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TDMS Study 05037-03 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                PENTACHLOROANISOLE                                  DATE: 09/05/94       
EXPERIMENT: 05037 TEST: 03                                                                                     TIME: 04:41:27       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NOI-ES-28024          ROUTE: GAVAGE                                                                      NTP C#: 56520        
PATHOLOGIST: J. HEATH                        S. EUSTIS                                                         CAS: 1825-21-4       
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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                                PENTACHLOROANISOLE                                  DATE: 09/05/94      
EXPERIMENT: 05037 TEST: 03                                                                                     TIME: 04:41:27      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: NOI-ES-28024          ROUTE: GAVAGE                                                                      NTP C#: 56520       
PATHOLOGIST: J. HEATH                        S. EUSTIS                                                         CAS: 1825-21-4      
 
 
 
 
 
                                                    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                                PENTACHLOROANISOLE                                  DATE: 09/05/94       
EXPERIMENT: 05037 TEST: 03                                                                                     TIME: 04:41:27       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NOI-ES-28024          ROUTE: GAVAGE                                                                      NTP C#: 56520        
PATHOLOGIST: J. HEATH                        S. EUSTIS                                                         CAS: 1825-21-4       
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                       IN THE ANALYSIS OF THE STUDY OF PENTACHLOROANISOLE
 
              ====================================================================================================
 
                                                           MALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Adrenal Medulla               Pheochromocytoma Benign
                                                           Pheochromocytoma: Benign, Complex, Malignant, NOS
                             Clitoral/Preputial Gland      Carcinoma
                                                           Carcinoma or Adenoma
                             Heart                         Schwannoma Benign
                             Islets, Pancreatic            Carcinoma or Adenoma
                             Lung                          Alveolar/Bronchiolar Adenoma
                             Mammary Gland                 Fibroadenoma
                                                           Fibroma, Fibroadenoma or Adenoma
                                                           Fibroma, Fibroadenoma, Carcinoma, or Adenoma
                             Pancreas                      Adenoma
                             Pituitary Gland: Pars Distalis or Unspecified Site
                                                           Adenoma
                                                           Carcinoma
                                                           Carcinoma or Adenoma
                             Testes                        Adenoma
                             Thyroid Gland: C-Cell         Carcinoma or Adenoma
                             All Organs                    Leukemia: Lymphocytic, Monocytic, Mononuclear,
                                                            or Undifferentiated
                                                           Benign Tumors
                                                           Malignant Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
 
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                PENTACHLOROANISOLE                                  DATE: 09/05/94       
EXPERIMENT: 05037 TEST: 03                                                                                     TIME: 04:41:27       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NOI-ES-28024          ROUTE: GAVAGE                                                                      NTP C#: 56520        
PATHOLOGIST: J. HEATH                        S. EUSTIS                                                         CAS: 1825-21-4       
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                       IN THE ANALYSIS OF THE STUDY OF PENTACHLOROANISOLE
 
              ====================================================================================================
 
                                                           FEMALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Adrenal Medulla               Pheochromocytoma Benign
                                                           Pheochromocytoma: Benign, Complex, Malignant, NOS
                             Clitoral/Preputial Gland      Adenoma
                                                           Carcinoma or Adenoma
                             Mammary Gland                 Adenoma
                                                           Fibroadenoma
                                                           Fibroma, Fibroadenoma or Adenoma
                                                           Fibroma, Fibroadenoma, Carcinoma, or Adenoma
                             Ovary                         Granulosa Cell Tumor Malignant
                             Thyroid Gland: C-Cell         Adenoma
                                                           Carcinoma or Adenoma
                             Uterus                        Polyp Stromal
                                                           Sarcoma Stromal or Polyp Stromal
                             All Organs                    Benign Tumors
                                                           Malignant Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
         DATE: 09/05/94                     EXPERIMENT: 05037 TEST: 03                                                 PAGE   1
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PENTACHLOROANISOLE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      10.MG/KG     20.MG/KG     40.MG/KG  |      VEHICLE         20.MG/KG        40.MG/KG      |
|                       |   15 SSAC      15 SSAC      15 SSAC      15 SSAC   |      15 SSAC         15 SSAC         15 SSAC       |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 12/50 (24%)  17/50 (34%)  23/50 (46%)  15/48 (31%) |     3/50 (6%)       7/50 (14%)      9/50 (18%)     |
|ADJUSTED (b)           |  37.4%        61.9%        73.6%        70.8%      |     10.0%           19.1%           19.5%          |
|TERMINAL (d)           |  6/24 (25%)  10/20 (50%)  16/24 (67%)   8/14 (57%) |     2/29 (7%)       6/35 (17%)      7/44 (16%)     |
|FIRST INCIDENCE (DAYS) |   527          520          684          548       |      718             673             712           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.010 **   P=0.077      P=0.020 *    P=0.015 *  |     P=0.193         P=0.247         P=0.219        |
|INCIDENTAL TUMOR       |  P<0.001 **   P=0.063      P=0.006 **   P=0.003 ** |     P=0.091         P=0.251         P=0.080        |
|LOGISTIC REGRESSION    |  P=0.001 **   P=0.070      P=0.006 **   P=0.004 ** |     P=0.135         P=0.232         P=0.170        |
|COCHRAN-ARMITAGE       |  P=0.256                                           |     P=0.049 *                                      |
|FISHER EXACT           |               P=0.189      P=0.018 *    P=0.282    |                     P=0.159         P=0.061        |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Malignant                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/50 (6%)    2/50 (4%)    4/50 (8%)    0/48 (0%)  |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |   8.2%         7.8%        14.7%         0.0%      |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |  0/24 (0%)    1/20 (5%)    2/24 (8%)    0/14 (0%)  |     0/29 (0%)       0/35 (0%)       0/44 (0%)      |
|FIRST INCIDENCE (DAYS) |   624          626          704          ---       |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.282N     P=0.603N     P=0.491      P=0.260N   |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |  P=0.352N     P=0.476N     P=0.386      P=0.294N   |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |  P=0.292N     P=0.509N     P=0.457      P=0.218N   |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |  P=0.147N                                          |       (e)                                          |
|FISHER EXACT           |               P=0.500N     P=0.500      P=0.129N   |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05037 TEST: 03                                                 PAGE   2
