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TDMS Study 05049-01 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                    DICHLORVOS                                      DATE: 09/07/94       
EXPERIMENT: 05049 TEST: 01                                                                                     TIME: 03:04:20       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-28024          ROUTE: GAVAGE                                                                      NTP C#: 00113B       
PATHOLOGIST: J. HEATH                        S. EUSTIS                                                         CAS: 62-73-7         
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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: Southern Research Inst                                    DICHLORVOS                                      DATE: 09/07/94      
EXPERIMENT: 05049 TEST: 01                                                                                     TIME: 03:04:20      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01-ES-28024          ROUTE: GAVAGE                                                                      NTP C#: 00113B      
PATHOLOGIST: J. HEATH                        S. EUSTIS                                                         CAS: 62-73-7        
 
 
 
 
 
                                                    RATS(FISCHER344)
                                              ----------------------------
             FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
             IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
 
 
                                                    ----------------
 
                                                    Adrenal Gland
                                                    Bone Marrow
                                                    Brain
                                                    Clitoral Gland
                                                    Epididymis
                                                    Heart
                                                    Islets, Pancreatic
                                                    Kidney
                                                    Liver
                                                    Lung
                                                    Nose
                                                    Ovary
                                                    Pancreas
                                                    Parathyroid Gland
                                                    Pituitary Gland
                                                    Preputial Gland
                                                    Prostate
                                                    Salivary Glands
                                                    Spleen
                                                    Testes
                                                    Thymus
                                                    Thyroid Gland
                                                    Urinary Bladder
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                    DICHLORVOS                                      DATE: 09/07/94       
EXPERIMENT: 05049 TEST: 01                                                                                     TIME: 03:04:20       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-28024          ROUTE: GAVAGE                                                                      NTP C#: 00113B       
PATHOLOGIST: J. HEATH                        S. EUSTIS                                                         CAS: 62-73-7         
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                           IN THE ANALYSIS OF THE STUDY OF DICHLORVOS
 
              ====================================================================================================
 
                                                           MALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Lung                          Alveolar/Bronchiolar Adenoma
                             Pancreas                      Adenoma
                             All Organs                    Leukemia: Lymphocytic, Monocytic, Mononuclear,
                                                            or Undifferentiated
                                                           Malignant Tumors
 
              ====================================================================================================
 
                                                           FEMALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Mammary Gland                 Fibroadenoma
                                                           Fibroma, Fibroadenoma or Adenoma
                                                           Fibroma, Fibroadenoma, Carcinoma, or Adenoma
                             Skin: Subcutaneous Tissue     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,
                                                            Neurofibroma, or Fibroma
                             All Organs                    Malignant Tumors
 
              ====================================================================================================
         DATE: 09/07/94                     EXPERIMENT: 05049 TEST: 01                                                 PAGE   1
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DICHLORVOS
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         4.0             8.0           |      VEHICLE         4.0             8.0           |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Cortex                                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       1/50 (2%)       0/50 (0%)      |     1/50 (2%)       4/50 (8%)       0/50 (0%)      |
|ADJUSTED (b)           |      3.0%            4.0%            0.0%          |      3.2%           12.5%            0.0%          |
|TERMINAL (d)           |     0/31 (0%)       1/25 (4%)       0/24 (0%)      |     1/31 (3%)       2/26 (8%)       0/26 (0%)      |
|FIRST INCIDENCE (DAYS) |      727             729 (T)         ---           |      729 (T)         656             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.411N        P=0.705         P=0.555N       |     P=0.491N        P=0.150         P=0.535N       |
|INCIDENTAL TUMOR       |     P=0.351N        P=0.756         P=0.452N       |     P=0.490N        P=0.167         P=0.535N       |
|LOGISTIC REGRESSION    |     P=0.409N        P=0.696         P=0.546N       |     P=0.456N        P=0.163         P=0.535N       |
|COCHRAN-ARMITAGE       |     P=0.347N                                       |     P=0.426N                                       |
|FISHER EXACT           |                     P=0.753N        P=0.500N       |                     P=0.181         P=0.500N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    21/50 (42%)     16/50 (32%)     14/50 (28%)     |     4/50 (8%)       1/50 (2%)       4/50 (8%)      |
|ADJUSTED (b)           |     57.6%           48.2%           43.8%          |     10.8%            3.8%           14.7%          |
|TERMINAL (d)           |    16/31 (52%)      9/25 (36%)      8/24 (33%)     |     2/31 (6%)       1/26 (4%)       3/26 (12%)     |
|FIRST INCIDENCE (DAYS) |      595             561             564           |      602             729 (T)         727           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.283N        P=0.472N        P=0.321N       |     P=0.522         P=0.225N        P=0.550        |
|INCIDENTAL TUMOR       |     P=0.129N        P=0.322N        P=0.166N       |     P=0.569         P=0.205N        P=0.603        |
|LOGISTIC REGRESSION    |     P=0.121N        P=0.332N        P=0.145N       |     P=0.563         P=0.187N        P=0.600        |
|COCHRAN-ARMITAGE       |     P=0.084N                                       |     P=0.569N                                       |
|FISHER EXACT           |                     P=0.204N        P=0.104N       |                     P=0.181N        P=0.643N       |
|=================================================================================================================================|
 
         DATE: 09/07/94                     EXPERIMENT: 05049 TEST: 01                                                 PAGE   2
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DICHLORVOS
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         4.0             8.0           |      VEHICLE         4.0             8.0           |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Malignant                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       6/50 (12%)      4/50 (8%)      |     0/50 (0%)       0/50 (0%)       2/50 (4%)      |
|ADJUSTED (b)           |      5.2%           22.9%           14.0%          |      0.0%            0.0%            7.7%          |
|TERMINAL (d)           |     0/31 (0%)       5/25 (20%)      2/24 (8%)      |     0/31 (0%)       0/26 (0%)       2/26 (8%)      |
|FIRST INCIDENCE (DAYS) |      657             695             692           |      ---             ---             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.187         P=0.076         P=0.260        |     P=0.091           (e)           P=0.200        |
|INCIDENTAL TUMOR       |     P=0.251         P=0.112         P=0.369        |     P=0.091           (e)           P=0.200        |
|LOGISTIC REGRESSION    |     P=0.231         P=0.090         P=0.317        |     P=0.091           (e)           P=0.200        |
|COCHRAN-ARMITAGE       |     P=0.279                                        |     P=0.106                                        |
|FISHER EXACT           |                     P=0.134         P=0.339        |                       (e)           P=0.247        |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    22/50 (44%)     21/50 (42%)     18/50 (36%)     |     4/50 (8%)       1/50 (2%)       6/50 (12%)     |
|ADJUSTED (b)           |     58.8%           62.6%           53.8%          |     10.8%            3.8%           22.1%          |
|TERMINAL (d)           |    16/31 (52%)     13/25 (52%)     10/24 (42%)     |     2/31 (6%)       1/26 (4%)       5/26 (19%)     |
|FIRST INCIDENCE (DAYS) |      595             561             564           |      602             729 (T)         727           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.505         P=0.325         P=0.558        |     P=0.231         P=0.225N        P=0.273        |
|INCIDENTAL TUMOR       |     P=0.340N        P=0.491         P=0.367N       |     P=0.263         P=0.205N        P=0.313        |
|LOGISTIC REGRESSION    |     P=0.336N        P=0.461         P=0.356N       |     P=0.257         P=0.187N        P=0.309        |
|COCHRAN-ARMITAGE       |     P=0.243N                                       |     P=0.307                                        |
|FISHER EXACT           |                     P=0.500N        P=0.270N       |                     P=0.181N        P=0.370        |
|=================================================================================================================================|
 
