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TR 351 Mouse Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                                     PARA-CHLOROANILINE                                  DATE: 09/03/94       
EXPERIMENT: 05020 TEST: 02                                                                                     TIME: 20:08:05       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1CP9565302          ROUTE: GAVAGE                                                                      NTP C#: 02039B       
PATHOLOGIST: R. PERSING                                                                                        CAS: 106-47-8        
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               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08    
LAB: Battelle Columbus                                     PARA-CHLOROANILINE                                  DATE: 09/03/94      
EXPERIMENT: 05020 TEST: 02                                                                                     TIME: 20:08:05      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: NO1CP9565302          ROUTE: GAVAGE                                                                      NTP C#: 02039B      
PATHOLOGIST: R. PERSING                                                                                        CAS: 106-47-8       
 
 
 
 
 
                                                    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 Gland
                                                    Bone Marrow
                                                    Brain
                                                    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                                     PARA-CHLOROANILINE                                  DATE: 09/03/94       
EXPERIMENT: 05020 TEST: 02                                                                                     TIME: 20:08:05       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1CP9565302          ROUTE: GAVAGE                                                                      NTP C#: 02039B       
PATHOLOGIST: R. PERSING                                                                                        CAS: 106-47-8        
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                       IN THE ANALYSIS OF THE STUDY OF PARA-CHLOROANILINE
 
              ====================================================================================================
 
                                                           MALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Liver                         Hemangiosarcoma
                                                           Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma
                                                           Hepatocellular Carcinoma or Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
                             Lung                          Alveolar/Bronchiolar Adenoma
                                                           Alveolar/Bronchiolar Carcinoma
                                                           Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
                             Skin: Subcutaneous Tissue     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,
                                                            Neurofibroma, or Fibroma
                             All Organs                    Hemangiosarcoma
                                                           Hemangiosarcoma or Hemangioma
                                                           Malignant Lymphoma And Histiocytic Sarcoma
                                                           Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,
                                                            NOS, or Undifferentiated Cell Type
                                                           Malignant Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
 
                                                           FEMALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Liver                         Hepatocellular Carcinoma
                             Lung                          Alveolar/Bronchiolar Adenoma
                             Pituitary Gland: Pars Distalis or Unspecified Site
                                                           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
 
              ====================================================================================================
         DATE: 09/03/94                     EXPERIMENT: 05020 TEST: 02                                                 PAGE   1
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PARA-CHLOROANILINE
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      3 MG/KG      10 MG/KG     30 MG/KG  |   VEHICLE      3 MG/KG      10 MG/KG     30 MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Gland: Non-medullary, Non-cortical                                                                                       |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/49 (0%)    0/5 (0%)     0/7 (0%)     2/50 (4%)  |  2/50 (4%)    0/5 (0%)     0/4 (0%)     0/49 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         5.7%      |   5.1%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/42 (0%)    0/0          0/0          2/35 (6%)  |  2/39 (5%)    0/0          0/1 (0%)     0/41 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          728 (T)   |   728 (T)      ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.139        (e)          (e)        P=0.199    |  P=0.163N       (e)        P=0.981N     P=0.227N   |