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PENTACHLOROANISOLE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      10.MG/KG     20.MG/KG     40.MG/KG  |      VEHICLE         20.MG/KG        40.MG/KG      |
|                       |   15 SSAC      15 SSAC      15 SSAC      15 SSAC   |      15 SSAC         15 SSAC         15 SSAC       |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 15/50 (30%)  18/50 (36%)  25/50 (50%)  15/48 (31%) |     3/50 (6%)       7/50 (14%)      9/50 (18%)     |
|ADJUSTED (b)           |  42.6%        65.7%        77.7%        70.8%      |     10.0%           19.1%           19.5%          |
|TERMINAL (d)           |  6/24 (25%)  11/20 (55%)  17/24 (71%)   8/14 (57%) |     2/29 (7%)       6/35 (17%)      7/44 (16%)     |
|FIRST INCIDENCE (DAYS) |   527          520          684          548       |      718             673             712           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.033 *    P=0.148      P=0.042 *    P=0.054    |     P=0.193         P=0.247         P=0.219        |
|INCIDENTAL TUMOR       |  P=0.003 **   P=0.140      P=0.010 **   P=0.013 *  |     P=0.091         P=0.251         P=0.080        |
|LOGISTIC REGRESSION    |  P=0.005 **   P=0.156      P=0.010 **   P=0.021 *  |     P=0.135         P=0.232         P=0.170        |
|COCHRAN-ARMITAGE       |  P=0.457                                           |     P=0.049 *                                      |
|FISHER EXACT           |               P=0.335      P=0.033 *    P=0.534    |                     P=0.159         P=0.061        |
|=================================================================================================================================|
|                                                                                                                                 |
|Brain                                                                                                                            |
|     Oligodendroglioma, Glioma, or Astrocytoma                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/50 (0%)    1/50 (2%)    0/50 (0%)  |     2/50 (4%)       0/4 (0%)        0/50 (0%)      |
|ADJUSTED (b)           |   0.0%         0.0%         3.3%         0.0%      |      4.6%            0.0%            0.0%          |
|TERMINAL (d)           |  0/24 (0%)    0/20 (0%)    0/24 (0%)    0/14 (0%)  |     0/29 (0%)       0/1 (0%)        0/44 (0%)      |
|FIRST INCIDENCE (DAYS) |   ---          ---          704          ---       |      444             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.628        (e)        P=0.500        (e)      |     P=0.084N        P=0.224N        P=0.213N       |
|INCIDENTAL TUMOR       |  P=0.584        (e)        P=0.446        (e)      |     P=0.397N          (e)           P=0.570N       |
|LOGISTIC REGRESSION    |  P=0.626        (e)        P=0.484        (e)      |     P=0.244N        P=0.739N        P=0.458N       |
|COCHRAN-ARMITAGE       |  P=0.688                                           |     P=0.138N                                       |
|FISHER EXACT           |                 (e)        P=0.500        (e)      |                     P=0.856N        P=0.247N       |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05037 TEST: 03                                                 PAGE   3
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PENTACHLOROANISOLE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      10.MG/KG     20.MG/KG     40.MG/KG  |      VEHICLE         20.MG/KG        40.MG/KG      |
|                       |   15 SSAC      15 SSAC      15 SSAC      15 SSAC   |      15 SSAC         15 SSAC         15 SSAC       |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    1/48 (2%)    5/50 (10%)   0/50 (0%)  |     5/50 (10%)      4/8 (50%)       3/50 (6%)      |
|ADJUSTED (b)           |   8.3%         2.6%        20.8%         0.0%      |     15.8%           57.1%            6.8%          |
|TERMINAL (d)           |  2/24 (8%)    0/19 (0%)    5/24 (21%)   0/14 (0%)  |     4/29 (14%)      4/7 (57%)       3/44 (7%)      |
|FIRST INCIDENCE (DAYS) |   729 (T)      578          729 (T)      ---       |      579             729 (T)         729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.498N     P=0.573N     P=0.209      P=0.362N   |     P=0.119N        P=0.101         P=0.177N       |
|INCIDENTAL TUMOR       |  P=0.504N     P=0.468N     P=0.209      P=0.362N   |     P=0.166N        P=0.026 *       P=0.240N       |
|LOGISTIC REGRESSION    |  P=0.536N     P=0.532N     P=0.209      P=0.362N   |     P=0.203N        P=0.025 *       P=0.276N       |
|COCHRAN-ARMITAGE       |  P=0.312N                                          |     P=0.321N                                       |
|FISHER EXACT           |               P=0.515N     P=0.218      P=0.247N   |                     P=0.015 *       P=0.357N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  6/50 (12%)   2/48 (4%)    1/50 (2%)    1/50 (2%)  |     3/50 (6%)       1/8 (13%)       2/50 (4%)      |
|ADJUSTED (b)           |  17.2%         5.1%         4.2%         6.3%      |      9.5%            2.6%            4.3%          |
|TERMINAL (d)           |  1/24 (4%)    0/19 (0%)    1/24 (4%)    0/14 (0%)  |     1/29 (3%)       0/7 (0%)        0/44 (0%)      |
|FIRST INCIDENCE (DAYS) |   507          577          729 (T)      702       |      705             702             712           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.095N     P=0.236N     P=0.072N     P=0.254N   |     P=0.251N        P=0.372N        P=0.320N       |
|INCIDENTAL TUMOR       |  P=0.110N     P=0.124N     P=0.066N     P=0.275N   |     P=0.471         P=0.544         P=0.633        |
|LOGISTIC REGRESSION    |  P=0.060N     P=0.129N     P=0.066N     P=0.184N   |     P=0.484N        P=0.841         P=0.593N       |
|COCHRAN-ARMITAGE       |  P=0.030N*                                         |     P=0.416N                                       |
|FISHER EXACT           |               P=0.148N     P=0.056N     P=0.056N   |                     P=0.457         P=0.500N       |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05037 TEST: 03                                                 PAGE   4
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PENTACHLOROANISOLE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      10.MG/KG     20.MG/KG     40.MG/KG  |      VEHICLE         20.MG/KG        40.MG/KG      |
|                       |   15 SSAC      15 SSAC      15 SSAC      15 SSAC   |      15 SSAC         15 SSAC         15 SSAC       |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  8/50 (16%)   3/48 (6%)    6/50 (12%)   1/50 (2%)  |     8/50 (16%)      5/8 (63%)       5/50 (10%)     |
|ADJUSTED (b)           |  24.4%         7.5%        25.0%         6.3%      |     24.2%           58.3%           10.8%          |
|TERMINAL (d)           |  3/24 (13%)   0/19 (0%)    6/24 (25%)   0/14 (0%)  |     5/29 (17%)      4/7 (57%)       3/44 (7%)      |
|FIRST INCIDENCE (DAYS) |   507          577          729 (T)      702       |      579             702             712           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.120N     P=0.204N     P=0.406N     P=0.133N   |     P=0.066N        P=0.334         P=0.094N       |
|INCIDENTAL TUMOR       |  P=0.138N     P=0.087N     P=0.408N     P=0.140N   |     P=0.255N        P=0.019 *       P=0.322N       |
|LOGISTIC REGRESSION    |  P=0.107N     P=0.101N     P=0.452N     P=0.100N   |     P=0.137N        P=0.022 *       P=0.177N       |
|COCHRAN-ARMITAGE       |  P=0.026N*                                         |     P=0.255N                                       |
|FISHER EXACT           |               P=0.113N     P=0.387N     P=0.015N*  |                     P=0.010 *       P=0.277N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Heart                                                                                                                            |
|     Schwannoma Benign                                                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/50 (6%)    1/50 (2%)    0/49 (0%)    0/50 (0%)  |     0/50 (0%)       0/0 (0%)        0/50 (0%)      |
|ADJUSTED (b)           |  12.5%         5.0%         0.0%         0.0%      |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |  3/24 (13%)   1/20 (5%)    0/23 (0%)    0/14 (0%)  |     0/29 (0%)       0/0             0/44 (0%)      |
|FIRST INCIDENCE (DAYS) |   729 (T)      729 (T)      ---          ---       |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.066N     P=0.370N     P=0.126N     P=0.228N   |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |  P=0.066N     P=0.370N     P=0.126N     P=0.228N   |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |  P=0.066N     P=0.370N     P=0.126N     P=0.228N   |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |  P=0.043N*                                         |       (e)                                          |
|FISHER EXACT           |               P=0.309N     P=0.125N     P=0.121N   |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05037 TEST: 03                                                 PAGE   5