         DATE: 09/07/94                     EXPERIMENT: 05049 TEST: 01                                                 PAGE   3
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DICHLORVOS
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         4.0             8.0           |      VEHICLE         4.0             8.0           |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Brain                                                                                                                            |
|     Oligodendroglioma, Glioma, or Astrocytoma                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       0/50 (0%)       1/48 (2%)      |     1/50 (2%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      5.4%            0.0%            4.2%          |      3.2%            0.0%            0.0%          |
|TERMINAL (d)           |     1/31 (3%)       0/25 (0%)       1/24 (4%)      |     1/31 (3%)       0/26 (0%)       0/26 (0%)      |
|FIRST INCIDENCE (DAYS) |      606             ---             729 (T)       |      729 (T)         ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.403N        P=0.269N        P=0.559N       |     P=0.302N        P=0.535N        P=0.535N       |
|INCIDENTAL TUMOR       |     P=0.365N        P=0.263N        P=0.513N       |     P=0.302N        P=0.535N        P=0.535N       |
|LOGISTIC REGRESSION    |     P=0.364N        P=0.223N        P=0.513N       |     P=0.302N        P=0.535N        P=0.535N       |
|COCHRAN-ARMITAGE       |     P=0.363N                                       |     P=0.274N                                       |
|FISHER EXACT           |                     P=0.247N        P=0.515N       |                     P=0.500N        P=0.500N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/48 (4%)       4/46 (9%)       3/45 (7%)      |     3/44 (7%)       1/43 (2%)       3/41 (7%)      |
|ADJUSTED (b)           |      5.4%           13.8%           11.2%          |      8.2%            4.3%           11.6%          |
|TERMINAL (d)           |     1/30 (3%)       2/23 (9%)       2/23 (9%)      |     1/29 (3%)       1/23 (4%)       2/23 (9%)      |
|FIRST INCIDENCE (DAYS) |      587             426             660           |      646             729 (T)         721           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.330         P=0.255         P=0.422        |     P=0.530         P=0.364N        P=0.578        |
|INCIDENTAL TUMOR       |     P=0.335         P=0.348         P=0.484        |     P=0.539         P=0.280N        P=0.581        |
|LOGISTIC REGRESSION    |     P=0.367         P=0.358         P=0.466        |     P=0.552         P=0.315N        P=0.601        |
|COCHRAN-ARMITAGE       |     P=0.380                                        |     P=0.584                                        |
|FISHER EXACT           |                     P=0.318         P=0.469        |                     P=0.317N        P=0.628        |
|=================================================================================================================================|
 
         DATE: 09/07/94                     EXPERIMENT: 05049 TEST: 01                                                 PAGE   4
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DICHLORVOS
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         4.0             8.0           |      VEHICLE         4.0             8.0           |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/48 (2%)       0/46 (0%)       3/45 (7%)      |     0/44 (0%)       0/43 (0%)       1/41 (2%)      |
|ADJUSTED (b)           |      3.3%            0.0%            9.5%          |      0.0%            0.0%            4.3%          |
|TERMINAL (d)           |     1/30 (3%)       0/23 (0%)       1/23 (4%)      |     0/29 (0%)       0/23 (0%)       1/23 (4%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         ---             652           |      ---             ---             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.164         P=0.553N        P=0.253        |     P=0.261           (e)           P=0.454        |
|INCIDENTAL TUMOR       |     P=0.199         P=0.553N        P=0.316        |     P=0.261           (e)           P=0.454        |
|LOGISTIC REGRESSION    |     P=0.180         P=0.553N        P=0.282        |     P=0.261           (e)           P=0.454        |
|COCHRAN-ARMITAGE       |     P=0.180                                        |     P=0.280                                        |
|FISHER EXACT           |                     P=0.511N        P=0.284        |                       (e)           P=0.482        |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/48 (6%)       4/46 (9%)       6/45 (13%)     |     3/44 (7%)       1/43 (2%)       4/41 (10%)     |
|ADJUSTED (b)           |      8.7%           13.8%           19.9%          |      8.2%            4.3%           15.8%          |
|TERMINAL (d)           |     2/30 (7%)       2/23 (9%)       3/23 (13%)     |     1/29 (3%)       1/23 (4%)       3/23 (13%)     |
|FIRST INCIDENCE (DAYS) |      587             426             652           |      646             729 (T)         721           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.135         P=0.390         P=0.173        |     P=0.348         P=0.364N        P=0.403        |
|INCIDENTAL TUMOR       |     P=0.149         P=0.490         P=0.240        |     P=0.348         P=0.280N        P=0.400        |
|LOGISTIC REGRESSION    |     P=0.159         P=0.514         P=0.209        |     P=0.362         P=0.315N        P=0.420        |
|COCHRAN-ARMITAGE       |     P=0.165                                        |     P=0.401                                        |
|FISHER EXACT           |                     P=0.476         P=0.211        |                     P=0.317N        P=0.460        |
|=================================================================================================================================|
 
         DATE: 09/07/94                     EXPERIMENT: 05049 TEST: 01                                                 PAGE   5
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DICHLORVOS
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         4.0             8.0           |      VEHICLE         4.0             8.0           |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     6/50 (12%)      6/48 (13%)      5/50 (10%)     |     1/50 (2%)       2/48 (4%)       1/50 (2%)      |
|ADJUSTED (b)           |     18.1%           19.3%           17.1%          |      2.6%            6.6%            3.8%          |
|TERMINAL (d)           |     5/31 (16%)      2/25 (8%)       3/24 (13%)     |     0/31 (0%)       1/26 (4%)       1/26 (4%)      |
|FIRST INCIDENCE (DAYS) |      646             645             623           |      692             701             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.542         P=0.473         P=0.610        |     P=0.557         P=0.467         P=0.715        |
|INCIDENTAL TUMOR       |     P=0.477N        P=0.582         P=0.574N       |     P=0.564         P=0.498         P=0.720        |
|LOGISTIC REGRESSION    |     P=0.485N        P=0.539         P=0.545N       |     P=0.588         P=0.475         P=0.744        |
|COCHRAN-ARMITAGE       |     P=0.445N                                       |     P=0.618                                        |
|FISHER EXACT           |                     P=0.591         P=0.500N       |                     P=0.485         P=0.753N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       2/50 (4%)       1/50 (2%)      |     0/50 (0%)       0/50 (0%)       1/50 (2%)      |
|ADJUSTED (b)           |      0.0%            6.5%            4.2%          |      0.0%            0.0%            3.8%          |
|TERMINAL (d)           |     0/31 (0%)       1/25 (4%)       1/24 (4%)      |     0/31 (0%)       0/26 (0%)       1/26 (4%)      |
|FIRST INCIDENCE (DAYS) |      ---             645             729 (T)       |      ---             ---             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.301         P=0.206         P=0.449        |     P=0.268           (e)           P=0.465        |
|INCIDENTAL TUMOR       |     P=0.329         P=0.234         P=0.449        |     P=0.268           (e)           P=0.465        |
|LOGISTIC REGRESSION    |     P=0.339         P=0.230         P=0.449        |     P=0.268           (e)           P=0.465        |
|COCHRAN-ARMITAGE       |     P=0.353                                        |     P=0.290                                        |
|FISHER EXACT           |                     P=0.247         P=0.500        |                       (e)           P=0.500        |
|=================================================================================================================================|
 