|INCIDENTAL TUMOR       |  P=0.139        (e)          (e)        P=0.199    |  P=0.163N       (e)        P=0.981N     P=0.227N   |
|LOGISTIC REGRESSION    |  P=0.139        (e)          (e)        P=0.199    |  P=0.163N       (e)        P=0.981N     P=0.227N   |
|COCHRAN-ARMITAGE       |  P=0.145                                           |  P=0.186N                                          |
|FISHER EXACT           |                 (e)          (e)        P=0.253    |               P=0.825N     P=0.856N     P=0.253N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/49 (0%)    0/4 (0%)     0/7 (0%)     0/50 (0%)  |  2/50 (4%)    0/5 (0%)     0/4 (0%)     0/49 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   5.1%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/42 (0%)    0/0          0/0          0/35 (0%)  |  2/39 (5%)    0/0          0/1 (0%)     0/41 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   728 (T)      ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.163N       (e)        P=0.981N     P=0.227N   |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.163N       (e)        P=0.981N     P=0.227N   |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.163N       (e)        P=0.981N     P=0.227N   |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.186N                                          |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.825N     P=0.856N     P=0.253N   |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05020 TEST: 02                                                 PAGE   2
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PARA-CHLOROANILINE
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      3 MG/KG      10 MG/KG     30 MG/KG  |   VEHICLE      3 MG/KG      10 MG/KG     30 MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/49 (0%)    0/4 (0%)     0/7 (0%)     0/50 (0%)  |  2/50 (4%)    0/5 (0%)     1/4 (25%)    0/49 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   5.1%         0.0%       100.0%         0.0%      |
|TERMINAL (d)           |  0/42 (0%)    0/0          0/0          0/35 (0%)  |  2/39 (5%)    0/0          1/1 (100%)   0/41 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   728 (T)      ---          728 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.155N       (e)        P=0.053      P=0.227N   |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.155N       (e)        P=0.053      P=0.227N   |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.155N       (e)        P=0.051      P=0.227N   |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.185N                                          |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.825N     P=0.210      P=0.253N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Bone Marrow                                                                                                                      |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    0/3 (0%)     0/7 (0%)     2/50 (4%)  |  0/48 (0%)    0/5 (0%)     0/3 (0%)     0/49 (0%)  |
|ADJUSTED (b)           |   2.3%         0.0%         0.0%         5.5%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  1/43 (2%)    0/0          0/0          1/35 (3%)  |  0/38 (0%)    0/0          0/0          0/41 (0%)  |
|FIRST INCIDENCE (DAYS) |   728 (T)      ---          ---          722       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.300        (e)          (e)        P=0.435    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.491        (e)          (e)        P=0.571    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.383        (e)          (e)        P=0.461    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.390                                           |    (e)                                             |
|FISHER EXACT           |               P=0.943N     P=0.877N     P=0.500    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05020 TEST: 02                                                 PAGE   3
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PARA-CHLOROANILINE
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      3 MG/KG      10 MG/KG     30 MG/KG  |   VEHICLE      3 MG/KG      10 MG/KG     30 MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/50 (10%)   2/49 (4%)    1/50 (2%)    5/50 (10%) |  3/50 (6%)    1/50 (2%)    1/50 (2%)    4/50 (8%)  |
|ADJUSTED (b)           |  11.6%         5.6%         3.4%        13.8%      |   7.7%         2.4%         2.3%         9.8%      |
|TERMINAL (d)           |  5/43 (12%)   2/36 (6%)    1/29 (3%)    4/35 (11%) |  3/39 (8%)    1/42 (2%)    1/44 (2%)    4/41 (10%) |
|FIRST INCIDENCE (DAYS) |   728 (T)      728 (T)      728 (T)      690       |   728 (T)      728 (T)      728 (T)      728 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.279      P=0.293N     P=0.214N     P=0.502    |  P=0.225      P=0.279N     P=0.263N     P=0.527    |
|INCIDENTAL TUMOR       |  P=0.298      P=0.293N     P=0.214N     P=0.577    |  P=0.225      P=0.279N     P=0.263N     P=0.527    |
|LOGISTIC REGRESSION    |  P=0.310      P=0.293N     P=0.214N     P=0.576    |  P=0.225      P=0.279N     P=0.263N     P=0.527    |
|COCHRAN-ARMITAGE       |  P=0.350                                           |  P=0.222                                           |
|FISHER EXACT           |               P=0.226N     P=0.102N     P=0.630N   |               P=0.309N     P=0.309N     P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    2/49 (4%)    1/50 (2%)    6/50 (12%) |  1/50 (2%)    0/50 (0%)    0/50 (0%)    1/50 (2%)  |
|ADJUSTED (b)           |   4.7%         4.9%         3.4%        14.9%      |   2.6%         0.0%         0.0%         2.4%      |
