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TDMS Study 05093-01 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                  P-NITROANILINE                                    DATE: 09/12/94       
EXPERIMENT: 05093 TEST: 01                                                                                     TIME: 21:32:08       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-45038          ROUTE: GAVAGE                                                                      NTP C#: 60786B       
PATHOLOGIST: H. GILES                        S. EUSTIS                                                         CAS: 100-01-6        
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08    
LAB: Southern Research Inst                                  P-NITROANILINE                                    DATE: 09/12/94      
EXPERIMENT: 05093 TEST: 01                                                                                     TIME: 21:32:08      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01-ES-45038          ROUTE: GAVAGE                                                                      NTP C#: 60786B      
PATHOLOGIST: H. GILES                        S. EUSTIS                                                         CAS: 100-01-6       
 
 
 
 
 
                                                    MICE(B6C3F1)
                                              ----------------------------
             FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
             IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
 
 
                                                    ----------------
 
                                                    Adrenal Gland
                                                    Bone Marrow
                                                    Brain
                                                    Clitoral Gland
                                                    Epididymis
                                                    Gallbladder
                                                    Heart
                                                    Islets, Pancreatic
                                                    Kidney
                                                    Liver
                                                    Lung
                                                    Nose
                                                    Ovary
                                                    Pancreas
                                                    Parathyroid Gland
                                                    Pituitary Gland
                                                    Preputial Gland
                                                    Prostate
                                                    Salivary Glands
                                                    Spleen
                                                    Testes
                                                    Thymus
                                                    Thyroid Gland
                                                    Urinary Bladder
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                  P-NITROANILINE                                    DATE: 09/12/94       
EXPERIMENT: 05093 TEST: 01                                                                                     TIME: 21:32:08       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-45038          ROUTE: GAVAGE                                                                      NTP C#: 60786B       
PATHOLOGIST: H. GILES                        S. EUSTIS                                                         CAS: 100-01-6        
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                         IN THE ANALYSIS OF THE STUDY OF P-NITROANILINE
 
              ====================================================================================================
 
                                                           MALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Liver                         Hemangiosarcoma
                                                           Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma or Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
                             Spleen                        Hemangiosarcoma
                             All Organs                    Hemangiosarcoma
                                                           Hemangiosarcoma or Hemangioma
                                                           Malignant Lymphoma And Histiocytic Sarcoma
                                                           Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,
                                                            NOS, or Undifferentiated Cell Type
                                                           Benign Tumors
                                                           Malignant Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
 
                                                           FEMALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             All Organs                    Malignant Lymphoma And Histiocytic Sarcoma
                                                           Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,
                                                            NOS, or Undifferentiated Cell Type
                                                           Malignant Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
         DATE: 09/12/94                     EXPERIMENT: 05093 TEST: 01                                                 PAGE   1
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- P-NITROANILINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      3 MG/KG      30 MG/KG     100MG/KG  |   VEHICLE      3 MG/KG      30 MG/KG     100MG/KG  |
|                       |   15 SSAC      15 SSAC      15 SSAC      15 SSAC   |   15 SSAC      15 SSAC      15 SSAC      15 SSAC   |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/70 (1%)    0/70 (0%)    1/70 (1%)    1/70 (1%)  |  0/70 (0%)    1/70 (1%)    2/70 (3%)    0/70 (0%)  |
|ADJUSTED (b)           |   2.5%         0.0%         2.8%         2.6%      |   0.0%         2.4%         6.3%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/9 (0%)     0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/9 (0%)     0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  0/33 (0%)    0/32 (0%)    1/36 (3%)    1/39 (3%)  |  0/29 (0%)    1/41 (2%)    2/32 (6%)    0/32 (0%)  |
|FIRST INCIDENCE (DAYS) |   721          ---          729 (T)      729 (T)   |   ---          729 (T)      729 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.572      P=0.538N     P=0.756N     P=0.736N   |  P=0.513N     P=0.569      P=0.260        (e)      |
|INCIDENTAL TUMOR       |  P=0.538      P=0.500N     P=0.727      P=0.752    |  P=0.513N     P=0.569      P=0.260        (e)      |
|LOGISTIC REGRESSION    |  P=0.562      P=0.517N     P=0.761      P=0.748N   |  P=0.513N     P=0.569      P=0.260        (e)      |
|COCHRAN-ARMITAGE       |  P=0.527                                           |  P=0.490N                                          |
|FISHER EXACT           |               P=0.500N     P=0.752N     P=0.752N   |               P=0.500      P=0.248        (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/70 (1%)    0/70 (0%)    2/70 (3%)    1/70 (1%)  |  1/70 (1%)    1/70 (1%)    2/70 (3%)    0/70 (0%)  |
|ADJUSTED (b)           |   2.5%         0.0%         5.0%         2.6%      |   3.4%         2.4%         6.3%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/9 (0%)     0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/9 (0%)     0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  0/33 (0%)    0/32 (0%)    1/36 (3%)    1/39 (3%)  |  1/29 (3%)    1/41 (2%)    2/32 (6%)    0/32 (0%)  |
|FIRST INCIDENCE (DAYS) |   721          ---          631          729 (T)   |   729 (T)      729 (T)      729 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.585      P=0.538N     P=0.504      P=0.736N   |  P=0.352N     P=0.683N     P=0.535      P=0.480N   |
|INCIDENTAL TUMOR       |  P=0.489      P=0.500N     P=0.464      P=0.752    |  P=0.352N     P=0.683N     P=0.535      P=0.480N   |
|LOGISTIC REGRESSION    |  P=0.559      P=0.517N     P=0.496      P=0.748N   |  P=0.352N     P=0.683N     P=0.535      P=0.480N   |
|COCHRAN-ARMITAGE       |  P=0.539                                           |  P=0.331N                                          |
|FISHER EXACT           |               P=0.500N     P=0.500      P=0.752N   |               P=0.752N     P=0.500      P=0.500N   |
|=================================================================================================================================|
 
         DATE: 09/12/94                     EXPERIMENT: 05093 TEST: 01                                                 PAGE   2
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- P-NITROANILINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      3 MG/KG      30 MG/KG     100MG/KG  |   VEHICLE      3 MG/KG      30 MG/KG     100MG/KG  |
|                       |   15 SSAC      15 SSAC      15 SSAC      15 SSAC   |   15 SSAC      15 SSAC      15 SSAC      15 SSAC   |
|=================================================================================================================================|
|                                                                                                                                 |
|Bone Marrow                                                                                                                      |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/70 (1%)    0/70 (0%)    1/70 (1%)    2/70 (3%)  |  0/70 (0%)    0/70 (0%)    1/70 (1%)    0/70 (0%)  |
|ADJUSTED (b)           |   2.4%         0.0%         2.8%         4.7%      |   0.0%         0.0%         2.3%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/9 (0%)     0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/9 (0%)     0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  0/33 (0%)    0/32 (0%)    1/36 (3%)    1/39 (3%)  |  0/29 (0%)    0/41 (0%)    0/32 (0%)    0/32 (0%)  |
|FIRST INCIDENCE (DAYS) |   667          ---          729 (T)      656       |   ---          ---          654          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.260      P=0.520N     P=0.751N     P=0.533    |  P=0.778N       (e)        P=0.525        (e)      |
|INCIDENTAL TUMOR       |  P=0.212      P=0.500N     P=0.727      P=0.461    |  P=0.701N       (e)        P=0.540        (e)      |
|LOGISTIC REGRESSION    |  P=0.234      P=0.504N     P=0.760      P=0.510    |  P=0.783N       (e)        P=0.505        (e)      |
|COCHRAN-ARMITAGE       |  P=0.219                                           |  P=0.785N                                          |
|FISHER EXACT           |               P=0.500N     P=0.752N     P=0.500    |                 (e)        P=0.500        (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Ear                                                                                                                              |
|     Fibrosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/70 (1%)    0/70 (0%)    2/70 (3%)    0/70 (0%)  |  0/70 (0%)    0/70 (0%)    0/70 (0%)    0/70 (0%)  |
|ADJUSTED (b)           |   3.0%         0.0%         5.6%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/9 (0%)     0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/9 (0%)     0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  1/33 (3%)    0/32 (0%)    2/36 (6%)    0/39 (0%)  |  0/29 (0%)    0/41 (0%)    0/32 (0%)    0/32 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      ---          729 (T)      ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.423N     P=0.506N     P=0.530      P=0.467N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.423N     P=0.506N     P=0.530      P=0.467N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.423N     P=0.506N     P=0.530      P=0.467N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.473N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.500N     P=0.500      P=0.500N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
 
