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TDMS Study 05086-02 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                                  O-BENZYL-P-CHLOROPHENOL                                DATE: 09/11/94       
EXPERIMENT: 05086 TEST: 02                                                                                     TIME: 09:32:40       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-45042          ROUTE: GAVAGE                                                                      NTP C#: 61201C       
PATHOLOGIST: M. RYAN                                                                                           CAS: 120-32-1        
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               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08    
LAB: Battelle Columbus                                  O-BENZYL-P-CHLOROPHENOL                                DATE: 09/11/94      
EXPERIMENT: 05086 TEST: 02                                                                                     TIME: 09:32:40      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01-ES-45042          ROUTE: GAVAGE                                                                      NTP C#: 61201C      
PATHOLOGIST: M. RYAN                                                                                           CAS: 120-32-1       
 
 
 
 
 
                                                    MICE(B6C3F1)
                                              ----------------------------
             FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
             IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
 
 
                                                    ----------------
 
                                                    Adrenal 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: Battelle Columbus                                  O-BENZYL-P-CHLOROPHENOL                                DATE: 09/11/94       
EXPERIMENT: 05086 TEST: 02                                                                                     TIME: 09:32:40       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-45042          ROUTE: GAVAGE                                                                      NTP C#: 61201C       
PATHOLOGIST: M. RYAN                                                                                           CAS: 120-32-1        
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                    IN THE ANALYSIS OF THE STUDY OF O-BENZYL-P-CHLOROPHENOL
 
              ====================================================================================================
 
                                                           MALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Kidney: Renal Tubule          Carcinoma or Adenoma
                             Lung                          Alveolar/Bronchiolar Adenoma
                                                           Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
 
              ====================================================================================================
 
                                                           FEMALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Liver                         Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma or Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
                             Pituitary Gland: Pars Distalis or Unspecified Site
                                                           Adenoma
                             Uterus                        Polyp Stromal
                             All Organs                    Malignant Lymphoma And Histiocytic Sarcoma
                                                           Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,
                                                            NOS, or Undifferentiated Cell Type
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
         DATE: 09/11/94                     EXPERIMENT: 05086 TEST: 02                                                 PAGE   1
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- O-BENZYL-P-CHLOROPHENOL
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      120MG/KG     240MG/KG     480MG/KG  |   0 MG/KG      120MG/KG     240MG/KG     480MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Gland: Non-medullary, Non-cortical                                                                                       |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/70 (1%)    1/70 (1%)    4/70 (6%)    1/69 (1%)  |  0/70 (0%)    0/70 (0%)    0/70 (0%)    0/70 (0%)  |
|ADJUSTED (b)           |   2.2%         3.0%        10.0%         3.3%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  1/45 (2%)    1/33 (3%)    4/40 (10%)   1/30 (3%)  |  0/37 (0%)    0/40 (0%)    0/33 (0%)    0/25 (0%)  |
|FIRST INCIDENCE (DAYS) |   722 (T)      722 (T)      722 (T)      722 (T)   |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.396      P=0.691      P=0.146      P=0.669    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.396      P=0.691      P=0.146      P=0.669    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.396      P=0.691      P=0.146      P=0.669    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.520                                           |    (e)                                             |
|FISHER EXACT           |               P=0.752N     P=0.183      P=0.748    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/70 (4%)    2/70 (3%)    4/70 (6%)    2/70 (3%)  |  4/70 (6%)    1/70 (1%)    2/70 (3%)    3/70 (4%)  |
|ADJUSTED (b)           |   6.4%         6.1%         8.6%         5.2%      |   9.5%         2.2%         5.5%         9.8%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    1/10 (10%) |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  2/45 (4%)    2/33 (6%)    2/40 (5%)    0/30 (0%)  |  2/37 (5%)    0/40 (0%)    1/33 (3%)    1/25 (4%)  |
|FIRST INCIDENCE (DAYS) |   650          722 (T)      433          456 (I)   |   605          588          685          658       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.563      P=0.623N     P=0.448      P=0.628N   |  P=0.469      P=0.189N     P=0.392N     P=0.623    |
|INCIDENTAL TUMOR       |  P=0.404N     P=0.552N     P=0.588N     P=0.489N   |  P=0.520N     P=0.268N     P=0.401N     P=0.544N   |
|LOGISTIC REGRESSION    |  P=0.528N     P=0.574N     P=0.483      P=0.555N   |  P=0.490N     P=0.194N     P=0.373N     P=0.609N   |