|TERMINAL (d)           |  2/43 (5%)    1/36 (3%)    1/29 (3%)    3/35 (9%)  |  1/39 (3%)    0/42 (0%)    0/44 (0%)    1/41 (2%)  |
|FIRST INCIDENCE (DAYS) |   728 (T)      479          728 (T)      399       |   728 (T)      ---          ---          728 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.031 *    P=0.637      P=0.636N     P=0.097    |  P=0.540      P=0.485N     P=0.476N     P=0.751N   |
|INCIDENTAL TUMOR       |  P=0.039 *    P=0.645      P=0.636N     P=0.186    |  P=0.540      P=0.485N     P=0.476N     P=0.751N   |
|LOGISTIC REGRESSION    |  P=0.036 *    P=0.667N     P=0.636N     P=0.153    |  P=0.540      P=0.485N     P=0.476N     P=0.751N   |
|COCHRAN-ARMITAGE       |  P=0.037 *                                         |  P=0.536                                           |
|FISHER EXACT           |               P=0.684      P=0.500N     P=0.134    |               P=0.500N     P=0.500N     P=0.753N   |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05020 TEST: 02                                                 PAGE   4
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PARA-CHLOROANILINE
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      3 MG/KG      10 MG/KG     30 MG/KG  |   VEHICLE      3 MG/KG      10 MG/KG     30 MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  9/50 (18%)  15/49 (31%)  10/50 (20%)   4/50 (8%)  |  5/50 (10%)   7/50 (14%)   8/50 (16%)   8/50 (16%) |
|ADJUSTED (b)           |  20.9%        36.0%        29.1%        11.4%      |  12.3%        16.7%        18.2%        19.0%      |
|TERMINAL (d)           |  9/43 (21%)  10/36 (28%)   7/29 (24%)   4/35 (11%) |  4/39 (10%)   7/42 (17%)   8/44 (18%)   7/41 (17%) |
|FIRST INCIDENCE (DAYS) |   728 (T)      432          443          728 (T)   |   672          728 (T)      728 (T)      722       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.044N*    P=0.060      P=0.205      P=0.209N   |  P=0.310      P=0.428      P=0.354      P=0.308    |
|INCIDENTAL TUMOR       |  P=0.024N*    P=0.124      P=0.317      P=0.209N   |  P=0.293      P=0.379      P=0.308      P=0.249    |
|LOGISTIC REGRESSION    |  P=0.020N*    P=0.097      P=0.478      P=0.209N   |  P=0.305      P=0.374      P=0.302      P=0.287    |
|COCHRAN-ARMITAGE       |  P=0.019N*                                         |  P=0.301                                           |
|FISHER EXACT           |               P=0.109      P=0.500      P=0.117N   |               P=0.380      P=0.277      P=0.277    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/50 (6%)    7/49 (14%)  11/50 (22%)  17/50 (34%) |  1/50 (2%)    2/50 (4%)    0/50 (0%)    5/50 (10%) |
|ADJUSTED (b)           |   7.0%        16.3%        25.9%        37.9%      |   2.1%         4.8%         0.0%        11.7%      |
|TERMINAL (d)           |  3/43 (7%)    2/36 (6%)    1/29 (3%)    8/35 (23%) |  0/39 (0%)    2/42 (5%)    0/44 (0%)    4/41 (10%) |
|FIRST INCIDENCE (DAYS) |   728 (T)      637          514          490       |   480          728 (T)      ---          616       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.127      P=0.011 *    P<0.001 ** |  P=0.034 *    P=0.512      P=0.492N     P=0.117    |
|INCIDENTAL TUMOR       |  P=0.001 **   P=0.282      P=0.245      P=0.002 ** |  P=0.062      P=0.517      P=0.500N     P=0.152    |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.149      P=0.069      P<0.001 ** |  P=0.028 *    P=0.509      P=0.656N     P=0.082    |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P=0.032 *                                         |
|FISHER EXACT           |               P=0.151      P=0.020 *    P<0.001 ** |               P=0.500      P=0.500N     P=0.102    |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05020 TEST: 02                                                 PAGE   5
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PARA-CHLOROANILINE
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      3 MG/KG      10 MG/KG     30 MG/KG  |   VEHICLE      3 MG/KG      10 MG/KG     30 MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 11/50 (22%)  21/49 (43%)  20/50 (40%)  21/50 (42%) |  6/50 (12%)   9/50 (18%)   8/50 (16%)  11/50 (22%) |
|ADJUSTED (b)           |  25.6%        46.4%        47.0%        47.1%      |  14.1%        21.4%        18.2%        25.4%      |
|TERMINAL (d)           | 11/43 (26%)  12/36 (33%)   8/29 (28%)  12/35 (34%) |  4/39 (10%)   9/42 (21%)   8/44 (18%)   9/41 (22%) |
|FIRST INCIDENCE (DAYS) |   728 (T)      432          443          490       |   480          728 (T)      728 (T)      616       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.081      P=0.012 *    P=0.007 **   P=0.010 *  |  P=0.171      P=0.335      P=0.472      P=0.174    |
|INCIDENTAL TUMOR       |  P=0.201      P=0.042 *    P=0.127      P=0.043 *  |  P=0.208      P=0.296      P=0.423      P=0.167    |
|LOGISTIC REGRESSION    |  P=0.158      P=0.019 *    P=0.045 *    P=0.027 *  |  P=0.180      P=0.278      P=0.395      P=0.146    |
|COCHRAN-ARMITAGE       |  P=0.115                                           |  P=0.161                                           |
|FISHER EXACT           |               P=0.022 *    P=0.041 *    P=0.026 *  |               P=0.288      P=0.387      P=0.143    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 11/50 (22%)  21/49 (43%)  20/50 (40%)  21/50 (42%) |  6/50 (12%)   9/50 (18%)   8/50 (16%)  11/50 (22%) |
|ADJUSTED (b)           |  25.6%        46.4%        47.0%        47.1%      |  14.1%        21.4%        18.2%        25.4%      |
|TERMINAL (d)           | 11/43 (26%)  12/36 (33%)   8/29 (28%)  12/35 (34%) |  4/39 (10%)   9/42 (21%)   8/44 (18%)   9/41 (22%) |