         DATE: 09/12/94                     EXPERIMENT: 05093 TEST: 01                                                 PAGE   3
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- P-NITROANILINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      3 MG/KG      30 MG/KG     100MG/KG  |   VEHICLE      3 MG/KG      30 MG/KG     100MG/KG  |
|                       |   15 SSAC      15 SSAC      15 SSAC      15 SSAC   |   15 SSAC      15 SSAC      15 SSAC      15 SSAC   |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/70 (6%)    5/70 (7%)    3/70 (4%)    7/70 (10%) |  3/70 (4%)    3/70 (4%)    4/70 (6%)    5/70 (7%)  |
|ADJUSTED (b)           |  11.5%        12.9%         7.8%        17.0%      |   9.9%         7.1%        12.5%        13.7%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/9 (0%)     0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/9 (0%)     0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  3/33 (9%)    2/32 (6%)    2/36 (6%)    5/39 (13%) |  2/29 (7%)    2/41 (5%)    4/32 (13%)   2/32 (6%)  |
|FIRST INCIDENCE (DAYS) |   724          525          631          724       |   725          700          729 (T)      708       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.305      P=0.471      P=0.467N     P=0.355    |  P=0.238      P=0.515N     P=0.551      P=0.429    |
|INCIDENTAL TUMOR       |  P=0.187      P=0.489      P=0.497N     P=0.292    |  P=0.344      P=0.655      P=0.562      P=0.465    |
|LOGISTIC REGRESSION    |  P=0.244      P=0.477      P=0.506N     P=0.308    |  P=0.275      P=0.571N     P=0.563      P=0.593N   |
|COCHRAN-ARMITAGE       |  P=0.207                                           |  P=0.265                                           |
|FISHER EXACT           |               P=0.500      P=0.500N     P=0.266    |               P=0.660N     P=0.500      P=0.359    |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/70 (1%)    2/70 (3%)    2/70 (3%)    0/70 (0%)  |  1/70 (1%)    0/70 (0%)    2/70 (3%)    0/70 (0%)  |
|ADJUSTED (b)           |   3.0%         5.6%         5.0%         0.0%      |   2.2%         0.0%         6.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/9 (0%)     0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/9 (0%)     0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  1/33 (3%)    0/32 (0%)    1/36 (3%)    0/39 (0%)  |  0/29 (0%)    0/41 (0%)    1/32 (3%)    0/32 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      681          631          ---       |   534          ---          723          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.201N     P=0.475      P=0.520      P=0.467N   |  P=0.480N     P=0.487N     P=0.519      P=0.496N   |
|INCIDENTAL TUMOR       |  P=0.277N     P=0.496      P=0.520      P=0.467N   |  P=0.405N     P=0.814N     P=0.509      P=0.545N   |
|LOGISTIC REGRESSION    |  P=0.218N     P=0.478      P=0.496      P=0.467N   |  P=0.469N     P=0.512N     P=0.510      P=0.506N   |
|COCHRAN-ARMITAGE       |  P=0.232N                                          |  P=0.473N                                          |
|FISHER EXACT           |               P=0.500      P=0.500      P=0.500N   |               P=0.500N     P=0.500      P=0.500N   |
|=================================================================================================================================|
 
         DATE: 09/12/94                     EXPERIMENT: 05093 TEST: 01                                                 PAGE   4
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- P-NITROANILINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      3 MG/KG      30 MG/KG     100MG/KG  |   VEHICLE      3 MG/KG      30 MG/KG     100MG/KG  |
|                       |   15 SSAC      15 SSAC      15 SSAC      15 SSAC   |   15 SSAC      15 SSAC      15 SSAC      15 SSAC   |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/70 (6%)    6/70 (9%)    4/70 (6%)    7/70 (10%) |  4/70 (6%)    3/70 (4%)    6/70 (9%)    5/70 (7%)  |
|ADJUSTED (b)           |  11.5%        15.5%        10.5%        17.0%      |  11.9%         7.1%        18.1%        13.7%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/9 (0%)     0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/9 (0%)     0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  3/33 (9%)    2/32 (6%)    3/36 (8%)    5/39 (13%) |  2/29 (7%)    2/41 (5%)    5/32 (16%)   2/32 (6%)  |
|FIRST INCIDENCE (DAYS) |   724          525          631          724       |   534          700          723          708       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.392      P=0.342      P=0.606N     P=0.355    |  P=0.338      P=0.357N     P=0.423      P=0.569    |
|INCIDENTAL TUMOR       |  P=0.253      P=0.360      P=0.634N     P=0.292    |  P=0.480      P=0.622N     P=0.426      P=0.591    |
|LOGISTIC REGRESSION    |  P=0.324      P=0.345      P=0.638      P=0.308    |  P=0.383      P=0.434N     P=0.409      P=0.554    |
|COCHRAN-ARMITAGE       |  P=0.278                                           |  P=0.368                                           |
|FISHER EXACT           |               P=0.372      P=0.641N     P=0.266    |               P=0.500N     P=0.372      P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Intestine Small: Jejunum                                                                                                         |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/70 (0%)    2/70 (3%)    0/70 (0%)    0/70 (0%)  |  0/70 (0%)    2/70 (3%)    1/70 (1%)    0/70 (0%)  |
|ADJUSTED (b)           |   0.0%         6.3%         0.0%         0.0%      |   0.0%         4.9%         2.4%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/9 (0%)     0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/9 (0%)     0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  0/33 (0%)    2/32 (6%)    0/36 (0%)    0/39 (0%)  |  0/29 (0%)    2/41 (5%)    0/32 (0%)    0/32 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          729 (T)      ---          ---       |   ---          729 (T)      667          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.294N     P=0.231        (e)          (e)      |  P=0.349N     P=0.317      P=0.520        (e)      |
|INCIDENTAL TUMOR       |  P=0.294N     P=0.231        (e)          (e)      |  P=0.305N     P=0.317      P=0.540        (e)      |
|LOGISTIC REGRESSION    |  P=0.294N     P=0.231        (e)          (e)      |  P=0.334N     P=0.317      P=0.506        (e)      |
|COCHRAN-ARMITAGE       |  P=0.326N                                          |  P=0.339N                                          |
|FISHER EXACT           |               P=0.248        (e)          (e)      |               P=0.248      P=0.500        (e)      |
|=================================================================================================================================|
 