|COCHRAN-ARMITAGE       |  P=0.479N                                          |  P=0.543N                                          |
|FISHER EXACT           |               P=0.500N     P=0.500      P=0.500N   |               P=0.183N     P=0.340N     P=0.500N   |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05086 TEST: 02                                                 PAGE   2
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- O-BENZYL-P-CHLOROPHENOL
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      120MG/KG     240MG/KG     480MG/KG  |   0 MG/KG      120MG/KG     240MG/KG     480MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney: Renal Tubule                                                                                                             |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/70 (0%)    2/70 (3%)    2/70 (3%)    2/70 (3%)  |  0/70 (0%)    0/70 (0%)    0/70 (0%)    0/70 (0%)  |
|ADJUSTED (b)           |   0.0%         6.1%         5.0%         6.2%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  0/45 (0%)    2/33 (6%)    2/40 (5%)    1/30 (3%)  |  0/37 (0%)    0/40 (0%)    0/33 (0%)    0/25 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          722 (T)      722 (T)      692       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.156      P=0.173      P=0.213      P=0.162    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.176      P=0.173      P=0.213      P=0.241    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.171      P=0.173      P=0.213      P=0.184    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.243                                           |    (e)                                             |
|FISHER EXACT           |               P=0.248      P=0.248      P=0.248    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney: Renal Tubule                                                                                                             |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/70 (0%)    0/70 (0%)    2/70 (3%)    1/70 (1%)  |  0/70 (0%)    0/70 (0%)    0/70 (0%)    0/70 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         5.0%         3.3%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  0/45 (0%)    0/33 (0%)    2/40 (5%)    1/30 (3%)  |  0/37 (0%)    0/40 (0%)    0/33 (0%)    0/25 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          722 (T)      722 (T)   |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.179        (e)        P=0.213      P=0.419    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.179        (e)        P=0.213      P=0.419    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.179        (e)        P=0.213      P=0.419    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.246                                           |    (e)                                             |
|FISHER EXACT           |                 (e)        P=0.248      P=0.500    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05086 TEST: 02                                                 PAGE   3
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- O-BENZYL-P-CHLOROPHENOL
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      120MG/KG     240MG/KG     480MG/KG  |   0 MG/KG      120MG/KG     240MG/KG     480MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney: Renal Tubule                                                                                                             |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/70 (0%)    2/70 (3%)    4/70 (6%)    3/70 (4%)  |  0/70 (0%)    0/70 (0%)    0/70 (0%)    0/70 (0%)  |
|ADJUSTED (b)           |   0.0%         6.1%        10.0%         9.4%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  0/45 (0%)    2/33 (6%)    4/40 (10%)   2/30 (7%)  |  0/37 (0%)    0/40 (0%)    0/33 (0%)    0/25 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          722 (T)      722 (T)      692       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.054      P=0.173      P=0.049 *    P=0.064    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.062      P=0.173      P=0.049 *    P=0.099    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.061      P=0.173      P=0.049 *    P=0.077    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.115                                           |    (e)                                             |
|FISHER EXACT           |               P=0.248      P=0.060      P=0.122    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/70 (4%)    0/70 (0%)    1/70 (1%)    2/70 (3%)  |  0/70 (0%)    0/70 (0%)    0/70 (0%)    0/70 (0%)  |
|ADJUSTED (b)           |   6.7%         0.0%         2.5%         5.3%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  3/45 (7%)    0/33 (0%)    1/40 (3%)    0/30 (0%)  |  0/37 (0%)    0/40 (0%)    0/33 (0%)    0/25 (0%)  |
|FIRST INCIDENCE (DAYS) |   722 (T)      ---          722 (T)      651       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.563      P=0.181N     P=0.348N     P=0.653N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.610      P=0.181N     P=0.348N     P=0.526N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.596      P=0.181N     P=0.348N     P=0.600N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.555N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.122N     P=0.310N     P=0.500N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05086 TEST: 02                                                 PAGE   4
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- O-BENZYL-P-CHLOROPHENOL
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      120MG/KG     240MG/KG     480MG/KG  |   0 MG/KG      120MG/KG     240MG/KG     480MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 21/70 (30%)  18/70 (26%)  20/70 (29%)  15/70 (21%) | 11/70 (16%)  14/70 (20%)  15/70 (21%)  14/70 (20%) |
|ADJUSTED (b)           |  45.6%        47.6%        41.8%        38.8%      |  27.3%        35.0%        42.3%        50.3%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    1/10 (10%)   1/10 (10%)   2/10 (20%) |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           | 20/45 (44%)  14/33 (42%)  13/40 (33%)   9/30 (30%) |  8/37 (22%)  14/40 (35%)  13/33 (39%)  12/25 (48%) |
|FIRST INCIDENCE (DAYS) |   646          455 (I)      433          387       |   694          722 (T)      668          437       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.531N     P=0.374      P=0.483      P=0.556    |  P=0.030 *    P=0.395      P=0.159      P=0.062    |