|FIRST INCIDENCE (DAYS) |   728 (T)      432          443          490       |   480          728 (T)      728 (T)      616       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.081      P=0.012 *    P=0.007 **   P=0.010 *  |  P=0.171      P=0.335      P=0.472      P=0.174    |
|INCIDENTAL TUMOR       |  P=0.201      P=0.042 *    P=0.127      P=0.043 *  |  P=0.208      P=0.296      P=0.423      P=0.167    |
|LOGISTIC REGRESSION    |  P=0.158      P=0.019 *    P=0.045 *    P=0.027 *  |  P=0.180      P=0.278      P=0.395      P=0.146    |
|COCHRAN-ARMITAGE       |  P=0.115                                           |  P=0.161                                           |
|FISHER EXACT           |               P=0.022 *    P=0.041 *    P=0.026 *  |               P=0.288      P=0.387      P=0.143    |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05020 TEST: 02                                                 PAGE   6
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PARA-CHLOROANILINE
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      3 MG/KG      10 MG/KG     30 MG/KG  |   VEHICLE      3 MG/KG      10 MG/KG     30 MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/50 (10%)   4/10 (40%)   5/14 (36%)   4/50 (8%)  |  5/50 (10%)   2/8 (25%)    1/7 (14%)    2/50 (4%)  |
|ADJUSTED (b)           |  11.6%        80.0%        69.2%        10.5%      |  12.2%        66.7%        33.3%         4.9%      |
|TERMINAL (d)           |  5/43 (12%)   4/5 (80%)    2/3 (67%)    2/35 (6%)  |  4/39 (10%)   2/3 (67%)    1/3 (33%)    2/41 (5%)  |
|FIRST INCIDENCE (DAYS) |   728 (T)      728 (T)      443          682       |   666          728 (T)      728 (T)      728 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.316N     P=0.001 **   P=0.006 **   P=0.611N   |  P=0.093N     P=0.228      P=0.688      P=0.203N   |
|INCIDENTAL TUMOR       |  P=0.124N     P=0.001 **   P=0.013 *    P=0.460N   |  P=0.096N     P=0.035 *    P=0.489      P=0.231N   |
|LOGISTIC REGRESSION    |  P=0.169N     P=0.001 **   P=0.007 **   P=0.546N   |  P=0.089N     P=0.054      P=0.548      P=0.206N   |
|COCHRAN-ARMITAGE       |  P=0.178N                                          |  P=0.112N                                          |
|FISHER EXACT           |               P=0.034 *    P=0.033 *    P=0.500N   |               P=0.245      P=0.562      P=0.218N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/50 (6%)    1/10 (10%)   3/14 (21%)   3/50 (6%)  |  1/50 (2%)    1/8 (13%)    0/7 (0%)     2/50 (4%)  |
|ADJUSTED (b)           |   7.0%        20.0%        37.1%         8.3%      |   2.6%        33.3%         0.0%         4.9%      |
|TERMINAL (d)           |  3/43 (7%)    1/5 (20%)    1/3 (33%)    2/35 (6%)  |  1/39 (3%)    1/3 (33%)    0/3 (0%)     2/41 (5%)  |
|FIRST INCIDENCE (DAYS) |   728 (T)      728 (T)      666          725       |   728 (T)      728 (T)      ---          728 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.569      P=0.444      P=0.056      P=0.566    |  P=0.583      P=0.160      P=0.952N     P=0.517    |
|INCIDENTAL TUMOR       |  P=0.367N     P=0.444      P=0.085      P=0.664    |  P=0.583      P=0.160      P=0.952N     P=0.517    |
|LOGISTIC REGRESSION    |  P=0.478N     P=0.444      P=0.011 *    P=0.594    |  P=0.583      P=0.160      P=0.952N     P=0.517    |
|COCHRAN-ARMITAGE       |  P=0.484N                                          |  P=0.535                                           |
|FISHER EXACT           |               P=0.528      P=0.113      P=0.661N   |               P=0.259      P=0.877N     P=0.500    |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05020 TEST: 02                                                 PAGE   7
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PARA-CHLOROANILINE
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      3 MG/KG      10 MG/KG     30 MG/KG  |   VEHICLE      3 MG/KG      10 MG/KG     30 MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  8/50 (16%)   5/10 (50%)   7/14 (50%)   6/50 (12%) |  6/50 (12%)   2/8 (25%)    1/7 (14%)    4/50 (8%)  |
|ADJUSTED (b)           |  18.6%       100.0%       100.0%        15.9%      |  14.7%        66.7%        33.3%         9.8%      |
|TERMINAL (d)           |  8/43 (19%)   5/5 (100%)   3/3 (100%)   4/35 (11%) |  5/39 (13%)   2/3 (67%)    1/3 (33%)    4/41 (10%) |
|FIRST INCIDENCE (DAYS) |   728 (T)      728 (T)      443          682       |   666          728 (T)      728 (T)      728 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.251N     P<0.001 **   P<0.001 **   P=0.538N   |  P=0.196N     P=0.265      P=0.712      P=0.344N   |
|INCIDENTAL TUMOR       |  P=0.079N     P<0.001 **   P=0.001 **   P=0.410N   |  P=0.198N     P=0.056      P=0.532      P=0.376N   |
|LOGISTIC REGRESSION    |  P=0.106N     P<0.001 **   P<0.001 **   P=0.456N   |  P=0.192N     P=0.076      P=0.587      P=0.356N   |
|COCHRAN-ARMITAGE       |  P=0.117N                                          |  P=0.241N                                          |
|FISHER EXACT           |               P=0.031 *    P=0.014 *    P=0.387N   |               P=0.303      P=0.622      P=0.370N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/49 (0%)    0/50 (0%)    0/50 (0%)  |  0/50 (0%)    2/50 (4%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   0.0%         4.8%         0.0%         0.0%      |
|TERMINAL (d)           |  0/43 (0%)    0/36 (0%)    0/29 (0%)    0/35 (0%)  |  0/39 (0%)    2/42 (5%)    0/44 (0%)    0/41 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   ---          728 (T)      ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.365N     P=0.255        (e)          (e)      |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.365N     P=0.255        (e)          (e)      |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.365N     P=0.255        (e)          (e)      |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.369N                                          |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.247        (e)          (e)      |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05020 TEST: 02                                                 PAGE   8