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PENTACHLOROANISOLE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      10.MG/KG     20.MG/KG     40.MG/KG  |      VEHICLE         20.MG/KG        40.MG/KG      |
|                       |   15 SSAC      15 SSAC      15 SSAC      15 SSAC   |      15 SSAC         15 SSAC         15 SSAC       |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  8/49 (16%)   2/49 (4%)    3/49 (6%)    6/50 (12%) |     0/50 (0%)       0/0 (0%)        0/50 (0%)      |
|ADJUSTED (b)           |  25.0%         7.3%        11.2%        32.5%      |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |  3/24 (13%)   0/20 (0%)    2/24 (8%)    3/14 (21%) |     0/29 (0%)       0/0             0/44 (0%)      |
|FIRST INCIDENCE (DAYS) |   594          604          701          514       |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.316      P=0.105N     P=0.122N     P=0.375    |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |  P=0.239      P=0.069N     P=0.147N     P=0.320    |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |  P=0.299      P=0.059N     P=0.122N     P=0.385    |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |  P=0.464N                                          |       (e)                                          |
|FISHER EXACT           |               P=0.046N*    P=0.100N     P=0.371N   |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  9/49 (18%)   2/49 (4%)    3/49 (6%)    6/50 (12%) |     0/50 (0%)       0/0 (0%)        0/50 (0%)      |
|ADJUSTED (b)           |  28.6%         7.3%        11.2%        32.5%      |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |  4/24 (17%)   0/20 (0%)    2/24 (8%)    3/14 (21%) |     0/29 (0%)       0/0             0/44 (0%)      |
|FIRST INCIDENCE (DAYS) |   594          604          701          514       |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.416      P=0.069N     P=0.077N     P=0.459    |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |  P=0.337      P=0.043N*    P=0.094N     P=0.408    |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |  P=0.396      P=0.037N*    P=0.078N     P=0.466    |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |  P=0.356N                                          |       (e)                                          |
|FISHER EXACT           |               P=0.025N*    P=0.060N     P=0.274N   |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05037 TEST: 03                                                 PAGE   6
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PENTACHLOROANISOLE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      10.MG/KG     20.MG/KG     40.MG/KG  |      VEHICLE         20.MG/KG        40.MG/KG      |
|                       |   15 SSAC      15 SSAC      15 SSAC      15 SSAC   |      15 SSAC         15 SSAC         15 SSAC       |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    5/50 (10%)   2/50 (4%)    2/50 (4%)  |     0/50 (0%)       1/7 (14%)       1/50 (2%)      |
|ADJUSTED (b)           |   3.8%        19.5%         7.6%        12.0%      |      0.0%            2.4%            2.3%          |
|TERMINAL (d)           |  0/24 (0%)    2/20 (10%)   1/24 (4%)    1/14 (7%)  |     0/29 (0%)       0/2 (0%)        1/44 (2%)      |
|FIRST INCIDENCE (DAYS) |   718          649          705          696       |      ---             673             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.395      P=0.059      P=0.500      P=0.305    |     P=0.435         P=0.536         P=0.583        |
|INCIDENTAL TUMOR       |  P=0.298      P=0.033 *    P=0.438      P=0.216    |     P=0.315         P=0.331         P=0.583        |
|LOGISTIC REGRESSION    |  P=0.361      P=0.075      P=0.478      P=0.279    |     P=0.372         P=0.119         P=0.583        |
|COCHRAN-ARMITAGE       |  P=0.544N                                          |     P=0.355                                        |
|FISHER EXACT           |               P=0.102      P=0.500      P=0.500    |                     P=0.123         P=0.500        |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    5/50 (10%)   2/50 (4%)    2/50 (4%)  |     0/50 (0%)       1/7 (14%)       1/50 (2%)      |
|ADJUSTED (b)           |   7.9%        19.5%         7.6%        12.0%      |      0.0%            2.4%            2.3%          |
|TERMINAL (d)           |  1/24 (4%)    2/20 (10%)   1/24 (4%)    1/14 (7%)  |     0/29 (0%)       0/2 (0%)        1/44 (2%)      |
|FIRST INCIDENCE (DAYS) |   718          649          705          696       |      ---             673             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.534      P=0.136      P=0.692N     P=0.477    |     P=0.435         P=0.536         P=0.583        |
|INCIDENTAL TUMOR       |  P=0.442      P=0.091      P=0.646      P=0.395    |     P=0.315         P=0.331         P=0.583        |
|LOGISTIC REGRESSION    |  P=0.499      P=0.157      P=0.679      P=0.448    |     P=0.372         P=0.119         P=0.583        |
|COCHRAN-ARMITAGE       |  P=0.396N                                          |     P=0.355                                        |
|FISHER EXACT           |               P=0.218      P=0.691N     P=0.691N   |                     P=0.123         P=0.500        |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05037 TEST: 03                                                 PAGE   7
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PENTACHLOROANISOLE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      10.MG/KG     20.MG/KG     40.MG/KG  |      VEHICLE         20.MG/KG        40.MG/KG      |
|                       |   15 SSAC      15 SSAC      15 SSAC      15 SSAC   |      15 SSAC         15 SSAC         15 SSAC       |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |     3/50 (6%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |      8.9%            0.0%            0.0%          |
|TERMINAL (d)           |  0/24 (0%)    0/20 (0%)    0/24 (0%)    0/14 (0%)  |     1/29 (3%)       0/35 (0%)       0/44 (0%)      |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |      640             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |     P=0.021N*       P=0.092N        P=0.072N       |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |     P=0.065N        P=0.145N        P=0.220N       |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |     P=0.035N*       P=0.116N        P=0.117N       |
|COCHRAN-ARMITAGE       |    (e)                                             |     P=0.037N*                                      |
|FISHER EXACT           |                 (e)          (e)          (e)      |                     P=0.121N        P=0.121N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |     3/50 (6%)       0/50 (0%)       1/50 (2%)      |
|ADJUSTED (b)           |   4.2%         0.0%         0.0%         0.0%      |      8.9%            0.0%            2.3%          |
|TERMINAL (d)           |  1/24 (4%)    0/20 (0%)    0/24 (0%)    0/14 (0%)  |     1/29 (3%)       0/35 (0%)       1/44 (2%)      |
|FIRST INCIDENCE (DAYS) |   729 (T)      ---          ---          ---       |      640             ---             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.348N     P=0.536N     P=0.500N     P=0.607N   |     P=0.109N        P=0.092N        P=0.192N       |
|INCIDENTAL TUMOR       |  P=0.348N     P=0.536N     P=0.500N     P=0.607N   |     P=0.233N        P=0.145N        P=0.411N       |
|LOGISTIC REGRESSION    |  P=0.348N     P=0.536N     P=0.500N     P=0.607N   |     P=0.163N        P=0.116N        P=0.287N       |
|COCHRAN-ARMITAGE       |  P=0.301N                                          |     P=0.174N                                       |
|FISHER EXACT           |               P=0.500N     P=0.500N     P=0.500N   |                     P=0.121N        P=0.309N       |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05037 TEST: 03                                                 PAGE   8
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PENTACHLOROANISOLE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      10.MG/KG     20.MG/KG     40.MG/KG  |      VEHICLE         20.MG/KG        40.MG/KG      |
|                       |   15 SSAC      15 SSAC      15 SSAC      15 SSAC   |      15 SSAC         15 SSAC         15 SSAC       |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroadenoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  6/50 (12%)   9/50 (18%)   2/50 (4%)    1/50 (2%)  |    16/50 (32%)     10/50 (20%)      7/50 (14%)     |
|ADJUSTED (b)           |  19.5%        40.5%         6.7%         7.1%      |     47.5%           26.1%           15.9%          |
|TERMINAL (d)           |  2/24 (8%)    7/20 (35%)   0/24 (0%)    1/14 (7%)  |    12/29 (41%)      7/35 (20%)      7/44 (16%)     |
|FIRST INCIDENCE (DAYS) |   683          689          703          729 (T)   |      522             687             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.055N     P=0.157      P=0.153N     P=0.213N   |     P=0.001N**      P=0.052N        P=0.002N**     |
|INCIDENTAL TUMOR       |  P=0.077N     P=0.101      P=0.200N     P=0.287N   |     P=0.006N**      P=0.070N        P=0.007N**     |
|LOGISTIC REGRESSION    |  P=0.057N     P=0.127      P=0.160N     P=0.224N   |     P=0.005N**      P=0.066N        P=0.008N**     |
