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TR 351 Rat Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                                     PARA-CHLOROANILINE                                  DATE: 09/03/94       
EXPERIMENT: 05020 TEST: 01                                                                                     TIME: 18:21:36       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1CP9565302          ROUTE: GAVAGE                                                                      NTP C#: 02039B       
PATHOLOGIST: J. TOFT                         S. EUSTIS                                                         CAS: 000106478       
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               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: 01                                                                                     TIME: 18:21:36      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: NO1CP9565302          ROUTE: GAVAGE                                                                      NTP C#: 02039B      
PATHOLOGIST: J. TOFT                         S. EUSTIS                                                         CAS: 000106478      
 
 
 
 
 
                                                    RATS(FISCHER344)
                                              ----------------------------
             FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
             IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
 
 
                                                    ----------------
 
                                                    Adrenal Gland
                                                    Bone Marrow
                                                    Brain
                                                    Clitoral Gland
                                                    Epididymis
                                                    Heart
                                                    Islets, Pancreatic
                                                    Kidney
                                                    Liver
                                                    Lung
                                                    Nose
                                                    Ovary
                                                    Pancreas
                                                    Parathyroid Gland
                                                    Pituitary Gland
                                                    Preputial Gland
                                                    Prostate
                                                    Salivary Glands
                                                    Spleen
                                                    Testes
                                                    Thymus
                                                    Thyroid Gland
                                                    Urinary Bladder
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                                     PARA-CHLOROANILINE                                  DATE: 09/03/94       
EXPERIMENT: 05020 TEST: 01                                                                                     TIME: 18:21:36       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1CP9565302          ROUTE: GAVAGE                                                                      NTP C#: 02039B       
PATHOLOGIST: J. TOFT                         S. EUSTIS                                                         CAS: 000106478       
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                       IN THE ANALYSIS OF THE STUDY OF PARA-CHLOROANILINE
 
              ====================================================================================================
 
                                                           MALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Adrenal Medulla               Pheochromocytoma Benign
                                                           Pheochromocytoma: Benign, Complex, Malignant, NOS
                             Clitoral/Preputial Gland      Adenoma
                                                           Carcinoma or Adenoma
                             Pituitary Gland: Pars Distalis or Unspecified Site
                                                           Adenoma
                                                           Carcinoma or Adenoma
                             Spleen                        Fibroma
                                                           Fibrosarcoma
                                                           Hemangiosarcoma
                                                           Osteosarcoma
                             Testes                        Adenoma
                             Thyroid Gland: Follicular Cell
                                                           Carcinoma or Adenoma
                             All Organs                    Hemangiosarcoma
                                                           Leukemia: Lymphocytic, Monocytic, Mononuclear,
                                                            or Undifferentiated
                                                           Osteosarcoma
                                                           Osteosarcoma or Osteoma
                                                           Benign Tumors
                                                           Malignant Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
 
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                                     PARA-CHLOROANILINE                                  DATE: 09/03/94       
EXPERIMENT: 05020 TEST: 01                                                                                     TIME: 18:21:36       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1CP9565302          ROUTE: GAVAGE                                                                      NTP C#: 02039B       
PATHOLOGIST: J. TOFT                         S. EUSTIS                                                         CAS: 000106478       
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                       IN THE ANALYSIS OF THE STUDY OF PARA-CHLOROANILINE
 
              ====================================================================================================
 
                                                           FEMALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             All Organs                    Leukemia: Lymphocytic, Monocytic, Mononuclear,
                                                            or Undifferentiated
                                                           Benign Tumors
                                                           Malignant Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
         DATE: 09/03/94                     EXPERIMENT: 05020 TEST: 01                                                 PAGE   1
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PARA-CHLOROANILINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      2 MG/KG      6 MG/KG      18 MG/KG  |   VEHICLE      2 MG/KG      6 MG/KG      18 MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 13/49 (27%)  14/49 (29%)  14/48 (29%)  25/49 (51%) |  2/50 (4%)    3/50 (6%)    1/50 (2%)    6/50 (12%) |
|ADJUSTED (b)           |  53.8%        40.3%        40.7%        79.5%      |   6.2%         7.7%         2.8%        16.2%      |
|TERMINAL (d)           |  8/18 (44%)  11/31 (35%)  12/32 (38%)  15/21 (71%) |  1/27 (4%)    3/39 (8%)    1/36 (3%)    6/37 (16%) |
|FIRST INCIDENCE (DAYS) |   633          651          476          618       |   557          729 (T)      729 (T)      729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.158N     P=0.134N     P=0.061    |  P=0.091      P=0.650      P=0.415N     P=0.248    |
|INCIDENTAL TUMOR       |  P=0.002 **   P=0.294N     P=0.410N     P=0.023 *  |  P=0.094      P=0.573      P=0.416N     P=0.238    |
|LOGISTIC REGRESSION    |  P=0.003 **   P=0.353N     P=0.504N     P=0.028 *  |  P=0.077      P=0.553      P=0.488N     P=0.192    |
|COCHRAN-ARMITAGE       |  P=0.003 **                                        |  P=0.062                                           |
|FISHER EXACT           |               P=0.500      P=0.475      P=0.011 *  |               P=0.500      P=0.500N     P=0.134    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 13/49 (27%)  14/49 (29%)  15/48 (31%)  26/49 (53%) |  2/50 (4%)    3/50 (6%)    1/50 (2%)    6/50 (12%) |
