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TDMS Study 05097-01 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Northwest                                 ALPHA-CHLOROACETOPHENONE                               DATE: 09/13/94       
EXPERIMENT: 05097 TEST: 01                                                                                     TIME: 06:34:05       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-38061          ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                                             NTP C#: 55107        
PATHOLOGIST: R. MILLER                                                                                         CAS: 532-27-4        
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08    
LAB: Battelle Northwest                                 ALPHA-CHLOROACETOPHENONE                               DATE: 09/13/94      
EXPERIMENT: 05097 TEST: 01                                                                                     TIME: 06:34:05      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01-ES-38061          ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                                             NTP C#: 55107       
PATHOLOGIST: R. MILLER                                                                                         CAS: 532-27-4       
 
 
 
 
 
                                                    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
                                                    Larynx
                                                    Liver
                                                    Lung
                                                    Nose
                                                    Ovary
                                                    Pancreas
                                                    Parathyroid Gland
                                                    Pituitary Gland
                                                    Preputial Gland
                                                    Prostate
                                                    Salivary Glands
                                                    Spleen
                                                    Testes
                                                    Thymus
                                                    Thyroid Gland
                                                    Urinary Bladder
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Northwest                                 ALPHA-CHLOROACETOPHENONE                               DATE: 09/13/94       
EXPERIMENT: 05097 TEST: 01                                                                                     TIME: 06:34:05       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-38061          ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                                             NTP C#: 55107        
PATHOLOGIST: R. MILLER                                                                                         CAS: 532-27-4        
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                    IN THE ANALYSIS OF THE STUDY OF ALPHA-CHLOROACETOPHENONE
 
              ====================================================================================================
 
                                                           MALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip)
                                                           Papilloma Squamous or Papilloma
                                                           Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma
                             Pharynx                       Squamous Cell Papilloma
                             All Organs                    Benign Tumors
 
              ====================================================================================================
 
                                                           FEMALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Mammary Gland                 Fibroadenoma
                                                           Fibroma, Fibroadenoma or Adenoma
                                                           Fibroma, Fibroadenoma, Carcinoma, or Adenoma
                             Pituitary Gland: Pars Distalis or Unspecified Site
                                                           Adenoma
                                                           Carcinoma or Adenoma
                             Thyroid Gland: C-Cell         Adenoma
                                                           Carcinoma or Adenoma
                             Thyroid Gland: Follicular Cell
                                                           Carcinoma
                                                           Carcinoma or Adenoma
                             All Organs                    Benign Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
         DATE: 09/13/94                     EXPERIMENT: 05097 TEST: 01                                                 PAGE   1
                        STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ALPHA-CHLOROACETOPHENONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         1 MG/M3         2 MG/M3       |      CONTROL         1 MG/M3         2 MG/M3       |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Cortex                                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/47 (2%)       2/49 (4%)       1/50 (2%)      |     5/49 (10%)      4/50 (8%)       4/48 (8%)      |
|ADJUSTED (b)           |      5.0%            9.1%            5.9%          |     19.2%           14.9%           16.7%          |
|TERMINAL (d)           |     0/14 (0%)       2/22 (9%)       1/17 (6%)      |     3/23 (13%)      2/20 (10%)      4/24 (17%)     |
|FIRST INCIDENCE (DAYS) |      715             735 (T)         735 (T)       |      679             640             735 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.586N        P=0.629         P=0.739N       |     P=0.399N        P=0.542N        P=0.473N       |
|INCIDENTAL TUMOR       |     P=0.619N        P=0.552         P=0.742        |     P=0.451N        P=0.481N        P=0.490N       |
|LOGISTIC REGRESSION    |     P=0.611N        P=0.591         P=0.756N       |     P=0.424N        P=0.479N        P=0.481N       |
|COCHRAN-ARMITAGE       |     P=0.603N                                       |     P=0.441N                                       |
|FISHER EXACT           |                     P=0.516         P=0.737N       |                     P=0.487N        P=0.513N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    14/46 (30%)     15/49 (31%)     20/50 (40%)     |     5/49 (10%)      4/50 (8%)       3/48 (6%)      |
|ADJUSTED (b)           |     56.1%           51.2%           71.1%          |     16.6%           15.6%           12.1%          |
|TERMINAL (d)           |     5/14 (36%)      8/22 (36%)     10/17 (59%)     |     2/23 (9%)       2/20 (10%)      2/23 (9%)      |
|FIRST INCIDENCE (DAYS) |      602             631             532           |      602             626             705           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.186         P=0.303N        P=0.229        |     P=0.288N        P=0.512N        P=0.350N       |
|INCIDENTAL TUMOR       |     P=0.117         P=0.526         P=0.174        |     P=0.377N        P=0.494N        P=0.463N       |
|LOGISTIC REGRESSION    |     P=0.124         P=0.483N        P=0.165        |     P=0.301N        P=0.476N        P=0.371N       |
|COCHRAN-ARMITAGE       |     P=0.185                                        |     P=0.299N                                       |
|FISHER EXACT           |                     P=0.581         P=0.222        |                     P=0.487N        P=0.369N       |
|=================================================================================================================================|
 
         DATE: 09/13/94                     EXPERIMENT: 05097 TEST: 01                                                 PAGE   2
                        STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ALPHA-CHLOROACETOPHENONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         1 MG/M3         2 MG/M3       |      CONTROL         1 MG/M3         2 MG/M3       |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Malignant                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/46 (4%)       1/49 (2%)       2/50 (4%)      |     0/49 (0%)       0/50 (0%)       0/48 (0%)      |
|ADJUSTED (b)           |      9.8%            4.5%            5.9%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     1/14 (7%)       1/22 (5%)       0/17 (0%)      |     0/23 (0%)       0/20 (0%)       0/23 (0%)      |
|FIRST INCIDENCE (DAYS) |      619             735 (T)         539           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.586N        P=0.390N        P=0.672N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.522N        P=0.375N        P=0.619N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.580N        P=0.458N        P=0.661N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.580N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.476N        P=0.659N       |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    15/46 (33%)     16/49 (33%)     21/50 (42%)     |     5/49 (10%)      4/50 (8%)       3/48 (6%)      |
|ADJUSTED (b)           |     57.3%           54.7%           72.2%          |     16.6%           15.6%           12.1%          |
|TERMINAL (d)           |     5/14 (36%)      9/22 (41%)     10/17 (59%)     |     2/23 (9%)       2/20 (10%)      2/23 (9%)      |
|FIRST INCIDENCE (DAYS) |      602             631             532           |      602             626             705           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.197         P=0.290N        P=0.238        |     P=0.288N        P=0.512N        P=0.350N       |
|INCIDENTAL TUMOR       |     P=0.116         P=0.554         P=0.167        |     P=0.377N        P=0.494N        P=0.463N       |
|LOGISTIC REGRESSION    |     P=0.130         P=0.479N        P=0.173        |     P=0.301N        P=0.476N        P=0.371N       |
|COCHRAN-ARMITAGE       |     P=0.193                                        |     P=0.299N                                       |
|FISHER EXACT           |                     P=0.585         P=0.230        |                     P=0.487N        P=0.369N       |
|=================================================================================================================================|
 