|COCHRAN-ARMITAGE       |  P=0.012N*                                         |     P=0.020N*                                      |
|FISHER EXACT           |               P=0.288      P=0.134N     P=0.056N   |                     P=0.127N        P=0.028N*      |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma or Adenoma                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  6/50 (12%)   9/50 (18%)   2/50 (4%)    1/50 (2%)  |    19/50 (38%)     10/50 (20%)      7/50 (14%)     |
|ADJUSTED (b)           |  19.5%        40.5%         6.7%         7.1%      |     53.4%           26.1%           15.9%          |
|TERMINAL (d)           |  2/24 (8%)    7/20 (35%)   0/24 (0%)    1/14 (7%)  |    13/29 (45%)      7/35 (20%)      7/44 (16%)     |
|FIRST INCIDENCE (DAYS) |   683          689          703          729 (T)   |      522             687             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.055N     P=0.157      P=0.153N     P=0.213N   |     P<0.001N**      P=0.013N*       P<0.001N**     |
|INCIDENTAL TUMOR       |  P=0.077N     P=0.101      P=0.200N     P=0.287N   |     P=0.001N**      P=0.020N*       P=0.002N**     |
|LOGISTIC REGRESSION    |  P=0.057N     P=0.127      P=0.160N     P=0.224N   |     P<0.001N**      P=0.017N*       P=0.001N**     |
|COCHRAN-ARMITAGE       |  P=0.012N*                                         |     P=0.004N**                                     |
|FISHER EXACT           |               P=0.288      P=0.134N     P=0.056N   |                     P=0.038N*       P=0.006N**     |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05037 TEST: 03                                                 PAGE   9
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PENTACHLOROANISOLE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      10.MG/KG     20.MG/KG     40.MG/KG  |      VEHICLE         20.MG/KG        40.MG/KG      |
|                       |   15 SSAC      15 SSAC      15 SSAC      15 SSAC   |      15 SSAC         15 SSAC         15 SSAC       |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  7/50 (14%)   9/50 (18%)   2/50 (4%)    1/50 (2%)  |    19/50 (38%)     10/50 (20%)      7/50 (14%)     |
|ADJUSTED (b)           |  23.2%        40.5%         6.7%         7.1%      |     53.4%           26.1%           15.9%          |
|TERMINAL (d)           |  3/24 (13%)   7/20 (35%)   0/24 (0%)    1/14 (7%)  |    13/29 (45%)      7/35 (20%)      7/44 (16%)     |
|FIRST INCIDENCE (DAYS) |   683          689          703          729 (T)   |      522             687             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.033N*    P=0.230      P=0.096N     P=0.152N   |     P<0.001N**      P=0.013N*       P<0.001N**     |
|INCIDENTAL TUMOR       |  P=0.047N*    P=0.162      P=0.125N     P=0.205N   |     P=0.001N**      P=0.020N*       P=0.002N**     |
|LOGISTIC REGRESSION    |  P=0.034N*    P=0.192      P=0.099N     P=0.161N   |     P<0.001N**      P=0.017N*       P=0.001N**     |
|COCHRAN-ARMITAGE       |  P=0.006N**                                        |     P=0.004N**                                     |
|FISHER EXACT           |               P=0.393      P=0.080N     P=0.030N*  |                     P=0.038N*       P=0.006N**     |
|=================================================================================================================================|
|                                                                                                                                 |
|Nose                                                                                                                             |
|     Squamous Cell Carcinoma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    2/50 (4%)    0/50 (0%)    0/50 (0%)  |     0/49 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |   2.6%         6.2%         0.0%         0.0%      |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |  0/24 (0%)    0/20 (0%)    0/24 (0%)    0/14 (0%)  |     0/28 (0%)       0/35 (0%)       0/44 (0%)      |
|FIRST INCIDENCE (DAYS) |   683          604          ---          ---       |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.277N     P=0.399      P=0.511N     P=0.628N   |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |  P=0.328N     P=0.463      P=0.554N     P=0.707N   |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |  P=0.225N     P=0.518      P=0.510N     P=0.616N   |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |  P=0.186N                                          |       (e)                                          |
|FISHER EXACT           |               P=0.500      P=0.500N     P=0.500N   |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05037 TEST: 03                                                 PAGE  10
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PENTACHLOROANISOLE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      10.MG/KG     20.MG/KG     40.MG/KG  |      VEHICLE         20.MG/KG        40.MG/KG      |
|                       |   15 SSAC      15 SSAC      15 SSAC      15 SSAC   |      15 SSAC         15 SSAC         15 SSAC       |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip)                                                                           |
|     Papilloma Squamous or Papilloma                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    1/50 (2%)    0/50 (0%)    2/50 (4%)  |     1/50 (2%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |   4.2%         4.3%         0.0%        14.3%      |      3.4%            0.0%            0.0%          |
|TERMINAL (d)           |  1/24 (4%)    0/20 (0%)    0/24 (0%)    2/14 (14%) |     1/29 (3%)       0/35 (0%)       0/44 (0%)      |
|FIRST INCIDENCE (DAYS) |   729 (T)      709          ---          729 (T)   |      729 (T)         ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.236      P=0.726      P=0.500N     P=0.314    |     P=0.216N        P=0.462N        P=0.417N       |
|INCIDENTAL TUMOR       |  P=0.212      P=0.680      P=0.500N     P=0.314    |     P=0.216N        P=0.462N        P=0.417N       |
|LOGISTIC REGRESSION    |  P=0.219      P=0.707      P=0.500N     P=0.314    |     P=0.216N        P=0.462N        P=0.417N       |
|COCHRAN-ARMITAGE       |  P=0.368                                           |     P=0.270N                                       |
|FISHER EXACT           |               P=0.753N     P=0.500N     P=0.500    |                     P=0.500N        P=0.500N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip)                                                                           |
|     Squamous Cell Carcinoma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/50 (0%)    2/50 (4%)    0/50 (0%)  |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |   0.0%         0.0%         5.3%         0.0%      |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |  0/24 (0%)    0/20 (0%)    0/24 (0%)    0/14 (0%)  |     0/29 (0%)       0/35 (0%)       0/44 (0%)      |
|FIRST INCIDENCE (DAYS) |   ---          ---          507          ---       |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.473        (e)        P=0.222        (e)      |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |  P=0.455        (e)        P=0.279        (e)      |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |  P=0.591        (e)        P=0.265        (e)      |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |  P=0.587                                           |       (e)                                          |
|FISHER EXACT           |                 (e)        P=0.247        (e)      |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05037 TEST: 03                                                 PAGE  11
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PENTACHLOROANISOLE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      10.MG/KG     20.MG/KG     40.MG/KG  |      VEHICLE         20.MG/KG        40.MG/KG      |
|                       |   15 SSAC      15 SSAC      15 SSAC      15 SSAC   |      15 SSAC         15 SSAC         15 SSAC       |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip)                                                                           |
|     Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    1/50 (2%)    2/50 (4%)    2/50 (4%)  |     1/50 (2%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |   4.2%         4.3%         5.3%        14.3%      |      3.4%            0.0%            0.0%          |
|TERMINAL (d)           |  1/24 (4%)    0/20 (0%)    0/24 (0%)    2/14 (14%) |     1/29 (3%)       0/35 (0%)       0/44 (0%)      |
|FIRST INCIDENCE (DAYS) |   729 (T)      709          507          729 (T)   |      729 (T)         ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.177      P=0.726      P=0.482      P=0.314    |     P=0.216N        P=0.462N        P=0.417N       |
|INCIDENTAL TUMOR       |  P=0.148      P=0.680      P=0.547      P=0.314    |     P=0.216N        P=0.462N        P=0.417N       |
|LOGISTIC REGRESSION    |  P=0.168      P=0.707      P=0.515      P=0.314    |     P=0.216N        P=0.462N        P=0.417N       |