         DATE: 09/07/94                     EXPERIMENT: 05049 TEST: 01                                                 PAGE   6
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DICHLORVOS
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         4.0             8.0           |      VEHICLE         4.0             8.0           |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       3/50 (6%)       2/50 (4%)      |     0/50 (0%)       1/50 (2%)       1/50 (2%)      |
|ADJUSTED (b)           |      3.0%           10.4%            8.3%          |      0.0%            2.9%            3.8%          |
|TERMINAL (d)           |     0/31 (0%)       2/25 (8%)       2/24 (8%)      |     0/31 (0%)       0/26 (0%)       1/26 (4%)      |
|FIRST INCIDENCE (DAYS) |      727             645             729 (T)       |      ---             704             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.306         P=0.239         P=0.409        |     P=0.302         P=0.489         P=0.465        |
|INCIDENTAL TUMOR       |     P=0.357         P=0.296         P=0.469        |     P=0.298         P=0.531         P=0.465        |
|LOGISTIC REGRESSION    |     P=0.349         P=0.263         P=0.407        |     P=0.311         P=0.491         P=0.465        |
|COCHRAN-ARMITAGE       |     P=0.394                                        |     P=0.335                                        |
|FISHER EXACT           |                     P=0.309         P=0.500        |                     P=0.500         P=0.500        |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       3/50 (6%)       2/50 (4%)      |     0/50 (0%)       1/50 (2%)       1/50 (2%)      |
|ADJUSTED (b)           |      3.0%           10.4%            8.3%          |      0.0%            2.9%            3.8%          |
|TERMINAL (d)           |     0/31 (0%)       2/25 (8%)       2/24 (8%)      |     0/31 (0%)       0/26 (0%)       1/26 (4%)      |
|FIRST INCIDENCE (DAYS) |      727             645             729 (T)       |      ---             704             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.306         P=0.239         P=0.409        |     P=0.302         P=0.489         P=0.465        |
|INCIDENTAL TUMOR       |     P=0.357         P=0.296         P=0.469        |     P=0.298         P=0.531         P=0.465        |
|LOGISTIC REGRESSION    |     P=0.349         P=0.263         P=0.407        |     P=0.311         P=0.491         P=0.465        |
|COCHRAN-ARMITAGE       |     P=0.394                                        |     P=0.335                                        |
|FISHER EXACT           |                     P=0.309         P=0.500        |                     P=0.500         P=0.500        |
|=================================================================================================================================|
 
         DATE: 09/07/94                     EXPERIMENT: 05049 TEST: 01                                                 PAGE   7
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DICHLORVOS
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         4.0             8.0           |      VEHICLE         4.0             8.0           |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       0/50 (0%)       3/49 (6%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      0.0%            0.0%           11.2%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/31 (0%)       0/25 (0%)       2/23 (9%)      |     0/31 (0%)       0/26 (0%)       0/26 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             660           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.033 *         (e)           P=0.088        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.036 *         (e)           P=0.101        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.037 *         (e)           P=0.104        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.041 *                                      |       (e)                                          |
|FISHER EXACT           |                       (e)           P=0.117        |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |     2/50 (4%)       2/50 (4%)       0/50 (0%)      |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |      4.9%            7.7%            0.0%          |
|TERMINAL (d)           |     0/31 (0%)       0/25 (0%)       0/24 (0%)      |     0/31 (0%)       2/26 (8%)       0/26 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      677             729 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.237N        P=0.649         P=0.287N       |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.225N        P=0.691         P=0.276N       |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.204N        P=0.677         P=0.234N       |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.187N                                       |
|FISHER EXACT           |                       (e)             (e)          |                     P=0.691N        P=0.247N       |
|=================================================================================================================================|
 
         DATE: 09/07/94                     EXPERIMENT: 05049 TEST: 01                                                 PAGE   8
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DICHLORVOS
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         4.0             8.0           |      VEHICLE         4.0             8.0           |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |     2/50 (4%)       2/50 (4%)       1/50 (2%)      |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |      4.9%            7.7%            3.8%          |
|TERMINAL (d)           |     0/31 (0%)       0/25 (0%)       0/24 (0%)      |     0/31 (0%)       2/26 (8%)       1/26 (4%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      677             729 (T)         729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.471N        P=0.649         P=0.568N       |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.464N        P=0.691         P=0.563N       |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.434N        P=0.677         P=0.517N       |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.401N                                       |
|FISHER EXACT           |                       (e)             (e)          |                     P=0.691N        P=0.500N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroadenoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     6/50 (12%)      1/50 (2%)       2/50 (4%)      |     9/50 (18%)     19/50 (38%)     16/50 (32%)     |
|ADJUSTED (b)           |     17.4%            3.2%            6.2%          |     24.5%           62.4%           45.6%          |
|TERMINAL (d)           |     4/31 (13%)      0/25 (0%)       0/24 (0%)      |     6/31 (19%)     15/26 (58%)      8/26 (31%)     |
|FIRST INCIDENCE (DAYS) |      646             684             660           |      547             545             582           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.117N        P=0.105N        P=0.218N       |     P=0.030 *       P=0.007 **      P=0.047 *      |
|INCIDENTAL TUMOR       |     P=0.061N        P=0.066N        P=0.134N       |     P=0.049 *       P=0.010 **      P=0.077        |
|LOGISTIC REGRESSION    |     P=0.078N        P=0.078N        P=0.154N       |     P=0.045 *       P=0.015 *       P=0.070        |
|COCHRAN-ARMITAGE       |     P=0.066N                                       |     P=0.070                                        |
|FISHER EXACT           |                     P=0.056N        P=0.134N       |                     P=0.022 *       P=0.083        |
|=================================================================================================================================|
 
         DATE: 09/07/94                     EXPERIMENT: 05049 TEST: 01                                                 PAGE   9
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DICHLORVOS
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         4.0             8.0           |      VEHICLE         4.0             8.0           |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma or Adenoma                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     6/50 (12%)      1/50 (2%)       2/50 (4%)      |     9/50 (18%)     19/50 (38%)     17/50 (34%)     |
|ADJUSTED (b)           |     17.4%            3.2%            6.2%          |     24.5%           62.4%           48.6%          |
|TERMINAL (d)           |     4/31 (13%)      0/25 (0%)       0/24 (0%)      |     6/31 (19%)     15/26 (58%)      9/26 (35%)     |
|FIRST INCIDENCE (DAYS) |      646             684             660           |      547             545             582           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.117N        P=0.105N        P=0.218N       |     P=0.019 *       P=0.007 **      P=0.030 *      |
|INCIDENTAL TUMOR       |     P=0.061N        P=0.066N        P=0.134N       |     P=0.030 *       P=0.010 **      P=0.049 *      |
|LOGISTIC REGRESSION    |     P=0.078N        P=0.078N        P=0.154N       |     P=0.028 *       P=0.015 *       P=0.044 *      |
|COCHRAN-ARMITAGE       |     P=0.066N                                       |     P=0.046 *                                      |
|FISHER EXACT           |                     P=0.056N        P=0.134N       |                     P=0.022 *       P=0.055        |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     6/50 (12%)      1/50 (2%)       2/50 (4%)      |    11/50 (22%)     20/50 (40%)     17/50 (34%)     |
|ADJUSTED (b)           |     17.4%            3.2%            6.2%          |     28.2%           65.8%           48.6%          |
|TERMINAL (d)           |     4/31 (13%)      0/25 (0%)       0/24 (0%)      |     6/31 (19%)     16/26 (62%)      9/26 (35%)     |
|FIRST INCIDENCE (DAYS) |      646             684             660           |      547             545             582           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.117N        P=0.105N        P=0.218N       |     P=0.049 *       P=0.015 *       P=0.074        |
|INCIDENTAL TUMOR       |     P=0.061N        P=0.066N        P=0.134N       |     P=0.074         P=0.022 *       P=0.112        |
|LOGISTIC REGRESSION    |     P=0.078N        P=0.078N        P=0.154N       |     P=0.072         P=0.028 *       P=0.113        |
|COCHRAN-ARMITAGE       |     P=0.066N                                       |     P=0.111                                        |
|FISHER EXACT           |                     P=0.056N        P=0.134N       |                     P=0.041 *       P=0.133        |
|=================================================================================================================================|
 