         DATE: 09/13/94                     EXPERIMENT: 05097 TEST: 01                                                 PAGE   3
                        STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ALPHA-CHLOROACETOPHENONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         1 MG/M3         2 MG/M3       |      CONTROL         1 MG/M3         2 MG/M3       |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|Brain                                                                                                                            |
|     Oligodendroglioma, Glioma, or Astrocytoma                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/49 (4%)       0/50 (0%)       1/50 (2%)      |     0/49 (0%)       0/30 (0%)       1/50 (2%)      |
|ADJUSTED (b)           |      5.4%            0.0%            2.0%          |      0.0%            0.0%            4.2%          |
|TERMINAL (d)           |     0/14 (0%)       0/22 (0%)       0/17 (0%)      |     0/23 (0%)       0/0             1/24 (4%)      |
|FIRST INCIDENCE (DAYS) |      577             ---             444           |      ---             ---             735 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.376N        P=0.237N        P=0.520N       |     P=0.316           (e)           P=0.508        |
|INCIDENTAL TUMOR       |     P=0.320N        P=0.272N        P=0.461N       |     P=0.316           (e)           P=0.508        |
|LOGISTIC REGRESSION    |     P=0.350N        P=0.242N        P=0.487N       |     P=0.316           (e)           P=0.508        |
|COCHRAN-ARMITAGE       |     P=0.355N                                       |     P=0.286                                        |
|FISHER EXACT           |                     P=0.242N        P=0.492N       |                       (e)           P=0.505        |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/45 (4%)       6/48 (13%)      5/50 (10%)     |     5/45 (11%)      2/33 (6%)       3/42 (7%)      |
|ADJUSTED (b)           |     12.3%           23.7%           25.7%          |     17.8%           40.0%           11.8%          |
|TERMINAL (d)           |     1/13 (8%)       4/22 (18%)      4/17 (24%)     |     3/22 (14%)      2/5 (40%)       2/23 (9%)      |
|FIRST INCIDENCE (DAYS) |      715             631             605           |      577             735 (T)         700           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.248         P=0.308         P=0.293        |     P=0.272N        P=0.675         P=0.340N       |
|INCIDENTAL TUMOR       |     P=0.208         P=0.206         P=0.264        |     P=0.360N        P=0.640         P=0.512N       |
|LOGISTIC REGRESSION    |     P=0.199         P=0.209         P=0.238        |     P=0.306N        P=0.420N        P=0.396N       |
|COCHRAN-ARMITAGE       |     P=0.232                                        |     P=0.314N                                       |
|FISHER EXACT           |                     P=0.156         P=0.264        |                     P=0.363N        P=0.396N       |
|=================================================================================================================================|
 
         DATE: 09/13/94                     EXPERIMENT: 05097 TEST: 01                                                 PAGE   4
                        STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ALPHA-CHLOROACETOPHENONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         1 MG/M3         2 MG/M3       |      CONTROL         1 MG/M3         2 MG/M3       |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/45 (4%)       7/48 (15%)      5/50 (10%)     |     5/45 (11%)      3/33 (9%)       4/42 (10%)     |
|ADJUSTED (b)           |     12.3%           27.9%           25.7%          |     17.8%           42.9%           14.2%          |
|TERMINAL (d)           |     1/13 (8%)       5/22 (23%)      4/17 (24%)     |     3/22 (14%)      2/5 (40%)       2/23 (9%)      |
|FIRST INCIDENCE (DAYS) |      715             631             605           |      577             731             666           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.263         P=0.228         P=0.293        |     P=0.405N        P=0.480         P=0.470N       |
|INCIDENTAL TUMOR       |     P=0.222         P=0.146         P=0.264        |     P=0.514N        P=0.488         P=0.625        |
|LOGISTIC REGRESSION    |     P=0.209         P=0.141         P=0.238        |     P=0.460N        P=0.640N        P=0.547N       |
|COCHRAN-ARMITAGE       |     P=0.244                                        |     P=0.471N                                       |
|FISHER EXACT           |                     P=0.095         P=0.264        |                     P=0.541N        P=0.544N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/47 (6%)       7/50 (14%)      1/48 (2%)      |     2/48 (4%)       0/29 (0%)       1/46 (2%)      |
|ADJUSTED (b)           |     19.3%           20.1%            2.9%          |      9.1%            0.0%            4.3%          |
|TERMINAL (d)           |     2/14 (14%)      1/22 (5%)       0/17 (0%)      |     2/22 (9%)       0/0             1/23 (4%)      |
|FIRST INCIDENCE (DAYS) |      722             556             612           |      735 (T)         ---             735 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.279N        P=0.278         P=0.266N       |     P=0.369N          (e)           P=0.484N       |
|INCIDENTAL TUMOR       |     P=0.368N        P=0.159         P=0.325N       |     P=0.369N          (e)           P=0.484N       |
|LOGISTIC REGRESSION    |     P=0.274N        P=0.190         P=0.305N       |     P=0.369N          (e)           P=0.484N       |
|COCHRAN-ARMITAGE       |     P=0.271N                                       |     P=0.381N                                       |
|FISHER EXACT           |                     P=0.185         P=0.301N       |                     P=0.386N        P=0.516N       |
|=================================================================================================================================|
 