|COCHRAN-ARMITAGE       |  P=0.335                                           |     P=0.270N                                       |
|FISHER EXACT           |               P=0.753N     P=0.500      P=0.500    |                     P=0.500N        P=0.500N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Granulosa Cell Tumor Malignant                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |     0/50 (0%)       2/5 (40%)       0/50 (0%)      |
|ADJUSTED (b)           |                                                    |      0.0%           40.0%            0.0%          |
|TERMINAL (d)           |                                                    |     0/29 (0%)       2/5 (40%)       0/44 (0%)      |
|FIRST INCIDENCE (DAYS) |                                                    |      ---             729 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.543N        P=0.007 **        (e)          |
|INCIDENTAL TUMOR       |                                                    |     P=0.543N        P=0.007 **        (e)          |
|LOGISTIC REGRESSION    |                                                    |     P=0.543N        P=0.007 **        (e)          |
|COCHRAN-ARMITAGE       |                                                    |     P=0.638                                        |
|FISHER EXACT           |                                                    |                     P=0.007 **        (e)          |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05037 TEST: 03                                                 PAGE  12
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PENTACHLOROANISOLE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      10.MG/KG     20.MG/KG     40.MG/KG  |      VEHICLE         20.MG/KG        40.MG/KG      |
|                       |   15 SSAC      15 SSAC      15 SSAC      15 SSAC   |      15 SSAC         15 SSAC         15 SSAC       |
|=================================================================================================================================|
|                                                                                                                                 |
|Pancreas                                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 12/49 (24%)   1/49 (2%)    1/49 (2%)    0/50 (0%)  |     2/50 (4%)       0/0 (0%)        0/50 (0%)      |
|ADJUSTED (b)           |  45.9%         4.5%         4.2%         0.0%      |      6.9%            0.0%            0.0%          |
|TERMINAL (d)           | 10/24 (42%)   0/20 (0%)    1/24 (4%)    0/14 (0%)  |     2/29 (7%)       0/0             0/44 (0%)      |
|FIRST INCIDENCE (DAYS) |   705          724          729 (T)      ---       |      729 (T)         ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001N**   P=0.004N**   P=0.001N**   P=0.005N** |     P=0.083N          (e)           P=0.152N       |
|INCIDENTAL TUMOR       |  P<0.001N**   P=0.005N**   P=0.001N**   P=0.005N** |     P=0.083N          (e)           P=0.152N       |
|LOGISTIC REGRESSION    |  P<0.001N**   P=0.003N**   P<0.001N**   P=0.004N** |     P=0.083N          (e)           P=0.152N       |
|COCHRAN-ARMITAGE       |  P<0.001N**                                        |     P=0.143N                                       |
|FISHER EXACT           |               P<0.001N**   P<0.001N**   P<0.001N** |                     P=1.000N        P=0.247N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 16/49 (33%)  22/50 (44%)  14/48 (29%)  10/50 (20%) |    18/49 (37%)     21/50 (42%)     20/50 (40%)     |
|ADJUSTED (b)           |  48.8%        60.8%        46.6%        48.8%      |     53.5%           50.9%           43.3%          |
|TERMINAL (d)           |  9/24 (38%)   8/20 (40%)   9/24 (38%)   4/14 (29%) |    13/28 (46%)     15/35 (43%)     18/44 (41%)     |
|FIRST INCIDENCE (DAYS) |   594          435          633          635       |      589             589             570           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.453N     P=0.063      P=0.445N     P=0.461    |     P=0.135N        P=0.496N        P=0.166N       |
|INCIDENTAL TUMOR       |  P=0.496      P=0.196      P=0.556N     P=0.393    |     P=0.468N        P=0.564         P=0.475N       |
|LOGISTIC REGRESSION    |  P=0.448N     P=0.169      P=0.521N     P=0.435    |     P=0.410N        P=0.559         P=0.468N       |
|COCHRAN-ARMITAGE       |  P=0.032N*                                         |     P=0.410                                        |
|FISHER EXACT           |               P=0.170      P=0.440N     P=0.115N   |                     P=0.371         P=0.449        |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05037 TEST: 03                                                 PAGE  13
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PENTACHLOROANISOLE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      10.MG/KG     20.MG/KG     40.MG/KG  |      VEHICLE         20.MG/KG        40.MG/KG      |
|                       |   15 SSAC      15 SSAC      15 SSAC      15 SSAC   |      15 SSAC         15 SSAC         15 SSAC       |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/49 (8%)    1/50 (2%)    1/48 (2%)    0/50 (0%)  |     2/49 (4%)       2/50 (4%)       3/50 (6%)      |
|ADJUSTED (b)           |  12.3%         5.0%         2.7%         0.0%      |      5.4%            5.7%            6.8%          |
|TERMINAL (d)           |  1/24 (4%)    1/20 (5%)    0/24 (0%)    0/14 (0%)  |     0/28 (0%)       2/35 (6%)       3/44 (7%)      |
|FIRST INCIDENCE (DAYS) |   617          729 (T)      654          ---       |      640             729 (T)         729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.070N     P=0.262N     P=0.199N     P=0.180N   |     P=0.580         P=0.622N        P=0.663        |
|INCIDENTAL TUMOR       |  P=0.083N     P=0.211N     P=0.246N     P=0.189N   |     P=0.420         P=0.678         P=0.436        |
|LOGISTIC REGRESSION    |  P=0.065N     P=0.211N     P=0.195N     P=0.151N   |     P=0.466         P=0.676N        P=0.534        |
|COCHRAN-ARMITAGE       |  P=0.033N*                                         |     P=0.417                                        |
|FISHER EXACT           |               P=0.175N     P=0.187N     P=0.056N   |                     P=0.684N        P=0.510        |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 20/49 (41%)  23/50 (46%)  15/48 (31%)  10/50 (20%) |    20/49 (41%)     23/50 (46%)     23/50 (46%)     |
|ADJUSTED (b)           |  56.3%        64.0%        48.1%        48.8%      |     56.0%           55.9%           49.9%          |
|TERMINAL (d)           | 10/24 (42%)   9/20 (45%)   9/24 (38%)   4/14 (29%) |    13/28 (46%)     17/35 (49%)     21/44 (48%)     |
|FIRST INCIDENCE (DAYS) |   594          435          633          635       |      589             589             570           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.244N     P=0.147      P=0.249N     P=0.475N   |     P=0.146N        P=0.468N        P=0.181N       |
|INCIDENTAL TUMOR       |  P=0.346N     P=0.392      P=0.344N     P=0.543N   |     P=0.539         P=0.554         P=0.582        |
|LOGISTIC REGRESSION    |  P=0.210N     P=0.357      P=0.291N     P=0.602    |     P=0.471N        P=0.564         P=0.543N       |
|COCHRAN-ARMITAGE       |  P=0.005N**                                        |     P=0.338                                        |
|FISHER EXACT           |               P=0.376      P=0.221N     P=0.021N*  |                     P=0.376         P=0.376        |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05037 TEST: 03                                                 PAGE  14
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PENTACHLOROANISOLE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      10.MG/KG     20.MG/KG     40.MG/KG  |      VEHICLE         20.MG/KG        40.MG/KG      |
|                       |   15 SSAC      15 SSAC      15 SSAC      15 SSAC   |      15 SSAC         15 SSAC         15 SSAC       |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Intermedia                                                                                                 |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/49 (0%)    0/50 (0%)    0/48 (0%)    0/50 (0%)  |     2/49 (4%)       2/50 (4%)       1/50 (2%)      |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |      7.1%            5.2%            2.3%          |
|TERMINAL (d)           |  0/24 (0%)    0/20 (0%)    0/24 (0%)    0/14 (0%)  |     2/28 (7%)       1/35 (3%)       1/44 (2%)      |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |      729 (T)         673             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |     P=0.253N        P=0.615N        P=0.344N       |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |     P=0.306N        P=0.609N        P=0.344N       |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |     P=0.304N        P=0.638N        P=0.344N       |
|COCHRAN-ARMITAGE       |    (e)                                             |     P=0.385N                                       |