|INCIDENTAL TUMOR       |  P=0.187N     P=0.565      P=0.393N     P=0.222N   |  P=0.077      P=0.265      P=0.182      P=0.133    |
|LOGISTIC REGRESSION    |  P=0.321N     P=0.565N     P=0.551      P=0.355N   |  P=0.081      P=0.295      P=0.164      P=0.114    |
|COCHRAN-ARMITAGE       |  P=0.168N                                          |  P=0.322                                           |
|FISHER EXACT           |               P=0.353N     P=0.500N     P=0.167N   |               P=0.330      P=0.257      P=0.330    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  7/70 (10%)  12/70 (17%)  11/70 (16%)   5/70 (7%)  |  2/70 (3%)    1/70 (1%)    3/70 (4%)    3/70 (4%)  |
|ADJUSTED (b)           |  14.8%        29.7%        23.7%        11.9%      |   5.4%         2.5%         8.1%         9.4%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    1/10 (10%) |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  5/45 (11%)   5/33 (15%)   6/40 (15%)   0/30 (0%)  |  2/37 (5%)    1/40 (3%)    1/33 (3%)    1/25 (4%)  |
|FIRST INCIDENCE (DAYS) |   650          650          370          456 (I)   |   722 (T)      722 (T)      678          554       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.447N     P=0.058      P=0.165      P=0.596N   |  P=0.167      P=0.473N     P=0.455      P=0.346    |
|INCIDENTAL TUMOR       |  P=0.104N     P=0.232      P=0.316      P=0.156N   |  P=0.282      P=0.473N     P=0.488      P=0.413    |
|LOGISTIC REGRESSION    |  P=0.220N     P=0.084      P=0.188      P=0.248N   |  P=0.219      P=0.473N     P=0.459      P=0.411    |
|COCHRAN-ARMITAGE       |  P=0.223N                                          |  P=0.303                                           |
|FISHER EXACT           |               P=0.162      P=0.225      P=0.382N   |               P=0.500N     P=0.500      P=0.500    |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05086 TEST: 02                                                 PAGE   5
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- O-BENZYL-P-CHLOROPHENOL
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      120MG/KG     240MG/KG     480MG/KG  |   0 MG/KG      120MG/KG     240MG/KG     480MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 25/70 (36%)  26/70 (37%)  27/70 (39%)  18/70 (26%) | 13/70 (19%)  15/70 (21%)  17/70 (24%)  16/70 (23%) |
|ADJUSTED (b)           |  52.0%        60.1%        53.5%        43.5%      |  32.3%        37.5%        46.7%        53.1%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    1/10 (10%)   1/10 (10%)   2/10 (20%) |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           | 22/45 (49%)  16/33 (48%)  17/40 (43%)   9/30 (30%) | 10/37 (27%)  15/40 (38%)  14/33 (42%)  12/25 (48%) |
|FIRST INCIDENCE (DAYS) |   646          455 (I)      370          387       |   694          722 (T)      668          437       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.485N     P=0.105      P=0.257      P=0.544    |  P=0.021 *    P=0.497      P=0.160      P=0.056    |
|INCIDENTAL TUMOR       |  P=0.063N     P=0.403      P=0.565N     P=0.106N   |  P=0.070      P=0.363      P=0.184      P=0.132    |
|LOGISTIC REGRESSION    |  P=0.233N     P=0.247      P=0.315      P=0.316N   |  P=0.067      P=0.385      P=0.162      P=0.112    |
|COCHRAN-ARMITAGE       |  P=0.101N                                          |  P=0.304                                           |
|FISHER EXACT           |               P=0.500      P=0.431      P=0.136N   |               P=0.416      P=0.269      P=0.339    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 25/70 (36%)  26/70 (37%)  27/70 (39%)  18/70 (26%) | 13/70 (19%)  15/70 (21%)  17/70 (24%)  16/70 (23%) |
|ADJUSTED (b)           |  52.0%        60.1%        53.5%        43.5%      |  32.3%        37.5%        46.7%        53.1%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    1/10 (10%)   1/10 (10%)   2/10 (20%) |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           | 22/45 (49%)  16/33 (48%)  17/40 (43%)   9/30 (30%) | 10/37 (27%)  15/40 (38%)  14/33 (42%)  12/25 (48%) |
|FIRST INCIDENCE (DAYS) |   646          455 (I)      370          387       |   694          722 (T)      668          437       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.485N     P=0.105      P=0.257      P=0.544    |  P=0.021 *    P=0.497      P=0.160      P=0.056    |
|INCIDENTAL TUMOR       |  P=0.063N     P=0.403      P=0.565N     P=0.106N   |  P=0.070      P=0.363      P=0.184      P=0.132    |
|LOGISTIC REGRESSION    |  P=0.233N     P=0.247      P=0.315      P=0.316N   |  P=0.067      P=0.385      P=0.162      P=0.112    |
|COCHRAN-ARMITAGE       |  P=0.101N                                          |  P=0.304                                           |
|FISHER EXACT           |               P=0.500      P=0.431      P=0.136N   |               P=0.416      P=0.269      P=0.339    |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05086 TEST: 02                                                 PAGE   6
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- O-BENZYL-P-CHLOROPHENOL
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      120MG/KG     240MG/KG     480MG/KG  |   0 MG/KG      120MG/KG     240MG/KG     480MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 13/70 (19%)  12/70 (17%)   6/70 (9%)    6/70 (9%)  |  3/69 (4%)    1/70 (1%)    0/70 (0%)    4/70 (6%)  |
|ADJUSTED (b)           |  27.3%        30.9%        15.0%        16.7%      |   7.4%         2.5%         0.0%        10.3%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  1/10 (10%)   2/10 (20%)   0/10 (0%)    2/10 (20%) |  0/10 (0%)    0/10 (0%)    0/10 (0%)    1/9 (11%)  |
|TERMINAL (d)           | 11/45 (24%)   8/33 (24%)   6/40 (15%)   4/30 (13%) |  2/36 (6%)    1/40 (3%)    0/33 (0%)    1/25 (4%)  |
|FIRST INCIDENCE (DAYS) |   455 (I)      456 (I)      722 (T)      455 (I)   |   560          722 (T)      ---          455 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.102N     P=0.390      P=0.106N     P=0.235N   |  P=0.209      P=0.286N     P=0.140N     P=0.364    |
|INCIDENTAL TUMOR       |  P=0.075N     P=0.569      P=0.115N     P=0.204N   |  P=0.353      P=0.303N     P=0.175N     P=0.569    |
|LOGISTIC REGRESSION    |  P=0.057N     P=0.560      P=0.095N     P=0.130N   |  P=0.289      P=0.316N     P=0.129N     P=0.474    |
|COCHRAN-ARMITAGE       |  P=0.030N*                                         |  P=0.318                                           |