|ADJUSTED (b)           |  53.8%        40.3%        43.6%        82.9%      |   6.2%         7.7%         2.8%        16.2%      |
|TERMINAL (d)           |  8/18 (44%)  11/31 (35%)  13/32 (41%)  16/21 (76%) |  1/27 (4%)    3/39 (8%)    1/36 (3%)    6/37 (16%) |
|FIRST INCIDENCE (DAYS) |   633          651          476          618       |   557          729 (T)      729 (T)      729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.158N     P=0.175N     P=0.041 *  |  P=0.091      P=0.650      P=0.415N     P=0.248    |
|INCIDENTAL TUMOR       |  P<0.001 **   P=0.294N     P=0.481N     P=0.013 *  |  P=0.094      P=0.573      P=0.416N     P=0.238    |
|LOGISTIC REGRESSION    |  P=0.001 **   P=0.353N     P=0.586N     P=0.017 *  |  P=0.077      P=0.553      P=0.488N     P=0.192    |
|COCHRAN-ARMITAGE       |  P=0.002 **                                        |  P=0.062                                           |
|FISHER EXACT           |               P=0.500      P=0.386      P=0.006 ** |               P=0.500      P=0.500N     P=0.134    |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05020 TEST: 01                                                 PAGE   2
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PARA-CHLOROANILINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      2 MG/KG      6 MG/KG      18 MG/KG  |   VEHICLE      2 MG/KG      6 MG/KG      18 MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/46 (2%)    7/12 (58%)   4/15 (27%)   2/48 (4%)  |  1/45 (2%)    1/5 (20%)    1/11 (9%)    4/48 (8%)  |
|ADJUSTED (b)           |   6.7%       100.0%        80.0%        10.0%      |   4.3%        50.0%         2.3%        10.6%      |
|TERMINAL (d)           |  1/15 (7%)    2/2 (100%)   4/5 (80%)    2/20 (10%) |  1/23 (4%)    1/2 (50%)    0/1 (0%)     3/35 (9%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      626          729 (T)      729 (T)   |   729 (T)      729 (T)      605          616       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.085N     P=0.004 **   P=0.004 **   P=0.602    |  P=0.352      P=0.183      P=0.554      P=0.309    |
|INCIDENTAL TUMOR       |  P=0.059N     P<0.001 **   P=0.004 **   P=0.602    |  P=0.383      P=0.183      P=0.559      P=0.293    |
|LOGISTIC REGRESSION    |  P=0.057N     P<0.001 **   P=0.004 **   P=0.602    |  P=0.362      P=0.183      P=0.359      P=0.265    |
|COCHRAN-ARMITAGE       |  P=0.127N                                          |  P=0.265                                           |
|FISHER EXACT           |               P<0.001 **   P=0.011 *    P=0.516    |               P=0.192      P=0.357      P=0.201    |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/46 (2%)    7/12 (58%)   4/15 (27%)   3/48 (6%)  |  1/45 (2%)    1/5 (20%)    1/11 (9%)    4/48 (8%)  |
|ADJUSTED (b)           |   6.7%       100.0%        80.0%        12.0%      |   4.3%        50.0%         2.3%        10.6%      |
|TERMINAL (d)           |  1/15 (7%)    2/2 (100%)   4/5 (80%)    2/20 (10%) |  1/23 (4%)    1/2 (50%)    0/1 (0%)     3/35 (9%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      626          729 (T)      535       |   729 (T)      729 (T)      605          616       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.178N     P=0.004 **   P=0.004 **   P=0.393    |  P=0.352      P=0.183      P=0.554      P=0.309    |
|INCIDENTAL TUMOR       |  P=0.120N     P<0.001 **   P=0.004 **   P=0.406    |  P=0.383      P=0.183      P=0.559      P=0.293    |
|LOGISTIC REGRESSION    |  P=0.130N     P<0.001 **   P=0.004 **   P=0.347    |  P=0.362      P=0.183      P=0.359      P=0.265    |
|COCHRAN-ARMITAGE       |  P=0.219N                                          |  P=0.265                                           |
|FISHER EXACT           |               P<0.001 **   P=0.011 *    P=0.325    |               P=0.192      P=0.357      P=0.201    |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05020 TEST: 01                                                 PAGE   3
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PARA-CHLOROANILINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      2 MG/KG      6 MG/KG      18 MG/KG  |   VEHICLE      2 MG/KG      6 MG/KG      18 MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/48 (6%)    0/4 (0%)     0/10 (0%)    1/46 (2%)  |  1/50 (2%)    0/5 (0%)     0/9 (0%)     1/48 (2%)  |
|ADJUSTED (b)           |  13.7%         0.0%         0.0%         3.6%      |   3.4%         0.0%         0.0%         2.7%      |
|TERMINAL (d)           |  2/18 (11%)   0/0          0/0          0/21 (0%)  |  0/27 (0%)    0/0          0/0          1/37 (3%)  |
|FIRST INCIDENCE (DAYS) |   633          ---          ---          712       |   722          ---          ---          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.295N     P=0.450N     P=0.478N     P=0.243N   |  P=0.676      P=0.431N     P=0.457N     P=0.697N   |
|INCIDENTAL TUMOR       |  P=0.274N     P=0.739N     P=0.682N     P=0.335N   |  P=0.640        (e)          (e)        P=0.727    |
|LOGISTIC REGRESSION    |  P=0.223N     P=0.906N     P=0.918N     P=0.274N   |  P=0.630N       (e)          (e)        P=0.716N   |
|COCHRAN-ARMITAGE       |  P=0.291N                                          |  P=0.648                                           |
|FISHER EXACT           |               P=0.783N     P=0.561N     P=0.325N   |               P=0.909N     P=0.847N     P=0.742    |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/48 (6%)    0/4 (0%)     0/10 (0%)    2/46 (4%)  |  1/50 (2%)    0/5 (0%)     0/9 (0%)     1/48 (2%)  |
|ADJUSTED (b)           |  13.7%         0.0%         0.0%         8.2%      |   3.4%         0.0%         0.0%         2.7%      |
|TERMINAL (d)           |  2/18 (11%)   0/0          0/0          1/21 (5%)  |  0/27 (0%)    0/0          0/0          1/37 (3%)  |
|FIRST INCIDENCE (DAYS) |   633          ---          ---          712       |   722          ---          ---          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.495N     P=0.450N     P=0.478N     P=0.418N   |  P=0.676      P=0.431N     P=0.457N     P=0.697N   |
|INCIDENTAL TUMOR       |  P=0.462N     P=0.739N     P=0.682N     P=0.519N   |  P=0.640        (e)          (e)        P=0.727    |
|LOGISTIC REGRESSION    |  P=0.396N     P=0.906N     P=0.918N     P=0.451N   |  P=0.630N       (e)          (e)        P=0.716N   |
|COCHRAN-ARMITAGE       |  P=0.511N                                          |  P=0.648                                           |
|FISHER EXACT           |               P=0.783N     P=0.561N     P=0.520N   |               P=0.909N     P=0.847N     P=0.742    |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05020 TEST: 01                                                 PAGE   4
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PARA-CHLOROANILINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      2 MG/KG      6 MG/KG      18 MG/KG  |   VEHICLE      2 MG/KG      6 MG/KG      18 MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/49 (0%)    5/50 (10%)   3/49 (6%)    0/49 (0%)  |  1/50 (2%)    1/50 (2%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   0.0%        15.6%         9.4%         0.0%      |   3.7%         2.3%         0.0%         0.0%      |
|TERMINAL (d)           |  0/18 (0%)    5/32 (16%)   3/32 (9%)    0/21 (0%)  |  1/27 (4%)    0/39 (0%)    0/36 (0%)    0/37 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          729 (T)      729 (T)      ---       |   729 (T)      693          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.190N     P=0.103      P=0.238        (e)      |  P=0.284N     P=0.681N     P=0.443N     P=0.437N   |
|INCIDENTAL TUMOR       |  P=0.190N     P=0.103      P=0.238        (e)      |  P=0.328N     P=0.720N     P=0.443N     P=0.437N   |
|LOGISTIC REGRESSION    |  P=0.190N     P=0.103      P=0.238        (e)      |  P=0.291N     P=0.720N     P=0.443N     P=0.437N   |
|COCHRAN-ARMITAGE       |  P=0.178N                                          |  P=0.305N                                          |
|FISHER EXACT           |               P=0.030 *    P=0.121        (e)      |               P=0.753N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/49 (2%)    1/50 (2%)    2/49 (4%)    0/49 (0%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   5.6%         3.1%         5.9%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  1/18 (6%)    1/32 (3%)    1/32 (3%)    0/21 (0%)  |  0/27 (0%)    0/39 (0%)    0/36 (0%)    0/37 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      729 (T)      716          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.345N     P=0.628N     P=0.693      P=0.469N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.332N     P=0.628N     P=0.539      P=0.469N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.322N     P=0.628N     P=0.647      P=0.469N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.334N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.747N     P=0.500      P=0.500N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05020 TEST: 01                                                 PAGE   5