         DATE: 09/07/94                     EXPERIMENT: 05049 TEST: 01                                                 PAGE  10
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DICHLORVOS
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         4.0             8.0           |      VEHICLE         4.0             8.0           |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip)                                                                           |
|     Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       0/50 (0%)       1/50 (2%)      |     0/50 (0%)       0/50 (0%)       2/50 (4%)      |
|ADJUSTED (b)           |      0.0%            0.0%            4.2%          |      0.0%            0.0%            5.8%          |
|TERMINAL (d)           |     0/31 (0%)       0/25 (0%)       1/24 (4%)      |     0/31 (0%)       0/26 (0%)       1/26 (4%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             729 (T)       |      ---             ---             383           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.257           (e)           P=0.449        |     P=0.100           (e)           P=0.220        |
|INCIDENTAL TUMOR       |     P=0.257           (e)           P=0.449        |     P=0.132           (e)           P=0.291        |
|LOGISTIC REGRESSION    |     P=0.257           (e)           P=0.449        |     P=0.106           (e)           P=0.320        |
|COCHRAN-ARMITAGE       |     P=0.290                                        |     P=0.106                                        |
|FISHER EXACT           |                       (e)           P=0.500        |                       (e)           P=0.247        |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Granulosa Cell Tumor                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |     2/50 (4%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |                                                    |      5.5%            0.0%            0.0%          |
|TERMINAL (d)           |                                                    |     1/31 (3%)       0/26 (0%)       0/26 (0%)      |
|FIRST INCIDENCE (DAYS) |                                                    |      646             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.116N        P=0.267N        P=0.279N       |
|INCIDENTAL TUMOR       |                                                    |     P=0.110N        P=0.241N        P=0.280N       |
|LOGISTIC REGRESSION    |                                                    |     P=0.095N        P=0.238N        P=0.237N       |
|COCHRAN-ARMITAGE       |                                                    |     P=0.094N                                       |
|FISHER EXACT           |                                                    |                     P=0.247N        P=0.247N       |
|=================================================================================================================================|
 
         DATE: 09/07/94                     EXPERIMENT: 05049 TEST: 01                                                 PAGE  11
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DICHLORVOS
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         4.0             8.0           |      VEHICLE         4.0             8.0           |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Pancreas                                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    16/50 (32%)     25/49 (51%)     30/50 (60%)     |     1/50 (2%)       1/47 (2%)       4/50 (8%)      |
|ADJUSTED (b)           |     45.2%           80.0%           82.5%          |      3.2%            4.0%           12.5%          |
|TERMINAL (d)           |    12/31 (39%)     19/25 (76%)     18/24 (75%)     |     1/31 (3%)       1/25 (4%)       2/26 (8%)      |
|FIRST INCIDENCE (DAYS) |      653             533             564           |      729 (T)         729 (T)         631           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P<0.001 **      P=0.006 **      P<0.001 **     |     P=0.085         P=0.714         P=0.140        |
|INCIDENTAL TUMOR       |     P<0.001 **      P=0.013 *       P=0.001 **     |     P=0.138         P=0.714         P=0.226        |
|LOGISTIC REGRESSION    |     P<0.001 **      P=0.007 **      P=0.001 **     |     P=0.102         P=0.714         P=0.171        |
|COCHRAN-ARMITAGE       |     P=0.003 **                                     |     P=0.111                                        |
|FISHER EXACT           |                     P=0.043 *       P=0.004 **     |                     P=0.737         P=0.181        |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     9/50 (18%)     11/48 (23%)      7/49 (14%)     |    27/50 (54%)     19/49 (39%)     19/50 (38%)     |
|ADJUSTED (b)           |     26.0%           31.6%           22.8%          |     63.7%           54.3%           58.3%          |
|TERMINAL (d)           |     6/31 (19%)      4/24 (17%)      4/24 (17%)     |    16/31 (52%)     11/26 (42%)     13/26 (50%)     |
|FIRST INCIDENCE (DAYS) |      674             426             592           |      547             545             486           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.539N        P=0.235         P=0.572N       |     P=0.228N        P=0.258N        P=0.265N       |
|INCIDENTAL TUMOR       |     P=0.372N        P=0.458         P=0.447N       |     P=0.114N        P=0.117N        P=0.151N       |
|LOGISTIC REGRESSION    |     P=0.373N        P=0.386         P=0.454N       |     P=0.098N        P=0.115N        P=0.124N       |
|COCHRAN-ARMITAGE       |     P=0.382N                                       |     P=0.063N                                       |
|FISHER EXACT           |                     P=0.362         P=0.410N       |                     P=0.094N        P=0.080N       |
|=================================================================================================================================|
 
         DATE: 09/07/94                     EXPERIMENT: 05049 TEST: 01                                                 PAGE  12
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DICHLORVOS
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         4.0             8.0           |      VEHICLE         4.0             8.0           |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       0/48 (0%)       2/49 (4%)      |     1/50 (2%)       2/49 (4%)       4/50 (8%)      |
|ADJUSTED (b)           |      2.0%            0.0%            6.4%          |      2.9%            7.7%           11.5%          |
|TERMINAL (d)           |     0/31 (0%)       0/24 (0%)       1/24 (4%)      |     0/31 (0%)       2/26 (8%)       1/26 (4%)      |
|FIRST INCIDENCE (DAYS) |      393             ---             621           |      711             729 (T)         557           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.364         P=0.500N        P=0.473        |     P=0.105         P=0.434         P=0.160        |
|INCIDENTAL TUMOR       |     P=0.415         P=0.318N        P=0.550        |     P=0.113         P=0.477         P=0.172        |
|LOGISTIC REGRESSION    |     P=0.403         P=0.386         P=0.541        |     P=0.119         P=0.470         P=0.189        |
|COCHRAN-ARMITAGE       |     P=0.379                                        |     P=0.123                                        |
|FISHER EXACT           |                     P=0.510N        P=0.492        |                     P=0.492         P=0.181        |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    10/50 (20%)     11/48 (23%)      9/49 (18%)     |    28/50 (56%)     21/49 (43%)     23/50 (46%)     |
|ADJUSTED (b)           |     27.5%           31.6%           28.4%          |     64.8%           60.4%           64.6%          |
|TERMINAL (d)           |     6/31 (19%)      4/24 (17%)      5/24 (21%)     |    16/31 (52%)     13/26 (50%)     14/26 (54%)     |
|FIRST INCIDENCE (DAYS) |      393             426             592           |      547             545             486           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.466         P=0.318         P=0.520        |     P=0.439N        P=0.337N        P=0.481N       |
|INCIDENTAL TUMOR       |     P=0.457N        P=0.599N        P=0.529N       |     P=0.284N        P=0.166N        P=0.340N       |
|LOGISTIC REGRESSION    |     P=0.452N        P=0.535         P=0.517N       |     P=0.252N        P=0.165N        P=0.289N       |
|COCHRAN-ARMITAGE       |     P=0.481N                                       |     P=0.177N                                       |
|FISHER EXACT           |                     P=0.458         P=0.520N       |                     P=0.134N        P=0.212N       |
|=================================================================================================================================|
 