         DATE: 09/12/94                     EXPERIMENT: 05093 TEST: 01                                                 PAGE   5
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- P-NITROANILINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      3 MG/KG      30 MG/KG     100MG/KG  |   VEHICLE      3 MG/KG      30 MG/KG     100MG/KG  |
|                       |   15 SSAC      15 SSAC      15 SSAC      15 SSAC   |   15 SSAC      15 SSAC      15 SSAC      15 SSAC   |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/70 (0%)    1/70 (1%)    3/70 (4%)    4/70 (6%)  |  1/70 (1%)    1/70 (1%)    0/70 (0%)    0/70 (0%)  |
|ADJUSTED (b)           |   0.0%         3.1%         7.4%         9.6%      |   2.9%         2.1%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/9 (0%)     0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    1/10 (10%)   0/10 (0%)  |  0/9 (0%)     0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  0/33 (0%)    1/32 (3%)    2/36 (6%)    3/39 (8%)  |  0/29 (0%)    0/41 (0%)    0/32 (0%)    0/32 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          729 (T)      452 (I)      563       |   701          553          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.065      P=0.494      P=0.133      P=0.083    |  P=0.307N     P=0.728N     P=0.484N     P=0.478N   |
|INCIDENTAL TUMOR       |  P=0.048 *    P=0.494      P=0.133      P=0.056    |  P=0.358N     P=0.608      P=0.460N     P=0.443N   |
|LOGISTIC REGRESSION    |  P=0.048 *    P=0.494      P=0.121      P=0.067    |  P=0.306N     P=0.753N     P=0.489N     P=0.483N   |
|COCHRAN-ARMITAGE       |  P=0.043 *                                         |  P=0.307N                                          |
|FISHER EXACT           |               P=0.500      P=0.122      P=0.060    |               P=0.752N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 20/70 (29%)  20/70 (29%)  17/70 (24%)  10/70 (14%) | 14/70 (20%)  13/70 (19%)  15/70 (21%)  11/70 (16%) |
|ADJUSTED (b)           |  48.3%        44.5%        40.6%        23.7%      |  40.9%        29.7%        39.8%        29.1%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/9 (0%)     0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|INTERIM SACRIFICE 2 (c)|  1/10 (10%)   2/10 (20%)   1/10 (10%)   1/10 (10%) |  1/9 (11%)    1/10 (10%)   0/10 (0%)    1/9 (11%)  |
|TERMINAL (d)           | 13/33 (39%)   9/32 (28%)  12/36 (33%)   8/39 (21%) | 10/29 (34%)  11/41 (27%)  10/32 (31%)   7/32 (22%) |
|FIRST INCIDENCE (DAYS) |   450 (I)      399          450 (I)      451 (I)   |   451 (I)      450 (I)      655          450 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.005N**   P=0.515      P=0.286N     P=0.013N*  |  P=0.364N     P=0.184N     P=0.545N     P=0.242N   |
|INCIDENTAL TUMOR       |  P=0.016N*    P=0.526N     P=0.339N     P=0.029N*  |  P=0.254N     P=0.301N     P=0.583N     P=0.274N   |
|LOGISTIC REGRESSION    |  P=0.015N*    P=0.552      P=0.357N     P=0.022N*  |  P=0.267N     P=0.354N     P=0.574      P=0.251N   |
|COCHRAN-ARMITAGE       |  P=0.015N*                                         |  P=0.300N                                          |
|FISHER EXACT           |               P=0.574N     P=0.351N     P=0.031N*  |               P=0.500N     P=0.500      P=0.330N   |
|=================================================================================================================================|
 
         DATE: 09/12/94                     EXPERIMENT: 05093 TEST: 01                                                 PAGE   6
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- P-NITROANILINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      3 MG/KG      30 MG/KG     100MG/KG  |   VEHICLE      3 MG/KG      30 MG/KG     100MG/KG  |
|                       |   15 SSAC      15 SSAC      15 SSAC      15 SSAC   |   15 SSAC      15 SSAC      15 SSAC      15 SSAC   |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 10/70 (14%)  13/70 (19%)  14/70 (20%)   7/70 (10%) |  8/70 (11%)   6/70 (9%)   10/70 (14%)   9/70 (13%) |
|ADJUSTED (b)           |  23.2%        29.6%        30.3%        14.6%      |  21.8%        13.4%        24.5%        22.5%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/9 (0%)     0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    1/10 (10%)   1/10 (10%)   1/10 (10%) |  1/9 (11%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  3/33 (9%)    4/32 (13%)   6/36 (17%)   1/39 (3%)  |  4/29 (14%)   3/41 (7%)    4/32 (13%)   3/32 (9%)  |
|FIRST INCIDENCE (DAYS) |   540          452 (I)      445          451 (I)   |   452 (I)      553          448          542       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.097N     P=0.288      P=0.287      P=0.257N   |  P=0.331      P=0.231N     P=0.476      P=0.592    |
|INCIDENTAL TUMOR       |  P=0.352N     P=0.410      P=0.174      P=0.563N   |  P=0.477      P=0.508N     P=0.392      P=0.533    |
|LOGISTIC REGRESSION    |  P=0.278N     P=0.486      P=0.197      P=0.443N   |  P=0.314      P=0.471N     P=0.422      P=0.461    |
|COCHRAN-ARMITAGE       |  P=0.137N                                          |  P=0.346                                           |
|FISHER EXACT           |               P=0.324      P=0.251      P=0.303N   |               P=0.390N     P=0.401      P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 26/70 (37%)  28/70 (40%)  27/70 (39%)  14/70 (20%) | 19/70 (27%)  18/70 (26%)  21/70 (30%)  17/70 (24%) |
|ADJUSTED (b)           |  57.8%        57.5%        56.6%        30.3%      |  49.2%        39.5%        51.5%        41.3%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/9 (0%)     0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|INTERIM SACRIFICE 2 (c)|  1/10 (10%)   2/10 (20%)   2/10 (20%)   1/10 (10%) |  2/9 (22%)    1/10 (10%)   0/10 (0%)    1/9 (11%)  |
|TERMINAL (d)           | 15/33 (45%)  12/32 (38%)  16/36 (44%)   8/39 (21%) | 11/29 (38%)  14/41 (34%)  13/32 (41%)   9/32 (28%) |
|FIRST INCIDENCE (DAYS) |   450 (I)      399          445          451 (I)   |   451 (I)      450 (I)      448          450 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.002N**   P=0.369      P=0.549N     P=0.010N** |  P=0.476N     P=0.164N     P=0.561      P=0.302N   |
|INCIDENTAL TUMOR       |  P=0.009N**   P=0.514      P=0.465      P=0.032N*  |  P=0.319N     P=0.411N     P=0.462      P=0.364N   |
|LOGISTIC REGRESSION    |  P=0.006N**   P=0.527      P=0.451      P=0.022N*  |  P=0.384N     P=0.353N     P=0.480      P=0.327N   |
|COCHRAN-ARMITAGE       |  P=0.005N**                                        |  P=0.401N                                          |
|FISHER EXACT           |               P=0.431      P=0.500      P=0.019N*  |               P=0.500N     P=0.426      P=0.423N   |
|=================================================================================================================================|
 