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PARA-CHLOROANILINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      2 MG/KG      6 MG/KG      18 MG/KG  |   VEHICLE      2 MG/KG      6 MG/KG      18 MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/49 (2%)    6/50 (12%)   5/49 (10%)   0/49 (0%)  |  1/50 (2%)    1/50 (2%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   5.6%        18.8%        15.0%         0.0%      |   3.7%         2.3%         0.0%         0.0%      |
|TERMINAL (d)           |  1/18 (6%)    6/32 (19%)   4/32 (13%)   0/21 (0%)  |  1/27 (4%)    0/39 (0%)    0/36 (0%)    0/37 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      729 (T)      716          ---       |   729 (T)      693          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.106N     P=0.196      P=0.279      P=0.469N   |  P=0.284N     P=0.681N     P=0.443N     P=0.437N   |
|INCIDENTAL TUMOR       |  P=0.104N     P=0.196      P=0.187      P=0.469N   |  P=0.328N     P=0.720N     P=0.443N     P=0.437N   |
|LOGISTIC REGRESSION    |  P=0.084N     P=0.196      P=0.241      P=0.469N   |  P=0.291N     P=0.720N     P=0.443N     P=0.437N   |
|COCHRAN-ARMITAGE       |  P=0.102N                                          |  P=0.305N                                          |
|FISHER EXACT           |               P=0.059      P=0.102      P=0.500N   |               P=0.753N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/49 (2%)    6/50 (12%)   5/49 (10%)   0/49 (0%)  |  1/50 (2%)    1/50 (2%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   5.6%        18.8%        15.0%         0.0%      |   3.7%         2.3%         0.0%         0.0%      |
|TERMINAL (d)           |  1/18 (6%)    6/32 (19%)   4/32 (13%)   0/21 (0%)  |  1/27 (4%)    0/39 (0%)    0/36 (0%)    0/37 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      729 (T)      716          ---       |   729 (T)      693          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.106N     P=0.196      P=0.279      P=0.469N   |  P=0.284N     P=0.681N     P=0.443N     P=0.437N   |
|INCIDENTAL TUMOR       |  P=0.104N     P=0.196      P=0.187      P=0.469N   |  P=0.328N     P=0.720N     P=0.443N     P=0.437N   |
|LOGISTIC REGRESSION    |  P=0.084N     P=0.196      P=0.241      P=0.469N   |  P=0.291N     P=0.720N     P=0.443N     P=0.437N   |
|COCHRAN-ARMITAGE       |  P=0.102N                                          |  P=0.305N                                          |
|FISHER EXACT           |               P=0.059      P=0.102      P=0.500N   |               P=0.753N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05020 TEST: 01                                                 PAGE   6
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PARA-CHLOROANILINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      2 MG/KG      6 MG/KG      18 MG/KG  |   VEHICLE      2 MG/KG      6 MG/KG      18 MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/49 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |  1/50 (2%)    1/50 (2%)    0/50 (0%)    3/50 (6%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   2.6%         2.6%         0.0%         8.1%      |
|TERMINAL (d)           |  0/18 (0%)    0/32 (0%)    0/32 (0%)    0/21 (0%)  |  0/27 (0%)    1/39 (3%)    0/36 (0%)    3/37 (8%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   605          729 (T)      ---          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.155      P=0.692N     P=0.475N     P=0.407    |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.163      P=0.733      P=0.469N     P=0.393    |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.141      P=0.769N     P=0.543N     P=0.351    |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.128                                           |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.753N     P=0.500N     P=0.309    |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroadenoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/49 (2%)    2/50 (4%)    3/50 (6%)    3/50 (6%)  |  8/50 (16%)  10/50 (20%)  13/50 (26%)   6/50 (12%) |
|ADJUSTED (b)           |   2.6%         6.3%         9.4%        12.3%      |  26.6%        25.6%        31.8%        15.7%      |
|TERMINAL (d)           |  0/18 (0%)    2/32 (6%)    3/32 (9%)    2/21 (10%) |  6/27 (22%)  10/39 (26%)   9/36 (25%)   5/37 (14%) |
|FIRST INCIDENCE (DAYS) |   626          729 (T)      729 (T)      680       |   400          729 (T)      539          688       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.231      P=0.655      P=0.469      P=0.356    |  P=0.138N     P=0.487N     P=0.375      P=0.192N   |
|INCIDENTAL TUMOR       |  P=0.247      P=0.505      P=0.376      P=0.310    |  P=0.174N     P=0.591N     P=0.212      P=0.286N   |
|LOGISTIC REGRESSION    |  P=0.297      P=0.558      P=0.364      P=0.345    |  P=0.174N     P=0.582      P=0.233      P=0.275N   |
|COCHRAN-ARMITAGE       |  P=0.292                                           |  P=0.229N                                          |
|FISHER EXACT           |               P=0.508      P=0.316      P=0.316    |               P=0.398      P=0.163      P=0.387N   |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05020 TEST: 01                                                 PAGE   7
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PARA-CHLOROANILINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      2 MG/KG      6 MG/KG      18 MG/KG  |   VEHICLE      2 MG/KG      6 MG/KG      18 MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma or Adenoma                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/49 (2%)    2/50 (4%)    3/50 (6%)    3/50 (6%)  |  9/50 (18%)  11/50 (22%)  13/50 (26%)   9/50 (18%) |
|ADJUSTED (b)           |   2.6%         6.3%         9.4%        12.3%      |  28.5%        28.2%        31.8%        23.6%      |
|TERMINAL (d)           |  0/18 (0%)    2/32 (6%)    3/32 (9%)    2/21 (10%) |  6/27 (22%)  11/39 (28%)   9/36 (25%)   8/37 (22%) |
|FIRST INCIDENCE (DAYS) |   626          729 (T)      729 (T)      680       |   400          729 (T)      539          688       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.231      P=0.655      P=0.469      P=0.356    |  P=0.307N     P=0.457N     P=0.475      P=0.342N   |
|INCIDENTAL TUMOR       |  P=0.247      P=0.505      P=0.376      P=0.310    |  P=0.357N     P=0.602N     P=0.301      P=0.459N   |
|LOGISTIC REGRESSION    |  P=0.297      P=0.558      P=0.364      P=0.345    |  P=0.371N     P=0.572      P=0.311      P=0.469N   |
|COCHRAN-ARMITAGE       |  P=0.292                                           |  P=0.451N                                          |
|FISHER EXACT           |               P=0.508      P=0.316      P=0.316    |               P=0.402      P=0.235      P=0.602N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/49 (2%)    2/50 (4%)    3/50 (6%)    3/50 (6%)  |  9/50 (18%)  11/50 (22%)  13/50 (26%)   9/50 (18%) |
|ADJUSTED (b)           |   2.6%         6.3%         9.4%        12.3%      |  28.5%        28.2%        31.8%        23.6%      |
|TERMINAL (d)           |  0/18 (0%)    2/32 (6%)    3/32 (9%)    2/21 (10%) |  6/27 (22%)  11/39 (28%)   9/36 (25%)   8/37 (22%) |
|FIRST INCIDENCE (DAYS) |   626          729 (T)      729 (T)      680       |   400          729 (T)      539          688       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.231      P=0.655      P=0.469      P=0.356    |  P=0.307N     P=0.457N     P=0.475      P=0.342N   |
|INCIDENTAL TUMOR       |  P=0.247      P=0.505      P=0.376      P=0.310    |  P=0.357N     P=0.602N     P=0.301      P=0.459N   |
|LOGISTIC REGRESSION    |  P=0.297      P=0.558      P=0.364      P=0.345    |  P=0.371N     P=0.572      P=0.311      P=0.469N   |
|COCHRAN-ARMITAGE       |  P=0.292                                           |  P=0.451N                                          |
|FISHER EXACT           |               P=0.508      P=0.316      P=0.316    |               P=0.402      P=0.235      P=0.602N   |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05020 TEST: 01                                                 PAGE   8