         DATE: 09/07/94                     EXPERIMENT: 05049 TEST: 01                                                 PAGE  13
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DICHLORVOS
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         4.0             8.0           |      VEHICLE         4.0             8.0           |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Intermedia                                                                                                 |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       0/48 (0%)       0/49 (0%)      |     0/50 (0%)       1/49 (2%)       1/50 (2%)      |
|ADJUSTED (b)           |      4.4%            0.0%            0.0%          |      0.0%            3.8%            2.5%          |
|TERMINAL (d)           |     0/31 (0%)       0/24 (0%)       0/24 (0%)      |     0/31 (0%)       1/26 (4%)       0/26 (0%)      |
|FIRST INCIDENCE (DAYS) |      576             ---             ---           |      ---             729 (T)         630           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.108N        P=0.269N        P=0.258N       |     P=0.310         P=0.465         P=0.486        |
|INCIDENTAL TUMOR       |     P=0.072N        P=0.221N        P=0.184N       |     P=0.397         P=0.465         P=0.638        |
|LOGISTIC REGRESSION    |     P=0.080N        P=0.191N        P=0.216N       |     P=0.337         P=0.465         P=0.537        |
|COCHRAN-ARMITAGE       |     P=0.097N                                       |     P=0.335                                        |
|FISHER EXACT           |                     P=0.258N        P=0.253N       |                     P=0.495         P=0.500        |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Intermedia                                                                                                 |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       0/48 (0%)       0/49 (0%)      |     1/50 (2%)       1/49 (2%)       1/50 (2%)      |
|ADJUSTED (b)           |      4.4%            0.0%            0.0%          |      2.0%            3.8%            2.5%          |
|TERMINAL (d)           |     0/31 (0%)       0/24 (0%)       0/24 (0%)      |     0/31 (0%)       1/26 (4%)       0/26 (0%)      |
|FIRST INCIDENCE (DAYS) |      576             ---             ---           |      404             729 (T)         630           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.108N        P=0.269N        P=0.258N       |     P=0.620         P=0.736         P=0.750        |
|INCIDENTAL TUMOR       |     P=0.072N        P=0.221N        P=0.184N       |     P=0.535N        P=0.737N        P=0.599N       |
|LOGISTIC REGRESSION    |     P=0.080N        P=0.191N        P=0.216N       |     P=0.611N        P=0.704N        P=0.658N       |
|COCHRAN-ARMITAGE       |     P=0.097N                                       |     P=0.647                                        |
|FISHER EXACT           |                     P=0.258N        P=0.253N       |                     P=0.747         P=0.753N       |
|=================================================================================================================================|
 
         DATE: 09/07/94                     EXPERIMENT: 05049 TEST: 01                                                 PAGE  14
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DICHLORVOS
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         4.0             8.0           |      VEHICLE         4.0             8.0           |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Prostate                                                                                                                         |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       1/50 (2%)       0/49 (0%)      |                                                    |
|ADJUSTED (b)           |      6.0%            4.0%            0.0%          |                                                    |
|TERMINAL (d)           |     1/31 (3%)       1/25 (4%)       0/24 (0%)      |                                                    |
|FIRST INCIDENCE (DAYS) |      719             729 (T)         ---           |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.204N        P=0.588N        P=0.302N       |                                                    |
|INCIDENTAL TUMOR       |     P=0.166N        P=0.530N        P=0.240N       |                                                    |
|LOGISTIC REGRESSION    |     P=0.191N        P=0.592N        P=0.276N       |                                                    |
|COCHRAN-ARMITAGE       |     P=0.150N                                       |                                                    |
|FISHER EXACT           |                     P=0.500N        P=0.253N       |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Basal Cell Carcinoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       1/50 (2%)       2/50 (4%)      |     0/50 (0%)       0/50 (0%)       1/50 (2%)      |
|ADJUSTED (b)           |      0.0%            4.0%            7.9%          |      0.0%            0.0%            3.8%          |
|TERMINAL (d)           |     0/31 (0%)       1/25 (4%)       1/24 (4%)      |     0/31 (0%)       0/26 (0%)       1/26 (4%)      |
|FIRST INCIDENCE (DAYS) |      ---             729 (T)         719           |      ---             ---             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.110         P=0.457         P=0.181        |     P=0.268           (e)           P=0.465        |
|INCIDENTAL TUMOR       |     P=0.134         P=0.457         P=0.236        |     P=0.268           (e)           P=0.465        |
|LOGISTIC REGRESSION    |     P=0.117         P=0.457         P=0.197        |     P=0.268           (e)           P=0.465        |
|COCHRAN-ARMITAGE       |     P=0.147                                        |     P=0.290                                        |
|FISHER EXACT           |                     P=0.500         P=0.247        |                       (e)           P=0.500        |
|=================================================================================================================================|
 
         DATE: 09/07/94                     EXPERIMENT: 05049 TEST: 01                                                 PAGE  15
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DICHLORVOS
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         4.0             8.0           |      VEHICLE         4.0             8.0           |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Keratoacanthoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/50 (6%)       4/50 (8%)       1/50 (2%)      |     1/50 (2%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      9.7%           12.5%            2.8%          |      3.2%            0.0%            0.0%          |
|TERMINAL (d)           |     3/31 (10%)      2/25 (8%)       0/24 (0%)      |     1/31 (3%)       0/26 (0%)       0/26 (0%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         607             667           |      729 (T)         ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.347N        P=0.410         P=0.381N       |     P=0.302N        P=0.535N        P=0.535N       |
|INCIDENTAL TUMOR       |     P=0.283N        P=0.416         P=0.353N       |     P=0.302N        P=0.535N        P=0.535N       |
|LOGISTIC REGRESSION    |     P=0.283N        P=0.459         P=0.338N       |     P=0.302N        P=0.535N        P=0.535N       |
|COCHRAN-ARMITAGE       |     P=0.268N                                       |     P=0.274N                                       |
|FISHER EXACT           |                     P=0.500         P=0.309N       |                     P=0.500N        P=0.500N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/50 (6%)       3/50 (6%)       2/50 (4%)      |     1/50 (2%)       1/50 (2%)       1/50 (2%)      |
|ADJUSTED (b)           |      8.4%           12.0%            6.2%          |      3.2%            3.8%            3.8%          |
|TERMINAL (d)           |     2/31 (6%)       3/25 (12%)      1/24 (4%)      |     1/31 (3%)       1/26 (4%)       1/26 (4%)      |
|FIRST INCIDENCE (DAYS) |      576             729 (T)         564           |      729 (T)         729 (T)         729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.520N        P=0.569         P=0.577N       |     P=0.596         P=0.723         P=0.723        |
|INCIDENTAL TUMOR       |     P=0.465N        P=0.578         P=0.497N       |     P=0.596         P=0.723         P=0.723        |
|LOGISTIC REGRESSION    |     P=0.430N        P=0.620         P=0.478N       |     P=0.596         P=0.723         P=0.723        |
|COCHRAN-ARMITAGE       |     P=0.421N                                       |     P=0.647                                        |
|FISHER EXACT           |                     P=0.661N        P=0.500N       |                     P=0.753N        P=0.753N       |
|=================================================================================================================================|
 