|FISHER EXACT           |                 (e)          (e)          (e)      |                     P=0.684N        P=0.492N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Basal Cell Carcinoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    0/50 (0%)    0/50 (0%)    2/50 (4%)  |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |   6.3%         0.0%         0.0%        11.0%      |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |  0/24 (0%)    0/20 (0%)    0/24 (0%)    1/14 (7%)  |     0/29 (0%)       0/35 (0%)       0/44 (0%)      |
|FIRST INCIDENCE (DAYS) |   703          ---          ---          548       |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.332      P=0.313N     P=0.245N     P=0.434    |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |  P=0.285      P=0.360N     P=0.297N     P=0.409    |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |  P=0.364      P=0.274N     P=0.255N     P=0.497    |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |  P=0.503                                           |       (e)                                          |
|FISHER EXACT           |               P=0.247N     P=0.247N     P=0.691N   |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05037 TEST: 03                                                 PAGE  15
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PENTACHLOROANISOLE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      10.MG/KG     20.MG/KG     40.MG/KG  |      VEHICLE         20.MG/KG        40.MG/KG      |
|                       |   15 SSAC      15 SSAC      15 SSAC      15 SSAC   |      15 SSAC         15 SSAC         15 SSAC       |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Carcinoma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/50 (0%)    2/50 (4%)    0/50 (0%)  |     0/50 (0%)       0/50 (0%)       1/50 (2%)      |
|ADJUSTED (b)           |   0.0%         0.0%         8.0%         0.0%      |      0.0%            0.0%            2.3%          |
|TERMINAL (d)           |  0/24 (0%)    0/20 (0%)    1/24 (4%)    0/14 (0%)  |     0/29 (0%)       0/35 (0%)       1/44 (2%)      |
|FIRST INCIDENCE (DAYS) |   ---          ---          719          ---       |      ---             ---             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.492        (e)        P=0.240        (e)      |     P=0.332           (e)           P=0.583        |
|INCIDENTAL TUMOR       |  P=0.453        (e)        P=0.210        (e)      |     P=0.332           (e)           P=0.583        |
|LOGISTIC REGRESSION    |  P=0.484        (e)        P=0.230        (e)      |     P=0.332           (e)           P=0.583        |
|COCHRAN-ARMITAGE       |  P=0.587                                           |     P=0.273                                        |
|FISHER EXACT           |                 (e)        P=0.247        (e)      |                       (e)           P=0.500        |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    0/50 (0%)    3/50 (6%)    0/50 (0%)  |     1/50 (2%)       0/50 (0%)       1/50 (2%)      |
|ADJUSTED (b)           |   4.2%         0.0%        12.0%         0.0%      |      3.4%            0.0%            2.3%          |
|TERMINAL (d)           |  1/24 (4%)    0/20 (0%)    2/24 (8%)    0/14 (0%)  |     1/29 (3%)       0/35 (0%)       1/44 (2%)      |
|FIRST INCIDENCE (DAYS) |   729 (T)      ---          719          ---       |      729 (T)         ---             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.642      P=0.536N     P=0.306      P=0.607N   |     P=0.577N        P=0.462N        P=0.666N       |
|INCIDENTAL TUMOR       |  P=0.617      P=0.536N     P=0.282      P=0.607N   |     P=0.577N        P=0.462N        P=0.666N       |
|LOGISTIC REGRESSION    |  P=0.633      P=0.536N     P=0.297      P=0.607N   |     P=0.577N        P=0.462N        P=0.666N       |
|COCHRAN-ARMITAGE       |  P=0.503N                                          |     P=0.668N                                       |
|FISHER EXACT           |               P=0.500N     P=0.309      P=0.500N   |                     P=0.500N        P=0.753N       |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05037 TEST: 03                                                 PAGE  16
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PENTACHLOROANISOLE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      10.MG/KG     20.MG/KG     40.MG/KG  |      VEHICLE         20.MG/KG        40.MG/KG      |
|                       |   15 SSAC      15 SSAC      15 SSAC      15 SSAC   |      15 SSAC         15 SSAC         15 SSAC       |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Trichoepithelioma, Basal Cell Carcinoma, or Basal Cell Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    1/50 (2%)    0/50 (0%)    2/50 (4%)  |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |   6.3%         2.8%         0.0%        11.0%      |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |  0/24 (0%)    0/20 (0%)    0/24 (0%)    1/14 (7%)  |     0/29 (0%)       0/35 (0%)       0/44 (0%)      |
|FIRST INCIDENCE (DAYS) |   703          613          ---          548       |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.405      P=0.596N     P=0.245N     P=0.434    |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |  P=0.349      P=0.537N     P=0.297N     P=0.409    |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |  P=0.466      P=0.506N     P=0.255N     P=0.497    |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |  P=0.593                                           |       (e)                                          |
|FISHER EXACT           |               P=0.500N     P=0.247N     P=0.691N   |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma,                                                                |
|     Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/50 (8%)    2/50 (4%)    3/50 (6%)    2/50 (4%)  |     1/50 (2%)       0/50 (0%)       1/50 (2%)      |
|ADJUSTED (b)           |  14.1%         7.6%        12.0%        11.0%      |      3.4%            0.0%            2.3%          |
|TERMINAL (d)           |  2/24 (8%)    1/20 (5%)    2/24 (8%)    1/14 (7%)  |     1/29 (3%)       0/35 (0%)       1/44 (2%)      |
|FIRST INCIDENCE (DAYS) |   703          613          719          548       |      729 (T)         ---             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.561N     P=0.448N     P=0.505N     P=0.643N   |     P=0.577N        P=0.462N        P=0.666N       |
|INCIDENTAL TUMOR       |  P=0.567      P=0.403N     P=0.562N     P=0.663N   |     P=0.577N        P=0.462N        P=0.666N       |
|LOGISTIC REGRESSION    |  P=0.584N     P=0.412N     P=0.527N     P=0.630N   |     P=0.577N        P=0.462N        P=0.666N       |
|COCHRAN-ARMITAGE       |  P=0.317N                                          |     P=0.668N                                       |
|FISHER EXACT           |               P=0.339N     P=0.500N     P=0.339N   |                     P=0.500N        P=0.753N       |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05037 TEST: 03                                                 PAGE  17
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PENTACHLOROANISOLE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      10.MG/KG     20.MG/KG     40.MG/KG  |      VEHICLE         20.MG/KG        40.MG/KG      |
|                       |   15 SSAC      15 SSAC      15 SSAC      15 SSAC   |      15 SSAC         15 SSAC         15 SSAC       |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/50 (8%)    1/50 (2%)    0/50 (0%)    1/50 (2%)  |     1/50 (2%)       1/50 (2%)       0/50 (0%)      |
|ADJUSTED (b)           |  14.8%         4.0%         0.0%         5.6%      |      2.3%            2.9%            0.0%          |
|TERMINAL (d)           |  3/24 (13%)   0/20 (0%)    0/24 (0%)    0/14 (0%)  |     0/29 (0%)       1/35 (3%)       0/44 (0%)      |
|FIRST INCIDENCE (DAYS) |   683          687          ---          697       |      579             729 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.179N     P=0.265N     P=0.065N     P=0.389N   |     P=0.283N        P=0.732N        P=0.483N       |
|INCIDENTAL TUMOR       |  P=0.219N     P=0.287N     P=0.072N     P=0.450N   |     P=0.440N        P=0.684         P=0.773N       |
|LOGISTIC REGRESSION    |  P=0.194N     P=0.248N     P=0.069N     P=0.416N   |     P=0.383N        P=0.749         P=0.650N       |
|COCHRAN-ARMITAGE       |  P=0.101N                                          |     P=0.334N                                       |
|FISHER EXACT           |               P=0.181N     P=0.059N     P=0.181N   |                     P=0.753N        P=0.500N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibrosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    1/50 (2%)    3/50 (6%)    0/50 (0%)  |     0/50 (0%)       1/50 (2%)       0/50 (0%)      |
|ADJUSTED (b)           |   7.1%         2.2%         9.6%         0.0%      |      0.0%            2.0%            0.0%          |
|TERMINAL (d)           |  1/24 (4%)    0/20 (0%)    1/24 (4%)    0/14 (0%)  |     0/29 (0%)       0/35 (0%)       0/44 (0%)      |
|FIRST INCIDENCE (DAYS) |   702          529          684          ---       |      ---             330             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.396N     P=0.567N     P=0.489      P=0.386N   |     P=0.732         P=0.504           (e)          |