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PARA-CHLOROANILINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      2 MG/KG      6 MG/KG      18 MG/KG  |   VEHICLE      2 MG/KG      6 MG/KG      18 MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip)                                                                           |
|     Papilloma Squamous or Papilloma                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/49 (4%)    1/50 (2%)    0/50 (0%)    1/50 (2%)  |  2/50 (4%)    0/50 (0%)    1/50 (2%)    0/50 (0%)  |
|ADJUSTED (b)           |   7.9%         3.1%         0.0%         2.6%      |   5.9%         0.0%         2.8%         0.0%      |
|TERMINAL (d)           |  0/18 (0%)    1/32 (3%)    0/32 (0%)    0/21 (0%)  |  0/27 (0%)    0/39 (0%)    1/36 (3%)    0/37 (0%)  |
|FIRST INCIDENCE (DAYS) |   639          729 (T)      ---          659       |   618          ---          729 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.495N     P=0.347N     P=0.170N     P=0.420N   |  P=0.244N     P=0.184N     P=0.423N     P=0.196N   |
|INCIDENTAL TUMOR       |  P=0.467N     P=0.572N     P=0.428N     P=0.500N   |  P=0.268N     P=0.314N     P=0.495N     P=0.284N   |
|LOGISTIC REGRESSION    |  P=0.492N     P=0.439N     P=0.219N     P=0.479N   |  P=0.263N     P=0.235N     P=0.475N     P=0.234N   |
|COCHRAN-ARMITAGE       |  P=0.496N                                          |  P=0.266N                                          |
|FISHER EXACT           |               P=0.492N     P=0.242N     P=0.492N   |               P=0.247N     P=0.500N     P=0.247N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip)                                                                           |
|     Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/49 (4%)    1/50 (2%)    0/50 (0%)    2/50 (4%)  |  2/50 (4%)    0/50 (0%)    1/50 (2%)    0/50 (0%)  |
|ADJUSTED (b)           |   7.9%         3.1%         0.0%         6.5%      |   5.9%         0.0%         2.8%         0.0%      |
|TERMINAL (d)           |  0/18 (0%)    1/32 (3%)    0/32 (0%)    0/21 (0%)  |  0/27 (0%)    0/39 (0%)    1/36 (3%)    0/37 (0%)  |
|FIRST INCIDENCE (DAYS) |   639          729 (T)      ---          659       |   618          ---          729 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.519      P=0.347N     P=0.170N     P=0.602N   |  P=0.244N     P=0.184N     P=0.423N     P=0.196N   |
|INCIDENTAL TUMOR       |  P=0.567      P=0.572N     P=0.428N     P=0.675N   |  P=0.268N     P=0.314N     P=0.495N     P=0.284N   |
|LOGISTIC REGRESSION    |  P=0.524      P=0.439N     P=0.219N     P=0.662N   |  P=0.263N     P=0.235N     P=0.475N     P=0.234N   |
|COCHRAN-ARMITAGE       |  P=0.517                                           |  P=0.266N                                          |
|FISHER EXACT           |               P=0.492N     P=0.242N     P=0.684N   |               P=0.247N     P=0.500N     P=0.247N   |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05020 TEST: 01                                                 PAGE   9
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PARA-CHLOROANILINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      2 MG/KG      6 MG/KG      18 MG/KG  |   VEHICLE      2 MG/KG      6 MG/KG      18 MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Granulosa-Theca Tumor Benign                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  0/50 (0%)    2/15 (13%)   0/15 (0%)    0/49 (0%)  |
|ADJUSTED (b)           |                                                    |   0.0%        20.0%         0.0%         0.0%      |
|TERMINAL (d)           |                                                    |  0/27 (0%)    2/10 (20%)   0/5 (0%)     0/37 (0%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   ---          729 (T)      ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.248N     P=0.061        (e)          (e)      |
|INCIDENTAL TUMOR       |                                                    |  P=0.248N     P=0.061        (e)          (e)      |
|LOGISTIC REGRESSION    |                                                    |  P=0.248N     P=0.061        (e)          (e)      |
|COCHRAN-ARMITAGE       |                                                    |  P=0.315N                                          |
|FISHER EXACT           |                                                    |               P=0.050        (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 20/47 (43%)  13/18 (72%)  11/19 (58%)  11/46 (24%) | 21/50 (42%)  13/33 (39%)  17/35 (49%)  23/50 (46%) |
|ADJUSTED (b)           |  61.4%        82.4%        83.3%        38.7%      |  56.9%        42.9%        53.7%        53.0%      |
|TERMINAL (d)           |  7/18 (39%)   8/10 (80%)   4/5 (80%)    5/20 (25%) | 12/27 (44%)   9/24 (38%)  10/22 (45%)  17/37 (46%) |
|FIRST INCIDENCE (DAYS) |   455          486          498          654       |   482          605          520          511       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.026N*    P=0.179N     P=0.187N     P=0.023N*  |  P=0.529N     P=0.071N     P=0.347N     P=0.294N   |
|INCIDENTAL TUMOR       |  P=0.001N**   P=0.065      P=0.163      P=0.020N*  |  P=0.454      P=0.393N     P=0.483      P=0.576    |
|LOGISTIC REGRESSION    |  P=0.002N**   P=0.048 *    P=0.115      P=0.027N*  |  P=0.466      P=0.353N     P=0.449      P=0.573N   |
|COCHRAN-ARMITAGE       |  P=0.004N**                                        |  P=0.354                                           |
|FISHER EXACT           |               P=0.030 *    P=0.195      P=0.045N*  |               P=0.498N     P=0.352      P=0.420    |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05020 TEST: 01                                                 PAGE  10
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PARA-CHLOROANILINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      2 MG/KG      6 MG/KG      18 MG/KG  |   VEHICLE      2 MG/KG      6 MG/KG      18 MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 20/47 (43%)  13/18 (72%)  12/19 (63%)  11/46 (24%) | 21/50 (42%)  13/33 (39%)  17/35 (49%)  24/50 (48%) |
|ADJUSTED (b)           |  61.4%        82.4%        83.8%        38.7%      |  56.9%        42.9%        53.7%        54.1%      |
|TERMINAL (d)           |  7/18 (39%)   8/10 (80%)   4/5 (80%)    5/20 (25%) | 12/27 (44%)   9/24 (38%)  10/22 (45%)  17/37 (46%) |
|FIRST INCIDENCE (DAYS) |   455          486          498          654       |   482          605          520          511       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.026N*    P=0.179N     P=0.234N     P=0.023N*  |  P=0.477      P=0.071N     P=0.347N     P=0.353N   |
|INCIDENTAL TUMOR       |  P<0.001N**   P=0.065      P=0.076      P=0.020N*  |  P=0.365      P=0.393N     P=0.483      P=0.494    |
|LOGISTIC REGRESSION    |  P=0.002N**   P=0.048 *    P=0.051      P=0.027N*  |  P=0.373      P=0.353N     P=0.449      P=0.507    |
|COCHRAN-ARMITAGE       |  P=0.004N**                                        |  P=0.273                                           |
|FISHER EXACT           |               P=0.030 *    P=0.107      P=0.045N*  |               P=0.498N     P=0.352      P=0.344    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Keratoacanthoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/49 (4%)    1/50 (2%)    1/50 (2%)    1/50 (2%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   9.8%         3.1%         2.8%         4.0%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  1/18 (6%)    1/32 (3%)    0/32 (0%)    0/21 (0%)  |  0/27 (0%)    0/39 (0%)    0/36 (0%)    0/37 (0%)  |
|FIRST INCIDENCE (DAYS) |   709          729 (T)      711          722       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.500N     P=0.317N     P=0.311N     P=0.423N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.428N     P=0.377N     P=0.595N     P=0.424N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.476N     P=0.360N     P=0.402N     P=0.424N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.483N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.492N     P=0.492N     P=0.492N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05020 TEST: 01                                                 PAGE  11
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PARA-CHLOROANILINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      2 MG/KG      6 MG/KG      18 MG/KG  |   VEHICLE      2 MG/KG      6 MG/KG      18 MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma,                                                                |