         DATE: 09/07/94                     EXPERIMENT: 05049 TEST: 01                                                 PAGE  16
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DICHLORVOS
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         4.0             8.0           |      VEHICLE         4.0             8.0           |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Trichoepithelioma, Basal Cell Carcinoma, or Basal Cell Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       1/50 (2%)       3/50 (6%)      |     0/50 (0%)       0/50 (0%)       1/50 (2%)      |
|ADJUSTED (b)           |      2.0%            4.0%           11.9%          |      0.0%            0.0%            3.8%          |
|TERMINAL (d)           |     0/31 (0%)       1/25 (4%)       2/24 (8%)      |     0/31 (0%)       0/26 (0%)       1/26 (4%)      |
|FIRST INCIDENCE (DAYS) |      522             729 (T)         719           |      ---             ---             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.161         P=0.727         P=0.236        |     P=0.268           (e)           P=0.465        |
|INCIDENTAL TUMOR       |     P=0.194         P=0.677N        P=0.318        |     P=0.268           (e)           P=0.465        |
|LOGISTIC REGRESSION    |     P=0.210         P=0.722N        P=0.315        |     P=0.268           (e)           P=0.465        |
|COCHRAN-ARMITAGE       |     P=0.213                                        |     P=0.290                                        |
|FISHER EXACT           |                     P=0.753N        P=0.309        |                       (e)           P=0.500        |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma,                                                                |
|     Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     7/50 (14%)      8/50 (16%)      6/50 (12%)     |     2/50 (4%)       1/50 (2%)       2/50 (4%)      |
|ADJUSTED (b)           |     19.6%           27.7%           19.9%          |      6.5%            3.8%            7.7%          |
|TERMINAL (d)           |     5/31 (16%)      6/25 (24%)      3/24 (13%)     |     2/31 (6%)       1/26 (4%)       2/26 (8%)      |
|FIRST INCIDENCE (DAYS) |      522             607             564           |      729 (T)         729 (T)         729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.503         P=0.356         P=0.586        |     P=0.558         P=0.562N        P=0.631        |
|INCIDENTAL TUMOR       |     P=0.501N        P=0.423         P=0.521N       |     P=0.558         P=0.562N        P=0.631        |
|LOGISTIC REGRESSION    |     P=0.472N        P=0.467         P=0.492N       |     P=0.558         P=0.562N        P=0.631        |
|COCHRAN-ARMITAGE       |     P=0.453N                                       |     P=0.608N                                       |
|FISHER EXACT           |                     P=0.500         P=0.500N       |                     P=0.500N        P=0.691N       |
|=================================================================================================================================|
 
         DATE: 09/07/94                     EXPERIMENT: 05049 TEST: 01                                                 PAGE  17
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DICHLORVOS
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         4.0             8.0           |      VEHICLE         4.0             8.0           |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     7/50 (14%)      6/50 (12%)      4/50 (8%)      |     0/50 (0%)       0/50 (0%)       2/50 (4%)      |
|ADJUSTED (b)           |     18.5%           20.6%           16.7%          |      0.0%            0.0%            7.7%          |
|TERMINAL (d)           |     4/31 (13%)      4/25 (16%)      4/24 (17%)     |     0/31 (0%)       0/26 (0%)       2/26 (8%)      |
|FIRST INCIDENCE (DAYS) |      576             644             729 (T)       |      ---             ---             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.349N        P=0.599         P=0.390N       |     P=0.091           (e)           P=0.200        |
|INCIDENTAL TUMOR       |     P=0.269N        P=0.582N        P=0.314N       |     P=0.091           (e)           P=0.200        |
|LOGISTIC REGRESSION    |     P=0.245N        P=0.522N        P=0.272N       |     P=0.091           (e)           P=0.200        |
|COCHRAN-ARMITAGE       |     P=0.220N                                       |     P=0.106                                        |
|FISHER EXACT           |                     P=0.500N        P=0.262N       |                       (e)           P=0.247        |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibrosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       0/50 (0%)       2/50 (4%)      |     0/50 (0%)       3/50 (6%)       1/50 (2%)      |
|ADJUSTED (b)           |      6.5%            0.0%            8.3%          |      0.0%            9.0%            3.8%          |
|TERMINAL (d)           |     2/31 (6%)       0/25 (0%)       2/24 (8%)      |     0/31 (0%)       0/26 (0%)       1/26 (4%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         ---             729 (T)       |      ---             695             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.562         P=0.286N        P=0.600        |     P=0.317         P=0.107         P=0.465        |
|INCIDENTAL TUMOR       |     P=0.562         P=0.286N        P=0.600        |     P=0.306         P=0.143         P=0.465        |
|LOGISTIC REGRESSION    |     P=0.562         P=0.286N        P=0.600        |     P=0.091         P=0.112         P=0.465        |
|COCHRAN-ARMITAGE       |     P=0.610N                                       |     P=0.362                                        |
|FISHER EXACT           |                     P=0.247N        P=0.691N       |                     P=0.121         P=0.500        |
|=================================================================================================================================|
 
         DATE: 09/07/94                     EXPERIMENT: 05049 TEST: 01                                                 PAGE  18
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DICHLORVOS
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         4.0             8.0           |      VEHICLE         4.0             8.0           |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,                                                                                   |
|     Neurofibroma, or Fibroma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     9/50 (18%)      6/50 (12%)      6/50 (12%)     |     0/50 (0%)       3/50 (6%)       3/50 (6%)      |
|ADJUSTED (b)           |     24.6%           20.6%           25.0%          |      0.0%            9.0%           11.5%          |
|TERMINAL (d)           |     6/31 (19%)      4/25 (16%)      6/24 (25%)     |     0/31 (0%)       0/26 (0%)       3/26 (12%)     |
|FIRST INCIDENCE (DAYS) |      576             644             729 (T)       |      ---             695             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.390N        P=0.429N        P=0.458N       |     P=0.076         P=0.107         P=0.091        |
|INCIDENTAL TUMOR       |     P=0.313N        P=0.379N        P=0.388N       |     P=0.069         P=0.143         P=0.091        |
|LOGISTIC REGRESSION    |     P=0.276N        P=0.323N        P=0.324N       |     P=0.019 *       P=0.112         P=0.091        |
|COCHRAN-ARMITAGE       |     P=0.233N                                       |     P=0.099                                        |
|FISHER EXACT           |                     P=0.288N        P=0.288N       |                     P=0.121         P=0.121        |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Schwannoma Malignant                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       1/50 (2%)       0/50 (0%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      6.5%            2.1%            0.0%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     2/31 (6%)       0/25 (0%)       0/24 (0%)      |     0/31 (0%)       0/26 (0%)       0/26 (0%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         477             ---           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.184N        P=0.555N        P=0.296N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.148N        P=0.431N        P=0.296N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.131N        P=0.453N        P=0.296N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.147N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.500N        P=0.247N       |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/07/94                     EXPERIMENT: 05049 TEST: 01                                                 PAGE  19
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DICHLORVOS
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         4.0             8.0           |      VEHICLE         4.0             8.0           |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       1/50 (2%)       0/50 (0%)      |     0/50 (0%)       1/50 (2%)       0/50 (0%)      |
|ADJUSTED (b)           |      6.5%            4.0%            0.0%          |      0.0%            3.8%            0.0%          |
|TERMINAL (d)           |     2/31 (6%)       1/25 (4%)       0/24 (0%)      |     0/31 (0%)       1/26 (4%)       0/26 (0%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         729 (T)         ---           |      ---             729 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.197N        P=0.575N        P=0.296N       |     P=0.698         P=0.465           (e)          |
|INCIDENTAL TUMOR       |     P=0.197N        P=0.575N        P=0.296N       |     P=0.698         P=0.465           (e)          |
|LOGISTIC REGRESSION    |     P=0.197N        P=0.575N        P=0.296N       |     P=0.698         P=0.465           (e)          |
|COCHRAN-ARMITAGE       |     P=0.147N                                       |     P=0.726                                        |
|FISHER EXACT           |                     P=0.500N        P=0.247N       |                     P=0.500           (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    45/50 (90%)     46/50 (92%)     46/50 (92%)     |                                                    |
|ADJUSTED (b)           |     97.8%          100.0%           97.8%          |                                                    |
|TERMINAL (d)           |    30/31 (97%)     25/25 (100%)    23/24 (96%)     |                                                    |
|FIRST INCIDENCE (DAYS) |      522             468             461           |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.069         P=0.078         P=0.079        |                                                    |
|INCIDENTAL TUMOR       |     P=0.279         P=0.208         P=0.362        |                                                    |
|LOGISTIC REGRESSION    |     P=0.323         P=0.185         P=0.427        |                                                    |
|COCHRAN-ARMITAGE       |     P=0.431                                        |                                                    |
|FISHER EXACT           |                     P=0.500         P=0.500        |                                                    |
|=================================================================================================================================|
 