         DATE: 09/13/94                     EXPERIMENT: 05097 TEST: 01                                                 PAGE   5
                        STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ALPHA-CHLOROACETOPHENONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         1 MG/M3         2 MG/M3       |      CONTROL         1 MG/M3         2 MG/M3       |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/47 (2%)       0/50 (0%)       0/48 (0%)      |     0/48 (0%)       0/29 (0%)       2/46 (4%)      |
|ADJUSTED (b)           |      7.1%            0.0%            0.0%          |      0.0%            0.0%            8.7%          |
|TERMINAL (d)           |     1/14 (7%)       0/22 (0%)       0/17 (0%)      |     0/22 (0%)       0/0             2/23 (9%)      |
|FIRST INCIDENCE (DAYS) |      735 (T)         ---             ---           |      ---             ---             735 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.233N        P=0.410N        P=0.461N       |     P=0.149           (e)           P=0.247        |
|INCIDENTAL TUMOR       |     P=0.233N        P=0.410N        P=0.461N       |     P=0.149           (e)           P=0.247        |
|LOGISTIC REGRESSION    |     P=0.231N        P=0.410N        P=0.461N       |     P=0.149           (e)           P=0.247        |
|COCHRAN-ARMITAGE       |     P=0.265N                                       |     P=0.106                                        |
|FISHER EXACT           |                     P=0.485N        P=0.495N       |                       (e)           P=0.237        |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     4/47 (9%)       7/50 (14%)      1/48 (2%)      |     2/48 (4%)       0/29 (0%)       3/46 (7%)      |
|ADJUSTED (b)           |     26.1%           20.1%            2.9%          |      9.1%            0.0%           13.0%          |
|TERMINAL (d)           |     3/14 (21%)      1/22 (5%)       0/17 (0%)      |     2/22 (9%)       0/0             3/23 (13%)     |
|FIRST INCIDENCE (DAYS) |      722             556             612           |      735 (T)         ---             735 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.169N        P=0.426         P=0.143N       |     P=0.428           (e)           P=0.521        |
|INCIDENTAL TUMOR       |     P=0.234N        P=0.287         P=0.180N       |     P=0.428           (e)           P=0.521        |
|LOGISTIC REGRESSION    |     P=0.171N        P=0.309         P=0.177N       |     P=0.428           (e)           P=0.521        |
|COCHRAN-ARMITAGE       |     P=0.168N                                       |     P=0.381                                        |
|FISHER EXACT           |                     P=0.299         P=0.174N       |                     P=0.386N        P=0.480        |
|=================================================================================================================================|
 
         DATE: 09/13/94                     EXPERIMENT: 05097 TEST: 01                                                 PAGE   6
                        STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ALPHA-CHLOROACETOPHENONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         1 MG/M3         2 MG/M3       |      CONTROL         1 MG/M3         2 MG/M3       |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/49 (4%)       2/50 (4%)       1/50 (2%)      |     1/49 (2%)       1/40 (3%)       1/49 (2%)      |
|ADJUSTED (b)           |     12.6%            7.1%            2.9%          |      4.3%           10.0%            4.2%          |
|TERMINAL (d)           |     1/14 (7%)       1/22 (5%)       0/17 (0%)      |     1/23 (4%)       1/10 (10%)      1/24 (4%)      |
|FIRST INCIDENCE (DAYS) |      722             631             630           |      735 (T)         735 (T)         735 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.359N        P=0.570N        P=0.465N       |     P=0.614N        P=0.566         P=0.753N       |
|INCIDENTAL TUMOR       |     P=0.411N        P=0.643N        P=0.539N       |     P=0.614N        P=0.566         P=0.753N       |
|LOGISTIC REGRESSION    |     P=0.389N        P=0.657N        P=0.502N       |     P=0.614N        P=0.566         P=0.753N       |
|COCHRAN-ARMITAGE       |     P=0.383N                                       |     P=0.635N                                       |
|FISHER EXACT           |                     P=0.684N        P=0.492N       |                     P=0.700         P=0.753N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       0/50 (0%)       1/50 (2%)      |     0/50 (0%)       2/50 (4%)       1/50 (2%)      |
|ADJUSTED (b)           |      0.0%            0.0%            5.9%          |      0.0%            7.6%            3.1%          |
|TERMINAL (d)           |     0/14 (0%)       0/22 (0%)       1/17 (6%)      |     0/23 (0%)       1/20 (5%)       0/24 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             735 (T)       |      ---             658             686           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.281           (e)           P=0.539        |     P=0.383         P=0.230         P=0.520        |
|INCIDENTAL TUMOR       |     P=0.281           (e)           P=0.539        |     P=0.361         P=0.259         P=0.500        |
|LOGISTIC REGRESSION    |     P=0.281           (e)           P=0.539        |     P=0.359         P=0.245         P=0.500        |
|COCHRAN-ARMITAGE       |     P=0.269                                        |     P=0.360                                        |
|FISHER EXACT           |                       (e)           P=0.500        |                     P=0.247         P=0.500        |
|=================================================================================================================================|
 
         DATE: 09/13/94                     EXPERIMENT: 05097 TEST: 01                                                 PAGE   7
                        STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ALPHA-CHLOROACETOPHENONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         1 MG/M3         2 MG/M3       |      CONTROL         1 MG/M3         2 MG/M3       |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       1/50 (2%)       0/50 (0%)      |     2/50 (4%)       2/50 (4%)       1/50 (2%)      |
|ADJUSTED (b)           |      0.0%            4.5%            0.0%          |      8.7%            8.0%            4.2%          |
|TERMINAL (d)           |     0/14 (0%)       1/22 (5%)       0/17 (0%)      |     2/23 (9%)       0/20 (0%)       1/24 (4%)      |
|FIRST INCIDENCE (DAYS) |      ---             735 (T)         ---           |      735 (T)         707             735 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.719N        P=0.590           (e)          |     P=0.378N        P=0.668         P=0.485N       |
|INCIDENTAL TUMOR       |     P=0.719N        P=0.590           (e)          |     P=0.380N        P=0.662N        P=0.485N       |
|LOGISTIC REGRESSION    |     P=0.719N        P=0.590           (e)          |     P=0.375N        P=0.697N        P=0.485N       |
|COCHRAN-ARMITAGE       |     P=0.731                                        |     P=0.390N                                       |
|FISHER EXACT           |                     P=0.500           (e)          |                     P=0.691N        P=0.500N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       1/50 (2%)       1/50 (2%)      |     2/50 (4%)       4/50 (8%)       2/50 (4%)      |
|ADJUSTED (b)           |      0.0%            4.5%            5.9%          |      8.7%           15.0%            7.2%          |
|TERMINAL (d)           |     0/14 (0%)       1/22 (5%)       1/17 (6%)      |     2/23 (9%)       1/20 (5%)       1/24 (4%)      |
|FIRST INCIDENCE (DAYS) |      ---             735 (T)         735 (T)       |      735 (T)         658             686           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.359         P=0.590         P=0.539        |     P=0.561N        P=0.312         P=0.674N       |
|INCIDENTAL TUMOR       |     P=0.359         P=0.590         P=0.539        |     P=0.579N        P=0.379         P=0.683N       |
|LOGISTIC REGRESSION    |     P=0.359         P=0.590         P=0.539        |     P=0.581N        P=0.347         P=0.684N       |
|COCHRAN-ARMITAGE       |     P=0.331                                        |     P=0.588N                                       |
|FISHER EXACT           |                     P=0.500         P=0.500        |                     P=0.339         P=0.691N       |
|=================================================================================================================================|
 