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PARA-CHLOROANILINE
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      3 MG/KG      10 MG/KG     30 MG/KG  |   VEHICLE      3 MG/KG      10 MG/KG     30 MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/49 (0%)    0/50 (0%)    0/50 (0%)  |  0/50 (0%)    2/50 (4%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   0.0%         4.8%         0.0%         0.0%      |
|TERMINAL (d)           |  0/43 (0%)    0/36 (0%)    0/29 (0%)    0/35 (0%)  |  0/39 (0%)    2/42 (5%)    0/44 (0%)    0/41 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   ---          728 (T)      ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.365N     P=0.255        (e)          (e)      |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.365N     P=0.255        (e)          (e)      |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.365N     P=0.255        (e)          (e)      |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.369N                                          |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.247        (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/40 (0%)    0/4 (0%)     0/4 (0%)     0/41 (0%)  |  3/46 (7%)    1/5 (20%)    2/6 (33%)    3/42 (7%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   8.1%       100.0%        66.7%         8.8%      |
|TERMINAL (d)           |  0/35 (0%)    0/0          0/0          0/28 (0%)  |  3/37 (8%)    1/1 (100%)   2/3 (67%)    3/34 (9%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   728 (T)      728 (T)      728 (T)      728 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.468N     P=0.099      P=0.022 *    P=0.624    |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.468N     P=0.099      P=0.022 *    P=0.624    |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.468N     P=0.099      P=0.022 *    P=0.624    |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.516N                                          |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.347      P=0.096      P=0.617    |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05020 TEST: 02                                                 PAGE   9
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PARA-CHLOROANILINE
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      3 MG/KG      10 MG/KG     30 MG/KG  |   VEHICLE      3 MG/KG      10 MG/KG     30 MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/50 (6%)    4/49 (8%)    5/50 (10%)   1/50 (2%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   7.0%        10.4%        16.2%         2.9%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  3/43 (7%)    3/36 (8%)    4/29 (14%)   1/35 (3%)  |  0/39 (0%)    0/42 (0%)    0/44 (0%)    0/41 (0%)  |
|FIRST INCIDENCE (DAYS) |   728 (T)      667          674          728 (T)   |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.228N     P=0.416      P=0.180      P=0.381N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.196N     P=0.488      P=0.255      P=0.381N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.191N     P=0.465      P=0.255      P=0.381N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.174N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.489      P=0.357      P=0.309N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibrosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  6/50 (12%)   3/49 (6%)    9/50 (18%)   4/50 (8%)  |  1/50 (2%)    0/50 (0%)    3/50 (6%)    3/50 (6%)  |
|ADJUSTED (b)           |  12.8%         8.3%        21.8%        10.2%      |   2.1%         0.0%         6.6%         7.0%      |
|TERMINAL (d)           |  3/43 (7%)    3/36 (8%)    2/29 (7%)    1/35 (3%)  |  0/39 (0%)    0/42 (0%)    2/44 (5%)    2/41 (5%)  |
|FIRST INCIDENCE (DAYS) |   502          728 (T)      389          682       |   527          ---          667          667       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.496N     P=0.317N     P=0.180      P=0.450N   |  P=0.131      P=0.504N     P=0.337      P=0.321    |
|INCIDENTAL TUMOR       |  P=0.294N     P=0.253N     P=0.511N     P=0.137N   |  P=0.090      P=0.500N     P=0.256      P=0.212    |
|LOGISTIC REGRESSION    |  P=0.428N     P=0.221N     P=0.496      P=0.321N   |  P=0.117      P=0.474N     P=0.260      P=0.268    |
|COCHRAN-ARMITAGE       |  P=0.436N                                          |  P=0.126                                           |
|FISHER EXACT           |               P=0.254N     P=0.288      P=0.370N   |               P=0.500N     P=0.309      P=0.309    |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05020 TEST: 02                                                 PAGE  10
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PARA-CHLOROANILINE
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      3 MG/KG      10 MG/KG     30 MG/KG  |   VEHICLE      3 MG/KG      10 MG/KG     30 MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,                                                                                   |
|     Neurofibroma, or Fibroma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  8/50 (16%)   7/49 (14%)  14/50 (28%)   5/50 (10%) |  1/50 (2%)    0/50 (0%)    3/50 (6%)    3/50 (6%)  |
|ADJUSTED (b)           |  17.2%        18.6%        34.1%        12.9%      |   2.1%         0.0%         6.6%         7.0%      |