         DATE: 09/07/94                     EXPERIMENT: 05049 TEST: 01                                                 PAGE  20
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DICHLORVOS
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         4.0             8.0           |      VEHICLE         4.0             8.0           |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     6/49 (12%)      9/49 (18%)      8/49 (16%)     |     5/50 (10%)      7/49 (14%)      5/50 (10%)     |
|ADJUSTED (b)           |     18.3%           28.4%           24.8%          |     14.8%           21.8%           15.3%          |
|TERMINAL (d)           |     5/31 (16%)      4/25 (16%)      3/23 (13%)     |     4/31 (13%)      3/26 (12%)      2/26 (8%)      |
|FIRST INCIDENCE (DAYS) |      674             653             623           |      596             656             631           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.200         P=0.175         P=0.243        |     P=0.447         P=0.295         P=0.525        |
|INCIDENTAL TUMOR       |     P=0.334         P=0.241         P=0.389        |     P=0.509         P=0.345         P=0.626        |
|LOGISTIC REGRESSION    |     P=0.290         P=0.212         P=0.353        |     P=0.517         P=0.341         P=0.610        |
|COCHRAN-ARMITAGE       |     P=0.333                                        |     P=0.556                                        |
|FISHER EXACT           |                     P=0.288         P=0.387        |                     P=0.365         P=0.630N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     6/49 (12%)     10/49 (20%)      8/49 (16%)     |     5/50 (10%)      8/49 (16%)      5/50 (10%)     |
|ADJUSTED (b)           |     18.3%           31.8%           24.8%          |     14.8%           25.2%           15.3%          |
|TERMINAL (d)           |     5/31 (16%)      5/25 (20%)      3/23 (13%)     |     4/31 (13%)      4/26 (15%)      2/26 (8%)      |
|FIRST INCIDENCE (DAYS) |      674             653             623           |      596             656             631           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.193         P=0.114         P=0.243        |     P=0.436         P=0.202         P=0.525        |
|INCIDENTAL TUMOR       |     P=0.323         P=0.160         P=0.389        |     P=0.497         P=0.240         P=0.626        |
|LOGISTIC REGRESSION    |     P=0.284         P=0.138         P=0.353        |     P=0.505         P=0.239         P=0.610        |
|COCHRAN-ARMITAGE       |     P=0.332                                        |     P=0.550                                        |
|FISHER EXACT           |                     P=0.207         P=0.387        |                     P=0.264         P=0.630N       |
|=================================================================================================================================|
 
         DATE: 09/07/94                     EXPERIMENT: 05049 TEST: 01                                                 PAGE  21
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DICHLORVOS
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         4.0             8.0           |      VEHICLE         4.0             8.0           |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |    15/50 (30%)     14/50 (28%)     13/50 (26%)     |
|ADJUSTED (b)           |                                                    |     39.8%           43.5%           34.7%          |
|TERMINAL (d)           |                                                    |    10/31 (32%)      9/26 (35%)      4/26 (15%)     |
|FIRST INCIDENCE (DAYS) |                                                    |      582             556             582           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.534         P=0.499         P=0.579N       |
|INCIDENTAL TUMOR       |                                                    |     P=0.373N        P=0.576         P=0.369N       |
|LOGISTIC REGRESSION    |                                                    |     P=0.423N        P=0.560N        P=0.434N       |
|COCHRAN-ARMITAGE       |                                                    |     P=0.372N                                       |
|FISHER EXACT           |                                                    |                     P=0.500N        P=0.412N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |     0/50 (0%)       0/50 (0%)       2/50 (4%)      |
|ADJUSTED (b)           |                                                    |      0.0%            0.0%            5.0%          |
|TERMINAL (d)           |                                                    |     0/31 (0%)       0/26 (0%)       0/26 (0%)      |
|FIRST INCIDENCE (DAYS) |                                                    |      ---             ---             587           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.098           (e)           P=0.218        |
|INCIDENTAL TUMOR       |                                                    |     P=0.138           (e)           P=0.290        |
|LOGISTIC REGRESSION    |                                                    |     P=0.110           (e)           P=0.281        |
|COCHRAN-ARMITAGE       |                                                    |     P=0.106                                        |
|FISHER EXACT           |                                                    |                       (e)           P=0.247        |
|=================================================================================================================================|
 
         DATE: 09/07/94                     EXPERIMENT: 05049 TEST: 01                                                 PAGE  22
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DICHLORVOS
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         4.0             8.0           |      VEHICLE         4.0             8.0           |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal or Polyp Stromal                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |    15/50 (30%)     14/50 (28%)     14/50 (28%)     |
|ADJUSTED (b)           |                                                    |     39.8%           43.5%           36.2%          |
|TERMINAL (d)           |                                                    |    10/31 (32%)      9/26 (35%)      4/26 (15%)     |
|FIRST INCIDENCE (DAYS) |                                                    |      582             556             582           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.454         P=0.499         P=0.499        |
|INCIDENTAL TUMOR       |                                                    |     P=0.437N        P=0.576         P=0.427N       |
|LOGISTIC REGRESSION    |                                                    |     P=0.501N        P=0.560N        P=0.507N       |
|COCHRAN-ARMITAGE       |                                                    |     P=0.457N                                       |
|FISHER EXACT           |                                                    |                     P=0.500N        P=0.500N       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Leukemia: Lymphocytic, Monocytic, Mononuclear,                                                                              |
|     or Undifferentiated                                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    11/50 (22%)     20/50 (40%)     21/50 (42%)     |    17/50 (34%)     21/50 (42%)     23/50 (46%)     |
|ADJUSTED (b)           |     31.7%           59.0%           57.1%          |     39.1%           53.2%           56.8%          |
|TERMINAL (d)           |     8/31 (26%)     12/25 (48%)      9/24 (38%)     |     7/31 (23%)      9/26 (35%)      9/26 (35%)     |
|FIRST INCIDENCE (DAYS) |      595             607             610           |      532             519             546           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.006 **      P=0.012 *       P=0.008 **     |     P=0.082         P=0.186         P=0.100        |
|INCIDENTAL TUMOR       |     P=0.018 *       P=0.019 *       P=0.026 *      |     P=0.169         P=0.262         P=0.202        |
|LOGISTIC REGRESSION    |     P=0.011 *       P=0.016 *       P=0.016 *      |     P=0.146         P=0.231         P=0.176        |
|COCHRAN-ARMITAGE       |     P=0.022 *                                      |     P=0.131                                        |
|FISHER EXACT           |                     P=0.041 *       P=0.026 *      |                     P=0.268         P=0.154        |
|=================================================================================================================================|
 