         DATE: 09/13/94                     EXPERIMENT: 05097 TEST: 01                                                 PAGE   8
                        STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ALPHA-CHLOROACETOPHENONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         1 MG/M3         2 MG/M3       |      CONTROL         1 MG/M3         2 MG/M3       |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroadenoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       1/50 (2%)       0/50 (0%)      |    12/50 (24%)     19/50 (38%)     23/50 (46%)     |
|ADJUSTED (b)           |      0.0%            4.5%            0.0%          |     42.2%           64.4%           61.9%          |
|TERMINAL (d)           |     0/14 (0%)       1/22 (5%)       0/17 (0%)      |     8/23 (35%)     11/20 (55%)     11/24 (46%)     |
|FIRST INCIDENCE (DAYS) |      ---             735 (T)         ---           |      533             553             490           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.719N        P=0.590           (e)          |     P=0.031 *       P=0.070         P=0.038 *      |
|INCIDENTAL TUMOR       |     P=0.719N        P=0.590           (e)          |     P=0.023 *       P=0.075         P=0.034 *      |
|LOGISTIC REGRESSION    |     P=0.719N        P=0.590           (e)          |     P=0.013 *       P=0.117         P=0.017 *      |
|COCHRAN-ARMITAGE       |     P=0.731                                        |     P=0.014 *                                      |
|FISHER EXACT           |                     P=0.500           (e)          |                     P=0.097         P=0.018 *      |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma or Adenoma                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       1/50 (2%)       1/50 (2%)      |    12/50 (24%)     20/50 (40%)     23/50 (46%)     |
|ADJUSTED (b)           |      0.0%            4.5%            5.9%          |     42.2%           65.4%           61.9%          |
|TERMINAL (d)           |     0/14 (0%)       1/22 (5%)       1/17 (6%)      |     8/23 (35%)     11/20 (55%)     11/24 (46%)     |
|FIRST INCIDENCE (DAYS) |      ---             735 (T)         735 (T)       |      533             553             490           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.359         P=0.590         P=0.539        |     P=0.033 *       P=0.050         P=0.038 *      |
|INCIDENTAL TUMOR       |     P=0.359         P=0.590         P=0.539        |     P=0.023 *       P=0.054         P=0.034 *      |
|LOGISTIC REGRESSION    |     P=0.359         P=0.590         P=0.539        |     P=0.013 *       P=0.082         P=0.017 *      |
|COCHRAN-ARMITAGE       |     P=0.331                                        |     P=0.015 *                                      |
|FISHER EXACT           |                     P=0.500         P=0.500        |                     P=0.066         P=0.018 *      |
|=================================================================================================================================|
 
         DATE: 09/13/94                     EXPERIMENT: 05097 TEST: 01                                                 PAGE   9
                        STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ALPHA-CHLOROACETOPHENONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         1 MG/M3         2 MG/M3       |      CONTROL         1 MG/M3         2 MG/M3       |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       2/50 (4%)       1/50 (2%)      |    13/50 (26%)     22/50 (44%)     23/50 (46%)     |
|ADJUSTED (b)           |      0.0%            9.1%            5.9%          |     46.0%           68.2%           61.9%          |
|TERMINAL (d)           |     0/14 (0%)       2/22 (9%)       1/17 (6%)      |     9/23 (39%)     11/20 (55%)     11/24 (46%)     |
|FIRST INCIDENCE (DAYS) |      ---             735 (T)         735 (T)       |      533             553             490           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.399         P=0.341         P=0.539        |     P=0.054         P=0.037 *       P=0.057        |
|INCIDENTAL TUMOR       |     P=0.399         P=0.341         P=0.539        |     P=0.039 *       P=0.042 *       P=0.055        |
|LOGISTIC REGRESSION    |     P=0.399         P=0.341         P=0.539        |     P=0.022 *       P=0.058         P=0.028 *      |
|COCHRAN-ARMITAGE       |     P=0.360                                        |     P=0.026 *                                      |
|FISHER EXACT           |                     P=0.247         P=0.500        |                     P=0.046 *       P=0.030 *      |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip)                                                                           |
|     Papilloma Squamous or Papilloma                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/50 (6%)       0/50 (0%)       0/50 (0%)      |     0/50 (0%)       0/50 (0%)       1/50 (2%)      |
|ADJUSTED (b)           |     12.0%            0.0%            0.0%          |      0.0%            0.0%            4.2%          |
|TERMINAL (d)           |     1/14 (7%)       0/22 (0%)       0/17 (0%)      |     0/23 (0%)       0/20 (0%)       1/24 (4%)      |
|FIRST INCIDENCE (DAYS) |      577             ---             ---           |      ---             ---             735 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.036N*       P=0.100N        P=0.126N       |     P=0.281           (e)           P=0.508        |
|INCIDENTAL TUMOR       |     P=0.043N*       P=0.112N        P=0.143N       |     P=0.281           (e)           P=0.508        |
|LOGISTIC REGRESSION    |     P=0.037N*       P=0.121N        P=0.121N       |     P=0.281           (e)           P=0.508        |
|COCHRAN-ARMITAGE       |     P=0.037N*                                      |     P=0.269                                        |
|FISHER EXACT           |                     P=0.121N        P=0.121N       |                       (e)           P=0.500        |
|=================================================================================================================================|
 
         DATE: 09/13/94                     EXPERIMENT: 05097 TEST: 01                                                 PAGE  10
                        STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ALPHA-CHLOROACETOPHENONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         1 MG/M3         2 MG/M3       |      CONTROL         1 MG/M3         2 MG/M3       |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip)                                                                           |
|     Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/50 (6%)       0/50 (0%)       0/50 (0%)      |     0/50 (0%)       0/50 (0%)       1/50 (2%)      |
|ADJUSTED (b)           |     12.0%            0.0%            0.0%          |      0.0%            0.0%            4.2%          |
|TERMINAL (d)           |     1/14 (7%)       0/22 (0%)       0/17 (0%)      |     0/23 (0%)       0/20 (0%)       1/24 (4%)      |
|FIRST INCIDENCE (DAYS) |      577             ---             ---           |      ---             ---             735 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.036N*       P=0.100N        P=0.126N       |     P=0.281           (e)           P=0.508        |
|INCIDENTAL TUMOR       |     P=0.043N*       P=0.112N        P=0.143N       |     P=0.281           (e)           P=0.508        |
|LOGISTIC REGRESSION    |     P=0.037N*       P=0.121N        P=0.121N       |     P=0.281           (e)           P=0.508        |
|COCHRAN-ARMITAGE       |     P=0.037N*                                      |     P=0.269                                        |
|FISHER EXACT           |                     P=0.121N        P=0.121N       |                       (e)           P=0.500        |
|=================================================================================================================================|
|                                                                                                                                 |
|Parathyroid Gland                                                                                                                |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/35 (0%)       2/33 (6%)       1/44 (2%)      |     0/32 (0%)       0/22 (0%)       1/38 (3%)      |
|ADJUSTED (b)           |      0.0%            6.8%            6.7%          |      0.0%            0.0%            5.6%          |
|TERMINAL (d)           |     0/8 (0%)        0/16 (0%)       1/15 (7%)      |     0/19 (0%)       0/0             1/18 (6%)      |
|FIRST INCIDENCE (DAYS) |      ---             700             735 (T)       |      ---             ---             735 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.385         P=0.287         P=0.625        |     P=0.299           (e)           P=0.489        |
|INCIDENTAL TUMOR       |     P=0.339         P=0.072         P=0.625        |     P=0.299           (e)           P=0.489        |
|LOGISTIC REGRESSION    |     P=0.421         P=0.242         P=0.625        |     P=0.299           (e)           P=0.489        |
|COCHRAN-ARMITAGE       |     P=0.428                                        |     P=0.308                                        |
|FISHER EXACT           |                     P=0.232         P=0.557        |                       (e)           P=0.543        |
|=================================================================================================================================|
 