         DATE: 09/12/94                     EXPERIMENT: 05093 TEST: 01                                                 PAGE   7
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- P-NITROANILINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      3 MG/KG      30 MG/KG     100MG/KG  |   VEHICLE      3 MG/KG      30 MG/KG     100MG/KG  |
|                       |   15 SSAC      15 SSAC      15 SSAC      15 SSAC   |   15 SSAC      15 SSAC      15 SSAC      15 SSAC   |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 26/70 (37%)  28/70 (40%)  27/70 (39%)  14/70 (20%) | 19/70 (27%)  18/70 (26%)  21/70 (30%)  17/70 (24%) |
|ADJUSTED (b)           |  57.8%        57.5%        56.6%        30.3%      |  49.2%        39.5%        51.5%        41.3%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/9 (0%)     0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|INTERIM SACRIFICE 2 (c)|  1/10 (10%)   2/10 (20%)   2/10 (20%)   1/10 (10%) |  2/9 (22%)    1/10 (10%)   0/10 (0%)    1/9 (11%)  |
|TERMINAL (d)           | 15/33 (45%)  12/32 (38%)  16/36 (44%)   8/39 (21%) | 11/29 (38%)  14/41 (34%)  13/32 (41%)   9/32 (28%) |
|FIRST INCIDENCE (DAYS) |   450 (I)      399          445          451 (I)   |   451 (I)      450 (I)      448          450 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.002N**   P=0.369      P=0.549N     P=0.010N** |  P=0.476N     P=0.164N     P=0.561      P=0.302N   |
|INCIDENTAL TUMOR       |  P=0.009N**   P=0.514      P=0.465      P=0.032N*  |  P=0.319N     P=0.411N     P=0.462      P=0.364N   |
|LOGISTIC REGRESSION    |  P=0.006N**   P=0.527      P=0.451      P=0.022N*  |  P=0.384N     P=0.353N     P=0.480      P=0.327N   |
|COCHRAN-ARMITAGE       |  P=0.005N**                                        |  P=0.401N                                          |
|FISHER EXACT           |               P=0.431      P=0.500      P=0.019N*  |               P=0.500N     P=0.426      P=0.423N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  7/70 (10%)   7/70 (10%)   8/70 (11%)   4/70 (6%)  |  2/70 (3%)    5/70 (7%)    4/70 (6%)    3/70 (4%)  |
|ADJUSTED (b)           |  17.0%        19.0%        21.6%         9.3%      |   6.9%        11.9%        11.3%         8.5%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/9 (0%)     0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    1/10 (10%) |  0/9 (0%)     0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  2/33 (6%)    3/32 (9%)    7/36 (19%)   3/39 (8%)  |  2/29 (7%)    4/41 (10%)   3/32 (9%)    2/32 (6%)  |
|FIRST INCIDENCE (DAYS) |   619          602          725          451 (I)   |   729 (T)      719          465          681       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.125N     P=0.547      P=0.538      P=0.215N   |  P=0.549N     P=0.373      P=0.376      P=0.548    |
|INCIDENTAL TUMOR       |  P=0.216N     P=0.557N     P=0.454      P=0.329N   |  P=0.487N     P=0.294      P=0.358      P=0.562    |
|LOGISTIC REGRESSION    |  P=0.158N     P=0.524N     P=0.491      P=0.248N   |  P=0.499N     P=0.326      P=0.357      P=0.553    |
|COCHRAN-ARMITAGE       |  P=0.195N                                          |  P=0.512N                                          |
|FISHER EXACT           |               P=0.610N     P=0.500      P=0.266N   |               P=0.221      P=0.340      P=0.500    |
|=================================================================================================================================|
 
         DATE: 09/12/94                     EXPERIMENT: 05093 TEST: 01                                                 PAGE   8
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- P-NITROANILINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      3 MG/KG      30 MG/KG     100MG/KG  |   VEHICLE      3 MG/KG      30 MG/KG     100MG/KG  |
|                       |   15 SSAC      15 SSAC      15 SSAC      15 SSAC   |   15 SSAC      15 SSAC      15 SSAC      15 SSAC   |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/70 (7%)    3/70 (4%)    1/70 (1%)    6/70 (9%)  |  0/70 (0%)    0/70 (0%)    2/70 (3%)    1/70 (1%)  |
|ADJUSTED (b)           |  13.4%         8.5%         2.5%        14.3%      |   0.0%         0.0%         4.6%         3.1%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/9 (0%)     0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/9 (0%)     0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  3/33 (9%)    2/32 (6%)    0/36 (0%)    4/39 (10%) |  0/29 (0%)    0/41 (0%)    0/32 (0%)    1/32 (3%)  |
|FIRST INCIDENCE (DAYS) |   640          654          701          656       |   ---          ---          465          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.337      P=0.383N     P=0.101N     P=0.591    |  P=0.356        (e)        P=0.251      P=0.520    |
|INCIDENTAL TUMOR       |  P=0.231      P=0.341N     P=0.126N     P=0.484    |  P=0.428        (e)        P=0.236      P=0.520    |
|LOGISTIC REGRESSION    |  P=0.188      P=0.384N     P=0.078N     P=0.531    |  P=0.359        (e)        P=0.238      P=0.520    |
|COCHRAN-ARMITAGE       |  P=0.244                                           |  P=0.357                                           |
|FISHER EXACT           |               P=0.359N     P=0.104N     P=0.500    |                 (e)        P=0.248      P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  9/70 (13%)  10/70 (14%)   9/70 (13%)  10/70 (14%) |  2/70 (3%)    5/70 (7%)    5/70 (7%)    4/70 (6%)  |
|ADJUSTED (b)           |  22.4%        26.4%        23.5%        23.1%      |   6.9%        11.9%        13.5%        11.6%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/9 (0%)     0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    1/10 (10%) |  0/9 (0%)     0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  4/33 (12%)   5/32 (16%)   7/36 (19%)   7/39 (18%) |  2/29 (7%)    4/41 (10%)   3/32 (9%)    3/32 (9%)  |
|FIRST INCIDENCE (DAYS) |   619          602          701          451 (I)   |   729 (T)      719          465          681       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.456N     P=0.440      P=0.555N     P=0.579N   |  P=0.469      P=0.373      P=0.255      P=0.386    |
|INCIDENTAL TUMOR       |  P=0.477      P=0.548      P=0.550      P=0.462    |  P=0.549      P=0.294      P=0.247      P=0.398    |
|LOGISTIC REGRESSION    |  P=0.555N     P=0.587      P=0.593      P=0.532    |  P=0.520      P=0.326      P=0.233      P=0.392    |
|COCHRAN-ARMITAGE       |  P=0.497                                           |  P=0.505                                           |
|FISHER EXACT           |               P=0.500      P=0.599N     P=0.500    |               P=0.221      P=0.221      P=0.340    |
|=================================================================================================================================|
 
