/0        |  1/39 (3%)    0/41 (0%)    0/2 (0%)     0/0        |
|FIRST INCIDENCE (DAYS) |   729 (T)      508          642          ---       |   735 (T)      ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.407N     P=0.104      P=0.620        (e)      |  P=0.998N     P=0.490N     P=0.982N       (e)      |
|INCIDENTAL TUMOR       |  P=0.002N**   P=0.118      P=0.787N       (e)      |  P=0.998N     P=0.490N     P=0.982N       (e)      |
|LOGISTIC REGRESSION    |  P=0.004N**   P=0.073      P=0.743        (e)      |  P=0.998N     P=0.490N     P=0.982N       (e)      |
|COCHRAN-ARMITAGE       |  P=0.046N*                                         |  P=0.374N                                          |
|FISHER EXACT           |               P=0.103      P=0.752N     P=0.500N   |               P=0.500N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Histiocytic Sarcoma                                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    1/60 (2%)    0/60 (0%)    0/60 (0%)  |  1/60 (2%)    2/60 (3%)    1/60 (2%)    0/60 (0%)  |
|ADJUSTED (b)           |   2.2%         2.3%         0.0%         0.0%      |   2.3%         4.7%         1.7%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    1/10 (10%)   0/10 (0%)  |
|TERMINAL (d)           |  1/45 (2%)    1/44 (2%)    0/15 (0%)    0/0        |  0/39 (0%)    1/41 (2%)    0/2 (0%)     0/0        |
|FIRST INCIDENCE (DAYS) |   729 (T)      729 (T)      ---          ---       |   630          701          460 (I)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.675N     P=0.757      P=0.718N       (e)      |  P=0.586N     P=0.525      P=0.755        (e)      |
|INCIDENTAL TUMOR       |  P=0.675N     P=0.757      P=0.718N       (e)      |  P=0.100N     P=0.301      P=0.686N     P=0.205N   |
|LOGISTIC REGRESSION    |  P=0.675N     P=0.757      P=0.718N       (e)      |  P=0.181N     P=0.503      P=0.731N     P=0.626N   |
|COCHRAN-ARMITAGE       |  P=0.199N                                          |  P=0.186N                                          |
|FISHER EXACT           |               P=0.752N     P=0.500N     P=0.500N   |               P=0.500      P=0.752N     P=0.500N   |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05212 TEST: 03                                                 PAGE  12
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- OXAZEPAM
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        125 PPM      2500 PPM     5000 PPM  |   0 PPM        125 PPM      2500 PPM     5000 PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma And Histiocytic Sarcoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/60 (5%)    2/60 (3%)    1/60 (2%)    1/60 (2%)  |  4/60 (7%)    5/60 (8%)    4/60 (7%)    0/60 (0%)  |
|ADJUSTED (b)           |   6.7%         4.5%         2.8%         2.9%      |   9.3%        11.4%        15.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    1/10 (10%)   0/10 (0%)  |
|TERMINAL (d)           |  3/45 (7%)    2/44 (5%)    0/15 (0%)    0/0        |  2/39 (5%)    3/41 (7%)    0/2 (0%)     0/0        |
|FIRST INCIDENCE (DAYS) |   729 (T)      729 (T)      646          542       |   622          662          393          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.246      P=0.510N     P=0.637N     P=0.433    |  P=0.420      P=0.536      P=0.273        (e)      |
|INCIDENTAL TUMOR       |  P=0.607N     P=0.510N     P=0.394N       (e)      |  P=0.005N**   P=0.293      P=0.585N     P=0.017N*  |
|LOGISTIC REGRESSION    |  P=0.499N     P=0.510N     P=0.401N     P=0.815N   |  P=0.060N     P=0.510      P=0.603N     P=0.228N   |
|COCHRAN-ARMITAGE       |  P=0.208N                                          |  P=0.036N*                                         |
|FISHER EXACT           |               P=0.500N     P=0.309N     P=0.309N   |               P=0.500      P=0.641N     P=0.059N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,                                                                        |
|     NOS, or Undifferentiated Cell Type                                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/60 (3%)    1/60 (2%)    1/60 (2%)    1/60 (2%)  |  3/60 (5%)    3/60 (5%)    3/60 (5%)    0/60 (0%)  |
|ADJUSTED (b)           |   4.4%         2.3%         2.8%         2.9%      |   7.2%         7.0%        13.6%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  2/45 (4%)    1/44 (2%)    0/15 (0%)    0/0        |  2/39 (5%)    2/41 (5%)    0/2 (0%)     0/0        |
|FIRST INCIDENCE (DAYS) |   729 (T)      729 (T)      646          542       |   622          662          393          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.155      P=0.508N     P=0.712      P=0.433    |  P=0.310      P=0.636N     P=0.233        (e)      |
|INCIDENTAL TUMOR       |  P=0.671      P=0.508N     P=0.527N       (e)      |  P=0.030N*    P=0.564      P=0.676N     P=0.205N   |
|LOGISTIC REGRESSION    |  P=0.618      P=0.508N     P=0.574N     P=0.801    |  P=0.171N     P=0.653N     P=0.652N     P=0.519N   |
|COCHRAN-ARMITAGE       |  P=0.442N                                          |  P=0.091N                                          |
|FISHER EXACT           |               P=0.500N     P=0.500N     P=0.500N   |               P=0.660N     P=0.660N     P=0.122N   |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05212 TEST: 03                                                 PAGE  13