|FISHER EXACT           |               P=0.500N     P=0.069N     P=0.069N   |               P=0.304N     P=0.120N     P=0.508    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/70 (3%)    3/70 (4%)    1/70 (1%)    1/70 (1%)  |  2/69 (3%)    2/70 (3%)    1/70 (1%)    1/70 (1%)  |
|ADJUSTED (b)           |   4.4%         8.6%         2.2%         3.3%      |   5.0%         5.0%         3.0%         4.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  2/45 (4%)    2/33 (6%)    0/40 (0%)    1/30 (3%)  |  1/36 (3%)    2/40 (5%)    1/33 (3%)    1/25 (4%)  |
|FIRST INCIDENCE (DAYS) |   722 (T)      687          588          722 (T)   |   694          722 (T)      722 (T)      722 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.383N     P=0.366      P=0.537N     P=0.640N   |  P=0.471N     P=0.669N     P=0.537N     P=0.625N   |
|INCIDENTAL TUMOR       |  P=0.280N     P=0.448      P=0.265N     P=0.640N   |  P=0.417N     P=0.635      P=0.508N     P=0.561N   |
|LOGISTIC REGRESSION    |  P=0.342N     P=0.411      P=0.519N     P=0.640N   |  P=0.435N     P=0.689      P=0.524N     P=0.595N   |
|COCHRAN-ARMITAGE       |  P=0.280N                                          |  P=0.334N                                          |
|FISHER EXACT           |               P=0.500      P=0.500N     P=0.500N   |               P=0.685N     P=0.495N     P=0.495N   |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05086 TEST: 02                                                 PAGE   7
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- O-BENZYL-P-CHLOROPHENOL
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      120MG/KG     240MG/KG     480MG/KG  |   0 MG/KG      120MG/KG     240MG/KG     480MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 15/70 (21%)  15/70 (21%)   7/70 (10%)   7/70 (10%) |  5/69 (7%)    3/70 (4%)    1/70 (1%)    5/70 (7%)  |
|ADJUSTED (b)           |  31.6%        38.2%        16.8%        19.9%      |  12.3%         7.5%         3.0%        14.1%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  1/10 (10%)   2/10 (20%)   0/10 (0%)    2/10 (20%) |  0/10 (0%)    0/10 (0%)    0/10 (0%)    1/9 (11%)  |
|TERMINAL (d)           | 13/45 (29%)  10/33 (30%)   6/40 (15%)   5/30 (17%) |  3/36 (8%)    3/40 (8%)    1/33 (3%)    2/25 (8%)  |
|FIRST INCIDENCE (DAYS) |   455 (I)      456 (I)      588          455 (I)   |   560          722 (T)      722 (T)      455 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.077N     P=0.265      P=0.086N     P=0.217N   |  P=0.350      P=0.325N     P=0.131N     P=0.443    |
|INCIDENTAL TUMOR       |  P=0.043N*    P=0.453      P=0.053N     P=0.189N   |  P=0.517      P=0.402N     P=0.143N     P=0.617N   |
|LOGISTIC REGRESSION    |  P=0.038N*    P=0.439      P=0.072N     P=0.111N   |  P=0.466      P=0.374N     P=0.117N     P=0.570    |
|COCHRAN-ARMITAGE       |  P=0.017N*                                         |  P=0.543                                           |
|FISHER EXACT           |               P=0.581N     P=0.051N     P=0.051N   |               P=0.351N     P=0.101N     P=0.619N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Granulosa Cell Tumor Benign                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  2/69 (3%)    0/69 (0%)    0/69 (0%)    0/69 (0%)  |
|ADJUSTED (b)           |                                                    |   5.6%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|                                                    |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|                                                    |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |                                                    |  2/36 (6%)    0/39 (0%)    0/33 (0%)    0/25 (0%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   722 (T)      ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.143N     P=0.221N     P=0.258N     P=0.322N   |
|INCIDENTAL TUMOR       |                                                    |  P=0.143N     P=0.221N     P=0.258N     P=0.322N   |
|LOGISTIC REGRESSION    |                                                    |  P=0.143N     P=0.221N     P=0.258N     P=0.322N   |
|COCHRAN-ARMITAGE       |                                                    |  P=0.115N                                          |
|FISHER EXACT           |                                                    |               P=0.248N     P=0.248N     P=0.248N   |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05086 TEST: 02                                                 PAGE   8
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- O-BENZYL-P-CHLOROPHENOL
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      120MG/KG     240MG/KG     480MG/KG  |   0 MG/KG      120MG/KG     240MG/KG     480MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/67 (0%)    0/68 (0%)    0/67 (0%)    0/66 (0%)  |  8/67 (12%)   4/70 (6%)    5/67 (7%)    1/67 (1%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |  21.3%        10.0%        15.1%         2.9%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  0/42 (0%)    0/32 (0%)    0/38 (0%)    0/30 (0%)  |  7/36 (19%)   4/40 (10%)   4/32 (13%)   0/25 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   692          722 (T)      714          652       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.061N     P=0.136N     P=0.358N     P=0.060N   |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.039N*    P=0.165N     P=0.330N     P=0.039N*  |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.045N*    P=0.164N     P=0.343N     P=0.043N*  |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.020N*                                         |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.162N     P=0.281N     P=0.016N*  |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibrosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/70 (0%)    0/70 (0%)    0/70 (0%)    1/70 (1%)  |  3/70 (4%)    0/70 (0%)    0/70 (0%)    1/70 (1%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         3.3%      |   6.9%         0.0%         0.0%         4.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  0/45 (0%)    0/33 (0%)    0/40 (0%)    1/30 (3%)  |  0/37 (0%)    0/40 (0%)    0/33 (0%)    1/25 (4%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          722 (T)   |   645          ---          ---          722 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.161        (e)          (e)        P=0.419    |  P=0.324N     P=0.131N     P=0.142N     P=0.428N   |
|INCIDENTAL TUMOR       |  P=0.161        (e)          (e)        P=0.419    |  P=0.191N     P=0.356N     P=0.093N     P=0.280N   |