         DATE: 09/12/94                     EXPERIMENT: 05093 TEST: 01                                                 PAGE   9
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- P-NITROANILINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      3 MG/KG      30 MG/KG     100MG/KG  |   VEHICLE      3 MG/KG      30 MG/KG     100MG/KG  |
|                       |   15 SSAC      15 SSAC      15 SSAC      15 SSAC   |   15 SSAC      15 SSAC      15 SSAC      15 SSAC   |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/68 (0%)    1/67 (1%)    0/68 (0%)    0/65 (0%)  |  4/68 (6%)    3/70 (4%)    5/68 (7%)    2/67 (3%)  |
|ADJUSTED (b)           |   0.0%         2.6%         0.0%         0.0%      |  12.5%         7.1%        16.1%         6.5%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/9 (0%)     0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/9 (0%)     0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  0/32 (0%)    0/30 (0%)    0/35 (0%)    0/34 (0%)  |  3/29 (10%)   2/41 (5%)    5/31 (16%)   2/31 (6%)  |
|FIRST INCIDENCE (DAYS) |   ---          659          ---          ---       |   599          719          729 (T)      729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.533N     P=0.485        (e)          (e)      |  P=0.363N     P=0.340N     P=0.539      P=0.307N   |
|INCIDENTAL TUMOR       |  P=0.576N     P=0.477        (e)          (e)      |  P=0.388N     P=0.448N     P=0.452      P=0.403N   |
|LOGISTIC REGRESSION    |  P=0.551N     P=0.492        (e)          (e)      |  P=0.318N     P=0.416N     P=0.534      P=0.308N   |
|COCHRAN-ARMITAGE       |  P=0.553N                                          |  P=0.328N                                          |
|FISHER EXACT           |               P=0.496        (e)          (e)      |               P=0.484N     P=0.500      P=0.347N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibrosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/70 (0%)    2/70 (3%)    0/70 (0%)    0/70 (0%)  |  1/70 (1%)    1/70 (1%)    1/70 (1%)    3/70 (4%)  |
|ADJUSTED (b)           |   0.0%         5.3%         0.0%         0.0%      |   3.4%         2.1%         1.7%         6.8%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/9 (0%)     0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/9 (0%)     0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  0/33 (0%)    1/32 (3%)    0/36 (0%)    0/39 (0%)  |  1/29 (3%)    0/41 (0%)    0/32 (0%)    0/32 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          584          ---          ---       |   729 (T)      581          424          477       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.307N     P=0.234        (e)          (e)      |  P=0.159      P=0.709N     P=0.743N     P=0.338    |
|INCIDENTAL TUMOR       |  P=0.377N     P=0.280        (e)          (e)      |  P=0.147      P=0.748      P=0.747      P=0.296    |
|LOGISTIC REGRESSION    |  P=0.322N     P=0.235        (e)          (e)      |  P=0.156      P=0.747N     P=0.762N     P=0.312    |
|COCHRAN-ARMITAGE       |  P=0.326N                                          |  P=0.156                                           |
|FISHER EXACT           |               P=0.248        (e)          (e)      |               P=0.752N     P=0.752N     P=0.310    |
|=================================================================================================================================|
 
         DATE: 09/12/94                     EXPERIMENT: 05093 TEST: 01                                                 PAGE  10
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- P-NITROANILINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      3 MG/KG      30 MG/KG     100MG/KG  |   VEHICLE      3 MG/KG      30 MG/KG     100MG/KG  |
|                       |   15 SSAC      15 SSAC      15 SSAC      15 SSAC   |   15 SSAC      15 SSAC      15 SSAC      15 SSAC   |
|=================================================================================================================================|
|                                                                                                                                 |
|Spleen                                                                                                                           |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/70 (6%)    0/70 (0%)    2/70 (3%)    2/70 (3%)  |  0/70 (0%)    1/69 (1%)    1/70 (1%)    2/70 (3%)  |
|ADJUSTED (b)           |  10.0%         0.0%         5.3%         4.5%      |   0.0%         2.3%         2.3%         5.7%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/9 (0%)     0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/9 (0%)     0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  0/33 (0%)    0/32 (0%)    1/36 (3%)    0/39 (0%)  |  0/29 (0%)    0/40 (0%)    0/32 (0%)    1/32 (3%)  |
|FIRST INCIDENCE (DAYS) |   667          ---          725          656       |   ---          700          654          716       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.534N     P=0.084N     P=0.332N     P=0.309N   |  P=0.209      P=0.535      P=0.525      P=0.270    |
|INCIDENTAL TUMOR       |  P=0.562      P=0.049N*    P=0.492N     P=0.450N   |  P=0.323      P=0.338      P=0.540      P=0.283    |
|LOGISTIC REGRESSION    |  P=0.569N     P=0.070N     P=0.342N     P=0.326N   |  P=0.216      P=0.522      P=0.505      P=0.264    |
|COCHRAN-ARMITAGE       |  P=0.602N                                          |  P=0.210                                           |
|FISHER EXACT           |               P=0.060N     P=0.340N     P=0.340N   |               P=0.496      P=0.500      P=0.248    |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Squamous Cell Carcinoma or Papilloma Squamous                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/70 (7%)    2/70 (3%)    2/70 (3%)    2/70 (3%)  |  3/70 (4%)    3/70 (4%)    1/70 (1%)    3/70 (4%)  |
|ADJUSTED (b)           |  13.0%         6.3%         4.5%         4.9%      |   8.7%         6.9%         3.1%         9.4%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/9 (0%)     0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|INTERIM SACRIFICE 2 (c)|  1/10 (10%)   0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/9 (0%)     0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  3/33 (9%)    2/32 (6%)    0/36 (0%)    1/39 (3%)  |  1/29 (3%)    2/41 (5%)    1/32 (3%)    3/32 (9%)  |
|FIRST INCIDENCE (DAYS) |   450 (I)      729 (T)      478          724       |   662          581          729 (T)      729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.252N     P=0.235N     P=0.208N     P=0.175N   |  P=0.567      P=0.544N     P=0.277N     P=0.613N   |
|INCIDENTAL TUMOR       |  P=0.328N     P=0.229N     P=0.252N     P=0.209N   |  P=0.563      P=0.585      P=0.254N     P=0.586N   |
|LOGISTIC REGRESSION    |  P=0.292N     P=0.231N     P=0.221N     P=0.206N   |  P=0.602      P=0.611N     P=0.283N     P=0.616N   |
|COCHRAN-ARMITAGE       |  P=0.310N                                          |  P=0.590                                           |
|FISHER EXACT           |               P=0.221N     P=0.221N     P=0.221N   |               P=0.660N     P=0.310N     P=0.660N   |
|=================================================================================================================================|
 