|INCIDENTAL TUMOR       |  P=0.442N     P=0.449N     P=0.427      P=0.421N   |     P=0.500         P=0.500           (e)          |
|LOGISTIC REGRESSION    |  P=0.381N     P=0.484N     P=0.462      P=0.388N   |     P=0.386         P=0.322           (e)          |
|COCHRAN-ARMITAGE       |  P=0.243N                                          |     P=0.730                                        |
|FISHER EXACT           |               P=0.500N     P=0.500      P=0.247N   |                     P=0.500           (e)          |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05037 TEST: 03                                                 PAGE  18
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PENTACHLOROANISOLE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      10.MG/KG     20.MG/KG     40.MG/KG  |      VEHICLE         20.MG/KG        40.MG/KG      |
|                       |   15 SSAC      15 SSAC      15 SSAC      15 SSAC   |      15 SSAC         15 SSAC         15 SSAC       |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,                                                                                   |
|     Neurofibroma, or Fibroma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  6/50 (12%)   2/50 (4%)    3/50 (6%)    1/50 (2%)  |     1/50 (2%)       2/50 (4%)       0/50 (0%)      |
|ADJUSTED (b)           |  21.3%         6.1%         9.6%         5.6%      |      2.3%            4.8%            0.0%          |
|TERMINAL (d)           |  4/24 (17%)   0/20 (0%)    1/24 (4%)    0/14 (0%)  |     0/29 (0%)       1/35 (3%)       0/44 (0%)      |
|FIRST INCIDENCE (DAYS) |   683          529          684          697       |      579             330             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.146N     P=0.225N     P=0.257N     P=0.211N   |     P=0.320N        P=0.532         P=0.483N       |
|INCIDENTAL TUMOR       |  P=0.185N     P=0.180N     P=0.303N     P=0.260N   |     P=0.610N        P=0.414         P=0.773N       |
|LOGISTIC REGRESSION    |  P=0.152N     P=0.163N     P=0.280N     P=0.223N   |     P=0.617N        P=0.389         P=0.650N       |
|COCHRAN-ARMITAGE       |  P=0.053N                                          |     P=0.365N                                       |
|FISHER EXACT           |               P=0.134N     P=0.243N     P=0.056N   |                     P=0.500         P=0.500N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 46/50 (92%)  45/50 (90%)  42/50 (84%)  24/50 (48%) |                                                    |
|ADJUSTED (b)           | 100.0%       100.0%       100.0%        95.9%      |                                                    |
|TERMINAL (d)           | 24/24 (100%) 20/20 (100%) 24/24 (100%) 13/14 (93%) |                                                    |
|FIRST INCIDENCE (DAYS) |   507          520          486          488       |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.272N     P=0.141      P=0.390N     P=0.452N   |                                                    |
|INCIDENTAL TUMOR       |  P=0.509N     P=0.623      P=0.512N     P=0.520N   |                                                    |
|LOGISTIC REGRESSION    |  P=0.479N     P=0.492      P=0.631N     P=0.555N   |                                                    |
|COCHRAN-ARMITAGE       |  P<0.001N**                                        |                                                    |
|FISHER EXACT           |               P=0.500N     P=0.178N     P<0.001N** |                                                    |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05037 TEST: 03                                                 PAGE  19
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PENTACHLOROANISOLE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      10.MG/KG     20.MG/KG     40.MG/KG  |      VEHICLE         20.MG/KG        40.MG/KG      |
|                       |   15 SSAC      15 SSAC      15 SSAC      15 SSAC   |      15 SSAC         15 SSAC         15 SSAC       |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 12/50 (24%)   6/50 (12%)   7/49 (14%)   5/50 (10%) |     7/50 (14%)      0/2 (0%)        9/50 (18%)     |
|ADJUSTED (b)           |  40.9%        21.7%        25.9%        24.5%      |     19.7%            0.0%           19.8%          |
|TERMINAL (d)           |  8/24 (33%)   2/20 (10%)   5/24 (21%)   1/14 (7%)  |     3/29 (10%)      0/2 (0%)        8/44 (18%)     |
|FIRST INCIDENCE (DAYS) |   649          520          687          548       |      444             ---             517           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.300N     P=0.226N     P=0.164N     P=0.391N   |     P=0.493N        P=0.046N*       P=0.524N       |
|INCIDENTAL TUMOR       |  P=0.390N     P=0.221N     P=0.201N     P=0.458N   |     P=0.292         P=0.772N        P=0.350        |
|LOGISTIC REGRESSION    |  P=0.338N     P=0.159N     P=0.192N     P=0.399N   |     P=0.290         P=0.700N        P=0.346        |
|COCHRAN-ARMITAGE       |  P=0.062N                                          |     P=0.341                                        |
|FISHER EXACT           |               P=0.096N     P=0.166N     P=0.054N   |                     P=0.747N        P=0.393        |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 13/50 (26%)   7/50 (14%)   7/49 (14%)   5/50 (10%) |     8/50 (16%)      0/2 (0%)        9/50 (18%)     |
|ADJUSTED (b)           |  42.7%        24.4%        25.9%        24.5%      |     22.8%            0.0%           19.8%          |
|TERMINAL (d)           |  8/24 (33%)   2/20 (10%)   5/24 (21%)   1/14 (7%)  |     4/29 (14%)      0/2 (0%)        8/44 (18%)     |
|FIRST INCIDENCE (DAYS) |   649          520          687          548       |      444             ---             517           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.222N     P=0.263N     P=0.117N     P=0.331N   |     P=0.362N        P=0.044N*       P=0.399N       |
|INCIDENTAL TUMOR       |  P=0.304N     P=0.271N     P=0.148N     P=0.400N   |     P=0.423         P=0.698N        P=0.485        |
|LOGISTIC REGRESSION    |  P=0.243N     P=0.170N     P=0.136N     P=0.327N   |     P=0.412         P=0.650N        P=0.471        |
|COCHRAN-ARMITAGE       |  P=0.034N*                                         |     P=0.448                                        |
|FISHER EXACT           |               P=0.105N     P=0.115N     P=0.033N*  |                     P=0.713N        P=0.500        |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05037 TEST: 03                                                 PAGE  20
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PENTACHLOROANISOLE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      10.MG/KG     20.MG/KG     40.MG/KG  |      VEHICLE         20.MG/KG        40.MG/KG      |
|                       |   15 SSAC      15 SSAC      15 SSAC      15 SSAC   |      15 SSAC         15 SSAC         15 SSAC       |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |    13/50 (26%)     13/50 (26%)      7/50 (14%)     |
|ADJUSTED (b)           |                                                    |     39.7%           32.9%           15.4%          |
|TERMINAL (d)           |                                                    |    10/29 (34%)      9/35 (26%)      6/44 (14%)     |
|FIRST INCIDENCE (DAYS) |                                                    |      526             667             517           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.011N*       P=0.381N        P=0.015N*      |
|INCIDENTAL TUMOR       |                                                    |     P=0.046N*       P=0.413N        P=0.050N*      |
|LOGISTIC REGRESSION    |                                                    |     P=0.044N*       P=0.453N        P=0.063N       |
|COCHRAN-ARMITAGE       |                                                    |     P=0.093N                                       |
|FISHER EXACT           |                                                    |                     P=0.590N        P=0.105N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |     2/50 (4%)       1/50 (2%)       0/50 (0%)      |
|ADJUSTED (b)           |                                                    |      5.0%            2.2%            0.0%          |
|TERMINAL (d)           |                                                    |     0/29 (0%)       0/35 (0%)       0/44 (0%)      |
|FIRST INCIDENCE (DAYS) |                                                    |      590             611             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.113N        P=0.448N        P=0.198N       |
|INCIDENTAL TUMOR       |                                                    |     P=0.464N        P=0.678         P=0.574N       |
|LOGISTIC REGRESSION    |                                                    |     P=0.221N        P=0.565N        P=0.343N       |
|COCHRAN-ARMITAGE       |                                                    |     P=0.143N                                       |