|     Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/49 (4%)    3/50 (6%)    2/50 (4%)    1/50 (2%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   9.8%         8.9%         5.8%         4.0%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  1/18 (6%)    2/32 (6%)    1/32 (3%)    0/21 (0%)  |  0/27 (0%)    0/39 (0%)    0/36 (0%)    0/37 (0%)  |
|FIRST INCIDENCE (DAYS) |   709          693          711          722       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.315N     P=0.634N     P=0.479N     P=0.423N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.258N     P=0.640      P=0.684      P=0.424N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.285N     P=0.658      P=0.578N     P=0.424N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.298N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.510      P=0.684N     P=0.492N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/49 (6%)    2/50 (4%)    1/50 (2%)    4/50 (8%)  |  2/50 (4%)    2/50 (4%)    0/50 (0%)    2/50 (4%)  |
|ADJUSTED (b)           |  13.2%         5.2%         3.1%        14.7%      |   7.4%         4.6%         0.0%         4.7%      |
|TERMINAL (d)           |  1/18 (6%)    1/32 (3%)    1/32 (3%)    2/21 (10%) |  2/27 (7%)    1/39 (3%)    0/36 (0%)    1/37 (3%)  |
|FIRST INCIDENCE (DAYS) |   680          626          729 (T)      676       |   729 (T)      605          ---          529       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.277      P=0.314N     P=0.150N     P=0.605    |  P=0.617N     P=0.569N     P=0.177N     P=0.594N   |
|INCIDENTAL TUMOR       |  P=0.340      P=0.510N     P=0.316N     P=0.614    |  P=0.635      P=0.659N     P=0.177N     P=0.686N   |
|LOGISTIC REGRESSION    |  P=0.318      P=0.425N     P=0.222N     P=0.584    |  P=0.611      P=0.651N     P=0.177N     P=0.679N   |
|COCHRAN-ARMITAGE       |  P=0.310                                           |  P=0.617                                           |
|FISHER EXACT           |               P=0.490N     P=0.301N     P=0.511    |               P=0.691N     P=0.247N     P=0.691N   |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05020 TEST: 01                                                 PAGE  12
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PARA-CHLOROANILINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      2 MG/KG      6 MG/KG      18 MG/KG  |   VEHICLE      2 MG/KG      6 MG/KG      18 MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibrosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/49 (2%)    2/50 (4%)    1/50 (2%)    0/50 (0%)  |  0/50 (0%)    1/50 (2%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   5.6%         4.9%         2.0%         0.0%      |   0.0%         2.3%         0.0%         0.0%      |
|TERMINAL (d)           |  1/18 (6%)    0/32 (0%)    0/32 (0%)    0/21 (0%)  |  0/27 (0%)    0/39 (0%)    0/36 (0%)    0/37 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      654          361          ---       |   ---          688          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.225N     P=0.637      P=0.690N     P=0.469N   |  P=0.570N     P=0.570        (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.279N     P=0.549      P=0.749N     P=0.469N   |  P=0.652N     P=0.500        (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.264N     P=0.537      P=0.714      P=0.469N   |  P=0.582N     P=0.518        (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.232N                                          |  P=0.585N                                          |
|FISHER EXACT           |               P=0.508      P=0.747N     P=0.495N   |               P=0.500        (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibroma or Fibroma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/49 (6%)    2/50 (4%)    1/50 (2%)    4/50 (8%)  |  2/50 (4%)    3/50 (6%)    0/50 (0%)    2/50 (4%)  |
|ADJUSTED (b)           |  13.2%         5.2%         3.1%        14.7%      |   7.4%         6.8%         0.0%         4.7%      |
|TERMINAL (d)           |  1/18 (6%)    1/32 (3%)    1/32 (3%)    2/21 (10%) |  2/27 (7%)    1/39 (3%)    0/36 (0%)    1/37 (3%)  |
|FIRST INCIDENCE (DAYS) |   680          626          729 (T)      676       |   729 (T)      605          ---          529       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.277      P=0.314N     P=0.150N     P=0.605    |  P=0.507N     P=0.647      P=0.177N     P=0.594N   |
|INCIDENTAL TUMOR       |  P=0.340      P=0.510N     P=0.316N     P=0.614    |  P=0.557N     P=0.539      P=0.177N     P=0.686N   |
|LOGISTIC REGRESSION    |  P=0.318      P=0.425N     P=0.222N     P=0.584    |  P=0.560N     P=0.559      P=0.177N     P=0.679N   |
|COCHRAN-ARMITAGE       |  P=0.310                                           |  P=0.555N                                          |
|FISHER EXACT           |               P=0.490N     P=0.301N     P=0.511    |               P=0.500      P=0.247N     P=0.691N   |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05020 TEST: 01                                                 PAGE  13
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PARA-CHLOROANILINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      2 MG/KG      6 MG/KG      18 MG/KG  |   VEHICLE      2 MG/KG      6 MG/KG      18 MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,                                                                                   |
|     Neurofibroma, or Fibroma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/49 (8%)    4/50 (8%)    2/50 (4%)    4/50 (8%)  |  2/50 (4%)    4/50 (8%)    0/50 (0%)    3/50 (6%)  |
|ADJUSTED (b)           |  18.3%         9.8%         5.1%        14.7%      |   7.4%         8.9%         0.0%         7.1%      |
|TERMINAL (d)           |  2/18 (11%)   1/32 (3%)    1/32 (3%)    2/21 (10%) |  2/27 (7%)    1/39 (3%)    0/36 (0%)    1/37 (3%)  |
|FIRST INCIDENCE (DAYS) |   680          626          361          676       |   729 (T)      605          ---          529       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.566      P=0.407N     P=0.164N     P=0.533N   |  P=0.600      P=0.500      P=0.177N     P=0.621    |
|INCIDENTAL TUMOR       |  P=0.572      P=0.626N     P=0.336N     P=0.529N   |  P=0.503      P=0.369      P=0.177N     P=0.476    |
|LOGISTIC REGRESSION    |  P=0.586      P=0.568N     P=0.328N     P=0.553N   |  P=0.544      P=0.390      P=0.177N     P=0.521    |
|COCHRAN-ARMITAGE       |  P=0.586                                           |  P=0.549                                           |
|FISHER EXACT           |               P=0.631N     P=0.329N     P=0.631N   |               P=0.339      P=0.247N     P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, or Sarcoma                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/49 (2%)    2/50 (4%)    1/50 (2%)    0/50 (0%)  |  0/50 (0%)    1/50 (2%)    0/50 (0%)    1/50 (2%)  |
|ADJUSTED (b)           |   5.6%         4.9%         2.0%         0.0%      |   0.0%         2.3%         0.0%         2.4%      |
|TERMINAL (d)           |  1/18 (6%)    0/32 (0%)    0/32 (0%)    0/21 (0%)  |  0/27 (0%)    0/39 (0%)    0/36 (0%)    0/37 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      654          361          ---       |   ---          688          ---          665       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.225N     P=0.637      P=0.690N     P=0.469N   |  P=0.484      P=0.570        (e)        P=0.556    |
|INCIDENTAL TUMOR       |  P=0.279N     P=0.549      P=0.749N     P=0.469N   |  P=0.363      P=0.500        (e)        P=0.419    |
|LOGISTIC REGRESSION    |  P=0.264N     P=0.537      P=0.714      P=0.469N   |  P=0.456      P=0.518        (e)        P=0.500    |
|COCHRAN-ARMITAGE       |  P=0.232N                                          |  P=0.459                                           |
|FISHER EXACT           |               P=0.508      P=0.747N     P=0.495N   |               P=0.500        (e)        P=0.500    |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05020 TEST: 01                                                 PAGE  14