         DATE: 09/12/94                     EXPERIMENT: 05093 TEST: 01                                                 PAGE  11
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- P-NITROANILINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      3 MG/KG      30 MG/KG     100MG/KG  |   VEHICLE      3 MG/KG      30 MG/KG     100MG/KG  |
|                       |   15 SSAC      15 SSAC      15 SSAC      15 SSAC   |   15 SSAC      15 SSAC      15 SSAC      15 SSAC   |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/70 (6%)    2/70 (3%)    2/70 (3%)    2/70 (3%)  |  3/70 (4%)    3/70 (4%)    1/70 (1%)    2/70 (3%)  |
|ADJUSTED (b)           |  10.6%         6.3%         4.5%         4.9%      |   8.7%         6.9%         3.1%         6.3%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/9 (0%)     0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|INTERIM SACRIFICE 2 (c)|  1/10 (10%)   0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/9 (0%)     0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  3/33 (9%)    2/32 (6%)    0/36 (0%)    1/39 (3%)  |  1/29 (3%)    2/41 (5%)    1/32 (3%)    2/32 (6%)  |
|FIRST INCIDENCE (DAYS) |   450 (I)      729 (T)      478          724       |   662          581          729 (T)      729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.336N     P=0.349N     P=0.322N     P=0.283N   |  P=0.436N     P=0.544N     P=0.277N     P=0.453N   |
|INCIDENTAL TUMOR       |  P=0.410N     P=0.349N     P=0.350N     P=0.308N   |  P=0.440N     P=0.585      P=0.254N     P=0.421N   |
|LOGISTIC REGRESSION    |  P=0.383N     P=0.351N     P=0.340N     P=0.325N   |  P=0.405N     P=0.611N     P=0.283N     P=0.456N   |
|COCHRAN-ARMITAGE       |  P=0.400N                                          |  P=0.415N                                          |
|FISHER EXACT           |               P=0.340N     P=0.340N     P=0.340N   |               P=0.660N     P=0.310N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/70 (1%)    1/70 (1%)    0/70 (0%)    0/70 (0%)  |  0/70 (0%)    3/70 (4%)    1/70 (1%)    1/70 (1%)  |
|ADJUSTED (b)           |   3.0%         3.1%         0.0%         0.0%      |   0.0%         7.3%         2.9%         3.1%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/9 (0%)     0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/9 (0%)     0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  1/33 (3%)    1/32 (3%)    0/36 (0%)    0/39 (0%)  |  0/29 (0%)    3/41 (7%)    0/32 (0%)    1/32 (3%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      729 (T)      ---          ---       |   ---          729 (T)      720          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.276N     P=0.755      P=0.483N     P=0.467N   |  P=0.557N     P=0.188      P=0.524      P=0.520    |
|INCIDENTAL TUMOR       |  P=0.276N     P=0.755      P=0.483N     P=0.467N   |  P=0.515N     P=0.188      P=0.540      P=0.520    |
|LOGISTIC REGRESSION    |  P=0.276N     P=0.755      P=0.483N     P=0.467N   |  P=0.530N     P=0.188      P=0.517      P=0.520    |
|COCHRAN-ARMITAGE       |  P=0.307N                                          |  P=0.534N                                          |
|FISHER EXACT           |               P=0.752N     P=0.500N     P=0.500N   |               P=0.122      P=0.500      P=0.500    |
|=================================================================================================================================|
 
         DATE: 09/12/94                     EXPERIMENT: 05093 TEST: 01                                                 PAGE  12
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- P-NITROANILINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      3 MG/KG      30 MG/KG     100MG/KG  |   VEHICLE      3 MG/KG      30 MG/KG     100MG/KG  |
|                       |   15 SSAC      15 SSAC      15 SSAC      15 SSAC   |   15 SSAC      15 SSAC      15 SSAC      15 SSAC   |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/70 (1%)    2/70 (3%)    0/70 (0%)    0/70 (0%)  |  0/70 (0%)    3/70 (4%)    1/70 (1%)    1/70 (1%)  |
|ADJUSTED (b)           |   3.0%         5.1%         0.0%         0.0%      |   0.0%         7.3%         2.9%         3.1%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/9 (0%)     0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    1/10 (10%)   0/10 (0%)    0/10 (0%)  |  0/9 (0%)     0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  1/33 (3%)    1/32 (3%)    0/36 (0%)    0/39 (0%)  |  0/29 (0%)    3/41 (7%)    0/32 (0%)    1/32 (3%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      452 (I)      ---          ---       |   ---          729 (T)      720          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.180N     P=0.493      P=0.483N     P=0.467N   |  P=0.557N     P=0.188      P=0.524      P=0.520    |
|INCIDENTAL TUMOR       |  P=0.180N     P=0.493      P=0.483N     P=0.467N   |  P=0.515N     P=0.188      P=0.540      P=0.520    |
|LOGISTIC REGRESSION    |  P=0.196N     P=0.498      P=0.483N     P=0.467N   |  P=0.530N     P=0.188      P=0.517      P=0.520    |
|COCHRAN-ARMITAGE       |  P=0.198N                                          |  P=0.534N                                          |
|FISHER EXACT           |               P=0.500      P=0.500N     P=0.500N   |               P=0.122      P=0.500      P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  0/70 (0%)    3/70 (4%)    0/70 (0%)    1/70 (1%)  |
|ADJUSTED (b)           |                                                    |   0.0%         6.8%         0.0%         3.1%      |
|INTERIM SACRIFICE 1 (c)|                                                    |  0/9 (0%)     0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|INTERIM SACRIFICE 2 (c)|                                                    |  0/9 (0%)     0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |                                                    |  0/29 (0%)    2/41 (5%)    0/32 (0%)    1/32 (3%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   ---          478          ---          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.574N     P=0.170        (e)        P=0.520    |
|INCIDENTAL TUMOR       |                                                    |  P=0.553N     P=0.070        (e)        P=0.520    |
|LOGISTIC REGRESSION    |                                                    |  P=0.550N     P=0.132        (e)        P=0.520    |
|COCHRAN-ARMITAGE       |                                                    |  P=0.554N                                          |
|FISHER EXACT           |                                                    |               P=0.122        (e)        P=0.500    |
|=================================================================================================================================|
 
         DATE: 09/12/94                     EXPERIMENT: 05093 TEST: 01                                                 PAGE  13
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- P-NITROANILINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      3 MG/KG      30 MG/KG     100MG/KG  |   VEHICLE      3 MG/KG      30 MG/KG     100MG/KG  |
|                       |   15 SSAC      15 SSAC      15 SSAC      15 SSAC   |   15 SSAC      15 SSAC      15 SSAC      15 SSAC   |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal or Polyp Stromal                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  1/70 (1%)    3/70 (4%)    1/70 (1%)    2/70 (3%)  |
|ADJUSTED (b)           |                                                    |   3.4%         6.8%         2.3%         6.3%      |
|INTERIM SACRIFICE 1 (c)|                                                    |  0/9 (0%)     0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|INTERIM SACRIFICE 2 (c)|                                                    |  0/9 (0%)     0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |                                                    |  1/29 (3%)    2/41 (5%)    0/32 (0%)    2/32 (6%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   729 (T)      478          560          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.584      P=0.408      P=0.747N     P=0.535    |
|INCIDENTAL TUMOR       |                                                    |  P=0.528      P=0.265      P=0.621      P=0.535    |
|LOGISTIC REGRESSION    |                                                    |  P=0.614      P=0.335      P=0.757N     P=0.535    |
|COCHRAN-ARMITAGE       |                                                    |  P=0.608                                           |
|FISHER EXACT           |                                                    |               P=0.310      P=0.752N     P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangioma                                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/70 (1%)    2/70 (3%)    1/70 (1%)    3/70 (4%)  |  0/70 (0%)    1/70 (1%)    1/70 (1%)    2/70 (3%)  |
|ADJUSTED (b)           |   3.0%         5.7%         2.8%         6.5%      |   0.0%         2.4%         2.9%         6.3%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    1/10 (10%) |  0/9 (0%)     0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/9 (0%)     0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  1/33 (3%)    1/32 (3%)    1/36 (3%)    2/39 (5%)  |  0/29 (0%)    1/41 (2%)    0/32 (0%)    2/32 (6%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      681          729 (T)      274 (I)   |   ---          729 (T)      720          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.316      P=0.484      P=0.742N     P=0.352    |  P=0.193      P=0.569      P=0.524      P=0.260    |
|INCIDENTAL TUMOR       |  P=0.297      P=0.493      P=0.742N     P=0.352    |  P=0.230      P=0.569      P=0.540      P=0.260    |
|LOGISTIC REGRESSION    |  P=0.268      P=0.477      P=0.742N     P=0.307    |  P=0.211      P=0.569      P=0.517      P=0.260    |
|COCHRAN-ARMITAGE       |  P=0.258                                           |  P=0.208                                           |
|FISHER EXACT           |               P=0.500      P=0.752N     P=0.310    |               P=0.500      P=0.500      P=0.248    |
|=================================================================================================================================|
 