         DATE: 09/13/94                     EXPERIMENT: 05097 TEST: 01                                                 PAGE  11
                        STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ALPHA-CHLOROACETOPHENONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         1 MG/M3         2 MG/M3       |      CONTROL         1 MG/M3         2 MG/M3       |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|Pharynx                                                                                                                          |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/50 (6%)       0/50 (0%)       0/50 (0%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |     12.0%            0.0%            0.0%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     1/14 (7%)       0/22 (0%)       0/17 (0%)      |     0/23 (0%)       0/20 (0%)       0/24 (0%)      |
|FIRST INCIDENCE (DAYS) |      577             ---             ---           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.036N*       P=0.100N        P=0.126N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.043N*       P=0.112N        P=0.143N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.037N*       P=0.121N        P=0.121N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.037N*                                      |       (e)                                          |
|FISHER EXACT           |                     P=0.121N        P=0.121N       |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    31/47 (66%)     35/50 (70%)     32/48 (67%)     |    27/49 (55%)     40/48 (83%)     30/49 (61%)     |
|ADJUSTED (b)           |     84.4%           86.8%           77.7%          |     73.1%           90.2%           84.8%          |
|TERMINAL (d)           |     8/13 (62%)     17/22 (77%)      8/16 (50%)     |    14/23 (61%)     14/18 (78%)     19/24 (79%)     |
|FIRST INCIDENCE (DAYS) |      318             449             444           |      533             553             512           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.491N        P=0.273N        P=0.523N       |     P=0.427         P=0.017 *       P=0.442        |
|INCIDENTAL TUMOR       |     P=0.465         P=0.381         P=0.479        |     P=0.165         P=0.006 **      P=0.267        |
|LOGISTIC REGRESSION    |     P=0.495         P=0.452         P=0.550        |     P=0.270         P=0.003 **      P=0.316        |
|COCHRAN-ARMITAGE       |     P=0.515                                        |     P=0.296                                        |
|FISHER EXACT           |                     P=0.417         P=0.557        |                     P=0.002 **      P=0.341        |
|=================================================================================================================================|
 
         DATE: 09/13/94                     EXPERIMENT: 05097 TEST: 01                                                 PAGE  12
                        STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ALPHA-CHLOROACETOPHENONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         1 MG/M3         2 MG/M3       |      CONTROL         1 MG/M3         2 MG/M3       |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/47 (2%)       0/50 (0%)       1/48 (2%)      |     3/49 (6%)       0/48 (0%)       5/49 (10%)     |
|ADJUSTED (b)           |      7.7%            0.0%            2.6%          |     12.3%            0.0%           16.8%          |
|TERMINAL (d)           |     1/13 (8%)       0/22 (0%)       0/16 (0%)      |     2/23 (9%)       0/18 (0%)       2/24 (8%)      |
|FIRST INCIDENCE (DAYS) |      735 (T)         ---             559           |      731             ---             523           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.669N        P=0.395N        P=0.751N       |     P=0.271         P=0.161N        P=0.374        |
|INCIDENTAL TUMOR       |     P=0.676         P=0.395N        P=0.760        |     P=0.357         P=0.130N        P=0.470        |
|LOGISTIC REGRESSION    |     P=0.663N        P=0.395N        P=0.757N       |     P=0.252         P=0.152N        P=0.355        |
|COCHRAN-ARMITAGE       |     P=0.666N                                       |     P=0.253                                        |
|FISHER EXACT           |                     P=0.485N        P=0.747N       |                     P=0.125N        P=0.357        |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    32/47 (68%)     35/50 (70%)     33/48 (69%)     |    30/49 (61%)     40/48 (83%)     35/49 (71%)     |
|ADJUSTED (b)           |     87.5%           86.8%           78.3%          |     80.0%           90.2%           91.7%          |
|TERMINAL (d)           |     9/13 (69%)     17/22 (77%)      8/16 (50%)     |    16/23 (70%)     14/18 (78%)     21/24 (88%)     |
|FIRST INCIDENCE (DAYS) |      318             449             444           |      533             553             512           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.489N        P=0.215N        P=0.521N       |     P=0.318         P=0.043 *       P=0.323        |
|INCIDENTAL TUMOR       |     P=0.464         P=0.488         P=0.478        |     P=0.089         P=0.025 *       P=0.174        |
|LOGISTIC REGRESSION    |     P=0.497         P=0.547         P=0.554        |     P=0.124         P=0.018 *       P=0.160        |
|COCHRAN-ARMITAGE       |     P=0.517                                        |     P=0.156                                        |
|FISHER EXACT           |                     P=0.506         P=0.560        |                     P=0.013 *       P=0.196        |
|=================================================================================================================================|
 
         DATE: 09/13/94                     EXPERIMENT: 05097 TEST: 01                                                 PAGE  13
                        STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ALPHA-CHLOROACETOPHENONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         1 MG/M3         2 MG/M3       |      CONTROL         1 MG/M3         2 MG/M3       |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Keratoacanthoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     4/50 (8%)       2/50 (4%)       4/50 (8%)      |     1/50 (2%)       0/50 (0%)       1/50 (2%)      |
|ADJUSTED (b)           |     21.2%            5.4%           20.1%          |      3.2%            0.0%            4.2%          |
|TERMINAL (d)           |     1/14 (7%)       0/22 (0%)       3/17 (18%)     |     0/23 (0%)       0/20 (0%)       1/24 (4%)      |
|FIRST INCIDENCE (DAYS) |      706             631             630           |      679             ---             735 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.550N        P=0.243N        P=0.586N       |     P=0.651N        P=0.494N        P=0.745N       |
|INCIDENTAL TUMOR       |     P=0.527         P=0.390N        P=0.602        |     P=0.665N        P=0.435N        P=0.756N       |
|LOGISTIC REGRESSION    |     P=0.576         P=0.306N        P=0.647        |     P=0.668N        P=0.499N        P=0.761N       |
|COCHRAN-ARMITAGE       |     P=0.579                                        |     P=0.669N                                       |
|FISHER EXACT           |                     P=0.339N        P=0.643N       |                     P=0.500N        P=0.753N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       2/50 (4%)       1/50 (2%)      |     0/50 (0%)       0/50 (0%)       1/50 (2%)      |
|ADJUSTED (b)           |      0.0%            7.7%            2.1%          |      0.0%            0.0%            3.4%          |
|TERMINAL (d)           |     0/14 (0%)       1/22 (5%)       0/17 (0%)      |     0/23 (0%)       0/20 (0%)       0/24 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             700             493           |      ---             ---             700           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.367         P=0.316         P=0.513        |     P=0.282           (e)           P=0.514        |
|INCIDENTAL TUMOR       |     P=0.411         P=0.227         P=0.638        |     P=0.258           (e)           P=0.500        |
|LOGISTIC REGRESSION    |     P=0.361         P=0.272         P=0.486        |     P=0.268           (e)           P=0.500        |
|COCHRAN-ARMITAGE       |     P=0.360                                        |     P=0.269                                        |
|FISHER EXACT           |                     P=0.247         P=0.500        |                       (e)           P=0.500        |
|=================================================================================================================================|
 