|LOGISTIC REGRESSION    |  P=0.160        (e)          (e)        P=0.419    |  P=0.294N     P=0.130N     P=0.134N     P=0.387N   |
|COCHRAN-ARMITAGE       |  P=0.199                                           |  P=0.248N                                          |
|FISHER EXACT           |                 (e)          (e)        P=0.500    |               P=0.122N     P=0.122N     P=0.310N   |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05086 TEST: 02                                                 PAGE   9
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- O-BENZYL-P-CHLOROPHENOL
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      120MG/KG     240MG/KG     480MG/KG  |   0 MG/KG      120MG/KG     240MG/KG     480MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/70 (0%)    2/70 (3%)    1/70 (1%)    0/70 (0%)  |  0/70 (0%)    0/70 (0%)    0/70 (0%)    0/70 (0%)  |
|ADJUSTED (b)           |   0.0%         5.5%         2.5%         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%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  0/45 (0%)    1/33 (3%)    1/40 (3%)    0/30 (0%)  |  0/37 (0%)    0/40 (0%)    0/33 (0%)    0/25 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          677          722 (T)      ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.537N     P=0.185      P=0.477        (e)      |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.501N     P=0.274      P=0.477        (e)      |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.515N     P=0.207      P=0.477        (e)      |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.461N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.248      P=0.500        (e)      |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,                                                                                   |
|     Neurofibroma, or Fibroma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/70 (0%)    0/70 (0%)    0/70 (0%)    1/70 (1%)  |  4/70 (6%)    0/70 (0%)    0/70 (0%)    1/70 (1%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         3.3%      |   9.4%         0.0%         0.0%         4.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  0/45 (0%)    0/33 (0%)    0/40 (0%)    1/30 (3%)  |  1/37 (3%)    0/40 (0%)    0/33 (0%)    1/25 (4%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          722 (T)   |   645          ---          ---          722 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.161        (e)          (e)        P=0.419    |  P=0.185N     P=0.068N     P=0.081N     P=0.298N   |
|INCIDENTAL TUMOR       |  P=0.161        (e)          (e)        P=0.419    |  P=0.104N     P=0.181N     P=0.052N     P=0.185N   |
|LOGISTIC REGRESSION    |  P=0.160        (e)          (e)        P=0.419    |  P=0.161N     P=0.070N     P=0.073N     P=0.257N   |
|COCHRAN-ARMITAGE       |  P=0.199                                           |  P=0.126N                                          |
|FISHER EXACT           |                 (e)          (e)        P=0.500    |               P=0.060N     P=0.060N     P=0.183N   |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05086 TEST: 02                                                 PAGE  10
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- O-BENZYL-P-CHLOROPHENOL
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      120MG/KG     240MG/KG     480MG/KG  |   0 MG/KG      120MG/KG     240MG/KG     480MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, or Sarcoma                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/70 (0%)    0/70 (0%)    0/70 (0%)    1/70 (1%)  |  4/70 (6%)    0/70 (0%)    0/70 (0%)    1/70 (1%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         3.3%      |   9.4%         0.0%         0.0%         4.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  0/45 (0%)    0/33 (0%)    0/40 (0%)    1/30 (3%)  |  1/37 (3%)    0/40 (0%)    0/33 (0%)    1/25 (4%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          722 (T)   |   645          ---          ---          722 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.161        (e)          (e)        P=0.419    |  P=0.185N     P=0.068N     P=0.081N     P=0.298N   |
|INCIDENTAL TUMOR       |  P=0.161        (e)          (e)        P=0.419    |  P=0.104N     P=0.181N     P=0.052N     P=0.185N   |
|LOGISTIC REGRESSION    |  P=0.160        (e)          (e)        P=0.419    |  P=0.161N     P=0.070N     P=0.073N     P=0.257N   |
|COCHRAN-ARMITAGE       |  P=0.199                                           |  P=0.126N                                          |
|FISHER EXACT           |                 (e)          (e)        P=0.500    |               P=0.060N     P=0.060N     P=0.183N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Spleen                                                                                                                           |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/70 (1%)    0/70 (0%)    2/69 (3%)    1/70 (1%)  |  0/70 (0%)    2/70 (3%)    1/70 (1%)    1/70 (1%)  |
|ADJUSTED (b)           |   2.2%         0.0%         4.7%         2.6%      |   0.0%         5.0%         3.0%         3.6%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  1/45 (2%)    0/33 (0%)    1/40 (3%)    0/30 (0%)  |  0/37 (0%)    2/40 (5%)    1/33 (3%)    0/25 (0%)  |
|FIRST INCIDENCE (DAYS) |   722 (T)      ---          615          651       |   ---          722 (T)      722 (T)      714       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.421      P=0.562N     P=0.458      P=0.688    |  P=0.379      P=0.256      P=0.477      P=0.439    |
|INCIDENTAL TUMOR       |  P=0.562      P=0.562N     P=0.735      P=0.759N   |  P=0.445      P=0.256      P=0.477      P=0.540    |
|LOGISTIC REGRESSION    |  P=0.457      P=0.562N     P=0.476      P=0.722    |  P=0.395      P=0.256      P=0.477      P=0.440    |
|COCHRAN-ARMITAGE       |  P=0.500                                           |  P=0.500                                           |
|FISHER EXACT           |               P=0.500N     P=0.495      P=0.752N   |               P=0.248      P=0.500      P=0.500    |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05086 TEST: 02                                                 PAGE  11
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- O-BENZYL-P-CHLOROPHENOL