         DATE: 09/12/94                     EXPERIMENT: 05093 TEST: 01                                                 PAGE  14
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- P-NITROANILINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      3 MG/KG      30 MG/KG     100MG/KG  |   VEHICLE      3 MG/KG      30 MG/KG     100MG/KG  |
|                       |   15 SSAC      15 SSAC      15 SSAC      15 SSAC   |   15 SSAC      15 SSAC      15 SSAC      15 SSAC   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/70 (6%)    1/70 (1%)    4/70 (6%)    8/70 (11%) |  1/70 (1%)    2/70 (3%)    2/70 (3%)    2/70 (3%)  |
|ADJUSTED (b)           |  10.0%         3.1%         9.8%        18.5%      |   2.9%         4.4%         5.4%         5.7%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/9 (0%)     0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    1/10 (10%)   0/10 (0%)  |  0/9 (0%)     0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  0/33 (0%)    1/32 (3%)    2/36 (6%)    5/39 (13%) |  0/29 (0%)    0/41 (0%)    1/32 (3%)    1/32 (3%)  |
|FIRST INCIDENCE (DAYS) |   667          729 (T)      452 (I)      563       |   701          553          654          716       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.046 *    P=0.219N     P=0.626N     P=0.246    |  P=0.501      P=0.554      P=0.535      P=0.544    |
|INCIDENTAL TUMOR       |  P=0.015 *    P=0.169N     P=0.514      P=0.117    |  P=0.570      P=0.260      P=0.558      P=0.579    |
|LOGISTIC REGRESSION    |  P=0.027 *    P=0.199N     P=0.638      P=0.197    |  P=0.481      P=0.524      P=0.517      P=0.537    |
|COCHRAN-ARMITAGE       |  P=0.022 *                                         |  P=0.506                                           |
|FISHER EXACT           |               P=0.183N     P=0.641N     P=0.183    |               P=0.500      P=0.500      P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma or Hemangioma                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/70 (7%)    3/70 (4%)    5/70 (7%)   11/70 (16%) |  1/70 (1%)    3/70 (4%)    3/70 (4%)    4/70 (6%)  |
|ADJUSTED (b)           |  12.7%         8.7%        12.5%        24.4%      |   2.9%         6.7%         8.1%        11.8%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    1/10 (10%) |  0/9 (0%)     0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    1/10 (10%)   0/10 (0%)  |  0/9 (0%)     0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  1/33 (3%)    2/32 (6%)    3/36 (8%)    7/39 (18%) |  0/29 (0%)    1/41 (2%)    1/32 (3%)    3/32 (9%)  |
|FIRST INCIDENCE (DAYS) |   667          681          452 (I)      274 (I)   |   701          553          654          716       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.030 *    P=0.408N     P=0.603N     P=0.146    |  P=0.217      P=0.383      P=0.347      P=0.219    |
|INCIDENTAL TUMOR       |  P=0.010 **   P=0.357N     P=0.524      P=0.066    |  P=0.276      P=0.161      P=0.367      P=0.236    |
|LOGISTIC REGRESSION    |  P=0.015 *    P=0.392N     P=0.624      P=0.098    |  P=0.234      P=0.337      P=0.325      P=0.215    |
|COCHRAN-ARMITAGE       |  P=0.012 *                                         |  P=0.226                                           |
|FISHER EXACT           |               P=0.359N     P=0.628N     P=0.091    |               P=0.310      P=0.310      P=0.183    |
|=================================================================================================================================|
 
         DATE: 09/12/94                     EXPERIMENT: 05093 TEST: 01                                                 PAGE  15
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- P-NITROANILINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      3 MG/KG      30 MG/KG     100MG/KG  |   VEHICLE      3 MG/KG      30 MG/KG     100MG/KG  |
|                       |   15 SSAC      15 SSAC      15 SSAC      15 SSAC   |   15 SSAC      15 SSAC      15 SSAC      15 SSAC   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma And Histiocytic Sarcoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/70 (7%)    2/70 (3%)    4/70 (6%)    0/70 (0%)  |  9/70 (13%)   3/70 (4%)    6/70 (9%)    6/70 (9%)  |
|ADJUSTED (b)           |  11.9%         5.3%        10.5%         0.0%      |  25.4%         7.0%        17.4%        15.1%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/9 (0%)     0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|INTERIM SACRIFICE 2 (c)|  1/10 (10%)   0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/9 (0%)     0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  2/33 (6%)    0/32 (0%)    3/36 (8%)    0/39 (0%)  |  4/29 (14%)   2/41 (5%)    4/32 (13%)   2/32 (6%)  |
|FIRST INCIDENCE (DAYS) |   450 (I)      681          680          ---       |   606          653          716          634       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.046N*    P=0.249N     P=0.472N     P=0.030N*  |  P=0.565      P=0.025N*    P=0.237N     P=0.230N   |
|INCIDENTAL TUMOR       |  P=0.069N     P=0.199N     P=0.525N     P=0.046N*  |  P=0.465N     P=0.102N     P=0.251N     P=0.279N   |
|LOGISTIC REGRESSION    |  P=0.054N     P=0.223N     P=0.505N     P=0.033N*  |  P=0.489N     P=0.036N*    P=0.237N     P=0.231N   |
|COCHRAN-ARMITAGE       |  P=0.059N                                          |  P=0.555N                                          |
|FISHER EXACT           |               P=0.221N     P=0.500N     P=0.029N*  |               P=0.064N     P=0.293N     P=0.293N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,                                                                        |
|     NOS, or Undifferentiated Cell Type                                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/70 (7%)    2/70 (3%)    4/70 (6%)    0/70 (0%)  |  9/70 (13%)   3/70 (4%)    6/70 (9%)    6/70 (9%)  |
|ADJUSTED (b)           |  11.9%         5.3%        10.5%         0.0%      |  25.4%         7.0%        17.4%        15.1%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/9 (0%)     0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|INTERIM SACRIFICE 2 (c)|  1/10 (10%)   0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/9 (0%)     0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  2/33 (6%)    0/32 (0%)    3/36 (8%)    0/39 (0%)  |  4/29 (14%)   2/41 (5%)    4/32 (13%)   2/32 (6%)  |
|FIRST INCIDENCE (DAYS) |   450 (I)      681          680          ---       |   606          653          716          634       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.046N*    P=0.249N     P=0.472N     P=0.030N*  |  P=0.565      P=0.025N*    P=0.237N     P=0.230N   |
|INCIDENTAL TUMOR       |  P=0.069N     P=0.199N     P=0.525N     P=0.046N*  |  P=0.465N     P=0.102N     P=0.251N     P=0.279N   |
|LOGISTIC REGRESSION    |  P=0.054N     P=0.223N     P=0.505N     P=0.033N*  |  P=0.489N     P=0.036N*    P=0.237N     P=0.231N   |
|COCHRAN-ARMITAGE       |  P=0.059N                                          |  P=0.555N                                          |
|FISHER EXACT           |               P=0.221N     P=0.500N     P=0.029N*  |               P=0.064N     P=0.293N     P=0.293N   |
|=================================================================================================================================|
 