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- OXAZEPAM
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        125 PPM      2500 PPM     5000 PPM  |   0 PPM        125 PPM      2500 PPM     5000 PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 32/60 (53%)  35/60 (58%)  46/60 (77%)  42/60 (70%) | 31/60 (52%)  42/60 (70%)  47/60 (78%)  48/60 (80%) |
|ADJUSTED (b)           |  65.1%        64.4%        94.9%       100.0%      |  68.3%        89.2%       100.0%       100.0%      |
|INTERIM SACRIFICE 1 (c)|  2/10 (20%)   5/10 (50%)   9/10 (90%)   9/10 (90%) |  2/10 (20%)   2/10 (20%)   9/10 (90%)  10/10 (100%)|
|TERMINAL (d)           | 28/45 (62%)  25/44 (57%)  13/15 (87%)   0/0        | 25/39 (64%)  36/41 (88%)   2/2 (100%)   0/0        |
|FIRST INCIDENCE (DAYS) |   460 (I)      453          460 (I)      401       |   460 (I)      460 (I)      393          403       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.325      P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.052      P<0.001 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P=0.006 **   P=0.455      P=0.002 **   P=0.003 ** |  P<0.001 **   P=0.036 *    P<0.001 **   P<0.001 ** |
|LOGISTIC REGRESSION    |  P=0.007 **   P=0.357      P=0.004 **   P=0.008 ** |  P<0.001 **   P=0.022 *    P<0.001 **   P<0.001 ** |
|COCHRAN-ARMITAGE       |  P=0.016 *                                         |  P=0.002 **                                        |
|FISHER EXACT           |               P=0.357      P=0.006 **   P=0.045 *  |               P=0.030 *    P=0.002 **   P<0.001 ** |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 17/60 (28%)  19/60 (32%)  51/60 (85%)  60/60 (100%)| 19/60 (32%)  15/60 (25%)  52/60 (87%)  54/60 (90%) |
|ADJUSTED (b)           |  34.7%        37.5%        98.1%       100.0%      |  39.3%        34.0%       100.0%       100.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    1/10 (10%)   4/10 (40%)  10/10 (100%)|  1/10 (10%)   0/10 (0%)    3/10 (30%)  10/10 (100%)|
|TERMINAL (d)           | 13/45 (29%)  13/44 (30%)  14/15 (93%)   0/0        | 11/39 (28%)  12/41 (29%)   2/2 (100%)   0/0        |
|FIRST INCIDENCE (DAYS) |   586          453          460 (I)      401       |   357          662          393          410       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.401      P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.236N     P<0.001 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P<0.001 **   P=0.474      P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.485N     P<0.001 **   P<0.001 ** |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.407      P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.259N     P<0.001 **   P<0.001 ** |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P<0.001 **                                        |
|FISHER EXACT           |               P=0.421      P<0.001 **   P<0.001 ** |               P=0.272N     P<0.001 **   P<0.001 ** |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05212 TEST: 03                                                 PAGE  14
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- OXAZEPAM
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        125 PPM      2500 PPM     5000 PPM  |   0 PPM        125 PPM      2500 PPM     5000 PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 39/60 (65%)  40/60 (67%)  59/60 (98%)  60/60 (100%)| 40/60 (67%)  45/60 (75%)  59/60 (98%)  57/60 (95%) |
|ADJUSTED (b)           |  76.3%        72.4%       100.0%       100.0%      |  79.5%        93.7%       100.0%       100.0%      |
|INTERIM SACRIFICE 1 (c)|  2/10 (20%)   5/10 (50%)   9/10 (90%)  10/10 (100%)|  3/10 (30%)   2/10 (20%)   9/10 (90%)  10/10 (100%)|
|TERMINAL (d)           | 33/45 (73%)  29/44 (66%)  15/15 (100%)  0/0        | 29/39 (74%)  38/41 (93%)   2/2 (100%)   0/0        |
|FIRST INCIDENCE (DAYS) |   460 (I)      453          460 (I)      401       |   357          460 (I)      393          403       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.449      P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.348      P<0.001 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P<0.001 **   P=0.557N     P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.083      P<0.001 **   P=0.007 ** |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.506      P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.196      P<0.001 **   P<0.001 ** |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P<0.001 **                                        |
|FISHER EXACT           |               P=0.500      P<0.001 **   P<0.001 ** |               P=0.211      P<0.001 **   P<0.001 ** |
|=================================================================================================================================|
 
 (a)  Number of tumor-bearing animals / number of animals examined at site.
 (b)  Kaplan-Meier estimated lifetime tumor incidence after adjustment for 
      intercurrent mortality.
 (c)  Observed incidence at interim kill.
          Male interim sacrifices(days):   460
          Female interim sacrifices(days): 460
 (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).