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      120MG/KG     240MG/KG     480MG/KG  |   0 MG/KG      120MG/KG     240MG/KG     480MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Squamous Cell Carcinoma or Papilloma Squamous                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/70 (3%)    1/70 (1%)    2/70 (3%)    2/70 (3%)  |  0/70 (0%)    3/70 (4%)    2/70 (3%)    1/70 (1%)  |
|ADJUSTED (b)           |   4.4%         2.5%         5.0%         6.7%      |   0.0%         7.2%         6.1%         3.6%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  2/45 (4%)    0/33 (0%)    2/40 (5%)    2/30 (7%)  |  0/37 (0%)    2/40 (5%)    2/33 (6%)    0/25 (0%)  |
|FIRST INCIDENCE (DAYS) |   722 (T)      673          722 (T)      722 (T)   |   ---          600          722 (T)      714       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.401      P=0.592N     P=0.652      P=0.541    |  P=0.418      P=0.126      P=0.213      P=0.439    |
|INCIDENTAL TUMOR       |  P=0.426      P=0.494N     P=0.652      P=0.541    |  P=0.489      P=0.115      P=0.213      P=0.540    |
|LOGISTIC REGRESSION    |  P=0.430      P=0.555N     P=0.652      P=0.541    |  P=0.471      P=0.112      P=0.213      P=0.440    |
|COCHRAN-ARMITAGE       |  P=0.526                                           |  P=0.555                                           |
|FISHER EXACT           |               P=0.500N     P=0.690N     P=0.690N   |               P=0.122      P=0.248      P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/70 (1%)    0/70 (0%)    2/70 (3%)    2/70 (3%)  |  0/70 (0%)    3/70 (4%)    2/70 (3%)    1/70 (1%)  |
|ADJUSTED (b)           |   2.2%         0.0%         5.0%         6.7%      |   0.0%         7.2%         6.1%         3.6%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  1/45 (2%)    0/33 (0%)    2/40 (5%)    2/30 (7%)  |  0/37 (0%)    2/40 (5%)    2/33 (6%)    0/25 (0%)  |
|FIRST INCIDENCE (DAYS) |   722 (T)      ---          722 (T)      722 (T)   |   ---          600          722 (T)      714       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.162      P=0.562N     P=0.459      P=0.360    |  P=0.418      P=0.126      P=0.213      P=0.439    |
|INCIDENTAL TUMOR       |  P=0.162      P=0.562N     P=0.459      P=0.360    |  P=0.489      P=0.115      P=0.213      P=0.540    |
|LOGISTIC REGRESSION    |  P=0.162      P=0.562N     P=0.459      P=0.360    |  P=0.471      P=0.112      P=0.213      P=0.440    |
|COCHRAN-ARMITAGE       |  P=0.246                                           |  P=0.555                                           |
|FISHER EXACT           |               P=0.500N     P=0.500      P=0.500    |               P=0.122      P=0.248      P=0.500    |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05086 TEST: 02                                                 PAGE  12
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- O-BENZYL-P-CHLOROPHENOL
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      120MG/KG     240MG/KG     480MG/KG  |   0 MG/KG      120MG/KG     240MG/KG     480MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/70 (1%)    2/70 (3%)    0/70 (0%)    0/70 (0%)  |  1/69 (1%)    1/70 (1%)    0/70 (0%)    1/70 (1%)  |
|ADJUSTED (b)           |   2.2%         6.1%         0.0%         0.0%      |   2.8%         2.5%         0.0%         4.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  1/45 (2%)    2/33 (6%)    0/40 (0%)    0/30 (0%)  |  1/36 (3%)    1/40 (3%)    0/33 (0%)    1/25 (4%)  |
|FIRST INCIDENCE (DAYS) |   722 (T)      722 (T)      ---          ---       |   722 (T)      722 (T)      ---          722 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.243N     P=0.392      P=0.523N     P=0.581N   |  P=0.602      P=0.738N     P=0.517N     P=0.678    |
|INCIDENTAL TUMOR       |  P=0.243N     P=0.392      P=0.523N     P=0.581N   |  P=0.602      P=0.738N     P=0.517N     P=0.678    |
|LOGISTIC REGRESSION    |  P=0.243N     P=0.392      P=0.523N     P=0.581N   |  P=0.602      P=0.738N     P=0.517N     P=0.678    |
|COCHRAN-ARMITAGE       |  P=0.189N                                          |  P=0.613N                                          |
|FISHER EXACT           |               P=0.500      P=0.500N     P=0.500N   |               P=0.748N     P=0.496N     P=0.748N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Leiomyosarcoma                                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  0/70 (0%)    2/70 (3%)    0/70 (0%)    1/70 (1%)  |
|ADJUSTED (b)           |                                                    |   0.0%         5.0%         0.0%         4.0%      |
|INTERIM SACRIFICE 1 (c)|                                                    |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|                                                    |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |                                                    |  0/37 (0%)    2/40 (5%)    0/33 (0%)    1/25 (4%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   ---          722 (T)      ---          722 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.429      P=0.256        (e)        P=0.422    |
|INCIDENTAL TUMOR       |                                                    |  P=0.429      P=0.256        (e)        P=0.422    |
|LOGISTIC REGRESSION    |                                                    |  P=0.429      P=0.256        (e)        P=0.422    |
|COCHRAN-ARMITAGE       |                                                    |  P=0.539                                           |
|FISHER EXACT           |                                                    |               P=0.248        (e)        P=0.500    |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05086 TEST: 02                                                 PAGE  13
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- O-BENZYL-P-CHLOROPHENOL
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      120MG/KG     240MG/KG     480MG/KG  |   0 MG/KG      120MG/KG     240MG/KG     480MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  1/70 (1%)    2/70 (3%)    0/70 (0%)    0/70 (0%)  |
|ADJUSTED (b)           |                                                    |   2.4%         4.4%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|                                                    |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|                                                    |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |                                                    |  0/37 (0%)    0/40 (0%)    0/33 (0%)    0/25 (0%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   706          510          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.232N     P=0.487      P=0.520N     P=0.569N   |