         DATE: 09/13/94                     EXPERIMENT: 05097 TEST: 01                                                 PAGE  14
                        STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ALPHA-CHLOROACETOPHENONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         1 MG/M3         2 MG/M3       |      CONTROL         1 MG/M3         2 MG/M3       |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma,                                                                |
|     Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     4/50 (8%)       4/50 (8%)       6/50 (12%)     |     1/50 (2%)       0/50 (0%)       2/50 (4%)      |
|ADJUSTED (b)           |     21.2%           12.7%           24.7%          |      3.2%            0.0%            7.5%          |
|TERMINAL (d)           |     1/14 (7%)       1/22 (5%)       3/17 (18%)     |     0/23 (0%)       0/20 (0%)       1/24 (4%)      |
|FIRST INCIDENCE (DAYS) |      706             631             493           |      679             ---             700           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.333         P=0.497N        P=0.433        |     P=0.382         P=0.494N        P=0.524        |
|INCIDENTAL TUMOR       |     P=0.265         P=0.593         P=0.346        |     P=0.361         P=0.435N        P=0.505        |
|LOGISTIC REGRESSION    |     P=0.296         P=0.599N        P=0.362        |     P=0.361         P=0.499N        P=0.502        |
|COCHRAN-ARMITAGE       |     P=0.303                                        |     P=0.360                                        |
|FISHER EXACT           |                     P=0.643N        P=0.370        |                     P=0.500N        P=0.500        |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       2/50 (4%)       1/50 (2%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      2.0%            4.4%            5.9%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/14 (0%)       0/22 (0%)       1/17 (6%)      |     0/23 (0%)       0/20 (0%)       0/24 (0%)      |
|FIRST INCIDENCE (DAYS) |      318             540             735 (T)       |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.622         P=0.505         P=0.739N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.549N        P=0.463         P=0.739N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.613         P=0.444         P=0.759        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.622N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.500         P=0.753N       |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/13/94                     EXPERIMENT: 05097 TEST: 01                                                 PAGE  15
                        STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ALPHA-CHLOROACETOPHENONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         1 MG/M3         2 MG/M3       |      CONTROL         1 MG/M3         2 MG/M3       |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,                                                                                   |
|     Neurofibroma, or Fibroma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       2/50 (4%)       2/50 (4%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      6.3%            4.4%           11.8%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/14 (0%)       0/22 (0%)       2/17 (12%)     |     0/23 (0%)       0/20 (0%)       0/24 (0%)      |
|FIRST INCIDENCE (DAYS) |      318             540             735 (T)       |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.598N        P=0.673N        P=0.667N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.560N        P=0.618         P=0.691        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.599         P=0.655         P=0.695N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.601                                        |       (e)                                          |
|FISHER EXACT           |                     P=0.691N        P=0.691N       |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    29/50 (58%)     31/50 (62%)     27/50 (54%)     |                                                    |
|ADJUSTED (b)           |     89.3%           85.4%           92.3%          |                                                    |
|TERMINAL (d)           |    11/14 (79%)     17/22 (77%)     15/17 (88%)     |                                                    |
|FIRST INCIDENCE (DAYS) |      577             505             444           |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.255N        P=0.182N        P=0.281N       |                                                    |
|INCIDENTAL TUMOR       |     P=0.451N        P=0.555         P=0.515N       |                                                    |
|LOGISTIC REGRESSION    |     P=0.406N        P=0.558         P=0.452N       |                                                    |
|COCHRAN-ARMITAGE       |     P=0.381N                                       |                                                    |
|FISHER EXACT           |                     P=0.419         P=0.420N       |                                                    |
|=================================================================================================================================|
 