         DATE: 09/12/94                     EXPERIMENT: 05093 TEST: 01                                                 PAGE  16
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- P-NITROANILINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      3 MG/KG      30 MG/KG     100MG/KG  |   VEHICLE      3 MG/KG      30 MG/KG     100MG/KG  |
|                       |   15 SSAC      15 SSAC      15 SSAC      15 SSAC   |   15 SSAC      15 SSAC      15 SSAC      15 SSAC   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 29/70 (41%)  34/70 (49%)  27/70 (39%)  22/70 (31%) | 24/70 (34%)  26/70 (37%)  24/70 (34%)  24/70 (34%) |
|ADJUSTED (b)           |  62.0%        70.2%        57.9%        47.8%      |  63.5%        55.0%        60.6%        57.7%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    1/10 (10%) |  0/9 (0%)     0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|INTERIM SACRIFICE 2 (c)|  2/10 (20%)   2/10 (20%)   1/10 (10%)   2/10 (20%) |  1/9 (11%)    1/10 (10%)   1/10 (10%)   1/9 (11%)  |
|TERMINAL (d)           | 16/33 (48%)  18/32 (56%)  17/36 (47%)  16/39 (41%) | 16/29 (55%)  20/41 (49%)  17/32 (53%)  15/32 (47%) |
|FIRST INCIDENCE (DAYS) |   450 (I)      399          445          274 (I)   |   451 (I)      450 (I)      452 (I)      450 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.011N*    P=0.207      P=0.358N     P=0.065N   |  P=0.517      P=0.227N     P=0.410N     P=0.401N   |
|INCIDENTAL TUMOR       |  P=0.052N     P=0.287      P=0.467N     P=0.143N   |  P=0.509N     P=0.566N     P=0.561      P=0.566N   |
|LOGISTIC REGRESSION    |  P=0.032N*    P=0.269      P=0.472N     P=0.108N   |  P=0.422N     P=0.522N     P=0.496N     P=0.434N   |
|COCHRAN-ARMITAGE       |  P=0.040N*                                         |  P=0.468N                                          |
|FISHER EXACT           |               P=0.248      P=0.432N     P=0.146N   |               P=0.430      P=0.571N     P=0.571N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 24/70 (34%)  24/70 (34%)  22/70 (31%)  16/70 (23%) | 22/70 (31%)  14/70 (20%)  20/70 (29%)  22/70 (31%) |
|ADJUSTED (b)           |  50.4%        50.4%        45.8%        33.4%      |  51.6%        29.2%        44.1%        48.1%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/9 (0%)     0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|INTERIM SACRIFICE 2 (c)|  1/10 (10%)   2/10 (20%)   2/10 (20%)   1/10 (10%) |  1/9 (11%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           | 10/33 (30%)   9/32 (28%)  11/36 (31%)   8/39 (21%) |  9/29 (31%)   8/41 (20%)   8/32 (25%)   9/32 (28%) |
|FIRST INCIDENCE (DAYS) |   450 (I)      452 (I)      445          451 (I)   |   452 (I)      341          424          477       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.029N*    P=0.479      P=0.387N     P=0.062N   |  P=0.232      P=0.022N*    P=0.326N     P=0.418N   |
|INCIDENTAL TUMOR       |  P=0.143N     P=0.474N     P=0.540N     P=0.173N   |  P=0.380      P=0.260N     P=0.418N     P=0.521N   |
|LOGISTIC REGRESSION    |  P=0.120N     P=0.411N     P=0.485N     P=0.136N   |  P=0.199      P=0.090N     P=0.570N     P=0.498    |
|COCHRAN-ARMITAGE       |  P=0.057N                                          |  P=0.240                                           |
|FISHER EXACT           |               P=0.571N     P=0.429N     P=0.095N   |               P=0.088N     P=0.427N     P=0.572N   |
|=================================================================================================================================|
 
         DATE: 09/12/94                     EXPERIMENT: 05093 TEST: 01                                                 PAGE  17
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- P-NITROANILINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      3 MG/KG      30 MG/KG     100MG/KG  |   VEHICLE      3 MG/KG      30 MG/KG     100MG/KG  |
|                       |   15 SSAC      15 SSAC      15 SSAC      15 SSAC   |   15 SSAC      15 SSAC      15 SSAC      15 SSAC   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 36/70 (51%)  41/70 (59%)  39/70 (56%)  31/70 (44%) | 37/70 (53%)  34/70 (49%)  35/70 (50%)  37/70 (53%) |
|ADJUSTED (b)           |  70.3%        80.1%        76.3%        61.5%      |  78.6%        66.5%        74.1%        76.8%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    1/10 (10%) |  0/9 (0%)     0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|INTERIM SACRIFICE 2 (c)|  3/10 (30%)   3/10 (30%)   3/10 (30%)   2/10 (20%) |  2/9 (22%)    1/10 (10%)   1/10 (10%)   1/9 (11%)  |
|TERMINAL (d)           | 18/33 (55%)  22/32 (69%)  24/36 (67%)  20/39 (51%) | 19/29 (66%)  24/41 (59%)  20/32 (63%)  21/32 (66%) |
|FIRST INCIDENCE (DAYS) |   450 (I)      399          445          274 (I)   |   451 (I)      341          424          450 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.023N*    P=0.209      P=0.483      P=0.121N   |  P=0.340      P=0.042N*    P=0.270N     P=0.349N   |
|INCIDENTAL TUMOR       |  P=0.129N     P=0.279      P=0.254      P=0.337N   |  P=0.486      P=0.506N     P=0.463N     P=0.565N   |
|LOGISTIC REGRESSION    |  P=0.076N     P=0.273      P=0.283      P=0.191N   |  P=0.418      P=0.282N     P=0.507N     P=0.565N   |
|COCHRAN-ARMITAGE       |  P=0.086N                                          |  P=0.427                                           |
|FISHER EXACT           |               P=0.248      P=0.367      P=0.249N   |               P=0.368N     P=0.433N     P=0.567N   |
|=================================================================================================================================|
 
 (a)  Number of tumor-bearing animals / number of animals examined at site.
 (b)  Kaplan-Meier estimated lifetime tumor incidence after adjustment for 
      intercurrent mortality.
 (c)  Observed incidence at interim kill.
          Male interim sacrifices(days):   273  450
          Female interim sacrifices(days): 273  450
 (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).