|INCIDENTAL TUMOR       |                                                    |  P=0.047N*    P=0.500      P=0.479N     P=0.460N   |
|LOGISTIC REGRESSION    |                                                    |  P=0.155N     P=0.447      P=0.517N     P=0.553N   |
|COCHRAN-ARMITAGE       |                                                    |  P=0.189N                                          |
|FISHER EXACT           |                                                    |               P=0.500      P=0.500N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangioma                                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/70 (3%)    0/70 (0%)    0/70 (0%)    1/70 (1%)  |  1/70 (1%)    1/70 (1%)    0/70 (0%)    1/70 (1%)  |
|ADJUSTED (b)           |   4.4%         0.0%         0.0%         3.3%      |   2.7%         2.5%         0.0%         4.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  2/45 (4%)    0/33 (0%)    0/40 (0%)    1/30 (3%)  |  1/37 (3%)    1/40 (3%)    0/33 (0%)    1/25 (4%)  |
|FIRST INCIDENCE (DAYS) |   722 (T)      ---          ---          722 (T)   |   722 (T)      722 (T)      ---          722 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.545N     P=0.309N     P=0.265N     P=0.640N   |  P=0.596      P=0.744N     P=0.523N     P=0.672    |
|INCIDENTAL TUMOR       |  P=0.545N     P=0.309N     P=0.265N     P=0.640N   |  P=0.596      P=0.744N     P=0.523N     P=0.672    |
|LOGISTIC REGRESSION    |  P=0.545N     P=0.309N     P=0.265N     P=0.640N   |  P=0.596      P=0.744N     P=0.523N     P=0.672    |
|COCHRAN-ARMITAGE       |  P=0.461N                                          |  P=0.616N                                          |
|FISHER EXACT           |               P=0.248N     P=0.248N     P=0.500N   |               P=0.752N     P=0.500N     P=0.752N   |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05086 TEST: 02                                                 PAGE  14
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- O-BENZYL-P-CHLOROPHENOL
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      120MG/KG     240MG/KG     480MG/KG  |   0 MG/KG      120MG/KG     240MG/KG     480MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/70 (6%)    2/70 (3%)    4/70 (6%)    3/70 (4%)  |  1/70 (1%)    4/70 (6%)    1/70 (1%)    1/70 (1%)  |
|ADJUSTED (b)           |   8.9%         5.5%         9.6%         8.5%      |   2.7%         9.5%         3.0%         3.6%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  4/45 (9%)    1/33 (3%)    3/40 (8%)    1/30 (3%)  |  1/37 (3%)    3/40 (8%)    1/33 (3%)    0/25 (0%)  |
|FIRST INCIDENCE (DAYS) |   722 (T)      677          615          651       |   722 (T)      510          722 (T)      714       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.476      P=0.479N     P=0.576      P=0.614    |  P=0.515N     P=0.197      P=0.736      P=0.681    |
|INCIDENTAL TUMOR       |  P=0.567N     P=0.405N     P=0.564N     P=0.585N   |  P=0.311N     P=0.333      P=0.736      P=0.742    |
|LOGISTIC REGRESSION    |  P=0.530      P=0.427N     P=0.590      P=0.630N   |  P=0.449N     P=0.166      P=0.736      P=0.689    |
|COCHRAN-ARMITAGE       |  P=0.519N                                          |  P=0.373N                                          |
|FISHER EXACT           |               P=0.340N     P=0.641N     P=0.500N   |               P=0.183      P=0.752N     P=0.752N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma or Hemangioma                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  6/70 (9%)    2/70 (3%)    4/70 (6%)    4/70 (6%)  |  2/70 (3%)    5/70 (7%)    1/70 (1%)    2/70 (3%)  |
|ADJUSTED (b)           |  13.3%         5.5%         9.6%        11.6%      |   5.4%        11.9%         3.0%         7.4%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  6/45 (13%)   1/33 (3%)    3/40 (8%)    2/30 (7%)  |  2/37 (5%)    4/40 (10%)   1/33 (3%)    1/25 (4%)  |
|FIRST INCIDENCE (DAYS) |   722 (T)      677          615          651       |   722 (T)      510          722 (T)      714       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.529      P=0.250N     P=0.446N     P=0.613N   |  P=0.552N     P=0.242      P=0.540N     P=0.555    |
|INCIDENTAL TUMOR       |  P=0.509N     P=0.200N     P=0.303N     P=0.519N   |  P=0.375N     P=0.373      P=0.540N     P=0.605    |
|LOGISTIC REGRESSION    |  P=0.556N     P=0.206N     P=0.434N     P=0.539N   |  P=0.476N     P=0.197      P=0.540N     P=0.567    |
|COCHRAN-ARMITAGE       |  P=0.431N                                          |  P=0.372N                                          |
|FISHER EXACT           |               P=0.137N     P=0.372N     P=0.372N   |               P=0.221      P=0.500N     P=0.690N   |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05086 TEST: 02                                                 PAGE  15
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- O-BENZYL-P-CHLOROPHENOL
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      120MG/KG     240MG/KG     480MG/KG  |   0 MG/KG      120MG/KG     240MG/KG     480MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma And Histiocytic Sarcoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/70 (3%)    0/70 (0%)    0/70 (0%)    1/70 (1%)  |  9/70 (13%)   9/70 (13%)  10/70 (14%)   3/70 (4%)  |
|ADJUSTED (b)           |   4.3%         0.0%         0.0%         3.3%      |  20.9%        20.8%        26.2%         8.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  1/45 (2%)    0/33 (0%)    0/40 (0%)    1/30 (3%)  |  5/37 (14%)   6/40 (15%)   7/33 (21%)   0/25 (0%)  |
|FIRST INCIDENCE (DAYS) |   699          ---          ---          722 (T)   |   640          588          449          437       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.540N     P=0.308N     P=0.265N     P=0.633N   |  P=0.198N     P=0.574N     P=0.406      P=0.176N   |
|INCIDENTAL TUMOR       |  P=0.501N     P=0.194N     P=0.310N     P=0.540N   |  P=0.036N*    P=0.356      P=0.485      P=0.036N*  |
|LOGISTIC REGRESSION    |  P=0.522N     P=0.275N     P=0.260N     P=0.598N   |  P=0.071N     P=0.332      P=0.406      P=0.071N   |
|COCHRAN-ARMITAGE       |  P=0.461N                                          |  P=0.057N                                          |
|FISHER EXACT           |               P=0.248N     P=0.248N     P=0.500N   |               P=0.599N     P=0.500      P=0.064N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,                                                                        |