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PARA-CHLOROANILINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      2 MG/KG      6 MG/KG      18 MG/KG  |   VEHICLE      2 MG/KG      6 MG/KG      18 MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Spleen                                                                                                                           |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/49 (0%)    0/50 (0%)    0/50 (0%)    2/50 (4%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         7.6%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/18 (0%)    0/32 (0%)    0/32 (0%)    1/21 (5%)  |  0/27 (0%)    0/39 (0%)    0/36 (0%)    0/37 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          680       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.032 *      (e)          (e)        P=0.279    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.053        (e)          (e)        P=0.285    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.042 *      (e)          (e)        P=0.271    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.042 *                                         |    (e)                                             |
|FISHER EXACT           |                 (e)          (e)        P=0.253    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Spleen                                                                                                                           |
|     Fibrosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/49 (0%)    1/50 (2%)    2/50 (4%)   17/50 (34%) |  0/50 (0%)    0/50 (0%)    1/50 (2%)    0/50 (0%)  |
|ADJUSTED (b)           |   0.0%         2.7%         5.7%        47.1%      |   0.0%         0.0%         2.8%         0.0%      |
|TERMINAL (d)           |  0/18 (0%)    0/32 (0%)    1/32 (3%)    5/21 (24%) |  0/27 (0%)    0/39 (0%)    1/36 (3%)    0/37 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          687          702          522       |   ---          ---          729 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.570      P=0.364      P<0.001 ** |  P=0.767N       (e)        P=0.557        (e)      |
|INCIDENTAL TUMOR       |  P<0.001 **   P=0.485      P=0.217      P<0.001 ** |  P=0.767N       (e)        P=0.557        (e)      |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.523      P=0.293      P<0.001 ** |  P=0.767N       (e)        P=0.557        (e)      |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P=0.785N                                          |
|FISHER EXACT           |               P=0.505      P=0.253      P<0.001 ** |                 (e)        P=0.500        (e)      |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05020 TEST: 01                                                 PAGE  15
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PARA-CHLOROANILINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      2 MG/KG      6 MG/KG      18 MG/KG  |   VEHICLE      2 MG/KG      6 MG/KG      18 MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Spleen                                                                                                                           |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/49 (0%)    0/50 (0%)    0/50 (0%)    4/50 (8%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%        12.0%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/18 (0%)    0/32 (0%)    0/32 (0%)    0/21 (0%)  |  0/27 (0%)    0/39 (0%)    0/36 (0%)    0/37 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          618       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.002 **     (e)          (e)        P=0.095    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.005 **     (e)          (e)        P=0.045 *  |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.002 **     (e)          (e)        P=0.068    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.002 **                                        |    (e)                                             |
|FISHER EXACT           |                 (e)          (e)        P=0.061    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Spleen                                                                                                                           |
|     Osteosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/49 (0%)    0/50 (0%)    1/50 (2%)   19/50 (38%) |  0/50 (0%)    0/50 (0%)    0/50 (0%)    1/50 (2%)  |
|ADJUSTED (b)           |   0.0%         0.0%         3.1%        62.8%      |   0.0%         0.0%         0.0%         2.7%      |
|TERMINAL (d)           |  0/18 (0%)    0/32 (0%)    1/32 (3%)   11/21 (52%) |  0/27 (0%)    0/39 (0%)    0/36 (0%)    1/37 (3%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          729 (T)      494       |   ---          ---          ---          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **     (e)        P=0.615      P<0.001 ** |  P=0.233        (e)          (e)        P=0.563    |
|INCIDENTAL TUMOR       |  P<0.001 **     (e)        P=0.615      P<0.001 ** |  P=0.233        (e)          (e)        P=0.563    |
|LOGISTIC REGRESSION    |  P<0.001 **     (e)        P=0.615      P<0.001 ** |  P=0.233        (e)          (e)        P=0.563    |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P=0.215                                           |
|FISHER EXACT           |                 (e)        P=0.505      P<0.001 ** |                 (e)          (e)        P=0.500    |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05020 TEST: 01                                                 PAGE  16
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PARA-CHLOROANILINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      2 MG/KG      6 MG/KG      18 MG/KG  |   VEHICLE      2 MG/KG      6 MG/KG      18 MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 36/49 (73%)  44/46 (96%)  44/50 (88%)  46/50 (92%) |                                                    |
|ADJUSTED (b)           |  94.4%       100.0%       100.0%       100.0%      |                                                    |
|TERMINAL (d)           | 16/18 (89%)  30/30 (100%) 32/32 (100%) 21/21 (100%)|                                                    |
|FIRST INCIDENCE (DAYS) |   466          556          476          415       |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.064      P=0.096N     P=0.064N     P=0.376    |                                                    |
|INCIDENTAL TUMOR       |  P=0.056      P=0.045 *    P=0.088      P=0.029 *  |                                                    |
|LOGISTIC REGRESSION    |  P=0.082      P=0.059      P=0.084      P=0.048 *  |                                                    |
|COCHRAN-ARMITAGE       |  P=0.073                                           |                                                    |
|FISHER EXACT           |               P=0.003 **   P=0.056      P=0.014 *  |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  9/48 (19%)   2/8 (25%)    0/10 (0%)    9/45 (20%) |  5/49 (10%)   0/6 (0%)     1/11 (9%)    5/48 (10%) |
|ADJUSTED (b)           |  43.5%        66.7%         0.0%        36.1%      |  16.9%         0.0%         2.1%        13.5%      |
|TERMINAL (d)           |  7/18 (39%)   2/3 (67%)    0/0          6/21 (29%) |  4/27 (15%)   0/0          0/1 (0%)     5/37 (14%) |
|FIRST INCIDENCE (DAYS) |   554          729 (T)      ---          686       |   537          ---          553          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.527N     P=0.520N     P=0.180N     P=0.440N   |  P=0.434N     P=0.469N     P=0.635N     P=0.436N   |
|INCIDENTAL TUMOR       |  P=0.422N     P=0.507      P=0.682N     P=0.536N   |  P=0.458N     P=0.872N     P=0.708      P=0.499N   |
|LOGISTIC REGRESSION    |  P=0.383N     P=0.377      P=0.872N     P=0.507N   |  P=0.533N     P=0.608N     P=0.702      P=0.541N   |
|COCHRAN-ARMITAGE       |  P=0.496                                           |  P=0.513                                           |
|FISHER EXACT           |               P=0.497      P=0.157N     P=0.543    |               P=0.548N     P=0.698N     P=0.617    |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05020 TEST: 01                                                 PAGE  17
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PARA-CHLOROANILINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      2 MG/KG      6 MG/KG      18 MG/KG  |   VEHICLE      2 MG/KG      6 MG/KG      18 MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 10/48 (21%)   3/8 (38%)    0/10 (0%)    9/45 (20%) |  6/49 (12%)   0/6 (0%)     2/11 (18%)   6/48 (13%) |
|ADJUSTED (b)           |  45.0%       100.0%         0.0%        36.1%      |  19.7%         0.0%       100.0%        16.2%      |
|TERMINAL (d)           |  7/18 (39%)   3/3 (100%)   0/0          6/21 (29%) |  4/27 (15%)   0/0          1/1 (100%)   6/37 (16%) |