         DATE: 09/13/94                     EXPERIMENT: 05097 TEST: 01                                                 PAGE  16
                        STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ALPHA-CHLOROACETOPHENONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         1 MG/M3         2 MG/M3       |      CONTROL         1 MG/M3         2 MG/M3       |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     5/45 (11%)      5/46 (11%)      2/48 (4%)      |     2/47 (4%)       3/30 (10%)      6/45 (13%)     |
|ADJUSTED (b)           |     25.7%           18.1%           11.8%          |      8.7%          100.0%           21.6%          |
|TERMINAL (d)           |     3/14 (21%)      3/21 (14%)      2/17 (12%)     |     2/23 (9%)       1/1 (100%)      3/24 (13%)     |
|FIRST INCIDENCE (DAYS) |      602             559             735 (T)       |      735 (T)         626             687           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.139N        P=0.471N        P=0.171N       |     P=0.128         P=0.045 *       P=0.151        |
|INCIDENTAL TUMOR       |     P=0.144N        P=0.478N        P=0.185N       |     P=0.078         P=0.049 *       P=0.100        |
|LOGISTIC REGRESSION    |     P=0.165N        P=0.614N        P=0.210N       |     P=0.092         P=0.190         P=0.122        |
|COCHRAN-ARMITAGE       |     P=0.154N                                       |     P=0.090                                        |
|FISHER EXACT           |                     P=0.616N        P=0.192N       |                     P=0.295         P=0.120        |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/45 (4%)       1/46 (2%)       1/48 (2%)      |     0/47 (0%)       0/30 (0%)       0/45 (0%)      |
|ADJUSTED (b)           |      4.7%            4.0%            5.9%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/14 (0%)       0/21 (0%)       1/17 (6%)      |     0/23 (0%)       0/1 (0%)        0/24 (0%)      |
|FIRST INCIDENCE (DAYS) |      577             716             735 (T)       |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.381N        P=0.482N        P=0.510N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.413N        P=0.531N        P=0.502N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.353N        P=0.509N        P=0.464N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.358N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.492N        P=0.476N       |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/13/94                     EXPERIMENT: 05097 TEST: 01                                                 PAGE  17
                        STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ALPHA-CHLOROACETOPHENONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         1 MG/M3         2 MG/M3       |      CONTROL         1 MG/M3         2 MG/M3       |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     6/45 (13%)      6/46 (13%)      3/48 (6%)      |     2/47 (4%)       3/30 (10%)      6/45 (13%)     |
|ADJUSTED (b)           |     27.4%           21.4%           17.6%          |      8.7%          100.0%           21.6%          |
|TERMINAL (d)           |     3/14 (21%)      3/21 (14%)      3/17 (18%)     |     2/23 (9%)       1/1 (100%)      3/24 (13%)     |
|FIRST INCIDENCE (DAYS) |      577             559             735 (T)       |      735 (T)         626             687           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.164N        P=0.462N        P=0.196N       |     P=0.128         P=0.045 *       P=0.151        |
|INCIDENTAL TUMOR       |     P=0.181N        P=0.507N        P=0.206N       |     P=0.078         P=0.049 *       P=0.100        |
|LOGISTIC REGRESSION    |     P=0.185N        P=0.606N        P=0.232N       |     P=0.092         P=0.190         P=0.122        |
|COCHRAN-ARMITAGE       |     P=0.173N                                       |     P=0.090                                        |
|FISHER EXACT           |                     P=0.605N        P=0.211N       |                     P=0.295         P=0.120        |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/45 (0%)       2/46 (4%)       1/48 (2%)      |     2/47 (4%)       0/30 (0%)       0/45 (0%)      |
|ADJUSTED (b)           |      0.0%            9.5%            5.9%          |      6.3%            0.0%            0.0%          |
|TERMINAL (d)           |     0/14 (0%)       2/21 (10%)      1/17 (6%)      |     1/23 (4%)       0/1 (0%)        0/24 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             735 (T)         735 (T)       |      533             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.401         P=0.330         P=0.539        |     P=0.123N        P=0.465N        P=0.250N       |
|INCIDENTAL TUMOR       |     P=0.401         P=0.330         P=0.539        |     P=0.038N*       P=0.469N        P=0.077N       |
|LOGISTIC REGRESSION    |     P=0.401         P=0.330         P=0.539        |     P=0.086N        P=0.279N        P=0.205N       |
|COCHRAN-ARMITAGE       |     P=0.378                                        |     P=0.114N                                       |
|FISHER EXACT           |                     P=0.253         P=0.516        |                     P=0.369N        P=0.258N       |
|=================================================================================================================================|
 
         DATE: 09/13/94                     EXPERIMENT: 05097 TEST: 01                                                 PAGE  18
                        STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ALPHA-CHLOROACETOPHENONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         1 MG/M3         2 MG/M3       |      CONTROL         1 MG/M3         2 MG/M3       |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/45 (2%)       2/46 (4%)       1/48 (2%)      |     2/47 (4%)       0/30 (0%)       0/45 (0%)      |
|ADJUSTED (b)           |      2.4%            9.5%            5.9%          |      6.3%            0.0%            0.0%          |
|TERMINAL (d)           |     0/14 (0%)       2/21 (10%)      1/17 (6%)      |     1/23 (4%)       0/1 (0%)        0/24 (0%)      |
|FIRST INCIDENCE (DAYS) |      602             735 (T)         735 (T)       |      533             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.595N        P=0.588         P=0.754N       |     P=0.123N        P=0.465N        P=0.250N       |
|INCIDENTAL TUMOR       |     P=0.593N        P=0.614         P=0.751N       |     P=0.038N*       P=0.469N        P=0.077N       |
|LOGISTIC REGRESSION    |     P=0.619N        P=0.513         P=0.751N       |     P=0.086N        P=0.279N        P=0.205N       |
|COCHRAN-ARMITAGE       |     P=0.601N                                       |     P=0.114N                                       |
|FISHER EXACT           |                     P=0.508         P=0.736N       |                     P=0.369N        P=0.258N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |     2/50 (4%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |                                                    |      8.2%            0.0%            0.0%          |
|TERMINAL (d)           |                                                    |     1/23 (4%)       0/20 (0%)       0/24 (0%)      |
|FIRST INCIDENCE (DAYS) |                                                    |      731             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.100N        P=0.270N        P=0.235N       |
|INCIDENTAL TUMOR       |                                                    |     P=0.091N        P=0.218N        P=0.235N       |
|LOGISTIC REGRESSION    |                                                    |     P=0.094N        P=0.255N        P=0.228N       |
|COCHRAN-ARMITAGE       |                                                    |     P=0.095N                                       |
|FISHER EXACT           |                                                    |                     P=0.247N        P=0.247N       |
|=================================================================================================================================|
 
         DATE: 09/13/94                     EXPERIMENT: 05097 TEST: 01                                                 PAGE  19
                        STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ALPHA-CHLOROACETOPHENONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         1 MG/M3         2 MG/M3       |      CONTROL         1 MG/M3         2 MG/M3       |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |     6/50 (12%)      6/50 (12%)      5/50 (10%)     |
|ADJUSTED (b)           |                                                    |     16.2%           16.3%           17.8%          |
|TERMINAL (d)           |                                                    |     1/23 (4%)       1/20 (5%)       3/24 (13%)     |
|FIRST INCIDENCE (DAYS) |                                                    |      573             560             666           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.425N        P=0.588N        P=0.476N       |
|INCIDENTAL TUMOR       |                                                    |     P=0.503         P=0.583N        P=0.622        |
|LOGISTIC REGRESSION    |                                                    |     P=0.533         P=0.556         P=0.500N       |
|COCHRAN-ARMITAGE       |                                                    |     P=0.437N                                       |
|FISHER EXACT           |                                                    |                     P=0.620N        P=0.500N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal or Polyp Stromal                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |     6/50 (12%)      7/50 (14%)      6/50 (12%)     |
|ADJUSTED (b)           |                                                    |     16.2%           18.1%           19.8%          |
|TERMINAL (d)           |                                                    |     1/23 (4%)       1/20 (5%)       3/24 (13%)     |
|FIRST INCIDENCE (DAYS) |                                                    |      573             560             575           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.544N        P=0.538         P=0.598N       |
|INCIDENTAL TUMOR       |                                                    |     P=0.321         P=0.543         P=0.448        |
|LOGISTIC REGRESSION    |                                                    |     P=0.360         P=0.420         P=0.445        |
|COCHRAN-ARMITAGE       |                                                    |     P=0.560N                                       |
|FISHER EXACT           |                                                    |                     P=0.500         P=0.620N       |
|=================================================================================================================================|
 