|     NOS, or Undifferentiated Cell Type                                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/70 (3%)    0/70 (0%)    0/70 (0%)    1/70 (1%)  |  9/70 (13%)   9/70 (13%)  10/70 (14%)   3/70 (4%)  |
|ADJUSTED (b)           |   4.3%         0.0%         0.0%         3.3%      |  20.9%        20.8%        26.2%         8.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  1/45 (2%)    0/33 (0%)    0/40 (0%)    1/30 (3%)  |  5/37 (14%)   6/40 (15%)   7/33 (21%)   0/25 (0%)  |
|FIRST INCIDENCE (DAYS) |   699          ---          ---          722 (T)   |   640          588          449          437       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.540N     P=0.308N     P=0.265N     P=0.633N   |  P=0.198N     P=0.574N     P=0.406      P=0.176N   |
|INCIDENTAL TUMOR       |  P=0.501N     P=0.194N     P=0.310N     P=0.540N   |  P=0.036N*    P=0.356      P=0.485      P=0.036N*  |
|LOGISTIC REGRESSION    |  P=0.522N     P=0.275N     P=0.260N     P=0.598N   |  P=0.071N     P=0.332      P=0.406      P=0.071N   |
|COCHRAN-ARMITAGE       |  P=0.461N                                          |  P=0.057N                                          |
|FISHER EXACT           |               P=0.248N     P=0.248N     P=0.500N   |               P=0.599N     P=0.500      P=0.064N   |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05086 TEST: 02                                                 PAGE  16
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- O-BENZYL-P-CHLOROPHENOL
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      120MG/KG     240MG/KG     480MG/KG  |   0 MG/KG      120MG/KG     240MG/KG     480MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 31/70 (44%)  27/70 (39%)  28/70 (40%)  28/70 (40%) | 29/70 (41%)  25/70 (36%)  22/70 (31%)  23/70 (33%) |
|ADJUSTED (b)           |  63.0%        66.3%        59.0%        68.5%      |  64.0%        56.6%        59.0%        65.5%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  1/10 (10%)   3/10 (30%)   1/10 (10%)   4/10 (40%) |  1/10 (10%)   0/10 (0%)    0/10 (0%)    1/9 (11%)  |
|TERMINAL (d)           | 27/45 (60%)  20/33 (61%)  21/40 (53%)  18/30 (60%) | 21/37 (57%)  21/40 (53%)  18/33 (55%)  14/25 (56%) |
|FIRST INCIDENCE (DAYS) |   455 (I)      455 (I)      433          387       |   456 (I)      510          668          437       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.151      P=0.298      P=0.554      P=0.131    |  P=0.261      P=0.218N     P=0.276N     P=0.366    |
|INCIDENTAL TUMOR       |  P=0.486      P=0.545N     P=0.350N     P=0.512    |  P=0.394N     P=0.339N     P=0.237N     P=0.418N   |
|LOGISTIC REGRESSION    |  P=0.383      P=0.525N     P=0.499N     P=0.427    |  P=0.492N     P=0.387N     P=0.219N     P=0.500N   |
|COCHRAN-ARMITAGE       |  P=0.387N                                          |  P=0.171N                                          |
|FISHER EXACT           |               P=0.303N     P=0.366N     P=0.366N   |               P=0.301N     P=0.146N     P=0.191N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 17/70 (24%)  16/70 (23%)  17/70 (24%)  11/70 (16%) | 18/70 (26%)  16/70 (23%)  15/70 (21%)  11/70 (16%) |
|ADJUSTED (b)           |  34.7%        38.0%        35.7%        28.6%      |  40.4%        36.2%        37.3%        32.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    1/10 (10%) |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           | 13/45 (29%)   7/33 (21%)  10/40 (25%)   5/30 (17%) | 11/37 (30%)  12/40 (30%)   9/33 (27%)   4/25 (16%) |
|FIRST INCIDENCE (DAYS) |   650          650          370          456 (I)   |   640          510          449          437       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.412N     P=0.309      P=0.432      P=0.494N   |  P=0.410N     P=0.375N     P=0.479N     P=0.412N   |
|INCIDENTAL TUMOR       |  P=0.067N     P=0.378N     P=0.395N     P=0.116N   |  P=0.051N     P=0.554      P=0.353N     P=0.110N   |
|LOGISTIC REGRESSION    |  P=0.144N     P=0.253N     P=0.494      P=0.162N   |  P=0.150N     P=0.585      P=0.461N     P=0.257N   |
|COCHRAN-ARMITAGE       |  P=0.125N                                          |  P=0.084N                                          |
|FISHER EXACT           |               P=0.500N     P=0.578N     P=0.145N   |               P=0.422N     P=0.345N     P=0.105N   |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05086 TEST: 02                                                 PAGE  17
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- O-BENZYL-P-CHLOROPHENOL
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      120MG/KG     240MG/KG     480MG/KG  |   0 MG/KG      120MG/KG     240MG/KG     480MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 39/70 (56%)  36/70 (51%)  38/70 (54%)  32/70 (46%) | 40/70 (57%)  35/70 (50%)  29/70 (41%)  30/70 (43%) |
|ADJUSTED (b)           |  76.4%        76.3%        74.3%        71.7%      |  81.5%        74.5%        72.0%        76.1%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|INTERIM SACRIFICE 2 (c)|  1/10 (10%)   3/10 (30%)   1/10 (10%)   4/10 (40%) |  1/10 (10%)   0/10 (0%)    0/10 (0%)    1/9 (11%)  |
|TERMINAL (d)           | 33/45 (73%)  22/33 (67%)  27/40 (68%)  18/30 (60%) | 28/37 (76%)  28/40 (70%)  22/33 (67%)  16/25 (64%) |
|FIRST INCIDENCE (DAYS) |   455 (I)      455 (I)      370          387       |   456 (I)      510          449          437       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.282      P=0.149      P=0.351      P=0.234    |  P=0.353      P=0.165N     P=0.137N     P=0.437    |
|INCIDENTAL TUMOR       |  P=0.176N     P=0.482N     P=0.370N     P=0.255N   |  P=0.097N     P=0.423N     P=0.052N     P=0.176N   |
|LOGISTIC REGRESSION    |  P=0.421N     P=0.482      P=0.469      P=0.484N   |  P=0.180N     P=0.424N     P=0.064N     P=0.322N   |
|COCHRAN-ARMITAGE       |  P=0.151N                                          |  P=0.049N*                                         |
|FISHER EXACT           |               P=0.367N     P=0.500N     P=0.155N   |               P=0.249N     P=0.045N*    P=0.064N   |
|=================================================================================================================================|
 
 (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):   93  455
          Female interim sacrifices(days): 93  455
 (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).