|FIRST INCIDENCE (DAYS) |   554          729 (T)      ---          686       |   537          ---          553          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.365N     P=0.619N     P=0.091N     P=0.341N   |  P=0.396N     P=0.187N     P=0.631      P=0.410N   |
|INCIDENTAL TUMOR       |  P=0.288N     P=0.271      P=0.454N     P=0.465N   |  P=0.432N     P=0.685N     P=0.228      P=0.521N   |
|LOGISTIC REGRESSION    |  P=0.244N     P=0.136      P=0.665N     P=0.422N   |  P=0.462N     P=0.567N     P=0.321      P=0.515N   |
|COCHRAN-ARMITAGE       |  P=0.482N                                          |  P=0.523                                           |
|FISHER EXACT           |               P=0.268      P=0.125N     P=0.563N   |               P=0.482N     P=0.454      P=0.606    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/48 (0%)    2/8 (25%)    0/10 (0%)    0/45 (0%)  |  0/49 (0%)    0/6 (0%)     0/11 (0%)    1/48 (2%)  |
|ADJUSTED (b)           |   0.0%        34.7%         0.0%         0.0%      |   0.0%         0.0%         0.0%         2.1%      |
|TERMINAL (d)           |  0/18 (0%)    1/3 (33%)    0/0          0/21 (0%)  |  0/27 (0%)    0/0          0/1 (0%)     0/37 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          486          ---          ---       |   ---          ---          ---          529       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.306N     P=0.088        (e)          (e)      |  P=0.225        (e)          (e)        P=0.527    |
|INCIDENTAL TUMOR       |  P=0.273N     P=0.041 *      (e)          (e)      |  P=0.177        (e)          (e)        P=0.331    |
|LOGISTIC REGRESSION    |  P=0.328N     P=0.008 **     (e)          (e)      |  P=0.207        (e)          (e)        P=0.367    |
|COCHRAN-ARMITAGE       |  P=0.307N                                          |  P=0.329                                           |
|FISHER EXACT           |               P=0.018 *      (e)          (e)      |                 (e)          (e)        P=0.495    |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05020 TEST: 01                                                 PAGE  18
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PARA-CHLOROANILINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      2 MG/KG      6 MG/KG      18 MG/KG  |   VEHICLE      2 MG/KG      6 MG/KG      18 MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Tongue                                                                                                                           |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/49 (4%)    1/50 (2%)    0/50 (0%)    1/50 (2%)  |  2/50 (4%)    0/50 (0%)    1/50 (2%)    0/50 (0%)  |
|ADJUSTED (b)           |   7.9%         3.1%         0.0%         2.6%      |   5.9%         0.0%         2.8%         0.0%      |
|TERMINAL (d)           |  0/18 (0%)    1/32 (3%)    0/32 (0%)    0/21 (0%)  |  0/27 (0%)    0/39 (0%)    1/36 (3%)    0/37 (0%)  |
|FIRST INCIDENCE (DAYS) |   639          729 (T)      ---          659       |   618          ---          729 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.495N     P=0.347N     P=0.170N     P=0.420N   |  P=0.244N     P=0.184N     P=0.423N     P=0.196N   |
|INCIDENTAL TUMOR       |  P=0.467N     P=0.572N     P=0.428N     P=0.500N   |  P=0.268N     P=0.314N     P=0.495N     P=0.284N   |
|LOGISTIC REGRESSION    |  P=0.492N     P=0.439N     P=0.219N     P=0.479N   |  P=0.263N     P=0.235N     P=0.475N     P=0.234N   |
|COCHRAN-ARMITAGE       |  P=0.496N                                          |  P=0.266N                                          |
|FISHER EXACT           |               P=0.492N     P=0.242N     P=0.492N   |               P=0.247N     P=0.500N     P=0.247N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  5/50 (10%)   6/50 (12%)   7/50 (14%)   6/50 (12%) |
|ADJUSTED (b)           |                                                    |  15.0%        14.5%        16.1%        16.2%      |
|TERMINAL (d)           |                                                    |  2/27 (7%)    4/39 (10%)   3/36 (8%)    6/37 (16%) |
|FIRST INCIDENCE (DAYS) |                                                    |   529          693          332          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.548N     P=0.528N     P=0.529      P=0.560N   |
|INCIDENTAL TUMOR       |                                                    |  P=0.484      P=0.501      P=0.335      P=0.583    |
|LOGISTIC REGRESSION    |                                                    |  P=0.497      P=0.586      P=0.304      P=0.597    |
|COCHRAN-ARMITAGE       |                                                    |  P=0.500                                           |
|FISHER EXACT           |                                                    |               P=0.500      P=0.380      P=0.500    |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05020 TEST: 01                                                 PAGE  19
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PARA-CHLOROANILINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      2 MG/KG      6 MG/KG      18 MG/KG  |   VEHICLE      2 MG/KG      6 MG/KG      18 MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Zymbal's Gland                                                                                                                   |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/49 (0%)    0/50 (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%         4.9%         0.0%         0.0%      |
|TERMINAL (d)           |  0/18 (0%)    0/32 (0%)    0/32 (0%)    0/21 (0%)  |  0/27 (0%)    1/39 (3%)    0/36 (0%)    0/37 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   ---          723          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.354N     P=0.325        (e)          (e)      |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.406N     P=0.280        (e)          (e)      |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.361N     P=0.310        (e)          (e)      |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.380N                                          |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.247        (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/49 (0%)    0/50 (0%)    0/50 (0%)    4/50 (8%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%        12.0%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/18 (0%)    0/32 (0%)    0/32 (0%)    0/21 (0%)  |  0/27 (0%)    0/39 (0%)    0/36 (0%)    0/37 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          618       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.002 **     (e)          (e)        P=0.095    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.005 **     (e)          (e)        P=0.045 *  |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.002 **     (e)          (e)        P=0.068    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.002 **                                        |    (e)                                             |
|FISHER EXACT           |                 (e)          (e)        P=0.061    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05020 TEST: 01                                                 PAGE  20
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PARA-CHLOROANILINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      2 MG/KG      6 MG/KG      18 MG/KG  |   VEHICLE      2 MG/KG      6 MG/KG      18 MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Leukemia: Lymphocytic, Monocytic, Mononuclear,                                                                              |
|     or Undifferentiated                                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 21/49 (43%)   3/50 (6%)    2/50 (4%)    3/50 (6%)  | 10/50 (20%)   2/50 (4%)    1/50 (2%)    1/50 (2%)  |
|ADJUSTED (b)           |  59.7%         8.7%         5.2%         9.8%      |  27.2%         4.6%         2.6%         2.7%      |
|TERMINAL (d)           |  5/18 (28%)   2/32 (6%)    1/32 (3%)    1/21 (5%)  |  2/27 (7%)    0/39 (0%)    0/36 (0%)    1/37 (3%)  |
|FIRST INCIDENCE (DAYS) |   466          674          498          615       |   529          617          711          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.001N**   P<0.001N**   P<0.001N**   P<0.001N** |  P=0.010N**   P=0.005N**   P=0.003N**   P=0.002N** |
|INCIDENTAL TUMOR       |  P<0.001N**   P<0.001N**   P<0.001N**   P<0.001N** |  P=0.018N*    P=0.029N*    P=0.010N**   P=0.009N** |
|LOGISTIC REGRESSION    |  P<0.001N**   P<0.001N**   P<0.001N**   P<0.001N** |  P=0.013N*    P=0.015N*    P=0.004N**   P=0.004N** |