|TERMINAL (d)           |  5/43 (12%)   6/36 (17%)   5/29 (17%)   2/35 (6%)  |  0/39 (0%)    0/42 (0%)    2/44 (5%)    2/41 (5%)  |
|FIRST INCIDENCE (DAYS) |   502          667          389          682       |   527          ---          667          667       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.316N     P=0.601      P=0.046 *    P=0.379N   |  P=0.131      P=0.504N     P=0.337      P=0.321    |
|INCIDENTAL TUMOR       |  P=0.143N     P=0.507N     P=0.419      P=0.122N   |  P=0.090      P=0.500N     P=0.256      P=0.212    |
|LOGISTIC REGRESSION    |  P=0.225N     P=0.507N     P=0.204      P=0.249N   |  P=0.117      P=0.474N     P=0.260      P=0.268    |
|COCHRAN-ARMITAGE       |  P=0.231N                                          |  P=0.126                                           |
|FISHER EXACT           |               P=0.517N     P=0.114      P=0.277N   |               P=0.500N     P=0.309      P=0.309    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, or Sarcoma                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  6/50 (12%)   3/49 (6%)   10/50 (20%)   4/50 (8%)  |  1/50 (2%)    0/50 (0%)    3/50 (6%)    3/50 (6%)  |
|ADJUSTED (b)           |  12.8%         8.3%        23.8%        10.2%      |   2.1%         0.0%         6.6%         7.0%      |
|TERMINAL (d)           |  3/43 (7%)    3/36 (8%)    2/29 (7%)    1/35 (3%)  |  0/39 (0%)    0/42 (0%)    2/44 (5%)    2/41 (5%)  |
|FIRST INCIDENCE (DAYS) |   502          728 (T)      389          682       |   527          ---          667          667       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.491N     P=0.317N     P=0.125      P=0.450N   |  P=0.131      P=0.504N     P=0.337      P=0.321    |
|INCIDENTAL TUMOR       |  P=0.277N     P=0.253N     P=0.555N     P=0.137N   |  P=0.090      P=0.500N     P=0.256      P=0.212    |
|LOGISTIC REGRESSION    |  P=0.423N     P=0.221N     P=0.389      P=0.321N   |  P=0.117      P=0.474N     P=0.260      P=0.268    |
|COCHRAN-ARMITAGE       |  P=0.431N                                          |  P=0.126                                           |
|FISHER EXACT           |               P=0.254N     P=0.207      P=0.370N   |               P=0.500N     P=0.309      P=0.309    |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05020 TEST: 02                                                 PAGE  11
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PARA-CHLOROANILINE
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      3 MG/KG      10 MG/KG     30 MG/KG  |   VEHICLE      3 MG/KG      10 MG/KG     30 MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Spleen                                                                                                                           |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/50 (6%)    2/47 (4%)    0/49 (0%)    5/49 (10%) |  1/50 (2%)    1/50 (2%)    1/50 (2%)    0/49 (0%)  |
|ADJUSTED (b)           |   7.0%         5.0%         0.0%        12.4%      |   2.6%         2.4%         2.3%         0.0%      |
|TERMINAL (d)           |  3/43 (7%)    1/36 (3%)    0/29 (0%)    2/35 (6%)  |  1/39 (3%)    1/42 (2%)    1/44 (2%)    0/41 (0%)  |
|FIRST INCIDENCE (DAYS) |   728 (T)      667          ---          628       |   728 (T)      728 (T)      728 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.125      P=0.566N     P=0.199N     P=0.281    |  P=0.318N     P=0.745N     P=0.735N     P=0.490N   |
|INCIDENTAL TUMOR       |  P=0.219      P=0.492N     P=0.199N     P=0.473    |  P=0.318N     P=0.745N     P=0.735N     P=0.490N   |
|LOGISTIC REGRESSION    |  P=0.146      P=0.543N     P=0.199N     P=0.341    |  P=0.318N     P=0.745N     P=0.736N     P=0.490N   |
|COCHRAN-ARMITAGE       |  P=0.145                                           |  P=0.327N                                          |
|FISHER EXACT           |               P=0.530N     P=0.125N     P=0.346    |               P=0.753N     P=0.753N     P=0.505N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    0/49 (0%)    0/50 (0%)    0/50 (0%)  |  1/50 (2%)    1/50 (2%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   4.7%         0.0%         0.0%         0.0%      |   2.6%         2.1%         0.0%         0.0%      |
|TERMINAL (d)           |  2/43 (5%)    0/36 (0%)    0/29 (0%)    0/35 (0%)  |  1/39 (3%)    0/42 (0%)    0/44 (0%)    0/41 (0%)  |
|FIRST INCIDENCE (DAYS) |   728 (T)      ---          ---          ---       |   728 (T)      439          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.270N     P=0.278N     P=0.329N     P=0.285N   |  P=0.297N     P=0.754N     P=0.476N     P=0.490N   |
|INCIDENTAL TUMOR       |  P=0.270N     P=0.278N     P=0.329N     P=0.285N   |  P=0.351N     P=0.752N     P=0.476N     P=0.490N   |
|LOGISTIC REGRESSION    |  P=0.270N     P=0.278N     P=0.329N     P=0.285N   |  P=0.349N     P=0.748N     P=0.476N     P=0.490N   |
|COCHRAN-ARMITAGE       |  P=0.241N                                          |  P=0.303N                                          |
|FISHER EXACT           |               P=0.253N     P=0.247N     P=0.247N   |               P=0.753N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05020 TEST: 02                                                 PAGE  12
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PARA-CHLOROANILINE
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      3 MG/KG      10 MG/KG     30 MG/KG  |   VEHICLE      3 MG/KG      10 MG/KG     30 MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/50 (8%)    0/5 (0%)     0/7 (0%)     3/48 (6%)  |  3/49 (6%)    0/4 (0%)     0/3 (0%)     2/49 (4%)  |