|FISHER EXACT           |                                                    |                     P=0.500N        P=0.247N       |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05037 TEST: 03                                                 PAGE  21
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PENTACHLOROANISOLE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      10.MG/KG     20.MG/KG     40.MG/KG  |      VEHICLE         20.MG/KG        40.MG/KG      |
|                       |   15 SSAC      15 SSAC      15 SSAC      15 SSAC   |      15 SSAC         15 SSAC         15 SSAC       |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal or Polyp Stromal                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |    15/50 (30%)     14/50 (28%)      7/50 (14%)     |
|ADJUSTED (b)           |                                                    |     42.7%           34.3%           15.4%          |
|TERMINAL (d)           |                                                    |    10/29 (34%)      9/35 (26%)      6/44 (14%)     |
|FIRST INCIDENCE (DAYS) |                                                    |      526             611             517           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.004N**      P=0.296N        P=0.005N**     |
|INCIDENTAL TUMOR       |                                                    |     P=0.039N*       P=0.449N        P=0.037N*      |
|LOGISTIC REGRESSION    |                                                    |     P=0.025N*       P=0.413N        P=0.035N*      |
|COCHRAN-ARMITAGE       |                                                    |     P=0.040N*                                      |
|FISHER EXACT           |                                                    |                     P=0.500N        P=0.045N*      |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Leukemia: Lymphocytic, Monocytic, Mononuclear,                                                                              |
|     or Undifferentiated                                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 23/50 (46%)  22/50 (44%)  15/50 (30%)   8/50 (16%) |    11/50 (22%)     14/50 (28%)      9/50 (18%)     |
|ADJUSTED (b)           |  72.0%        63.3%        43.0%        40.0%      |     32.8%           32.8%           20.5%          |
|TERMINAL (d)           | 16/24 (67%)   9/20 (45%)   7/24 (29%)   3/14 (21%) |     8/29 (28%)      8/35 (23%)      9/44 (20%)     |
|FIRST INCIDENCE (DAYS) |   611          488          486          548       |      526             345             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.051N     P=0.341      P=0.108N     P=0.122N   |     P=0.098N        P=0.513         P=0.115N       |
|INCIDENTAL TUMOR       |  P=0.060N     P=0.393N     P=0.097N     P=0.136N   |     P=0.337N        P=0.325         P=0.226N       |
|LOGISTIC REGRESSION    |  P=0.031N*    P=0.560      P=0.113N     P=0.130N   |     P=0.347N        P=0.327         P=0.277N       |
|COCHRAN-ARMITAGE       |  P<0.001N**                                        |     P=0.363N                                       |
|FISHER EXACT           |               P=0.500N     P=0.074N     P=0.001N** |                     P=0.322         P=0.402N       |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05037 TEST: 03                                                 PAGE  22
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PENTACHLOROANISOLE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      10.MG/KG     20.MG/KG     40.MG/KG  |      VEHICLE         20.MG/KG        40.MG/KG      |
|                       |   15 SSAC      15 SSAC      15 SSAC      15 SSAC   |      15 SSAC         15 SSAC         15 SSAC       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Mesothelioma Benign, Malignant, NOS                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/50 (6%)    4/50 (8%)    1/50 (2%)    1/50 (2%)  |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |   8.4%        11.2%         4.0%         7.1%      |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |  0/24 (0%)    0/20 (0%)    0/24 (0%)    1/14 (7%)  |     0/29 (0%)       0/35 (0%)       0/44 (0%)      |
|FIRST INCIDENCE (DAYS) |   624          520          719          729 (T)   |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.296N     P=0.385      P=0.320N     P=0.556N   |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |  P=0.354N     P=0.646      P=0.418N     P=0.591N   |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |  P=0.214N     P=0.547      P=0.326N     P=0.533N   |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |  P=0.136N                                          |       (e)                                          |
|FISHER EXACT           |               P=0.500      P=0.309N     P=0.309N   |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 49/50 (98%)  49/50 (98%)  45/50 (90%)  26/50 (52%) |    40/50 (80%)     35/50 (70%)     35/50 (70%)     |
|ADJUSTED (b)           | 100.0%       100.0%       100.0%       100.0%      |     90.8%           79.5%           71.4%          |
|TERMINAL (d)           | 24/24 (100%) 20/20 (100%) 24/24 (100%) 14/14 (100%)|    25/29 (86%)     26/35 (74%)     30/44 (68%)     |
|FIRST INCIDENCE (DAYS) |   507          435          486          488       |      444             589             517           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.299N     P=0.115      P=0.407N     P=0.491N   |     P<0.001N**      P=0.036N*       P=0.001N**     |
|INCIDENTAL TUMOR       |  P=0.654      P=0.748N       (e)          (e)      |     P=0.067N        P=0.079N        P=0.113N       |
|LOGISTIC REGRESSION    |  P=0.654      P=0.748N       (e)          (e)      |     P=0.037N*       P=0.064N        P=0.077N       |
|COCHRAN-ARMITAGE       |  P<0.001N**                                        |     P=0.154N                                       |
|FISHER EXACT           |               P=0.753N     P=0.102N     P<0.001N** |                     P=0.178N        P=0.178N       |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05037 TEST: 03                                                 PAGE  23
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PENTACHLOROANISOLE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      10.MG/KG     20.MG/KG     40.MG/KG  |      VEHICLE         20.MG/KG        40.MG/KG      |
|                       |   15 SSAC      15 SSAC      15 SSAC      15 SSAC   |      15 SSAC         15 SSAC         15 SSAC       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 39/50 (78%)  33/50 (66%)  28/50 (56%)  11/50 (22%) |    22/50 (44%)     20/50 (40%)     18/50 (36%)     |
|ADJUSTED (b)           |  88.2%        76.8%        68.4%        54.2%      |     52.2%           45.4%           37.4%          |
|TERMINAL (d)           | 19/24 (79%)  11/20 (55%)  12/24 (50%)   5/14 (36%) |    10/29 (34%)     12/35 (34%)     14/44 (32%)     |
|FIRST INCIDENCE (DAYS) |   507          437          486          548       |      353             330             517           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.007N**   P=0.482      P=0.097N     P=0.014N*  |     P=0.034N*       P=0.231N        P=0.042N*      |
|INCIDENTAL TUMOR       |  P=0.001N**   P=0.088N     P=0.039N*    P=0.003N** |     P=0.526N        P=0.527N        P=0.576N       |
|LOGISTIC REGRESSION    |  P<0.001N**   P=0.151N     P=0.037N*    P=0.001N** |     P=0.423N        P=0.514N        P=0.415N       |
|COCHRAN-ARMITAGE       |  P<0.001N**                                        |     P=0.238N                                       |
|FISHER EXACT           |               P=0.133N     P=0.016N*    P<0.001N** |                     P=0.420N        P=0.270N       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 49/50 (98%)  50/50 (100%) 45/50 (90%)  26/50 (52%) |    45/50 (90%)     41/50 (82%)     41/50 (82%)     |
|ADJUSTED (b)           | 100.0%       100.0%       100.0%       100.0%      |     93.7%           83.7%           83.6%          |
|TERMINAL (d)           | 24/24 (100%) 20/20 (100%) 24/24 (100%) 14/14 (100%)|    26/29 (90%)     27/35 (77%)     36/44 (82%)     |
|FIRST INCIDENCE (DAYS) |   507          435          486          488       |      353             330             517           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.288N     P=0.093      P=0.407N     P=0.491N   |     P<0.001N**      P=0.057N        P<0.001N**     |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |     P=0.228N        P=0.171N        P=0.200N       |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |     P=0.133N        P=0.160N        P=0.113N       |
|COCHRAN-ARMITAGE       |  P<0.001N**                                        |     P=0.165N                                       |
|FISHER EXACT           |               P=0.500      P=0.102N     P<0.001N** |                     P=0.194N        P=0.194N       |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05037 TEST: 03                                                 PAGE  24
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PENTACHLOROANISOLE
 
                                                 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).
NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.