         DATE: 09/07/94                     EXPERIMENT: 05049 TEST: 01                                                 PAGE  23
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DICHLORVOS
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         4.0             8.0           |      VEHICLE         4.0             8.0           |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma And Histiocytic Sarcoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       0/50 (0%)       2/50 (4%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      0.0%            0.0%            6.2%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/31 (0%)       0/25 (0%)       1/24 (4%)      |     0/31 (0%)       0/26 (0%)       0/26 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             564           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.096           (e)           P=0.210        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.119           (e)           P=0.253        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.108           (e)           P=0.253        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.106                                        |       (e)                                          |
|FISHER EXACT           |                       (e)           P=0.247        |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,                                                                        |
|     NOS, or Undifferentiated Cell Type                                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       0/50 (0%)       2/50 (4%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      0.0%            0.0%            6.2%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/31 (0%)       0/25 (0%)       1/24 (4%)      |     0/31 (0%)       0/26 (0%)       0/26 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             564           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.096           (e)           P=0.210        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.119           (e)           P=0.253        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.108           (e)           P=0.253        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.106                                        |       (e)                                          |
|FISHER EXACT           |                       (e)           P=0.247        |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/07/94                     EXPERIMENT: 05049 TEST: 01                                                 PAGE  24
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DICHLORVOS
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         4.0             8.0           |      VEHICLE         4.0             8.0           |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Mesothelioma Benign, Malignant, NOS                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/50 (6%)       2/50 (4%)       1/50 (2%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      8.7%            7.3%            2.4%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     2/31 (6%)       1/25 (4%)       0/24 (0%)      |     0/31 (0%)       0/26 (0%)       0/26 (0%)      |
|FIRST INCIDENCE (DAYS) |      651             691             623           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.287N        P=0.591N        P=0.361N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.225N        P=0.528N        P=0.294N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.236N        P=0.549N        P=0.300N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.227N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.500N        P=0.309N       |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    49/50 (98%)     49/50 (98%)     49/50 (98%)     |    40/50 (80%)     40/50 (80%)     39/50 (78%)     |
|ADJUSTED (b)           |    100.0%          100.0%          100.0%          |     88.7%           93.0%           90.6%          |
|TERMINAL (d)           |    31/31 (100%)    25/25 (100%)    24/24 (100%)    |    26/31 (84%)     23/26 (88%)     22/26 (85%)     |
|FIRST INCIDENCE (DAYS) |      522             426             461           |      547             545             486           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.094         P=0.108         P=0.100        |     P=0.225         P=0.228         P=0.266        |
|INCIDENTAL TUMOR       |     P=0.560         P=0.500         P=0.667        |     P=0.429         P=0.356         P=0.550        |
|LOGISTIC REGRESSION    |     P=0.672         P=0.500         P=0.764        |     P=0.432         P=0.393         P=0.518        |
|COCHRAN-ARMITAGE       |     P=0.647                                        |     P=0.456N                                       |
|FISHER EXACT           |                     P=0.753N        P=0.753N       |                     P=0.598N        P=0.500N       |
|=================================================================================================================================|
 
         DATE: 09/07/94                     EXPERIMENT: 05049 TEST: 01                                                 PAGE  25
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DICHLORVOS
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         4.0             8.0           |      VEHICLE         4.0             8.0           |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    25/50 (50%)     29/50 (58%)     32/50 (64%)     |    23/50 (46%)     32/50 (64%)     30/50 (60%)     |
|ADJUSTED (b)           |     59.0%           79.7%           75.3%          |     48.6%           73.8%           67.6%          |
|TERMINAL (d)           |    14/31 (45%)     18/25 (72%)     14/24 (58%)     |     8/31 (26%)     15/26 (58%)     12/26 (46%)     |
|FIRST INCIDENCE (DAYS) |      393             477             564           |      404             446             383           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.028 *       P=0.085         P=0.041 *      |     P=0.060         P=0.049 *       P=0.081        |
|INCIDENTAL TUMOR       |     P=0.086         P=0.199         P=0.141        |     P=0.112         P=0.050 *       P=0.167        |
|LOGISTIC REGRESSION    |     P=0.066         P=0.170         P=0.100        |     P=0.121         P=0.042 *       P=0.181        |
|COCHRAN-ARMITAGE       |     P=0.095                                        |     P=0.089                                        |
|FISHER EXACT           |                     P=0.274         P=0.113        |                     P=0.054         P=0.115        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    50/50 (100%)    49/50 (98%)     50/50 (100%)    |    47/50 (94%)     46/50 (92%)     46/50 (92%)     |
|ADJUSTED (b)           |    100.0%          100.0%          100.0%          |     94.0%           95.8%           93.9%          |
|TERMINAL (d)           |    31/31 (100%)    25/25 (100%)    24/24 (100%)    |    28/31 (90%)     24/26 (92%)     23/26 (88%)     |
|FIRST INCIDENCE (DAYS) |      393             426             461           |      404             446             383           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.098         P=0.142         P=0.106        |     P=0.220         P=0.267         P=0.253        |
|INCIDENTAL TUMOR       |     P=0.758         P=0.718N          (e)          |     P=0.387N        P=0.581         P=0.469N       |
|LOGISTIC REGRESSION    |     P=0.535N        P=0.517N          (e)          |     P=0.501N        P=0.662N        P=0.502N       |
|COCHRAN-ARMITAGE       |     P=0.726N                                       |     P=0.425N                                       |
|FISHER EXACT           |                     P=0.500N        P=1.000N       |                     P=0.500N        P=0.500N       |
|=================================================================================================================================|
 
         DATE: 09/07/94                     EXPERIMENT: 05049 TEST: 01                                                 PAGE  26
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DICHLORVOS
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
 
 (a)  Number of tumor-bearing animals / number of animals examined at site.
 (b)  Kaplan-Meier estimated lifetime tumor incidence after adjustment for 
      intercurrent mortality.
 (d)  Observed incidence at terminal kill.
 (f)  Beneath the control incidence are the P-values associated with the trend 
      test.  Beneath the dosed group incidence are the P-values corresponding to 
      pairwise comparisons between the controls and that dosed group.  The life
      table analysis regards tumors in animals dying  prior to terminal kill as
      being (directly or indirectly) the cause of death.  The incidental tumor 
      test regards these lesions as non-fatal.  Logistic regression is an alternative
      method for analyzing the incidence of non-fatal tumors.  The Cochran-Armitage
      and Fisher's exact tests compare directly the overall incidence rates.  
      For all tests, a negative trend is indicated by "N".
 (e)  Value of Statistic cannot be computed. 
 (I)  Interim sacrifice
 (T)  Terminal sacrifice
  #   Tumor rates based on number of animals necropsied.
 
  *   To the right of any statistical result, indicates significance at (P<=0.05).
  **  To the right of any statistical result, indicates significance at (P<=0.01).

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