|ADJUSTED (b)           |   9.3%         0.0%         0.0%         8.6%      |   7.7%         0.0%         0.0%         4.9%      |
|TERMINAL (d)           |  4/43 (9%)    0/0          0/0          3/35 (9%)  |  3/39 (8%)    0/0          0/0          2/41 (5%)  |
|FIRST INCIDENCE (DAYS) |   728 (T)      ---          ---          728 (T)   |   728 (T)      ---          ---          728 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.560N       (e)          (e)        P=0.612N   |  P=0.417N       (e)          (e)        P=0.477N   |
|INCIDENTAL TUMOR       |  P=0.560N       (e)          (e)        P=0.612N   |  P=0.417N       (e)          (e)        P=0.477N   |
|LOGISTIC REGRESSION    |  P=0.560N       (e)          (e)        P=0.612N   |  P=0.417N       (e)          (e)        P=0.477N   |
|COCHRAN-ARMITAGE       |  P=0.532N                                          |  P=0.475N                                          |
|FISHER EXACT           |               P=0.675N     P=0.583N     P=0.523N   |               P=0.786N     P=0.834N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/50 (8%)    4/49 (8%)    1/50 (2%)   10/50 (20%) |  2/50 (4%)    1/50 (2%)    1/50 (2%)    1/50 (2%)  |
|ADJUSTED (b)           |   9.3%         9.7%         3.4%        23.9%      |   5.1%         2.4%         2.3%         2.4%      |
|TERMINAL (d)           |  4/43 (9%)    2/36 (6%)    1/29 (3%)    5/35 (14%) |  2/39 (5%)    1/42 (2%)    1/44 (2%)    1/41 (2%)  |
|FIRST INCIDENCE (DAYS) |   728 (T)      479          728 (T)      399       |   728 (T)      728 (T)      728 (T)      728 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.011 *    P=0.560      P=0.315N     P=0.047 *  |  P=0.483N     P=0.474N     P=0.458N     P=0.483N   |
|INCIDENTAL TUMOR       |  P=0.019 *    P=0.633      P=0.315N     P=0.124    |  P=0.483N     P=0.474N     P=0.458N     P=0.483N   |
|LOGISTIC REGRESSION    |  P=0.014 *    P=0.639N     P=0.315N     P=0.084    |  P=0.483N     P=0.474N     P=0.458N     P=0.483N   |
|COCHRAN-ARMITAGE       |  P=0.014 *                                         |  P=0.488N                                          |
|FISHER EXACT           |               P=0.631      P=0.181N     P=0.074    |               P=0.500N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05020 TEST: 02                                                 PAGE  13
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PARA-CHLOROANILINE
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      3 MG/KG      10 MG/KG     30 MG/KG  |   VEHICLE      3 MG/KG      10 MG/KG     30 MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma or Hemangioma                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/50 (8%)    4/49 (8%)    1/50 (2%)   10/50 (20%) |  2/50 (4%)    1/50 (2%)    1/50 (2%)    1/50 (2%)  |
|ADJUSTED (b)           |   9.3%         9.7%         3.4%        23.9%      |   5.1%         2.4%         2.3%         2.4%      |
|TERMINAL (d)           |  4/43 (9%)    2/36 (6%)    1/29 (3%)    5/35 (14%) |  2/39 (5%)    1/42 (2%)    1/44 (2%)    1/41 (2%)  |
|FIRST INCIDENCE (DAYS) |   728 (T)      479          728 (T)      399       |   728 (T)      728 (T)      728 (T)      728 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.011 *    P=0.560      P=0.315N     P=0.047 *  |  P=0.483N     P=0.474N     P=0.458N     P=0.483N   |
|INCIDENTAL TUMOR       |  P=0.019 *    P=0.633      P=0.315N     P=0.124    |  P=0.483N     P=0.474N     P=0.458N     P=0.483N   |
|LOGISTIC REGRESSION    |  P=0.014 *    P=0.639N     P=0.315N     P=0.084    |  P=0.483N     P=0.474N     P=0.458N     P=0.483N   |
|COCHRAN-ARMITAGE       |  P=0.014 *                                         |  P=0.488N                                          |
|FISHER EXACT           |               P=0.631      P=0.181N     P=0.074    |               P=0.500N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma And Histiocytic Sarcoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 10/50 (20%)   3/49 (6%)    9/50 (18%)   3/50 (6%)  | 19/50 (38%)  12/50 (24%)   5/50 (10%)  10/50 (20%) |
|ADJUSTED (b)           |  21.6%         7.7%        23.9%         8.0%      |  41.3%        27.8%        10.3%        23.0%      |
|TERMINAL (d)           |  7/43 (16%)   1/36 (3%)    4/29 (14%)   2/35 (6%)  | 12/39 (31%)  11/42 (26%)   2/44 (5%)    8/41 (20%) |
|FIRST INCIDENCE (DAYS) |   496          674          423          682       |   666          528          521          609       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.149N     P=0.072N     P=0.443      P=0.074N   |  P=0.082N     P=0.083N     P=0.001N**   P=0.041N*  |
|INCIDENTAL TUMOR       |  P=0.066N     P=0.014N*    P=0.283N     P=0.020N*  |  P=0.048N*    P=0.180N     P<0.001N**   P=0.040N*  |
|LOGISTIC REGRESSION    |  P=0.095N     P=0.037N*    P=0.397N     P=0.034N*  |  P=0.031N*    P=0.165N     P<0.001N**   P=0.032N*  |
|COCHRAN-ARMITAGE       |  P=0.098N                                          |  P=0.078N                                          |
|FISHER EXACT           |               P=0.039N*    P=0.500N     P=0.036N*  |               P=0.097N     P<0.001N**   P=0.038N*  |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05020 TEST: 02                                                 PAGE  14
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PARA-CHLOROANILINE
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      3 MG/KG      10 MG/KG     30 MG/KG  |   VEHICLE      3 MG/KG      10 MG/KG     30 MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,                                                                        |
|     NOS, or Undifferentiated Cell Type                                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 10/50 (20%)   3/49 (6%)    9/50 (18%)   3/50 (6%)  | 19/50 (38%)  12/50 (24%)   5/50 (10%)  10/50 (20%) |