|COCHRAN-ARMITAGE       |  P<0.001N**                                        |  P=0.012N*                                         |
|FISHER EXACT           |               P<0.001N**   P<0.001N**   P<0.001N** |               P=0.014N*    P=0.004N**   P=0.004N** |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Mesothelioma Benign, Malignant, NOS                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/49 (2%)    3/50 (6%)    1/50 (2%)    2/50 (4%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   3.0%         8.0%         2.9%         7.1%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/18 (0%)    1/32 (3%)    0/32 (0%)    1/21 (5%)  |  0/27 (0%)    0/39 (0%)    0/36 (0%)    0/37 (0%)  |
|FIRST INCIDENCE (DAYS) |   639          651          716          624       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.570      P=0.478      P=0.679N     P=0.543    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.602      P=0.240      P=0.572      P=0.399    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.587      P=0.333      P=0.749N     P=0.512    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.581                                           |    (e)                                             |
|FISHER EXACT           |               P=0.316      P=0.747N     P=0.508    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05020 TEST: 01                                                 PAGE  21
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PARA-CHLOROANILINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      2 MG/KG      6 MG/KG      18 MG/KG  |   VEHICLE      2 MG/KG      6 MG/KG      18 MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Osteosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/49 (2%)    1/50 (2%)    1/50 (2%)   19/50 (38%) |  0/50 (0%)    0/50 (0%)    1/50 (2%)    1/50 (2%)  |
|ADJUSTED (b)           |   2.8%         2.0%         3.1%        62.8%      |   0.0%         0.0%         2.7%         2.7%      |
|TERMINAL (d)           |  0/18 (0%)    0/32 (0%)    1/32 (3%)   11/21 (52%) |  0/27 (0%)    0/39 (0%)    0/36 (0%)    1/37 (3%)  |
|FIRST INCIDENCE (DAYS) |   628          529          729 (T)      494       |   ---          ---          721          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.718N     P=0.688N     P<0.001 ** |  P=0.329        (e)        P=0.549      P=0.563    |
|INCIDENTAL TUMOR       |  P<0.001 **   P=0.540      P=0.741      P<0.001 ** |  P=0.277        (e)        P=0.419      P=0.563    |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.687      P=0.749N     P<0.001 ** |  P=0.323        (e)        P=0.540      P=0.563    |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P=0.305                                           |
|FISHER EXACT           |               P=0.747N     P=0.747N     P<0.001 ** |                 (e)        P=0.500      P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Osteosarcoma or Osteoma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/49 (2%)    1/50 (2%)    1/50 (2%)   19/50 (38%) |  0/50 (0%)    0/50 (0%)    1/50 (2%)    1/50 (2%)  |
|ADJUSTED (b)           |   2.8%         2.0%         3.1%        62.8%      |   0.0%         0.0%         2.7%         2.7%      |
|TERMINAL (d)           |  0/18 (0%)    0/32 (0%)    1/32 (3%)   11/21 (52%) |  0/27 (0%)    0/39 (0%)    0/36 (0%)    1/37 (3%)  |
|FIRST INCIDENCE (DAYS) |   628          529          729 (T)      494       |   ---          ---          721          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.718N     P=0.688N     P<0.001 ** |  P=0.329        (e)        P=0.549      P=0.563    |
|INCIDENTAL TUMOR       |  P<0.001 **   P=0.540      P=0.741      P<0.001 ** |  P=0.277        (e)        P=0.419      P=0.563    |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.687      P=0.749N     P<0.001 ** |  P=0.323        (e)        P=0.540      P=0.563    |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P=0.305                                           |
|FISHER EXACT           |               P=0.747N     P=0.747N     P<0.001 ** |                 (e)        P=0.500      P=0.500    |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05020 TEST: 01                                                 PAGE  22
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PARA-CHLOROANILINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      2 MG/KG      6 MG/KG      18 MG/KG  |   VEHICLE      2 MG/KG      6 MG/KG      18 MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 44/49 (90%)  49/50 (98%)  47/50 (94%)  47/50 (94%) | 32/50 (64%)  27/50 (54%)  31/50 (62%)  36/50 (72%) |
|ADJUSTED (b)           | 100.0%        98.0%       100.0%       100.0%      |  79.3%        61.2%        64.2%        78.0%      |
|TERMINAL (d)           | 18/18 (100%) 31/32 (97%)  32/32 (100%) 21/21 (100%)| 19/27 (70%)  22/39 (56%)  19/36 (53%)  27/37 (73%) |
|FIRST INCIDENCE (DAYS) |   455          486          476          415       |   400          605          332          511       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.305      P=0.016N*    P=0.009N**   P=0.309N   |  P=0.374      P=0.009N**   P=0.119N     P=0.237N   |
|INCIDENTAL TUMOR       |  P=0.352N     P=0.572      P=0.700N     P=0.541N   |  P=0.163      P=0.100N     P=0.369N     P=0.517    |
|LOGISTIC REGRESSION    |  P=0.445N     P=0.548      P=0.576      P=0.564N   |  P=0.178      P=0.064N     P=0.384N     P=0.490    |
|COCHRAN-ARMITAGE       |  P=0.527                                           |  P=0.093                                           |
|FISHER EXACT           |               P=0.098      P=0.346      P=0.346    |               P=0.208N     P=0.500N     P=0.260    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 28/49 (57%)  14/50 (28%)  13/50 (26%)  43/50 (86%) | 10/50 (20%)   6/50 (12%)   4/50 (8%)    6/50 (12%) |
|ADJUSTED (b)           |  70.7%        31.7%        30.8%        91.4%      |  27.2%        13.7%        10.5%        14.8%      |
|TERMINAL (d)           |  7/18 (39%)   4/32 (13%)   5/32 (16%)  17/21 (81%) |  2/27 (7%)    2/39 (5%)    2/36 (6%)    3/37 (8%)  |
|FIRST INCIDENCE (DAYS) |   330          486          338          494       |   529          617          711          644       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P<0.001N**   P<0.001N**   P=0.145    |  P=0.223N     P=0.082N     P=0.038N*    P=0.103N   |
|INCIDENTAL TUMOR       |  P<0.001 **   P=0.007N**   P=0.019N*    P=0.002 ** |  P=0.384N     P=0.300N     P=0.136N     P=0.310N   |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.006N**   P=0.002N**   P=0.003 ** |  P=0.230N     P=0.184N     P=0.059N     P=0.182N   |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P=0.284N                                          |
|FISHER EXACT           |               P=0.003N**   P=0.002N**   P=0.001 ** |               P=0.207N     P=0.074N     P=0.207N   |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05020 TEST: 01                                                 PAGE  23
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PARA-CHLOROANILINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      2 MG/KG      6 MG/KG      18 MG/KG  |   VEHICLE      2 MG/KG      6 MG/KG      18 MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 46/49 (94%)  49/50 (98%)  49/50 (98%)  49/50 (98%) | 37/50 (74%)  30/50 (60%)  34/50 (68%)  40/50 (80%) |
|ADJUSTED (b)           | 100.0%        98.0%       100.0%       100.0%      |  84.1%        63.8%        69.2%        83.3%      |
|TERMINAL (d)           | 18/18 (100%) 31/32 (97%)  32/32 (100%) 21/21 (100%)| 20/27 (74%)  22/39 (56%)  21/36 (58%)  29/37 (78%) |
|FIRST INCIDENCE (DAYS) |   330          486          338          415       |   400          605          332          511       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.269      P=0.008N**   P=0.011N*    P=0.305N   |  P=0.417      P=0.004N**   P=0.059N     P=0.155N   |
|INCIDENTAL TUMOR       |  P=0.535      P=0.719N     P=0.560      P=0.733N   |  P=0.123      P=0.047N*    P=0.267N     P=0.547    |
|LOGISTIC REGRESSION    |  P=0.580      P=0.708N     P=0.567      P=0.734N   |  P=0.190      P=0.051N     P=0.188N     P=0.572N   |
|COCHRAN-ARMITAGE       |  P=0.335                                           |  P=0.086                                           |
|FISHER EXACT           |               P=0.301      P=0.301      P=0.301    |               P=0.101N     P=0.330N     P=0.318    |
|=================================================================================================================================|
 
 (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).