         DATE: 09/13/94                     EXPERIMENT: 05097 TEST: 01                                                 PAGE  20
                        STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ALPHA-CHLOROACETOPHENONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         1 MG/M3         2 MG/M3       |      CONTROL         1 MG/M3         2 MG/M3       |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Leukemia: Lymphocytic, Monocytic, Mononuclear,                                                                              |
|     or Undifferentiated                                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    29/50 (58%)     26/50 (52%)     27/50 (54%)     |    27/50 (54%)     23/50 (46%)     20/50 (40%)     |
|ADJUSTED (b)           |     83.2%           65.1%           80.3%          |     72.4%           57.0%           53.8%          |
|TERMINAL (d)           |     9/14 (64%)      9/22 (41%)     11/17 (65%)     |    13/23 (57%)      5/20 (25%)      8/24 (33%)     |
|FIRST INCIDENCE (DAYS) |      447             540             540           |      577             519             505           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.323N        P=0.102N        P=0.329N       |     P=0.120N        P=0.360N        P=0.128N       |
|INCIDENTAL TUMOR       |     P=0.498         P=0.403N        P=0.572        |     P=0.071N        P=0.153N        P=0.077N       |
|LOGISTIC REGRESSION    |     P=0.390N        P=0.297N        P=0.435N       |     P=0.096N        P=0.143N        P=0.114N       |
|COCHRAN-ARMITAGE       |     P=0.382N                                       |     P=0.096N                                       |
|FISHER EXACT           |                     P=0.344N        P=0.420N       |                     P=0.274N        P=0.115N       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Mesothelioma Benign, Malignant, NOS                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       3/50 (6%)       0/50 (0%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |     14.3%           11.3%            0.0%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     2/14 (14%)      1/22 (5%)       0/17 (0%)      |     0/23 (0%)       0/20 (0%)       0/24 (0%)      |
|FIRST INCIDENCE (DAYS) |      735 (T)         702             ---           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.172N        P=0.655         P=0.194N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.219N        P=0.531         P=0.194N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.188N        P=0.590         P=0.194N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.202N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.500         P=0.247N       |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/13/94                     EXPERIMENT: 05097 TEST: 01                                                 PAGE  21
                        STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ALPHA-CHLOROACETOPHENONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         1 MG/M3         2 MG/M3       |      CONTROL         1 MG/M3         2 MG/M3       |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    44/50 (88%)     48/50 (96%)     48/50 (96%)     |    39/50 (78%)     47/50 (94%)     43/50 (86%)     |
|ADJUSTED (b)           |     97.8%          100.0%          100.0%          |     88.2%           97.9%          100.0%          |
|TERMINAL (d)           |    13/14 (93%)     22/22 (100%)    17/17 (100%)    |    18/23 (78%)     19/20 (95%)     24/24 (100%)    |
|FIRST INCIDENCE (DAYS) |      318             449             444           |      533             553             490           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.434         P=0.205N        P=0.469        |     P=0.396         P=0.125         P=0.411        |
|INCIDENTAL TUMOR       |     P=0.030 *       P=0.163         P=0.054        |     P=0.026 *       P=0.050         P=0.064        |
|LOGISTIC REGRESSION    |     P=0.074         P=0.186         P=0.122        |     P=0.027 *       P=0.038 *       P=0.155        |
|COCHRAN-ARMITAGE       |     P=0.080                                        |     P=0.157                                        |
|FISHER EXACT           |                     P=0.134         P=0.134        |                     P=0.020 *       P=0.218        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    34/50 (68%)     35/50 (70%)     30/50 (60%)     |    32/50 (64%)     26/50 (52%)     29/50 (58%)     |
|ADJUSTED (b)           |     88.3%           82.7%           81.7%          |     77.4%           61.5%           71.6%          |
|TERMINAL (d)           |    10/14 (71%)     15/22 (68%)     11/17 (65%)     |    14/23 (61%)      5/20 (25%)     13/24 (54%)     |
|FIRST INCIDENCE (DAYS) |      447             261             444           |      533             519             258           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.228N        P=0.188N        P=0.252N       |     P=0.304N        P=0.266N        P=0.325N       |
|INCIDENTAL TUMOR       |     P=0.385N        P=0.523         P=0.410N       |     P=0.292N        P=0.068N        P=0.320N       |
|LOGISTIC REGRESSION    |     P=0.232N        P=0.550         P=0.268N       |     P=0.306N        P=0.080N        P=0.343N       |
|COCHRAN-ARMITAGE       |     P=0.230N                                       |     P=0.306N                                       |
|FISHER EXACT           |                     P=0.500         P=0.266N       |                     P=0.156N        P=0.341N       |
|=================================================================================================================================|
 
         DATE: 09/13/94                     EXPERIMENT: 05097 TEST: 01                                                 PAGE  22
                        STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ALPHA-CHLOROACETOPHENONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         1 MG/M3         2 MG/M3       |      CONTROL         1 MG/M3         2 MG/M3       |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    48/50 (96%)     50/50 (100%)    49/50 (98%)     |    45/50 (90%)     50/50 (100%)    48/50 (96%)     |
|ADJUSTED (b)           |    100.0%          100.0%          100.0%          |     93.8%          100.0%          100.0%          |
|TERMINAL (d)           |    14/14 (100%)    22/22 (100%)    17/17 (100%)    |    20/23 (87%)     20/20 (100%)    24/24 (100%)    |
|FIRST INCIDENCE (DAYS) |      318             261             444           |      533             519             258           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.458N        P=0.137N        P=0.474N       |     P=0.452         P=0.235         P=0.469        |
|INCIDENTAL TUMOR       |     P=0.233         P=0.347         P=0.341        |     P=0.029 *       P=0.102         P=0.055        |
|LOGISTIC REGRESSION    |     P=0.389         P=0.236         P=0.608        |     P=0.113         P=0.063         P=0.202        |
|COCHRAN-ARMITAGE       |     P=0.360                                        |     P=0.118                                        |
|FISHER EXACT           |                     P=0.247         P=0.500        |                     P=0.028 *       P=0.218        |
|=================================================================================================================================|
 
 (a)  Number of tumor-bearing animals / number of animals examined at site.
 (b)  Kaplan-Meier estimated lifetime tumor incidence after adjustment for 
      intercurrent mortality.
 (d)  Observed incidence at terminal kill.
 (f)  Beneath the control incidence are the P-values associated with the trend 
      test.  Beneath the dosed group incidence are the P-values corresponding to 
      pairwise comparisons between the controls and that dosed group.  The life
      table analysis regards tumors in animals dying  prior to terminal kill as
      being (directly or indirectly) the cause of death.  The incidental tumor 
      test regards these lesions as non-fatal.  Logistic regression is an alternative
      method for analyzing the incidence of non-fatal tumors.  The Cochran-Armitage
      and Fisher's exact tests compare directly the overall incidence rates.  
      For all tests, a negative trend is indicated by "N".
 (e)  Value of Statistic cannot be computed. 
 (I)  Interim sacrifice
 (T)  Terminal sacrifice
  #   Tumor rates based on number of animals necropsied.
 
  *   To the right of any statistical result, indicates significance at (P<=0.05).
  **  To the right of any statistical result, indicates significance at (P<=0.01).

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