|ADJUSTED (b)           |  21.6%         7.7%        23.9%         8.0%      |  41.3%        27.8%        10.3%        23.0%      |
|TERMINAL (d)           |  7/43 (16%)   1/36 (3%)    4/29 (14%)   2/35 (6%)  | 12/39 (31%)  11/42 (26%)   2/44 (5%)    8/41 (20%) |
|FIRST INCIDENCE (DAYS) |   496          674          423          682       |   666          528          521          609       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.149N     P=0.072N     P=0.443      P=0.074N   |  P=0.082N     P=0.083N     P=0.001N**   P=0.041N*  |
|INCIDENTAL TUMOR       |  P=0.066N     P=0.014N*    P=0.283N     P=0.020N*  |  P=0.048N*    P=0.180N     P<0.001N**   P=0.040N*  |
|LOGISTIC REGRESSION    |  P=0.095N     P=0.037N*    P=0.397N     P=0.034N*  |  P=0.031N*    P=0.165N     P<0.001N**   P=0.032N*  |
|COCHRAN-ARMITAGE       |  P=0.098N                                          |  P=0.078N                                          |
|FISHER EXACT           |               P=0.039N*    P=0.500N     P=0.036N*  |               P=0.097N     P<0.001N**   P=0.038N*  |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 23/50 (46%)  20/49 (41%)  17/50 (34%)  18/50 (36%) | 20/50 (40%)  15/50 (30%)  12/50 (24%)  17/50 (34%) |
|ADJUSTED (b)           |  53.5%        47.0%        46.7%        47.2%      |  48.5%        34.8%        27.3%        40.5%      |
|TERMINAL (d)           | 23/43 (53%)  14/36 (39%)  11/29 (38%)  15/35 (43%) | 18/39 (46%)  14/42 (33%)  12/44 (27%)  16/41 (39%) |
|FIRST INCIDENCE (DAYS) |   728 (T)      432          443          682       |   666          439          728 (T)      722       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.420N     P=0.540      P=0.502      P=0.505N   |  P=0.461N     P=0.139N     P=0.028N*    P=0.275N   |
|INCIDENTAL TUMOR       |  P=0.283N     P=0.456N     P=0.360N     P=0.364N   |  P=0.499N     P=0.175N     P=0.040N*    P=0.332N   |
|LOGISTIC REGRESSION    |  P=0.240N     P=0.422N     P=0.247N     P=0.341N   |  P=0.442N     P=0.214N     P=0.048N*    P=0.316N   |
|COCHRAN-ARMITAGE       |  P=0.223N                                          |  P=0.484N                                          |
|FISHER EXACT           |               P=0.376N     P=0.154N     P=0.208N   |               P=0.201N     P=0.066N     P=0.339N   |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05020 TEST: 02                                                 PAGE  15
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PARA-CHLOROANILINE
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      3 MG/KG      10 MG/KG     30 MG/KG  |   VEHICLE      3 MG/KG      10 MG/KG     30 MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 25/50 (50%)  16/49 (33%)  28/50 (56%)  27/50 (54%) | 24/50 (48%)  16/50 (32%)  10/50 (20%)  21/50 (42%) |
|ADJUSTED (b)           |  51.0%        36.7%        56.7%        57.2%      |  50.0%        37.1%        20.5%        46.4%      |
|TERMINAL (d)           | 19/43 (44%)   9/36 (25%)   8/29 (28%)  15/35 (43%) | 15/39 (38%)  15/42 (36%)   6/44 (14%)  17/41 (41%) |
|FIRST INCIDENCE (DAYS) |   496          479          389          399       |   480          528          521          609       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.103      P=0.179N     P=0.088      P=0.210    |  P=0.502      P=0.066N     P=0.003N**   P=0.307N   |
|INCIDENTAL TUMOR       |  P=0.300      P=0.025N*    P=0.187N     P=0.481N   |  P=0.516N     P=0.129N     P=0.002N**   P=0.360N   |
|LOGISTIC REGRESSION    |  P=0.227      P=0.068N     P=0.338N     P=0.503    |  P=0.435N     P=0.083N     P=0.004N**   P=0.320N   |
|COCHRAN-ARMITAGE       |  P=0.132                                           |  P=0.476                                           |
|FISHER EXACT           |               P=0.061N     P=0.344      P=0.421    |               P=0.076N     P=0.003N**   P=0.344N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 40/50 (80%)  30/49 (61%)  35/50 (70%)  36/50 (72%) | 36/50 (72%)  26/50 (52%)  21/50 (42%)  31/50 (62%) |
|ADJUSTED (b)           |  81.6%        65.1%        71.1%        76.5%      |  75.0%        59.0%        43.5%        67.3%      |
|TERMINAL (d)           | 34/43 (79%)  20/36 (56%)  15/29 (52%)  24/35 (69%) | 27/39 (69%)  24/42 (57%)  17/44 (39%)  26/41 (63%) |
|FIRST INCIDENCE (DAYS) |   496          432          389          399       |   480          439          521          609       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.296      P=0.258N     P=0.215      P=0.405    |  P=0.474N     P=0.024N*    P=0.002N**   P=0.169N   |
|INCIDENTAL TUMOR       |  P=0.386N     P=0.024N*    P=0.034N*    P=0.187N   |  P=0.411N     P=0.039N*    P=0.001N**   P=0.189N   |
|LOGISTIC REGRESSION    |  P=0.436N     P=0.038N*    P=0.078N     P=0.229N   |  P=0.443N     P=0.036N*    P=0.002N**   P=0.143N   |
|COCHRAN-ARMITAGE       |  P=0.546N                                          |  P=0.512N                                          |
|FISHER EXACT           |               P=0.033N*    P=0.178N     P=0.241N   |               P=0.032N*    P=0.002N**   P=0.198N   |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05020 TEST: 02                                                 PAGE  16
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PARA-CHLOROANILINE
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
 
 (a)  Number of tumor-bearing animals / number of animals examined at site.
 (b)  Kaplan-Meier estimated lifetime tumor incidence after adjustment for 
      intercurrent mortality.
 (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).
NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.